A 6-Month Study Of CP-690,550 Versus Tacrolimus In Kidney Transplant Patients

A 6-Month, Phase 2, Multicenter, Randomized, Open-Label, Comparative Study Of 2 Dose Levels Of CP-690,550 Administered Concomitantly With IL-2 Receptor Antagonist Induction Therapy, Mycophenolate Mofetil And Corticosteroids Versus A Tacrolimus-Based Immunosuppressive Regimen For The Prevention Of Allograft Rejection In De Novo Renal Allograft Recipients

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00106639

Enrollment

Registered

2005-03-29

Start date

2005-05-31

Completion date

2006-07-31

Last updated

2013-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation

Keywords

tofacitinib, CP-690550, kidney transplant

Brief summary

This Phase 2 study was designed to evaluate the safety and efficacy of 2 dose levels of CP-690,550 (15 mg twice daily and 30 mg twice) against tacrolimus, in combination with basiliximab induction, mycophenolate mofetil and corticosteroids, in kidney transplant patients. Stage 1 was to randomize approximately 54 subjects. After all Stage 1 subjects had completed 6 months of treatment, Stage 2 was to randomize an additional 195 subjects to the same treatment groups.

Interventions

DRUGCP-690,550

15 mg twice daily

DRUGtacrolimus

dose adjusted according to level

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Recipient of a first-time kidney transplant * Between the ages of 18 and 70 years, inclusive

Exclusion criteria

* Recipient of any non-kidney transplant

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With First Biopsy Proven Acute Rejection (BPAR) at Month 6	Baseline up to Month 6	BPAR categorized as acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification.
Glomerular Filtration Rate (GFR) by Nankivell Equation at Month 6	Month 6	GFR: index of kidney function described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated by creatinine clearance (CLcr) using Nankivell equation. CLcr by Nankivell equation= (6.7 per serum creatinine) plus (0.25\body weight) minus (0.5\serum urea) minus (100 per square height) plus (35 for male/25 for female). A normal GFR is \>90 milliliter/minute (mL/min), although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR \<15 mL/min indicated kidney failure.

Secondary

Measure	Time frame	Description
Number of Participants With First Biopsy Proven Acute Rejection (BPAR) at Month 3	Baseline up to Month 3	BPAR categorized as acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification.
Number of Participants With First Biopsy Proven Chronic Allograft Nephropathy (BPCAN)	Month 3, 6	BPCAN categorized as chronic allograft nephropathy as interpreted by the central blinded pathologist according to the Banff 97 working classification.
Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR)	Month 3, 6	Ordered categorical severity of first BPAR was classified according to the Banff Classification. Grade IA: moderate tubulitis, grade IB: severe tubulitis, grade IIA: mild to moderate intimal arteritis, grade IIB: severe intimal arteritis, grade III: transmural arteritis. (Racusen et al: The Banff classification, 1999).
Number of Participants With Ordered Categorical Severity of First Biopsy Proven Chronic Allograft Nephropathy (BPCAN)	Month 3, 6	Ordered categorical severity of first BPCAN was classified according to the Banff Classification. Grade I: mild, grade II: moderate and grade III: severe interstitial fibrosis and tubular atrophy/loss. (Racusen et al: The Banff classification, 1999).
Number of Participants With Efficacy Failure	Month 3, 6	Efficacy failure was the first occurrence of BPAR, graft loss or participant's death.
Number of Participants With Graft Loss	Month 6	Graft loss was defined as graft nephrectomy, participant's death due to graft loss, re-transplantation, or return to dialysis for greater than or equal to (\>=) 6 consecutive weeks.
Number of Participants Who Died	Month 6	—
Number of Participants With Rejection	Month 3, 6	Rejection was defined as first occurrence of BPAR, antibody mediated rejection, or suspicious for acute rejection.
Population Pharmacokinetics (PK)	Pre-dose on Day 1, 3, 7, 14, Month 1, 3, 6, between 1 to 2 hours post-dose at Month 3 and between 3 to 4 hours post-dose at Month 6	Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.
Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets	Baseline, Day 14, Month 1, 3, 6	The absolute cell counts of cluster of differentiation 8 (CD8): Cytotoxic T-lymphocytes reactive with major histocompatibility complex-1 (MHC-I), CD19: B- Lymphocytes, CD56: natural killer cells were determined using FACS, a specialized type of flow cytometry which sorts a heterogeneous mixture based upon the specific light scattering and fluorescent characteristics of each cell.
Reticulocyte Count	Baseline, Day 14, Month 1, 3, 6	Reticulocytes are slightly immature red blood cells in the blood. Reticulocyte counts are reported as cells\10\^3 per cubic millimeter (cells\10\^3/mm\^3).
Trough Levels of Tacrolimus (TAC)	Pre-dose on Day 14, Month 1, 3, 6	—
36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Baseline, Month 6	SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores (CS). Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 how would you rate your health in general now? (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Baseline, Day 14, Month 1, 3, 6	—
Absolute Platelet Levels	Baseline, Day 14, Month 1, 3, 6	—
End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL)	Baseline, Month 6	ESRD-SCL:43-item disease specific self-administered questionnaire. Participants' rated questionAt the moment,how much do you suffer?for each item on 5 point scale,ranged (Ra) 0(not at all)to 4(extremely).Consisted of 6 subscales:cardiac and renal dysfunction;Ra 0-28,increased(In) growth of gum and hair;Ra 0-20,limited cognitive capacity;Ra 0-32,limited physical capacity;Ra 0-40,side effects (SEs) of corticosteroids;Ra 0-20,transplantation associated psychological distress(TAPD);Ra 0-32(higher scores=greater dysfunction for each subscale).Total score:0-172,higher scores=greater dysfunction.
Healthcare Resource Utilization Questionnaire (HCRUQ)	Baseline, Month 6	Healthcare Resource Utilization Questionnaire (HCRUQ) was used to assess healthcare resources which included number of events such as physician and other health professional visits, number of treatments or diagnostic tests, number of hospitalizations, and number of emergency room visits.
Healthcare Resource Utilization Questionnaire (HCRUQ) - 5th Question	Month 6	Fifth question in the HCRUQ was Upon discharge from the hospital, did you return to your previous place of residence? and number of participants who responded yes or no to the question was reported.
Glomerular Filtration Rate (GFR) by Cockcroft-Gault	Day 14, Month 1, 3, 6	GFR: index of kidney function described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated using Cockcroft-Gault equation. GFR by Cockcroft-Gault equation= body weight\(140 minus age in years) divided by (72\serum creatinine). For females, value obtained was multiplied by 0.85. A normal GFR is \>90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR \<15 mL/min indicated kidney failure.
Glomerular Filtration Rate (GFR) by Modification of Diet in Renal Disease (MDRD) Equation	Day 14, Month 1, 3, 6	GFR: index of kidney function described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated using MDRD equation. GFR by MDRD equation= 170 \* (serum creatinine) \^ (-0.999)\(age in years)\^(-0.176)\(0.762 if female) \* (1.18 if black)\(blood urea nitrogen concentration)\^(-0.170)\(serum albumin concentration)\^(0.318). Normal GFR is \>90 mL/min/1.73 square meter (m\^2), although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR \<15 mL/min indicated kidney failure.
Glomerular Filtration Rate (GFR) by Reciprocal of Serum Creatinine (1/sCr)	Day 14, Month 1, 3, 6	GFR is a measure of renal function. The reciprocal of serum creatinine is an estimate of GFR.
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)	Baseline up to Month 8 (2 months follow-up)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 2 months after last dose that were absent before treatment or that worsened relative to pretreatment state.
Number of Participants With First Clinically Significant Infection	Month 3, 6	Clinically significant (Viral, Bacterial and Fungal) infection was defined as the presence of presumed or documented infection confirmed by culture, biopsy, genomic or serologic findings post-randomization and required hospitalization or anti-infective treatment, or otherwise deemed significant by the Investigator.
Number of Participants With New Onset Diabetes Mellitus (NODM)	Month 3, 6	—
Fasting Serum Glucose Levels	Baseline, Day 14, Month 1, 3, 6	—
Number of Participants With Hypercholesterolemia	Baseline, Day 14, Month 1, 3, 6	Hypercholesterolemia is a condition characterized by very high levels of cholesterol in the blood. Hypercholesterolemia was defined as a value of total serum cholesterol greater than 240 mg/dL.
Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels	Baseline, Day 14, Month 1, 3, 6	—
Number of Participants With Hypertriglyceridemia	Baseline, Day 14, Month 1, 3, 6	Hypertriglyceridemia was defined as a value of triglycerides greater than 200 mg/dL.
Supine Systolic and Diastolic Blood Pressure (BP)	Baseline, Day 2, 3, 14, Month 1, 3, 6	—
Number of Participants With Drug Usage	Baseline, Day 14, Month 1, 3, 6	Lipid lowering agents, antihypertensive agents, oral hypoglycemic agents (OHA) , anti-diabetic agents (ADA) and insulin drug usage was collected.
Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load	Baseline, Month 1, 3, 6 for CMV; Baseline, Day 14, Month 1, 3, 6 for EBV	—
BK Virus (BKV) Deoxyribonucleic Acid (DNA) Load	Baseline, Month 1, 3, 6	—
Hemoglobin Level	Baseline, Day 14, Month 1, 3, 6	Hemoglobin is the protein molecule in red blood cells that carries oxygen from the lungs to the body's tissues and returns carbon dioxide from the tissues back to the lungs.
Number of Participants With Cytomegalovirus (CMV) Disease	Month 3, 6	—
Alanine Aminotransferase (ALT) Level	Baseline, Day 14, Month 1, 3, 6	ALT is the enzyme found in the liver and it is measured to see if the liver is damaged or diseased.
Electrocardiogram (ECG) Parameters	Baseline, Month 3, 6	ECG parameters included PR interval, QT interval, corrected QT using Bazett's formula (QTcB) and QTc using Fridericia's formula (QTcF) interval, and QRS width.
Number of Participants With Discontinuation	Month 1, 2, 3, 4, 5, 6	—
Hematocrit Level	Baseline, Day 14, Month 1, 3, 6	The hematocrit is recorded as the percentage of volume of red blood cells (RBCs) in a blood sample.
Number of Participants With Treatment Failure	Month 3, 6	Treatment failure was defined as the first occurrence of BPAR, graft loss, participant's death or premature discontinuation of study medication for any reason.

Countries

United States

Participant flow

Participants by arm

Arm	Count
CP-690,550 15 mg CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.	20
CP-690,550 30 mg CP-690,550 30 mg tablet orally twice daily up to Month 6.	20
Tacrolimus Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.	21
Total	61

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Adverse Event	3	4	1
Overall Study	Participant defaulted	0	1	1
Overall Study	Protocol Violation	0	1	0
Overall Study	Withdrawal by Subject	0	1	0

Baseline characteristics

Characteristic	CP-690,550 15 mg	CP-690,550 30 mg	Tacrolimus	Total
Age Continuous	46.9 years STANDARD_DEVIATION 8.5	44.3 years STANDARD_DEVIATION 12.3	42.8 years STANDARD_DEVIATION 11.8	44.6 years STANDARD_DEVIATION 11
Sex: Female, Male Female	12 Participants	4 Participants	8 Participants	24 Participants
Sex: Female, Male Male	8 Participants	16 Participants	13 Participants	37 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	20 / 20	18 / 20	20 / 21
serious Total, serious adverse events	8 / 20	10 / 20	6 / 21

Outcome results

Primary

Glomerular Filtration Rate (GFR) by Nankivell Equation at Month 6

GFR: index of kidney function described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated by creatinine clearance (CLcr) using Nankivell equation. CLcr by Nankivell equation= (6.7 per serum creatinine) plus (0.25\*body weight) minus (0.5\*serum urea) minus (100 per square height) plus (35 for male/25 for female). A normal GFR is \>90 milliliter/minute (mL/min), although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR \<15 mL/min indicated kidney failure.

Time frame: Month 6

Population: FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies those participants evaluable for this measure.

Arm	Measure	Value (MEAN)	Dispersion
CP-690,550 15 mg	Glomerular Filtration Rate (GFR) by Nankivell Equation at Month 6	76.53 mL/min	Standard Deviation 10.04
CP-690,550 30 mg	Glomerular Filtration Rate (GFR) by Nankivell Equation at Month 6	71.50 mL/min	Standard Deviation 14.68
Tacrolimus	Glomerular Filtration Rate (GFR) by Nankivell Equation at Month 6	78.70 mL/min	Standard Deviation 12.61

Primary

Number of Participants With First Biopsy Proven Acute Rejection (BPAR) at Month 6

BPAR categorized as acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification.

Time frame: Baseline up to Month 6

Population: Full analysis set (FAS) included all randomized participants who received at least 1 dose of study medication.

Arm	Measure	Value (NUMBER)
CP-690,550 15 mg	Number of Participants With First Biopsy Proven Acute Rejection (BPAR) at Month 6	1 participants
CP-690,550 30 mg	Number of Participants With First Biopsy Proven Acute Rejection (BPAR) at Month 6	4 participants
Tacrolimus	Number of Participants With First Biopsy Proven Acute Rejection (BPAR) at Month 6	1 participants

Secondary

36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores (CS). Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 how would you rate your health in general now? (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).

Time frame: Baseline, Month 6

Population: FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies those participants evaluable at specific time points for each arm group respectively.

Arm	Measure	Group	Value (MEAN)	Dispersion
CP-690,550 15 mg	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Social functioning: Month 6 (n= 15, 10, 17)	51.03 units on a scale	Standard Deviation 8.36
CP-690,550 15 mg	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Role emotional: Month 6 (n= 15, 10, 17)	48.36 units on a scale	Standard Deviation 12.51
CP-690,550 15 mg	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Physical CS: Baseline (n= 15, 17, 17)	45.37 units on a scale	Standard Deviation 8.6
CP-690,550 15 mg	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	General health: Month 6 (n= 15, 10, 17)	49.79 units on a scale	Standard Deviation 8.12
CP-690,550 15 mg	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Role emotional: Baseline (n= 16, 17, 17)	41.06 units on a scale	Standard Deviation 17.34
CP-690,550 15 mg	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Physical CS: Month 6 (n= 15, 10, 17)	50.67 units on a scale	Standard Deviation 8.98
CP-690,550 15 mg	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Vitality: Month 6 (n= 15, 10, 17)	56.25 units on a scale	Standard Deviation 10.66
CP-690,550 15 mg	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Q2: Month 6 (n= 15, 10, 17)	1.07 units on a scale	Standard Deviation 0.26
CP-690,550 15 mg	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Physical functioning: Baseline (n= 16, 17, 17)	47.30 units on a scale	Standard Deviation 8.31
CP-690,550 15 mg	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Social functioning: Baseline (n= 16, 17, 17)	39.46 units on a scale	Standard Deviation 13.24
CP-690,550 15 mg	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Q2: Baseline (n= 16, 17, 17)	3.25 units on a scale	Standard Deviation 1.24
CP-690,550 15 mg	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Physical functioning: Month 6 (n= 15, 10, 17)	47.49 units on a scale	Standard Deviation 12.03
CP-690,550 15 mg	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Mental CS: Baseline (n= 15, 17, 17)	45.18 units on a scale	Standard Deviation 13.79
CP-690,550 15 mg	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Vitality: Baseline (n= 16, 17, 17)	46.43 units on a scale	Standard Deviation 12.55
CP-690,550 15 mg	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Role physical: Month 6 (n= 15, 10, 17)	51.14 units on a scale	Standard Deviation 8.81
CP-690,550 15 mg	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Mental CS: Month 6 (n= 15, 10, 17)	52.38 units on a scale	Standard Deviation 11.18
CP-690,550 15 mg	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	General health: Baseline (n= 15, 17, 17)	44.48 units on a scale	Standard Deviation 10.72
CP-690,550 15 mg	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Bodily pain: Baseline (n= 16, 17, 17)	49.89 units on a scale	Standard Deviation 10.55
CP-690,550 15 mg	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Mental health: Baseline (n= 16, 17, 17)	47.90 units on a scale	Standard Deviation 11.84
CP-690,550 15 mg	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Bodily pain: Month 6 (n=15, 10, 17)	54.79 units on a scale	Standard Deviation 10.3
CP-690,550 15 mg	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Role physical: Baseline (n= 16, 17, 17)	38.64 units on a scale	Standard Deviation 12.74
CP-690,550 15 mg	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Mental health: Month 6 (n= 15, 10, 17)	52.82 units on a scale	Standard Deviation 11.16
CP-690,550 30 mg	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Role physical: Baseline (n= 16, 17, 17)	36.69 units on a scale	Standard Deviation 12.35
CP-690,550 30 mg	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Bodily pain: Baseline (n= 16, 17, 17)	52.15 units on a scale	Standard Deviation 10.91
CP-690,550 30 mg	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Bodily pain: Month 6 (n=15, 10, 17)	55.06 units on a scale	Standard Deviation 8.77
CP-690,550 30 mg	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	General health: Baseline (n= 15, 17, 17)	43.40 units on a scale	Standard Deviation 9.47
CP-690,550 30 mg	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	General health: Month 6 (n= 15, 10, 17)	49.50 units on a scale	Standard Deviation 6.71
CP-690,550 30 mg	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Mental CS: Baseline (n= 15, 17, 17)	42.15 units on a scale	Standard Deviation 12.2
CP-690,550 30 mg	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Mental CS: Month 6 (n= 15, 10, 17)	56.18 units on a scale	Standard Deviation 5.22
CP-690,550 30 mg	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Mental health: Baseline (n= 16, 17, 17)	46.53 units on a scale	Standard Deviation 10.79
CP-690,550 30 mg	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Mental health: Month 6 (n= 15, 10, 17)	54.51 units on a scale	Standard Deviation 5.97
CP-690,550 30 mg	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Physical CS: Baseline (n= 15, 17, 17)	44.71 units on a scale	Standard Deviation 10.76
CP-690,550 30 mg	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Physical CS: Month 6 (n= 15, 10, 17)	49.76 units on a scale	Standard Deviation 6.31
CP-690,550 30 mg	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Physical functioning: Baseline (n= 16, 17, 17)	43.79 units on a scale	Standard Deviation 12.69
CP-690,550 30 mg	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Physical functioning: Month 6 (n= 15, 10, 17)	48.40 units on a scale	Standard Deviation 7.58
CP-690,550 30 mg	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Q2: Baseline (n= 16, 17, 17)	3.18 units on a scale	Standard Deviation 1.33
CP-690,550 30 mg	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Q2: Month 6 (n= 15, 10, 17)	1.10 units on a scale	Standard Deviation 0.32
CP-690,550 30 mg	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Role emotional: Baseline (n= 16, 17, 17)	37.81 units on a scale	Standard Deviation 16.2
CP-690,550 30 mg	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Role emotional: Month 6 (n= 15, 10, 17)	52.77 units on a scale	Standard Deviation 8.56
CP-690,550 30 mg	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Role physical: Month 6 (n= 15, 10, 17)	50.73 units on a scale	Standard Deviation 9.25
CP-690,550 30 mg	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Social functioning: Baseline (n= 16, 17, 17)	41.45 units on a scale	Standard Deviation 10.95
CP-690,550 30 mg	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Social functioning: Month 6 (n= 15, 10, 17)	53.58 units on a scale	Standard Deviation 5.27
CP-690,550 30 mg	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Vitality: Baseline (n= 16, 17, 17)	43.46 units on a scale	Standard Deviation 11.12
CP-690,550 30 mg	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Vitality: Month 6 (n= 15, 10, 17)	58.65 units on a scale	Standard Deviation 4.76
Tacrolimus	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Role emotional: Baseline (n= 16, 17, 17)	39.64 units on a scale	Standard Deviation 15.26
Tacrolimus	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Mental health: Month 6 (n= 15, 10, 17)	51.17 units on a scale	Standard Deviation 8.45
Tacrolimus	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Bodily pain: Month 6 (n=15, 10, 17)	57.54 units on a scale	Standard Deviation 8.93
Tacrolimus	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Role emotional: Month 6 (n= 15, 10, 17)	49.70 units on a scale	Standard Deviation 13.33
Tacrolimus	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Mental health: Baseline (n= 16, 17, 17)	49.68 units on a scale	Standard Deviation 7.64
Tacrolimus	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Mental CS: Month 6 (n= 15, 10, 17)	51.62 units on a scale	Standard Deviation 9.11
Tacrolimus	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Role physical: Baseline (n= 16, 17, 17)	33.66 units on a scale	Standard Deviation 8.84
Tacrolimus	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Mental CS: Baseline (n= 15, 17, 17)	46.73 units on a scale	Standard Deviation 8.4
Tacrolimus	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Vitality: Month 6 (n= 15, 10, 17)	58.52 units on a scale	Standard Deviation 10.73
Tacrolimus	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Role physical: Month 6 (n= 15, 10, 17)	50.51 units on a scale	Standard Deviation 11.09
Tacrolimus	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	General health: Month 6 (n= 15, 10, 17)	53.80 units on a scale	Standard Deviation 8.85
Tacrolimus	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Vitality: Baseline (n= 16, 17, 17)	46.77 units on a scale	Standard Deviation 9.29
Tacrolimus	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Social functioning: Baseline (n= 16, 17, 17)	42.73 units on a scale	Standard Deviation 10.75
Tacrolimus	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Physical functioning: Month 6 (n= 15, 10, 17)	50.72 units on a scale	Standard Deviation 10.28
Tacrolimus	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Physical functioning: Baseline (n= 16, 17, 17)	41.20 units on a scale	Standard Deviation 13.43
Tacrolimus	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	General health: Baseline (n= 15, 17, 17)	43.65 units on a scale	Standard Deviation 7.46
Tacrolimus	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Q2: Baseline (n= 16, 17, 17)	2.59 units on a scale	Standard Deviation 1.06
Tacrolimus	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Physical CS: Month 6 (n= 15, 10, 17)	53.87 units on a scale	Standard Deviation 8.87
Tacrolimus	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Bodily pain: Baseline (n= 16, 17, 17)	50.46 units on a scale	Standard Deviation 11.14
Tacrolimus	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Q2: Month 6 (n= 15, 10, 17)	1.41 units on a scale	Standard Deviation 1.06
Tacrolimus	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Physical CS: Baseline (n= 15, 17, 17)	41.11 units on a scale	Standard Deviation 9.76
Tacrolimus	36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)	Social functioning: Month 6 (n= 15, 10, 17)	50.75 units on a scale	Standard Deviation 9.62

Secondary

Absolute Platelet Levels

Time frame: Baseline, Day 14, Month 1, 3, 6

Population: Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here 'n' signifies those participants evaluable at specific time points.

Arm	Measure	Group	Value (MEAN)	Dispersion
CP-690,550 15 mg	Absolute Platelet Levels	Platelet: Month 3 (n= 19, 17, 20)	273.84 platelets*10^3/mm^3	Standard Deviation 89.95
CP-690,550 15 mg	Absolute Platelet Levels	Platelet: Month 1 (n= 19,18, 19)	249.68 platelets*10^3/mm^3	Standard Deviation 73.7
CP-690,550 15 mg	Absolute Platelet Levels	Platelet: Baseline (n= 20, 20, 21)	186.75 platelets*10^3/mm^3	Standard Deviation 59.33
CP-690,550 15 mg	Absolute Platelet Levels	Platelet: Day 14 (n= 18, 19, 18)	330.17 platelets*10^3/mm^3	Standard Deviation 107.04
CP-690,550 15 mg	Absolute Platelet Levels	Platelet: Month 6 (n= 16, 14, 18)	272.19 platelets*10^3/mm^3	Standard Deviation 88.19
CP-690,550 30 mg	Absolute Platelet Levels	Platelet: Month 1 (n= 19,18, 19)	274.50 platelets*10^3/mm^3	Standard Deviation 88.3
CP-690,550 30 mg	Absolute Platelet Levels	Platelet: Baseline (n= 20, 20, 21)	204.85 platelets*10^3/mm^3	Standard Deviation 54.44
CP-690,550 30 mg	Absolute Platelet Levels	Platelet: Day 14 (n= 18, 19, 18)	367.84 platelets*10^3/mm^3	Standard Deviation 101.31
CP-690,550 30 mg	Absolute Platelet Levels	Platelet: Month 3 (n= 19, 17, 20)	307.00 platelets*10^3/mm^3	Standard Deviation 92.4
CP-690,550 30 mg	Absolute Platelet Levels	Platelet: Month 6 (n= 16, 14, 18)	263.43 platelets*10^3/mm^3	Standard Deviation 109.78
Tacrolimus	Absolute Platelet Levels	Platelet: Month 6 (n= 16, 14, 18)	225.17 platelets*10^3/mm^3	Standard Deviation 59.53
Tacrolimus	Absolute Platelet Levels	Platelet: Month 3 (n= 19, 17, 20)	241.60 platelets*10^3/mm^3	Standard Deviation 66.8
Tacrolimus	Absolute Platelet Levels	Platelet: Baseline (n= 20, 20, 21)	195.19 platelets*10^3/mm^3	Standard Deviation 47.97
Tacrolimus	Absolute Platelet Levels	Platelet: Month 1 (n= 19,18, 19)	276.79 platelets*10^3/mm^3	Standard Deviation 72.08
Tacrolimus	Absolute Platelet Levels	Platelet: Day 14 (n= 18, 19, 18)	301.28 platelets*10^3/mm^3	Standard Deviation 90.95

Secondary

Alanine Aminotransferase (ALT) Level

ALT is the enzyme found in the liver and it is measured to see if the liver is damaged or diseased.

Time frame: Baseline, Day 14, Month 1, 3, 6

Population: Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, 'n' signifies those participants evaluable at specific time points for each arm group respectively.

Arm	Measure	Group	Value (MEAN)	Dispersion
CP-690,550 15 mg	Alanine Aminotransferase (ALT) Level	Month 3 (n= 18, 18, 20)	26.28 unit/liter	Standard Deviation 10.56
CP-690,550 15 mg	Alanine Aminotransferase (ALT) Level	Month 1 (n= 20, 18, 19)	28.95 unit/liter	Standard Deviation 14.16
CP-690,550 15 mg	Alanine Aminotransferase (ALT) Level	Baseline (n= 19, 20, 21)	24.84 unit/liter	Standard Deviation 18.52
CP-690,550 15 mg	Alanine Aminotransferase (ALT) Level	Day 14 (n= 19, 19, 20)	39.05 unit/liter	Standard Deviation 35.77
CP-690,550 15 mg	Alanine Aminotransferase (ALT) Level	Month 6 (n= 17, 14, 18)	31.06 unit/liter	Standard Deviation 20.31
CP-690,550 30 mg	Alanine Aminotransferase (ALT) Level	Month 1 (n= 20, 18, 19)	56.39 unit/liter	Standard Deviation 57.47
CP-690,550 30 mg	Alanine Aminotransferase (ALT) Level	Baseline (n= 19, 20, 21)	18.45 unit/liter	Standard Deviation 9.39
CP-690,550 30 mg	Alanine Aminotransferase (ALT) Level	Day 14 (n= 19, 19, 20)	70.63 unit/liter	Standard Deviation 66.72
CP-690,550 30 mg	Alanine Aminotransferase (ALT) Level	Month 3 (n= 18, 18, 20)	36.22 unit/liter	Standard Deviation 31.4
CP-690,550 30 mg	Alanine Aminotransferase (ALT) Level	Month 6 (n= 17, 14, 18)	37.86 unit/liter	Standard Deviation 19.81
Tacrolimus	Alanine Aminotransferase (ALT) Level	Month 6 (n= 17, 14, 18)	23.28 unit/liter	Standard Deviation 21.5
Tacrolimus	Alanine Aminotransferase (ALT) Level	Month 3 (n= 18, 18, 20)	16.10 unit/liter	Standard Deviation 6.98
Tacrolimus	Alanine Aminotransferase (ALT) Level	Baseline (n= 19, 20, 21)	18.33 unit/liter	Standard Deviation 10.36
Tacrolimus	Alanine Aminotransferase (ALT) Level	Month 1 (n= 20, 18, 19)	21.32 unit/liter	Standard Deviation 10.72
Tacrolimus	Alanine Aminotransferase (ALT) Level	Day 14 (n= 19, 19, 20)	31.50 unit/liter	Standard Deviation 27.89

Secondary

BK Virus (BKV) Deoxyribonucleic Acid (DNA) Load

Time frame: Baseline, Month 1, 3, 6

Arm	Measure	Group	Value (MEAN)	Dispersion
CP-690,550 15 mg	BK Virus (BKV) Deoxyribonucleic Acid (DNA) Load	Month 3 (n= 18, 18, 20)	0.00 Copies/20 mcL plasma	Standard Deviation 0
CP-690,550 15 mg	BK Virus (BKV) Deoxyribonucleic Acid (DNA) Load	Month 6 (n= 15, 13, 18)	5.07 Copies/20 mcL plasma	Standard Deviation 16.55
CP-690,550 15 mg	BK Virus (BKV) Deoxyribonucleic Acid (DNA) Load	Month 1 (n= 20, 18, 18)	0.00 Copies/20 mcL plasma	Standard Deviation 0
CP-690,550 15 mg	BK Virus (BKV) Deoxyribonucleic Acid (DNA) Load	Baseline (n= 20, 19, 19)	0.00 Copies/20 mcL plasma	Standard Deviation 0
CP-690,550 30 mg	BK Virus (BKV) Deoxyribonucleic Acid (DNA) Load	Baseline (n= 20, 19, 19)	0.05 Copies/20 mcL plasma	Standard Deviation 0.23
CP-690,550 30 mg	BK Virus (BKV) Deoxyribonucleic Acid (DNA) Load	Month 1 (n= 20, 18, 18)	5.33 Copies/20 mcL plasma	Standard Deviation 22.13
CP-690,550 30 mg	BK Virus (BKV) Deoxyribonucleic Acid (DNA) Load	Month 6 (n= 15, 13, 18)	189.85 Copies/20 mcL plasma	Standard Deviation 664.27
CP-690,550 30 mg	BK Virus (BKV) Deoxyribonucleic Acid (DNA) Load	Month 3 (n= 18, 18, 20)	7.56 Copies/20 mcL plasma	Standard Deviation 21.55
Tacrolimus	BK Virus (BKV) Deoxyribonucleic Acid (DNA) Load	Month 6 (n= 15, 13, 18)	0.06 Copies/20 mcL plasma	Standard Deviation 0.24
Tacrolimus	BK Virus (BKV) Deoxyribonucleic Acid (DNA) Load	Baseline (n= 20, 19, 19)	0.05 Copies/20 mcL plasma	Standard Deviation 0.23
Tacrolimus	BK Virus (BKV) Deoxyribonucleic Acid (DNA) Load	Month 1 (n= 20, 18, 18)	0.00 Copies/20 mcL plasma	Standard Deviation 0
Tacrolimus	BK Virus (BKV) Deoxyribonucleic Acid (DNA) Load	Month 3 (n= 18, 18, 20)	7.95 Copies/20 mcL plasma	Standard Deviation 28.96

Secondary

Electrocardiogram (ECG) Parameters

ECG parameters included PR interval, QT interval, corrected QT using Bazett's formula (QTcB) and QTc using Fridericia's formula (QTcF) interval, and QRS width.

Time frame: Baseline, Month 3, 6

Population: Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies those participants evaluable at specific time points for each arm group respectively.

Arm	Measure	Group	Value (MEAN)	Dispersion
CP-690,550 15 mg	Electrocardiogram (ECG) Parameters	QT: Month 6 (n= 16, 13, 19)	401.44 millisecond	Standard Deviation 28.53
CP-690,550 15 mg	Electrocardiogram (ECG) Parameters	PR: Month 6 (n= 16, 13, 19)	161.44 millisecond	Standard Deviation 24.43
CP-690,550 15 mg	Electrocardiogram (ECG) Parameters	QTcF: Month 3 (n= 19, 16, 18)	405.05 millisecond	Standard Deviation 23.63
CP-690,550 15 mg	Electrocardiogram (ECG) Parameters	QTcB: Baseline (n= 15, 12, 17)	454.77 millisecond	Standard Deviation 27.29
CP-690,550 15 mg	Electrocardiogram (ECG) Parameters	PR: Month 3 (n= 19, 15, 18)	156.37 millisecond	Standard Deviation 20.22
CP-690,550 15 mg	Electrocardiogram (ECG) Parameters	QTcF: Baseline (n= 15, 12, 17)	439.77 millisecond	Standard Deviation 25.54
CP-690,550 15 mg	Electrocardiogram (ECG) Parameters	QTcB: Month 3 (n= 19, 16, 18)	417.25 millisecond	Standard Deviation 27.22
CP-690,550 15 mg	Electrocardiogram (ECG) Parameters	QRS: Baseline (n= 15, 12, 17)	88.80 millisecond	Standard Deviation 12.21
CP-690,550 15 mg	Electrocardiogram (ECG) Parameters	QTcB: Month 6 (n= 16, 13, 19)	416.83 millisecond	Standard Deviation 21.01
CP-690,550 15 mg	Electrocardiogram (ECG) Parameters	QT: Baseline (n= 15, 12, 17)	412.40 millisecond	Standard Deviation 38.35
CP-690,550 15 mg	Electrocardiogram (ECG) Parameters	QRS: Month 6 (n= 16, 13, 19)	91.75 millisecond	Standard Deviation 16.13
CP-690,550 15 mg	Electrocardiogram (ECG) Parameters	PR: Baseline (n= 15, 11, 17)	147.60 millisecond	Standard Deviation 21.18
CP-690,550 15 mg	Electrocardiogram (ECG) Parameters	QT: Month 3 (n= 19, 16, 18)	383.32 millisecond	Standard Deviation 38
CP-690,550 15 mg	Electrocardiogram (ECG) Parameters	QRS: Month 3 (n= 19, 16, 18)	87.74 millisecond	Standard Deviation 14.18
CP-690,550 15 mg	Electrocardiogram (ECG) Parameters	QTcF: Month 6 (n= 16, 13, 19)	411.44 millisecond	Standard Deviation 20.17
CP-690,550 30 mg	Electrocardiogram (ECG) Parameters	QTcF: Month 6 (n= 16, 13, 19)	401.24 millisecond	Standard Deviation 24.06
CP-690,550 30 mg	Electrocardiogram (ECG) Parameters	PR: Baseline (n= 15, 11, 17)	141.82 millisecond	Standard Deviation 50.77
CP-690,550 30 mg	Electrocardiogram (ECG) Parameters	PR: Month 3 (n= 19, 15, 18)	156.00 millisecond	Standard Deviation 59.08
CP-690,550 30 mg	Electrocardiogram (ECG) Parameters	PR: Month 6 (n= 16, 13, 19)	163.23 millisecond	Standard Deviation 26.94
CP-690,550 30 mg	Electrocardiogram (ECG) Parameters	QT: Baseline (n= 15, 12, 17)	404.50 millisecond	Standard Deviation 43.33
CP-690,550 30 mg	Electrocardiogram (ECG) Parameters	QT: Month 3 (n= 19, 16, 18)	378.88 millisecond	Standard Deviation 28.47
CP-690,550 30 mg	Electrocardiogram (ECG) Parameters	QT: Month 6 (n= 16, 13, 19)	383.85 millisecond	Standard Deviation 33.68
CP-690,550 30 mg	Electrocardiogram (ECG) Parameters	QTcB: Baseline (n= 15, 12, 17)	447.37 millisecond	Standard Deviation 36.95
CP-690,550 30 mg	Electrocardiogram (ECG) Parameters	QTcB: Month 3 (n= 19, 16, 18)	412.23 millisecond	Standard Deviation 29.22
CP-690,550 30 mg	Electrocardiogram (ECG) Parameters	QTcB: Month 6 (n= 16, 13, 19)	410.48 millisecond	Standard Deviation 22.24
CP-690,550 30 mg	Electrocardiogram (ECG) Parameters	QTcF: Baseline (n= 15, 12, 17)	432.22 millisecond	Standard Deviation 34.93
CP-690,550 30 mg	Electrocardiogram (ECG) Parameters	QTcF: Month 3 (n= 19, 16, 18)	400.60 millisecond	Standard Deviation 25.74
CP-690,550 30 mg	Electrocardiogram (ECG) Parameters	QRS: Baseline (n= 15, 12, 17)	102.67 millisecond	Standard Deviation 29.47
CP-690,550 30 mg	Electrocardiogram (ECG) Parameters	QRS: Month 3 (n= 19, 16, 18)	102.13 millisecond	Standard Deviation 39.78
CP-690,550 30 mg	Electrocardiogram (ECG) Parameters	QRS: Month 6 (n= 16, 13, 19)	90.31 millisecond	Standard Deviation 32.15
Tacrolimus	Electrocardiogram (ECG) Parameters	QT: Month 6 (n= 16, 13, 19)	384.68 millisecond	Standard Deviation 20.24
Tacrolimus	Electrocardiogram (ECG) Parameters	QRS: Month 3 (n= 19, 16, 18)	88.22 millisecond	Standard Deviation 10.14
Tacrolimus	Electrocardiogram (ECG) Parameters	QTcF: Month 3 (n= 19, 16, 18)	400.62 millisecond	Standard Deviation 28.63
Tacrolimus	Electrocardiogram (ECG) Parameters	QT: Month 3 (n= 19, 16, 18)	384.00 millisecond	Standard Deviation 33.23
Tacrolimus	Electrocardiogram (ECG) Parameters	QT: Baseline (n= 15, 12, 17)	393.88 millisecond	Standard Deviation 34.75
Tacrolimus	Electrocardiogram (ECG) Parameters	QTcF: Month 6 (n= 16, 13, 19)	403.41 millisecond	Standard Deviation 17.51
Tacrolimus	Electrocardiogram (ECG) Parameters	PR: Month 6 (n= 16, 13, 19)	154.53 millisecond	Standard Deviation 23.21
Tacrolimus	Electrocardiogram (ECG) Parameters	PR: Baseline (n= 15, 11, 17)	151.53 millisecond	Standard Deviation 16.92
Tacrolimus	Electrocardiogram (ECG) Parameters	QRS: Baseline (n= 15, 12, 17)	92.82 millisecond	Standard Deviation 9.08
Tacrolimus	Electrocardiogram (ECG) Parameters	QTcB: Month 3 (n= 19, 16, 18)	409.81 millisecond	Standard Deviation 34.15
Tacrolimus	Electrocardiogram (ECG) Parameters	PR: Month 3 (n= 19, 15, 18)	150.17 millisecond	Standard Deviation 20.38
Tacrolimus	Electrocardiogram (ECG) Parameters	QTcB: Month 6 (n= 16, 13, 19)	413.55 millisecond	Standard Deviation 25.05
Tacrolimus	Electrocardiogram (ECG) Parameters	QTcB: Baseline (n= 15, 12, 17)	447.42 millisecond	Standard Deviation 22.44
Tacrolimus	Electrocardiogram (ECG) Parameters	QRS: Month 6 (n= 16, 13, 19)	89.74 millisecond	Standard Deviation 9.89
Tacrolimus	Electrocardiogram (ECG) Parameters	QTcF: Baseline (n= 15, 12, 17)	428.57 millisecond	Standard Deviation 23.95

Secondary

End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL)

ESRD-SCL:43-item disease specific self-administered questionnaire. Participants' rated questionAt the moment,how much do you suffer?for each item on 5 point scale,ranged (Ra) 0(not at all)to 4(extremely).Consisted of 6 subscales:cardiac and renal dysfunction;Ra 0-28,increased(In) growth of gum and hair;Ra 0-20,limited cognitive capacity;Ra 0-32,limited physical capacity;Ra 0-40,side effects (SEs) of corticosteroids;Ra 0-20,transplantation associated psychological distress(TAPD);Ra 0-32(higher scores=greater dysfunction for each subscale).Total score:0-172,higher scores=greater dysfunction.

Time frame: Baseline, Month 6

Arm	Measure	Group	Value (MEAN)	Dispersion
CP-690,550 15 mg	End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL)	Cardiac and renal dysfunction:Baseline(n=13,15,17)	0.60 units on a scale	Standard Deviation 0.43
CP-690,550 15 mg	End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL)	Cardiac and renal dysfunction:Month 6(n=15,10,16)	0.26 units on a scale	Standard Deviation 0.27
CP-690,550 15 mg	End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL)	In growth of gum and hair: Baseline (n=14,15,17)	0.19 units on a scale	Standard Deviation 0.36
CP-690,550 15 mg	End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL)	In growth of gum and hair: Month 6 (n=15,9,16)	0.17 units on a scale	Standard Deviation 0.27
CP-690,550 15 mg	End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL)	Limited cognitive capacity: Baseline (n=14,15,17)	0.68 units on a scale	Standard Deviation 0.65
CP-690,550 15 mg	End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL)	Limited cognitive capacity: Month 6 (n=15,10,17))	0.55 units on a scale	Standard Deviation 0.49
CP-690,550 15 mg	End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL)	Limited physical capacity: Baseline (n=14,15,17)	0.65 units on a scale	Standard Deviation 0.46
CP-690,550 15 mg	End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL)	Limited physical capacity: Month 6 (n=15,10,16)	0.41 units on a scale	Standard Deviation 0.39
CP-690,550 15 mg	End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL)	SEs of corticosteroids: Baseline (n=13,15,17)	0.58 units on a scale	Standard Deviation 0.64
CP-690,550 15 mg	End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL)	SEs of corticosteroids: Month 6 (n=15,10,16)	0.65 units on a scale	Standard Deviation 0.78
CP-690,550 15 mg	End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL)	TAPD: Baseline (n=14,15,17)	1.10 units on a scale	Standard Deviation 0.68
CP-690,550 15 mg	End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL)	TAPD: Month 6 (n=15,10,16)	0.69 units on a scale	Standard Deviation 0.44
CP-690,550 30 mg	End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL)	TAPD: Month 6 (n=15,10,16)	0.51 units on a scale	Standard Deviation 0.36
CP-690,550 30 mg	End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL)	Cardiac and renal dysfunction:Baseline(n=13,15,17)	0.78 units on a scale	Standard Deviation 0.68
CP-690,550 30 mg	End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL)	Limited physical capacity: Baseline (n=14,15,17)	0.77 units on a scale	Standard Deviation 0.57
CP-690,550 30 mg	End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL)	SEs of corticosteroids: Baseline (n=13,15,17)	0.44 units on a scale	Standard Deviation 0.51
CP-690,550 30 mg	End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL)	Cardiac and renal dysfunction:Month 6(n=15,10,16)	0.30 units on a scale	Standard Deviation 0.32
CP-690,550 30 mg	End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL)	Limited cognitive capacity: Month 6 (n=15,10,17))	0.16 units on a scale	Standard Deviation 0.31
CP-690,550 30 mg	End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL)	TAPD: Baseline (n=14,15,17)	1.14 units on a scale	Standard Deviation 0.78
CP-690,550 30 mg	End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL)	In growth of gum and hair: Baseline (n=14,15,17)	0.11 units on a scale	Standard Deviation 0.15
CP-690,550 30 mg	End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL)	Limited physical capacity: Month 6 (n=15,10,16)	0.49 units on a scale	Standard Deviation 0.48
CP-690,550 30 mg	End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL)	Limited cognitive capacity: Baseline (n=14,15,17)	0.58 units on a scale	Standard Deviation 0.69
CP-690,550 30 mg	End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL)	In growth of gum and hair: Month 6 (n=15,9,16)	0.11 units on a scale	Standard Deviation 0.15
CP-690,550 30 mg	End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL)	SEs of corticosteroids: Month 6 (n=15,10,16)	0.52 units on a scale	Standard Deviation 0.48
Tacrolimus	End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL)	In growth of gum and hair: Month 6 (n=15,9,16)	0.10 units on a scale	Standard Deviation 0.22
Tacrolimus	End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL)	Limited cognitive capacity: Baseline (n=14,15,17)	0.78 units on a scale	Standard Deviation 0.57
Tacrolimus	End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL)	SEs of corticosteroids: Month 6 (n=15,10,16)	0.24 units on a scale	Standard Deviation 0.43
Tacrolimus	End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL)	Limited cognitive capacity: Month 6 (n=15,10,17))	0.35 units on a scale	Standard Deviation 0.46
Tacrolimus	End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL)	Limited physical capacity: Baseline (n=14,15,17)	0.62 units on a scale	Standard Deviation 0.35
Tacrolimus	End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL)	Limited physical capacity: Month 6 (n=15,10,16)	0.38 units on a scale	Standard Deviation 0.53
Tacrolimus	End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL)	TAPD: Baseline (n=14,15,17)	0.97 units on a scale	Standard Deviation 0.47
Tacrolimus	End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL)	Cardiac and renal dysfunction:Baseline(n=13,15,17)	0.67 units on a scale	Standard Deviation 0.6
Tacrolimus	End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL)	Cardiac and renal dysfunction:Month 6(n=15,10,16)	0.22 units on a scale	Standard Deviation 0.28
Tacrolimus	End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL)	SEs of corticosteroids: Baseline (n=13,15,17)	0.68 units on a scale	Standard Deviation 0.74
Tacrolimus	End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL)	In growth of gum and hair: Baseline (n=14,15,17)	0.13 units on a scale	Standard Deviation 0.26
Tacrolimus	End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL)	TAPD: Month 6 (n=15,10,16)	0.58 units on a scale	Standard Deviation 0.7

Secondary

Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load

Time frame: Baseline, Month 1, 3, 6 for CMV; Baseline, Day 14, Month 1, 3, 6 for EBV

Arm	Measure	Group	Value (MEAN)	Dispersion
CP-690,550 15 mg	Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load	EBV: Month 3 (n= 18, 18, 20)	0.28 Copies/500 ng DNA	Standard Deviation 0.57
CP-690,550 15 mg	Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load	CMV: Month 6 (n= 15, 13, 18)	58.87 Copies/500 ng DNA	Standard Deviation 226.33
CP-690,550 15 mg	Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load	CMV: Baseline (n= 20, 19, 19)	0.00 Copies/500 ng DNA	Standard Deviation 0
CP-690,550 15 mg	Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load	EBV: Month 6 (n= 15, 13, 18)	0.73 Copies/500 ng DNA	Standard Deviation 1.79
CP-690,550 15 mg	Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load	EBV: Baseline (n= 20, 19, 19)	2.65 Copies/500 ng DNA	Standard Deviation 11.39
CP-690,550 15 mg	Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load	CMV: Month 3 (n= 18, 18, 20)	55.67 Copies/500 ng DNA	Standard Deviation 235.67
CP-690,550 15 mg	Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load	EBV: Month 1 (n= 20, 18, 18)	5.25 Copies/500 ng DNA	Standard Deviation 20.97
CP-690,550 15 mg	Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load	EBV: Day 14 (n= 18, 19, 20)	4.22 Copies/500 ng DNA	Standard Deviation 13.82
CP-690,550 15 mg	Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load	CMV: Month 1 (n= 20, 18, 18)	0.15 Copies/500 ng DNA	Standard Deviation 0.49
CP-690,550 30 mg	Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load	EBV: Month 6 (n= 15, 13, 18)	15.15 Copies/500 ng DNA	Standard Deviation 27.62
CP-690,550 30 mg	Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load	EBV: Baseline (n= 20, 19, 19)	0.26 Copies/500 ng DNA	Standard Deviation 0.81
CP-690,550 30 mg	Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load	EBV: Day 14 (n= 18, 19, 20)	0.58 Copies/500 ng DNA	Standard Deviation 0.9
CP-690,550 30 mg	Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load	EBV: Month 1 (n= 20, 18, 18)	0.50 Copies/500 ng DNA	Standard Deviation 0.92
CP-690,550 30 mg	Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load	EBV: Month 3 (n= 18, 18, 20)	0.28 Copies/500 ng DNA	Standard Deviation 0.46
CP-690,550 30 mg	Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load	CMV: Baseline (n= 20, 19, 19)	0.00 Copies/500 ng DNA	Standard Deviation 0
CP-690,550 30 mg	Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load	CMV: Month 1 (n= 20, 18, 18)	43.50 Copies/500 ng DNA	Standard Deviation 184.55
CP-690,550 30 mg	Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load	CMV: Month 3 (n= 18, 18, 20)	4.06 Copies/500 ng DNA	Standard Deviation 16.71
CP-690,550 30 mg	Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load	CMV: Month 6 (n= 15, 13, 18)	2.38 Copies/500 ng DNA	Standard Deviation 5.45
Tacrolimus	Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load	EBV: Month 1 (n= 20, 18, 18)	1.94 Copies/500 ng DNA	Standard Deviation 5.23
Tacrolimus	Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load	EBV: Baseline (n= 20, 19, 19)	3.21 Copies/500 ng DNA	Standard Deviation 11.27
Tacrolimus	Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load	CMV: Month 1 (n= 20, 18, 18)	0.00 Copies/500 ng DNA	Standard Deviation 0
Tacrolimus	Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load	EBV: Day 14 (n= 18, 19, 20)	3.60 Copies/500 ng DNA	Standard Deviation 9.32
Tacrolimus	Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load	CMV: Month 6 (n= 15, 13, 18)	0.00 Copies/500 ng DNA	Standard Deviation 0
Tacrolimus	Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load	EBV: Month 6 (n= 15, 13, 18)	0.61 Copies/500 ng DNA	Standard Deviation 1.46
Tacrolimus	Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load	EBV: Month 3 (n= 18, 18, 20)	0.65 Copies/500 ng DNA	Standard Deviation 1.95
Tacrolimus	Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load	CMV: Month 3 (n= 18, 18, 20)	0.05 Copies/500 ng DNA	Standard Deviation 0.22
Tacrolimus	Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load	CMV: Baseline (n= 20, 19, 19)	0.00 Copies/500 ng DNA	Standard Deviation 0

Secondary

Fasting Serum Glucose Levels

Time frame: Baseline, Day 14, Month 1, 3, 6

Arm	Measure	Group	Value (MEAN)	Dispersion
CP-690,550 15 mg	Fasting Serum Glucose Levels	Day 14 (n= 19, 19, 20)	131.58 mg/dL	Standard Deviation 85.36
CP-690,550 15 mg	Fasting Serum Glucose Levels	Month 6 (n= 17, 14, 18)	108.76 mg/dL	Standard Deviation 36.78
CP-690,550 15 mg	Fasting Serum Glucose Levels	Baseline: (n= 18, 19, 21)	114.50 mg/dL	Standard Deviation 63.72
CP-690,550 15 mg	Fasting Serum Glucose Levels	Month 1 (n= 20, 18, 19)	120.35 mg/dL	Standard Deviation 90.42
CP-690,550 15 mg	Fasting Serum Glucose Levels	Month 3 (n= 18, 18, 20)	93.56 mg/dL	Standard Deviation 21.94
CP-690,550 30 mg	Fasting Serum Glucose Levels	Month 3 (n= 18, 18, 20)	92.56 mg/dL	Standard Deviation 34.75
CP-690,550 30 mg	Fasting Serum Glucose Levels	Month 1 (n= 20, 18, 19)	85.22 mg/dL	Standard Deviation 18.4
CP-690,550 30 mg	Fasting Serum Glucose Levels	Month 6 (n= 17, 14, 18)	94.57 mg/dL	Standard Deviation 19.41
CP-690,550 30 mg	Fasting Serum Glucose Levels	Day 14 (n= 19, 19, 20)	95.58 mg/dL	Standard Deviation 32.45
CP-690,550 30 mg	Fasting Serum Glucose Levels	Baseline: (n= 18, 19, 21)	102.68 mg/dL	Standard Deviation 63.26
Tacrolimus	Fasting Serum Glucose Levels	Day 14 (n= 19, 19, 20)	99.85 mg/dL	Standard Deviation 32.43
Tacrolimus	Fasting Serum Glucose Levels	Baseline: (n= 18, 19, 21)	90.29 mg/dL	Standard Deviation 19.87
Tacrolimus	Fasting Serum Glucose Levels	Month 1 (n= 20, 18, 19)	99.16 mg/dL	Standard Deviation 29.37
Tacrolimus	Fasting Serum Glucose Levels	Month 3 (n= 18, 18, 20)	101.05 mg/dL	Standard Deviation 22.79
Tacrolimus	Fasting Serum Glucose Levels	Month 6 (n= 17, 14, 18)	95.11 mg/dL	Standard Deviation 22.68

Secondary

Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets

The absolute cell counts of cluster of differentiation 8 (CD8): Cytotoxic T-lymphocytes reactive with major histocompatibility complex-1 (MHC-I), CD19: B- Lymphocytes, CD56: natural killer cells were determined using FACS, a specialized type of flow cytometry which sorts a heterogeneous mixture based upon the specific light scattering and fluorescent characteristics of each cell.

Time frame: Baseline, Day 14, Month 1, 3, 6

Arm	Measure	Group	Value (MEAN)	Dispersion
CP-690,550 15 mg	Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets	CD19: Baseline (n= 19, 19, 19)	69.74 cells per microliter (cells/mcL)	Standard Deviation 47.6
CP-690,550 15 mg	Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets	CD8: Month 1 (n= 17, 18, 19)	333.00 cells per microliter (cells/mcL)	Standard Deviation 226.24
CP-690,550 15 mg	Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets	CD56: Baseline (n= 19, 19, 19)	153.89 cells per microliter (cells/mcL)	Standard Deviation 120.1
CP-690,550 15 mg	Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets	CD19: Day 14 (n= 19, 19, 19)	353.68 cells per microliter (cells/mcL)	Standard Deviation 418.37
CP-690,550 15 mg	Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets	CD8: Day 14 (n= 19, 19, 19)	449.84 cells per microliter (cells/mcL)	Standard Deviation 327.09
CP-690,550 15 mg	Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets	CD19: Month 6 (n= 14, 11, 15)	156.50 cells per microliter (cells/mcL)	Standard Deviation 75.62
CP-690,550 15 mg	Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets	CD19: Month 1 (n= 17, 18, 19)	282.41 cells per microliter (cells/mcL)	Standard Deviation 334.27
CP-690,550 15 mg	Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets	CD56: Month 1 (n= 17, 18, 19)	214.29 cells per microliter (cells/mcL)	Standard Deviation 399.94
CP-690,550 15 mg	Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets	CD19: Month 3 (n= 18, 18, 20)	128.39 cells per microliter (cells/mcL)	Standard Deviation 87.89
CP-690,550 15 mg	Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets	CD8: Month 3 (n= 18, 18, 20)	212.94 cells per microliter (cells/mcL)	Standard Deviation 133.54
CP-690,550 15 mg	Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets	CD56: Month 6 (n= 14, 11, 15)	126.71 cells per microliter (cells/mcL)	Standard Deviation 153.23
CP-690,550 15 mg	Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets	CD8: Baseline (n= 19, 19, 19)	113.95 cells per microliter (cells/mcL)	Standard Deviation 80.91
CP-690,550 15 mg	Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets	CD8: Month 6 (n= 14, 11, 15)	278.93 cells per microliter (cells/mcL)	Standard Deviation 198.35
CP-690,550 15 mg	Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets	CD56: Month 3 (n= 18, 18, 20)	85.56 cells per microliter (cells/mcL)	Standard Deviation 69.64
CP-690,550 15 mg	Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets	CD56: Day 14 (n= 19, 19, 19)	163.11 cells per microliter (cells/mcL)	Standard Deviation 162.67
CP-690,550 30 mg	Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets	CD56: Day 14 (n= 19, 19, 19)	151.68 cells per microliter (cells/mcL)	Standard Deviation 113.41
CP-690,550 30 mg	Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets	CD8: Baseline (n= 19, 19, 19)	114.05 cells per microliter (cells/mcL)	Standard Deviation 86.28
CP-690,550 30 mg	Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets	CD8: Day 14 (n= 19, 19, 19)	471.79 cells per microliter (cells/mcL)	Standard Deviation 335.83
CP-690,550 30 mg	Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets	CD8: Month 1 (n= 17, 18, 19)	354.39 cells per microliter (cells/mcL)	Standard Deviation 245.74
CP-690,550 30 mg	Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets	CD8: Month 3 (n= 18, 18, 20)	252.72 cells per microliter (cells/mcL)	Standard Deviation 165.94
CP-690,550 30 mg	Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets	CD8: Month 6 (n= 14, 11, 15)	201.09 cells per microliter (cells/mcL)	Standard Deviation 180.41
CP-690,550 30 mg	Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets	CD19: Baseline (n= 19, 19, 19)	89.37 cells per microliter (cells/mcL)	Standard Deviation 74.13
CP-690,550 30 mg	Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets	CD19: Day 14 (n= 19, 19, 19)	486.84 cells per microliter (cells/mcL)	Standard Deviation 410.32
CP-690,550 30 mg	Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets	CD19: Month 1 (n= 17, 18, 19)	291.28 cells per microliter (cells/mcL)	Standard Deviation 208.87
CP-690,550 30 mg	Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets	CD19: Month 3 (n= 18, 18, 20)	217.67 cells per microliter (cells/mcL)	Standard Deviation 276.83
CP-690,550 30 mg	Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets	CD19: Month 6 (n= 14, 11, 15)	176.18 cells per microliter (cells/mcL)	Standard Deviation 169.09
CP-690,550 30 mg	Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets	CD56: Baseline (n= 19, 19, 19)	127.84 cells per microliter (cells/mcL)	Standard Deviation 54.51
CP-690,550 30 mg	Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets	CD56: Month 1 (n= 17, 18, 19)	101.11 cells per microliter (cells/mcL)	Standard Deviation 91.63
CP-690,550 30 mg	Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets	CD56: Month 3 (n= 18, 18, 20)	70.00 cells per microliter (cells/mcL)	Standard Deviation 49.56
CP-690,550 30 mg	Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets	CD56: Month 6 (n= 14, 11, 15)	36.27 cells per microliter (cells/mcL)	Standard Deviation 47.13
Tacrolimus	Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets	CD19: Baseline (n= 19, 19, 19)	111.32 cells per microliter (cells/mcL)	Standard Deviation 90.13
Tacrolimus	Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets	CD56: Month 3 (n= 18, 18, 20)	144.15 cells per microliter (cells/mcL)	Standard Deviation 80.96
Tacrolimus	Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets	CD56: Baseline (n= 19, 19, 19)	165.95 cells per microliter (cells/mcL)	Standard Deviation 97.05
Tacrolimus	Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets	CD8: Month 6 (n= 14, 11, 15)	300.33 cells per microliter (cells/mcL)	Standard Deviation 195.51
Tacrolimus	Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets	CD8: Month 3 (n= 18, 18, 20)	261.35 cells per microliter (cells/mcL)	Standard Deviation 156.93
Tacrolimus	Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets	CD56: Day 14 (n= 19, 19, 19)	212.00 cells per microliter (cells/mcL)	Standard Deviation 294.38
Tacrolimus	Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets	CD8: Month 1 (n= 17, 18, 19)	380.89 cells per microliter (cells/mcL)	Standard Deviation 257.68
Tacrolimus	Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets	CD8: Baseline (n= 19, 19, 19)	160.37 cells per microliter (cells/mcL)	Standard Deviation 146.56
Tacrolimus	Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets	CD56: Month 1 (n= 17, 18, 19)	162.16 cells per microliter (cells/mcL)	Standard Deviation 80.31
Tacrolimus	Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets	CD19: Month 1 (n= 17, 18, 19)	343.58 cells per microliter (cells/mcL)	Standard Deviation 301.42
Tacrolimus	Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets	CD8: Day 14 (n= 19, 19, 19)	401.68 cells per microliter (cells/mcL)	Standard Deviation 313.64
Tacrolimus	Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets	CD19: Month 3 (n= 18, 18, 20)	168.20 cells per microliter (cells/mcL)	Standard Deviation 138.1
Tacrolimus	Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets	CD19: Day 14 (n= 19, 19, 19)	303.95 cells per microliter (cells/mcL)	Standard Deviation 302.66
Tacrolimus	Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets	CD56: Month 6 (n= 14, 11, 15)	173.53 cells per microliter (cells/mcL)	Standard Deviation 119.79
Tacrolimus	Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets	CD19: Month 6 (n= 14, 11, 15)	188.80 cells per microliter (cells/mcL)	Standard Deviation 130.84

Secondary

Glomerular Filtration Rate (GFR) by Cockcroft-Gault

GFR: index of kidney function described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated using Cockcroft-Gault equation. GFR by Cockcroft-Gault equation= body weight\*(140 minus age in years) divided by (72\*serum creatinine). For females, value obtained was multiplied by 0.85. A normal GFR is \>90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR \<15 mL/min indicated kidney failure.

Time frame: Day 14, Month 1, 3, 6

Arm	Measure	Group	Value (MEAN)	Dispersion
CP-690,550 15 mg	Glomerular Filtration Rate (GFR) by Cockcroft-Gault	Day 14 (n= 19, 19, 20)	73.24 mL/min	Standard Deviation 19.14
CP-690,550 15 mg	Glomerular Filtration Rate (GFR) by Cockcroft-Gault	Month 1 (n= 20, 18, 19)	80.73 mL/min	Standard Deviation 23.47
CP-690,550 15 mg	Glomerular Filtration Rate (GFR) by Cockcroft-Gault	Month 3 (n= 18, 18, 20)	81.84 mL/min	Standard Deviation 15.81
CP-690,550 15 mg	Glomerular Filtration Rate (GFR) by Cockcroft-Gault	Month 6 (n= 17, 14, 18)	82.17 mL/min	Standard Deviation 19.27
CP-690,550 30 mg	Glomerular Filtration Rate (GFR) by Cockcroft-Gault	Month 6 (n= 17, 14, 18)	79.99 mL/min	Standard Deviation 19.72
CP-690,550 30 mg	Glomerular Filtration Rate (GFR) by Cockcroft-Gault	Day 14 (n= 19, 19, 20)	78.37 mL/min	Standard Deviation 20.08
CP-690,550 30 mg	Glomerular Filtration Rate (GFR) by Cockcroft-Gault	Month 3 (n= 18, 18, 20)	81.99 mL/min	Standard Deviation 14.95
CP-690,550 30 mg	Glomerular Filtration Rate (GFR) by Cockcroft-Gault	Month 1 (n= 20, 18, 19)	81.83 mL/min	Standard Deviation 11.54
Tacrolimus	Glomerular Filtration Rate (GFR) by Cockcroft-Gault	Month 6 (n= 17, 14, 18)	91.89 mL/min	Standard Deviation 16.66
Tacrolimus	Glomerular Filtration Rate (GFR) by Cockcroft-Gault	Month 1 (n= 20, 18, 19)	79.90 mL/min	Standard Deviation 19.15
Tacrolimus	Glomerular Filtration Rate (GFR) by Cockcroft-Gault	Month 3 (n= 18, 18, 20)	86.86 mL/min	Standard Deviation 20.03
Tacrolimus	Glomerular Filtration Rate (GFR) by Cockcroft-Gault	Day 14 (n= 19, 19, 20)	76.14 mL/min	Standard Deviation 17.14

Secondary

Glomerular Filtration Rate (GFR) by Modification of Diet in Renal Disease (MDRD) Equation

GFR: index of kidney function described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated using MDRD equation. GFR by MDRD equation= 170 \* (serum creatinine) \^ (-0.999)\*(age in years)\^(-0.176)\*(0.762 if female) \* (1.18 if black)\*(blood urea nitrogen concentration)\^(-0.170)\*(serum albumin concentration)\^(0.318). Normal GFR is \>90 mL/min/1.73 square meter (m\^2), although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR \<15 mL/min indicated kidney failure.

Time frame: Day 14, Month 1, 3, 6

Arm	Measure	Group	Value (MEAN)	Dispersion
CP-690,550 15 mg	Glomerular Filtration Rate (GFR) by Modification of Diet in Renal Disease (MDRD) Equation	Day 14 (n= 19, 19, 20)	60.67 mL/min/1.73 m^2	Standard Deviation 19.01
CP-690,550 15 mg	Glomerular Filtration Rate (GFR) by Modification of Diet in Renal Disease (MDRD) Equation	Month 1 (n= 20, 18, 19)	66.82 mL/min/1.73 m^2	Standard Deviation 20.83
CP-690,550 15 mg	Glomerular Filtration Rate (GFR) by Modification of Diet in Renal Disease (MDRD) Equation	Month 3 (n= 18, 18, 20)	64.58 mL/min/1.73 m^2	Standard Deviation 13.68
CP-690,550 15 mg	Glomerular Filtration Rate (GFR) by Modification of Diet in Renal Disease (MDRD) Equation	Month 6 (n= 17, 14, 18)	63.59 mL/min/1.73 m^2	Standard Deviation 12.02
CP-690,550 30 mg	Glomerular Filtration Rate (GFR) by Modification of Diet in Renal Disease (MDRD) Equation	Month 6 (n= 17, 14, 18)	58.95 mL/min/1.73 m^2	Standard Deviation 16.19
CP-690,550 30 mg	Glomerular Filtration Rate (GFR) by Modification of Diet in Renal Disease (MDRD) Equation	Day 14 (n= 19, 19, 20)	57.97 mL/min/1.73 m^2	Standard Deviation 16.32
CP-690,550 30 mg	Glomerular Filtration Rate (GFR) by Modification of Diet in Renal Disease (MDRD) Equation	Month 3 (n= 18, 18, 20)	62.04 mL/min/1.73 m^2	Standard Deviation 12.46
CP-690,550 30 mg	Glomerular Filtration Rate (GFR) by Modification of Diet in Renal Disease (MDRD) Equation	Month 1 (n= 20, 18, 19)	62.70 mL/min/1.73 m^2	Standard Deviation 9.5
Tacrolimus	Glomerular Filtration Rate (GFR) by Modification of Diet in Renal Disease (MDRD) Equation	Month 6 (n= 17, 14, 18)	68.29 mL/min/1.73 m^2	Standard Deviation 22.1
Tacrolimus	Glomerular Filtration Rate (GFR) by Modification of Diet in Renal Disease (MDRD) Equation	Month 1 (n= 20, 18, 19)	62.55 mL/min/1.73 m^2	Standard Deviation 22.47
Tacrolimus	Glomerular Filtration Rate (GFR) by Modification of Diet in Renal Disease (MDRD) Equation	Month 3 (n= 18, 18, 20)	66.45 mL/min/1.73 m^2	Standard Deviation 22
Tacrolimus	Glomerular Filtration Rate (GFR) by Modification of Diet in Renal Disease (MDRD) Equation	Day 14 (n= 19, 19, 20)	56.70 mL/min/1.73 m^2	Standard Deviation 21.39

Secondary

Glomerular Filtration Rate (GFR) by Reciprocal of Serum Creatinine (1/sCr)

GFR is a measure of renal function. The reciprocal of serum creatinine is an estimate of GFR.

Time frame: Day 14, Month 1, 3, 6

Arm	Measure	Group	Value (MEAN)	Dispersion
CP-690,550 15 mg	Glomerular Filtration Rate (GFR) by Reciprocal of Serum Creatinine (1/sCr)	Day 14 (n= 19, 19, 20)	0.87 deciliter/mg (dL/mg)	Standard Deviation 0.28
CP-690,550 15 mg	Glomerular Filtration Rate (GFR) by Reciprocal of Serum Creatinine (1/sCr)	Month 1 (n= 20, 18, 19)	0.91 deciliter/mg (dL/mg)	Standard Deviation 0.3
CP-690,550 15 mg	Glomerular Filtration Rate (GFR) by Reciprocal of Serum Creatinine (1/sCr)	Month 3 (n= 18, 18, 20)	0.86 deciliter/mg (dL/mg)	Standard Deviation 0.21
CP-690,550 15 mg	Glomerular Filtration Rate (GFR) by Reciprocal of Serum Creatinine (1/sCr)	Month 6 (n= 17, 14, 18)	0.86 deciliter/mg (dL/mg)	Standard Deviation 0.19
CP-690,550 30 mg	Glomerular Filtration Rate (GFR) by Reciprocal of Serum Creatinine (1/sCr)	Month 6 (n= 17, 14, 18)	0.73 deciliter/mg (dL/mg)	Standard Deviation 0.19
CP-690,550 30 mg	Glomerular Filtration Rate (GFR) by Reciprocal of Serum Creatinine (1/sCr)	Day 14 (n= 19, 19, 20)	0.75 deciliter/mg (dL/mg)	Standard Deviation 0.19
CP-690,550 30 mg	Glomerular Filtration Rate (GFR) by Reciprocal of Serum Creatinine (1/sCr)	Month 3 (n= 18, 18, 20)	0.77 deciliter/mg (dL/mg)	Standard Deviation 0.18
CP-690,550 30 mg	Glomerular Filtration Rate (GFR) by Reciprocal of Serum Creatinine (1/sCr)	Month 1 (n= 20, 18, 19)	0.79 deciliter/mg (dL/mg)	Standard Deviation 0.14
Tacrolimus	Glomerular Filtration Rate (GFR) by Reciprocal of Serum Creatinine (1/sCr)	Month 6 (n= 17, 14, 18)	0.84 deciliter/mg (dL/mg)	Standard Deviation 0.19
Tacrolimus	Glomerular Filtration Rate (GFR) by Reciprocal of Serum Creatinine (1/sCr)	Month 1 (n= 20, 18, 19)	0.78 deciliter/mg (dL/mg)	Standard Deviation 0.24
Tacrolimus	Glomerular Filtration Rate (GFR) by Reciprocal of Serum Creatinine (1/sCr)	Month 3 (n= 18, 18, 20)	0.82 deciliter/mg (dL/mg)	Standard Deviation 0.21
Tacrolimus	Glomerular Filtration Rate (GFR) by Reciprocal of Serum Creatinine (1/sCr)	Day 14 (n= 19, 19, 20)	0.75 deciliter/mg (dL/mg)	Standard Deviation 0.24

Secondary

Healthcare Resource Utilization Questionnaire (HCRUQ)

Healthcare Resource Utilization Questionnaire (HCRUQ) was used to assess healthcare resources which included number of events such as physician and other health professional visits, number of treatments or diagnostic tests, number of hospitalizations, and number of emergency room visits.

Time frame: Baseline, Month 6

Arm	Measure	Group	Value (MEAN)	Dispersion
CP-690,550 15 mg	Healthcare Resource Utilization Questionnaire (HCRUQ)	Physician visits: Baseline (n= 15, 16, 17)	3.33 events	Standard Deviation 4.15
CP-690,550 15 mg	Healthcare Resource Utilization Questionnaire (HCRUQ)	Physician visits: Month 6 (n= 10, 7, 10)	4.20 events	Standard Deviation 6.34
CP-690,550 15 mg	Healthcare Resource Utilization Questionnaire (HCRUQ)	Emergency room visits: Baseline (n= 16, 16, 17)	0.06 events	Standard Deviation 0.25
CP-690,550 15 mg	Healthcare Resource Utilization Questionnaire (HCRUQ)	Emergency room visits: Month 6 (n= 10, 7, 10)	0.50 events	Standard Deviation 0.85
CP-690,550 15 mg	Healthcare Resource Utilization Questionnaire (HCRUQ)	Diagnostic tests: Baseline (n= 14, 16, 17)	7.14 events	Standard Deviation 8.56
CP-690,550 15 mg	Healthcare Resource Utilization Questionnaire (HCRUQ)	Diagnostic tests: Month 6 (n= 10, 7, 10)	0.40 events	Standard Deviation 0.97
CP-690,550 15 mg	Healthcare Resource Utilization Questionnaire (HCRUQ)	Hospital visits: Baseline (n= 15, 16, 17)	0.07 events	Standard Deviation 0.26
CP-690,550 15 mg	Healthcare Resource Utilization Questionnaire (HCRUQ)	Hospital visits: Month 6 (n= 10, 7, 10)	0.60 events	Standard Deviation 1.07
CP-690,550 30 mg	Healthcare Resource Utilization Questionnaire (HCRUQ)	Emergency room visits: Baseline (n= 16, 16, 17)	0.19 events	Standard Deviation 0.4
CP-690,550 30 mg	Healthcare Resource Utilization Questionnaire (HCRUQ)	Hospital visits: Baseline (n= 15, 16, 17)	0.00 events	Standard Deviation 0
CP-690,550 30 mg	Healthcare Resource Utilization Questionnaire (HCRUQ)	Emergency room visits: Month 6 (n= 10, 7, 10)	0.14 events	Standard Deviation 0.38
CP-690,550 30 mg	Healthcare Resource Utilization Questionnaire (HCRUQ)	Diagnostic tests: Baseline (n= 14, 16, 17)	5.88 events	Standard Deviation 6.06
CP-690,550 30 mg	Healthcare Resource Utilization Questionnaire (HCRUQ)	Hospital visits: Month 6 (n= 10, 7, 10)	0.43 events	Standard Deviation 0.79
CP-690,550 30 mg	Healthcare Resource Utilization Questionnaire (HCRUQ)	Diagnostic tests: Month 6 (n= 10, 7, 10)	0.86 events	Standard Deviation 1.21
CP-690,550 30 mg	Healthcare Resource Utilization Questionnaire (HCRUQ)	Physician visits: Baseline (n= 15, 16, 17)	4.31 events	Standard Deviation 4.74
CP-690,550 30 mg	Healthcare Resource Utilization Questionnaire (HCRUQ)	Physician visits: Month 6 (n= 10, 7, 10)	7.29 events	Standard Deviation 8.88
Tacrolimus	Healthcare Resource Utilization Questionnaire (HCRUQ)	Physician visits: Month 6 (n= 10, 7, 10)	8.70 events	Standard Deviation 8.63
Tacrolimus	Healthcare Resource Utilization Questionnaire (HCRUQ)	Hospital visits: Month 6 (n= 10, 7, 10)	0.10 events	Standard Deviation 0.32
Tacrolimus	Healthcare Resource Utilization Questionnaire (HCRUQ)	Physician visits: Baseline (n= 15, 16, 17)	4.47 events	Standard Deviation 6.32
Tacrolimus	Healthcare Resource Utilization Questionnaire (HCRUQ)	Emergency room visits: Month 6 (n= 10, 7, 10)	0.10 events	Standard Deviation 0.32
Tacrolimus	Healthcare Resource Utilization Questionnaire (HCRUQ)	Hospital visits: Baseline (n= 15, 16, 17)	0.00 events	Standard Deviation 0
Tacrolimus	Healthcare Resource Utilization Questionnaire (HCRUQ)	Diagnostic tests: Month 6 (n= 10, 7, 10)	4.20 events	Standard Deviation 12.25
Tacrolimus	Healthcare Resource Utilization Questionnaire (HCRUQ)	Diagnostic tests: Baseline (n= 14, 16, 17)	16.06 events	Standard Deviation 28.45
Tacrolimus	Healthcare Resource Utilization Questionnaire (HCRUQ)	Emergency room visits: Baseline (n= 16, 16, 17)	0.00 events	Standard Deviation 0

Secondary

Healthcare Resource Utilization Questionnaire (HCRUQ) - 5th Question

Fifth question in the HCRUQ was Upon discharge from the hospital, did you return to your previous place of residence? and number of participants who responded yes or no to the question was reported.

Time frame: Month 6

Population: FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure.

Arm	Measure	Group	Value (NUMBER)
CP-690,550 15 mg	Healthcare Resource Utilization Questionnaire (HCRUQ) - 5th Question	Yes	7 participants
CP-690,550 15 mg	Healthcare Resource Utilization Questionnaire (HCRUQ) - 5th Question	No	2 participants
CP-690,550 30 mg	Healthcare Resource Utilization Questionnaire (HCRUQ) - 5th Question	Yes	6 participants
CP-690,550 30 mg	Healthcare Resource Utilization Questionnaire (HCRUQ) - 5th Question	No	0 participants
Tacrolimus	Healthcare Resource Utilization Questionnaire (HCRUQ) - 5th Question	Yes	6 participants
Tacrolimus	Healthcare Resource Utilization Questionnaire (HCRUQ) - 5th Question	No	1 participants

Secondary

Hematocrit Level

The hematocrit is recorded as the percentage of volume of red blood cells (RBCs) in a blood sample.

Time frame: Baseline, Day 14, Month 1, 3, 6

Population: Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here 'n' signifies those participants evaluable at specific time points for each arm group respectively.

Arm	Measure	Group	Value (MEAN)	Dispersion
CP-690,550 15 mg	Hematocrit Level	Month 3 (n= 19, 17, 20)	38.53 percentage of blood	Standard Deviation 5.3
CP-690,550 15 mg	Hematocrit Level	Month 1 (n= 19, 18, 19)	38.74 percentage of blood	Standard Deviation 2.81
CP-690,550 15 mg	Hematocrit Level	Baseline (n= 20, 20, 21)	34.75 percentage of blood	Standard Deviation 4.82
CP-690,550 15 mg	Hematocrit Level	Day 14 (n= 18, 19, 18)	37.78 percentage of blood	Standard Deviation 3.73
CP-690,550 15 mg	Hematocrit Level	Month 6 (n= 16, 14, 18)	40.19 percentage of blood	Standard Deviation 3.75
CP-690,550 30 mg	Hematocrit Level	Month 1 (n= 19, 18, 19)	38.22 percentage of blood	Standard Deviation 3.89
CP-690,550 30 mg	Hematocrit Level	Baseline (n= 20, 20, 21)	33.30 percentage of blood	Standard Deviation 5.02
CP-690,550 30 mg	Hematocrit Level	Day 14 (n= 18, 19, 18)	37.16 percentage of blood	Standard Deviation 3.5
CP-690,550 30 mg	Hematocrit Level	Month 3 (n= 19, 17, 20)	37.12 percentage of blood	Standard Deviation 4.37
CP-690,550 30 mg	Hematocrit Level	Month 6 (n= 16, 14, 18)	37.86 percentage of blood	Standard Deviation 6.14
Tacrolimus	Hematocrit Level	Month 6 (n= 16, 14, 18)	43.67 percentage of blood	Standard Deviation 3.88
Tacrolimus	Hematocrit Level	Baseline (n= 20, 20, 21)	36.86 percentage of blood	Standard Deviation 5.18
Tacrolimus	Hematocrit Level	Month 3 (n= 19, 17, 20)	39.50 percentage of blood	Standard Deviation 4.05
Tacrolimus	Hematocrit Level	Month 1 (n= 19, 18, 19)	37.95 percentage of blood	Standard Deviation 3.99
Tacrolimus	Hematocrit Level	Day 14 (n= 18, 19, 18)	37.11 percentage of blood	Standard Deviation 4.83

Secondary

Hemoglobin Level

Hemoglobin is the protein molecule in red blood cells that carries oxygen from the lungs to the body's tissues and returns carbon dioxide from the tissues back to the lungs.

Time frame: Baseline, Day 14, Month 1, 3, 6

Arm	Measure	Group	Value (MEAN)	Dispersion
CP-690,550 15 mg	Hemoglobin Level	Month 3 (n= 19, 17, 20)	12.35 g/dL	Standard Deviation 1.79
CP-690,550 15 mg	Hemoglobin Level	Month 1 (n= 19, 18, 19)	12.16 g/dL	Standard Deviation 1.04
CP-690,550 15 mg	Hemoglobin Level	Baseline (n= 20, 20, 21)	11.04 g/dL	Standard Deviation 1.48
CP-690,550 15 mg	Hemoglobin Level	Day 14 (n= 19, 19, 18)	11.83 g/dL	Standard Deviation 1.29
CP-690,550 15 mg	Hemoglobin Level	Month 6 (n= 16, 14, 18)	12.83 g/dL	Standard Deviation 1.54
CP-690,550 30 mg	Hemoglobin Level	Month 1 (n= 19, 18, 19)	12.29 g/dL	Standard Deviation 1.12
CP-690,550 30 mg	Hemoglobin Level	Baseline (n= 20, 20, 21)	10.65 g/dL	Standard Deviation 1.43
CP-690,550 30 mg	Hemoglobin Level	Day 14 (n= 19, 19, 18)	11.68 g/dL	Standard Deviation 0.89
CP-690,550 30 mg	Hemoglobin Level	Month 3 (n= 19, 17, 20)	12.20 g/dL	Standard Deviation 1.55
CP-690,550 30 mg	Hemoglobin Level	Month 6 (n= 16, 14, 18)	12.41 g/dL	Standard Deviation 1.99
Tacrolimus	Hemoglobin Level	Month 6 (n= 16, 14, 18)	14.26 g/dL	Standard Deviation 1.32
Tacrolimus	Hemoglobin Level	Month 3 (n= 19, 17, 20)	12.91 g/dL	Standard Deviation 1.43
Tacrolimus	Hemoglobin Level	Baseline (n= 20, 20, 21)	11.84 g/dL	Standard Deviation 1.37
Tacrolimus	Hemoglobin Level	Month 1 (n= 19, 18, 19)	12.20 g/dL	Standard Deviation 1.42
Tacrolimus	Hemoglobin Level	Day 14 (n= 19, 19, 18)	11.93 g/dL	Standard Deviation 1.67

Secondary

Number of Participants Who Died

Time frame: Month 6

Population: FAS included all randomized participants who received at least 1 dose of study medication.

Arm	Measure	Value (NUMBER)
CP-690,550 15 mg	Number of Participants Who Died	0 participants
CP-690,550 30 mg	Number of Participants Who Died	0 participants
Tacrolimus	Number of Participants Who Died	0 participants

Secondary

Number of Participants With Cytomegalovirus (CMV) Disease

Time frame: Month 3, 6

Population: FAS included all randomized participants who received at least 1 dose of study medication and based on time due to lost of follow-up, or up to Month 6. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies those participants evaluable at specific time points for each arm group respectively.

Arm	Measure	Group	Value (NUMBER)
CP-690,550 15 mg	Number of Participants With Cytomegalovirus (CMV) Disease	Month 3 (n= 20, 19, 20)	0 participants
CP-690,550 15 mg	Number of Participants With Cytomegalovirus (CMV) Disease	Month 6 (n= 19, 16, 20)	2 participants
CP-690,550 30 mg	Number of Participants With Cytomegalovirus (CMV) Disease	Month 3 (n= 20, 19, 20)	4 participants
CP-690,550 30 mg	Number of Participants With Cytomegalovirus (CMV) Disease	Month 6 (n= 19, 16, 20)	4 participants
Tacrolimus	Number of Participants With Cytomegalovirus (CMV) Disease	Month 3 (n= 20, 19, 20)	0 participants
Tacrolimus	Number of Participants With Cytomegalovirus (CMV) Disease	Month 6 (n= 19, 16, 20)	0 participants

Secondary

Number of Participants With Discontinuation

Time frame: Month 1, 2, 3, 4, 5, 6

Population: FAS included all randomized participants who received at least 1 dose of study medication.

Arm	Measure	Group	Value (NUMBER)
CP-690,550 15 mg	Number of Participants With Discontinuation	Month 1	0 participants
CP-690,550 15 mg	Number of Participants With Discontinuation	Month 2	1 participants
CP-690,550 15 mg	Number of Participants With Discontinuation	Month 3	1 participants
CP-690,550 15 mg	Number of Participants With Discontinuation	Month 4	1 participants
CP-690,550 15 mg	Number of Participants With Discontinuation	Month 5	2 participants
CP-690,550 15 mg	Number of Participants With Discontinuation	Month 6	2 participants
CP-690,550 30 mg	Number of Participants With Discontinuation	Month 6	6 participants
CP-690,550 30 mg	Number of Participants With Discontinuation	Month 1	1 participants
CP-690,550 30 mg	Number of Participants With Discontinuation	Month 4	2 participants
CP-690,550 30 mg	Number of Participants With Discontinuation	Month 5	4 participants
CP-690,550 30 mg	Number of Participants With Discontinuation	Month 2	1 participants
CP-690,550 30 mg	Number of Participants With Discontinuation	Month 3	1 participants
Tacrolimus	Number of Participants With Discontinuation	Month 2	0 participants
Tacrolimus	Number of Participants With Discontinuation	Month 3	1 participants
Tacrolimus	Number of Participants With Discontinuation	Month 6	1 participants
Tacrolimus	Number of Participants With Discontinuation	Month 4	1 participants
Tacrolimus	Number of Participants With Discontinuation	Month 1	0 participants
Tacrolimus	Number of Participants With Discontinuation	Month 5	1 participants

Secondary

Number of Participants With Drug Usage

Lipid lowering agents, antihypertensive agents, oral hypoglycemic agents (OHA) , anti-diabetic agents (ADA) and insulin drug usage was collected.

Time frame: Baseline, Day 14, Month 1, 3, 6

Population: FAS included all randomized participants who received at least 1 dose of study medication. Here 'n' signifies those participants evaluable at specific time points for each arm group respectively.

Arm	Measure	Group	Value (NUMBER)
CP-690,550 15 mg	Number of Participants With Drug Usage	Antihypertensive: Baseline ( n= 20, 20, 21)	17 participants
CP-690,550 15 mg	Number of Participants With Drug Usage	Lipid Lowering: Month 1 (n= 20, 19, 21)	5 participants
CP-690,550 15 mg	Number of Participants With Drug Usage	OHA, ADA, insulin usage: Baseline (n= 20, 20, 21)	9 participants
CP-690,550 15 mg	Number of Participants With Drug Usage	Antihypertensive: Day 14 (n= 20, 19, 21)	15 participants
CP-690,550 15 mg	Number of Participants With Drug Usage	Lipid Lowering: Day 14 (n= 20, 19, 21)	3 participants
CP-690,550 15 mg	Number of Participants With Drug Usage	Antihypertensive: Month 6 (n= 18, 15, 20)	14 participants
CP-690,550 15 mg	Number of Participants With Drug Usage	Antihypertensive: Month 1 (n= 20, 19, 21)	15 participants
CP-690,550 15 mg	Number of Participants With Drug Usage	OHA, ADA, insulin usage: Month 1 (n= 20, 19, 21)	5 participants
CP-690,550 15 mg	Number of Participants With Drug Usage	Antihypertensive: Month 3 (n= 20, 19, 20)	16 participants
CP-690,550 15 mg	Number of Participants With Drug Usage	Lipid Lowering: Month 3 (n= 20, 19, 20)	8 participants
CP-690,550 15 mg	Number of Participants With Drug Usage	OHA, ADA, insulin usage: Month 6 (n= 18, 15, 20)	6 participants
CP-690,550 15 mg	Number of Participants With Drug Usage	Lipid Lowering: Baseline ( n= 20, 20, 21)	6 participants
CP-690,550 15 mg	Number of Participants With Drug Usage	Lipid Lowering: Month 6 (n= 18, 15, 20)	10 participants
CP-690,550 15 mg	Number of Participants With Drug Usage	OHA, ADA, insulin usage: Month 3 (n= 20, 19, 20)	5 participants
CP-690,550 15 mg	Number of Participants With Drug Usage	OHA, ADA, insulin usage: Day 14 (n= 20, 19, 21)	5 participants
CP-690,550 30 mg	Number of Participants With Drug Usage	OHA, ADA, insulin usage: Day 14 (n= 20, 19, 21)	4 participants
CP-690,550 30 mg	Number of Participants With Drug Usage	Lipid Lowering: Baseline ( n= 20, 20, 21)	9 participants
CP-690,550 30 mg	Number of Participants With Drug Usage	Lipid Lowering: Day 14 (n= 20, 19, 21)	4 participants
CP-690,550 30 mg	Number of Participants With Drug Usage	Lipid Lowering: Month 1 (n= 20, 19, 21)	5 participants
CP-690,550 30 mg	Number of Participants With Drug Usage	Lipid Lowering: Month 3 (n= 20, 19, 20)	9 participants
CP-690,550 30 mg	Number of Participants With Drug Usage	Lipid Lowering: Month 6 (n= 18, 15, 20)	8 participants
CP-690,550 30 mg	Number of Participants With Drug Usage	Antihypertensive: Baseline ( n= 20, 20, 21)	18 participants
CP-690,550 30 mg	Number of Participants With Drug Usage	Antihypertensive: Day 14 (n= 20, 19, 21)	19 participants
CP-690,550 30 mg	Number of Participants With Drug Usage	Antihypertensive: Month 1 (n= 20, 19, 21)	18 participants
CP-690,550 30 mg	Number of Participants With Drug Usage	Antihypertensive: Month 3 (n= 20, 19, 20)	18 participants
CP-690,550 30 mg	Number of Participants With Drug Usage	Antihypertensive: Month 6 (n= 18, 15, 20)	11 participants
CP-690,550 30 mg	Number of Participants With Drug Usage	OHA, ADA, insulin usage: Baseline (n= 20, 20, 21)	7 participants
CP-690,550 30 mg	Number of Participants With Drug Usage	OHA, ADA, insulin usage: Month 1 (n= 20, 19, 21)	4 participants
CP-690,550 30 mg	Number of Participants With Drug Usage	OHA, ADA, insulin usage: Month 3 (n= 20, 19, 20)	4 participants
CP-690,550 30 mg	Number of Participants With Drug Usage	OHA, ADA, insulin usage: Month 6 (n= 18, 15, 20)	3 participants
Tacrolimus	Number of Participants With Drug Usage	Antihypertensive: Baseline ( n= 20, 20, 21)	18 participants
Tacrolimus	Number of Participants With Drug Usage	OHA, ADA, insulin usage: Month 3 (n= 20, 19, 20)	3 participants
Tacrolimus	Number of Participants With Drug Usage	OHA, ADA, insulin usage: Baseline (n= 20, 20, 21)	5 participants
Tacrolimus	Number of Participants With Drug Usage	Lipid Lowering: Month 6 (n= 18, 15, 20)	7 participants
Tacrolimus	Number of Participants With Drug Usage	Lipid Lowering: Month 3 (n= 20, 19, 20)	5 participants
Tacrolimus	Number of Participants With Drug Usage	OHA, ADA, insulin usage: Day 14 (n= 20, 19, 21)	3 participants
Tacrolimus	Number of Participants With Drug Usage	Lipid Lowering: Month 1 (n= 20, 19, 21)	4 participants
Tacrolimus	Number of Participants With Drug Usage	Lipid Lowering: Baseline ( n= 20, 20, 21)	9 participants
Tacrolimus	Number of Participants With Drug Usage	OHA, ADA, insulin usage: Month 1 (n= 20, 19, 21)	3 participants
Tacrolimus	Number of Participants With Drug Usage	Antihypertensive: Month 1 (n= 20, 19, 21)	16 participants
Tacrolimus	Number of Participants With Drug Usage	Lipid Lowering: Day 14 (n= 20, 19, 21)	4 participants
Tacrolimus	Number of Participants With Drug Usage	Antihypertensive: Month 3 (n= 20, 19, 20)	17 participants
Tacrolimus	Number of Participants With Drug Usage	Antihypertensive: Day 14 (n= 20, 19, 21)	15 participants
Tacrolimus	Number of Participants With Drug Usage	OHA, ADA, insulin usage: Month 6 (n= 18, 15, 20)	2 participants
Tacrolimus	Number of Participants With Drug Usage	Antihypertensive: Month 6 (n= 18, 15, 20)	16 participants

Secondary

Number of Participants With Efficacy Failure

Efficacy failure was the first occurrence of BPAR, graft loss or participant's death.

Time frame: Month 3, 6

Population: FAS included all randomized participants who received at least 1 dose of study medication.

Arm	Measure	Group	Value (NUMBER)
CP-690,550 15 mg	Number of Participants With Efficacy Failure	Month 6	1 participants
CP-690,550 15 mg	Number of Participants With Efficacy Failure	Month 3	0 participants
CP-690,550 30 mg	Number of Participants With Efficacy Failure	Month 3	4 participants
CP-690,550 30 mg	Number of Participants With Efficacy Failure	Month 6	4 participants
Tacrolimus	Number of Participants With Efficacy Failure	Month 3	1 participants
Tacrolimus	Number of Participants With Efficacy Failure	Month 6	1 participants

Secondary

Number of Participants With First Biopsy Proven Acute Rejection (BPAR) at Month 3

BPAR categorized as acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification.

Time frame: Baseline up to Month 3

Population: FAS included all randomized participants who received at least 1 dose of study medication.

Arm	Measure	Value (NUMBER)
CP-690,550 15 mg	Number of Participants With First Biopsy Proven Acute Rejection (BPAR) at Month 3	0 participants
CP-690,550 30 mg	Number of Participants With First Biopsy Proven Acute Rejection (BPAR) at Month 3	4 participants
Tacrolimus	Number of Participants With First Biopsy Proven Acute Rejection (BPAR) at Month 3	1 participants

Secondary

Number of Participants With First Biopsy Proven Chronic Allograft Nephropathy (BPCAN)

BPCAN categorized as chronic allograft nephropathy as interpreted by the central blinded pathologist according to the Banff 97 working classification.

Time frame: Month 3, 6

Population: FAS included all randomized participants who received at least 1 dose of study medication.

Arm	Measure	Group	Value (NUMBER)
CP-690,550 15 mg	Number of Participants With First Biopsy Proven Chronic Allograft Nephropathy (BPCAN)	Month 6	0 participants
CP-690,550 15 mg	Number of Participants With First Biopsy Proven Chronic Allograft Nephropathy (BPCAN)	Month 3	0 participants
CP-690,550 30 mg	Number of Participants With First Biopsy Proven Chronic Allograft Nephropathy (BPCAN)	Month 3	0 participants
CP-690,550 30 mg	Number of Participants With First Biopsy Proven Chronic Allograft Nephropathy (BPCAN)	Month 6	2 participants
Tacrolimus	Number of Participants With First Biopsy Proven Chronic Allograft Nephropathy (BPCAN)	Month 3	0 participants
Tacrolimus	Number of Participants With First Biopsy Proven Chronic Allograft Nephropathy (BPCAN)	Month 6	0 participants

Secondary

Number of Participants With First Clinically Significant Infection

Clinically significant (Viral, Bacterial and Fungal) infection was defined as the presence of presumed or documented infection confirmed by culture, biopsy, genomic or serologic findings post-randomization and required hospitalization or anti-infective treatment, or otherwise deemed significant by the Investigator.

Time frame: Month 3, 6

Population: FAS included all randomized participants who received at least 1 dose of study medication.

Arm	Measure	Group	Value (NUMBER)
CP-690,550 15 mg	Number of Participants With First Clinically Significant Infection	Month 6	6 participants
CP-690,550 15 mg	Number of Participants With First Clinically Significant Infection	Month 3	2 participants
CP-690,550 30 mg	Number of Participants With First Clinically Significant Infection	Month 3	7 participants
CP-690,550 30 mg	Number of Participants With First Clinically Significant Infection	Month 6	11 participants
Tacrolimus	Number of Participants With First Clinically Significant Infection	Month 3	3 participants
Tacrolimus	Number of Participants With First Clinically Significant Infection	Month 6	5 participants

Secondary

Number of Participants With Graft Loss

Graft loss was defined as graft nephrectomy, participant's death due to graft loss, re-transplantation, or return to dialysis for greater than or equal to (\>=) 6 consecutive weeks.

Time frame: Month 6

Population: FAS included all randomized participants who received at least 1 dose of study medication.

Arm	Measure	Value (NUMBER)
CP-690,550 15 mg	Number of Participants With Graft Loss	0 participants
CP-690,550 30 mg	Number of Participants With Graft Loss	0 participants
Tacrolimus	Number of Participants With Graft Loss	0 participants

Secondary

Number of Participants With Hypercholesterolemia

Hypercholesterolemia is a condition characterized by very high levels of cholesterol in the blood. Hypercholesterolemia was defined as a value of total serum cholesterol greater than 240 mg/dL.

Time frame: Baseline, Day 14, Month 1, 3, 6

Arm	Measure	Group	Value (NUMBER)
CP-690,550 15 mg	Number of Participants With Hypercholesterolemia	Month 3 (n= 18, 18, 20)	5 participants
CP-690,550 15 mg	Number of Participants With Hypercholesterolemia	Month 1 (n= 20, 18, 19)	8 participants
CP-690,550 15 mg	Number of Participants With Hypercholesterolemia	Baseline (n= 18, 19, 21)	1 participants
CP-690,550 15 mg	Number of Participants With Hypercholesterolemia	Day 14 (n= 19, 19, 20)	5 participants
CP-690,550 15 mg	Number of Participants With Hypercholesterolemia	Month 6 (n= 17, 14, 18)	4 participants
CP-690,550 30 mg	Number of Participants With Hypercholesterolemia	Month 1 (n= 20, 18, 19)	6 participants
CP-690,550 30 mg	Number of Participants With Hypercholesterolemia	Baseline (n= 18, 19, 21)	1 participants
CP-690,550 30 mg	Number of Participants With Hypercholesterolemia	Day 14 (n= 19, 19, 20)	5 participants
CP-690,550 30 mg	Number of Participants With Hypercholesterolemia	Month 3 (n= 18, 18, 20)	5 participants
CP-690,550 30 mg	Number of Participants With Hypercholesterolemia	Month 6 (n= 17, 14, 18)	3 participants
Tacrolimus	Number of Participants With Hypercholesterolemia	Month 6 (n= 17, 14, 18)	1 participants
Tacrolimus	Number of Participants With Hypercholesterolemia	Month 3 (n= 18, 18, 20)	2 participants
Tacrolimus	Number of Participants With Hypercholesterolemia	Baseline (n= 18, 19, 21)	0 participants
Tacrolimus	Number of Participants With Hypercholesterolemia	Month 1 (n= 20, 18, 19)	2 participants
Tacrolimus	Number of Participants With Hypercholesterolemia	Day 14 (n= 19, 19, 20)	1 participants

Secondary

Number of Participants With Hypertriglyceridemia

Hypertriglyceridemia was defined as a value of triglycerides greater than 200 mg/dL.

Time frame: Baseline, Day 14, Month 1, 3, 6

Arm	Measure	Group	Value (NUMBER)
CP-690,550 15 mg	Number of Participants With Hypertriglyceridemia	Month 3 (n= 18, 18, 20)	5 participants
CP-690,550 15 mg	Number of Participants With Hypertriglyceridemia	Month 1 (n= 20, 18, 19)	7 participants
CP-690,550 15 mg	Number of Participants With Hypertriglyceridemia	Baseline (n= 18, 19, 21)	4 participants
CP-690,550 15 mg	Number of Participants With Hypertriglyceridemia	Day 14 (n= 19, 19, 20)	7 participants
CP-690,550 15 mg	Number of Participants With Hypertriglyceridemia	Month 6 (n= 17, 14, 18)	5 participants
CP-690,550 30 mg	Number of Participants With Hypertriglyceridemia	Month 1 (n= 20, 18, 19)	5 participants
CP-690,550 30 mg	Number of Participants With Hypertriglyceridemia	Baseline (n= 18, 19, 21)	7 participants
CP-690,550 30 mg	Number of Participants With Hypertriglyceridemia	Day 14 (n= 19, 19, 20)	2 participants
CP-690,550 30 mg	Number of Participants With Hypertriglyceridemia	Month 3 (n= 18, 18, 20)	5 participants
CP-690,550 30 mg	Number of Participants With Hypertriglyceridemia	Month 6 (n= 17, 14, 18)	5 participants
Tacrolimus	Number of Participants With Hypertriglyceridemia	Month 6 (n= 17, 14, 18)	1 participants
Tacrolimus	Number of Participants With Hypertriglyceridemia	Month 3 (n= 18, 18, 20)	2 participants
Tacrolimus	Number of Participants With Hypertriglyceridemia	Baseline (n= 18, 19, 21)	5 participants
Tacrolimus	Number of Participants With Hypertriglyceridemia	Month 1 (n= 20, 18, 19)	3 participants
Tacrolimus	Number of Participants With Hypertriglyceridemia	Day 14 (n= 19, 19, 20)	6 participants

Secondary

Number of Participants With New Onset Diabetes Mellitus (NODM)

Time frame: Month 3, 6

Population: FAS included all randomized participants who received at least 1 dose of study medication.

Arm	Measure	Group	Value (NUMBER)
CP-690,550 15 mg	Number of Participants With New Onset Diabetes Mellitus (NODM)	Month 3	0 participants
CP-690,550 15 mg	Number of Participants With New Onset Diabetes Mellitus (NODM)	Month 6	1 participants
CP-690,550 30 mg	Number of Participants With New Onset Diabetes Mellitus (NODM)	Month 3	0 participants
CP-690,550 30 mg	Number of Participants With New Onset Diabetes Mellitus (NODM)	Month 6	0 participants
Tacrolimus	Number of Participants With New Onset Diabetes Mellitus (NODM)	Month 3	2 participants
Tacrolimus	Number of Participants With New Onset Diabetes Mellitus (NODM)	Month 6	2 participants

Secondary

Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR)

Ordered categorical severity of first BPAR was classified according to the Banff Classification. Grade IA: moderate tubulitis, grade IB: severe tubulitis, grade IIA: mild to moderate intimal arteritis, grade IIB: severe intimal arteritis, grade III: transmural arteritis. (Racusen et al: The Banff classification, 1999).

Time frame: Month 3, 6

Population: FAS included all randomized participants who received at least 1 dose of study medication.

Arm	Measure	Group	Value (NUMBER)
CP-690,550 15 mg	Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR)	Month 3: IA	0 participants
CP-690,550 15 mg	Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR)	Month 3: IB	0 participants
CP-690,550 15 mg	Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR)	Month 3: IIA	0 participants
CP-690,550 15 mg	Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR)	Month 3: IIB	0 participants
CP-690,550 15 mg	Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR)	Month 3: III	0 participants
CP-690,550 15 mg	Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR)	Month 6: IA	0 participants
CP-690,550 15 mg	Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR)	Month 6: IB	0 participants
CP-690,550 15 mg	Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR)	Month 6: IIA	1 participants
CP-690,550 15 mg	Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR)	Month 6: IIB	0 participants
CP-690,550 15 mg	Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR)	Month 6: III	0 participants
CP-690,550 30 mg	Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR)	Month 6: IIB	1 participants
CP-690,550 30 mg	Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR)	Month 3: IA	1 participants
CP-690,550 30 mg	Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR)	Month 6: IA	1 participants
CP-690,550 30 mg	Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR)	Month 3: III	0 participants
CP-690,550 30 mg	Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR)	Month 3: IB	0 participants
CP-690,550 30 mg	Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR)	Month 6: III	0 participants
CP-690,550 30 mg	Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR)	Month 6: IIA	2 participants
CP-690,550 30 mg	Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR)	Month 3: IIA	2 participants
CP-690,550 30 mg	Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR)	Month 6: IB	0 participants
CP-690,550 30 mg	Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR)	Month 3: IIB	1 participants
Tacrolimus	Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR)	Month 6: IIA	1 participants
Tacrolimus	Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR)	Month 3: IIB	0 participants
Tacrolimus	Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR)	Month 3: III	0 participants
Tacrolimus	Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR)	Month 6: IA	0 participants
Tacrolimus	Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR)	Month 6: IIB	0 participants
Tacrolimus	Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR)	Month 6: IB	0 participants
Tacrolimus	Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR)	Month 3: IA	0 participants
Tacrolimus	Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR)	Month 6: III	0 participants
Tacrolimus	Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR)	Month 3: IB	0 participants
Tacrolimus	Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR)	Month 3: IIA	0 participants

Secondary

Number of Participants With Ordered Categorical Severity of First Biopsy Proven Chronic Allograft Nephropathy (BPCAN)

Ordered categorical severity of first BPCAN was classified according to the Banff Classification. Grade I: mild, grade II: moderate and grade III: severe interstitial fibrosis and tubular atrophy/loss. (Racusen et al: The Banff classification, 1999).

Time frame: Month 3, 6

Population: FAS included all randomized participants who received at least 1 dose of study medication.

Arm	Measure	Group	Value (NUMBER)
CP-690,550 15 mg	Number of Participants With Ordered Categorical Severity of First Biopsy Proven Chronic Allograft Nephropathy (BPCAN)	Month 3: Any severity	0 participants
CP-690,550 15 mg	Number of Participants With Ordered Categorical Severity of First Biopsy Proven Chronic Allograft Nephropathy (BPCAN)	Month 6: I	0 participants
CP-690,550 30 mg	Number of Participants With Ordered Categorical Severity of First Biopsy Proven Chronic Allograft Nephropathy (BPCAN)	Month 3: Any severity	0 participants
CP-690,550 30 mg	Number of Participants With Ordered Categorical Severity of First Biopsy Proven Chronic Allograft Nephropathy (BPCAN)	Month 6: I	2 participants
Tacrolimus	Number of Participants With Ordered Categorical Severity of First Biopsy Proven Chronic Allograft Nephropathy (BPCAN)	Month 3: Any severity	0 participants
Tacrolimus	Number of Participants With Ordered Categorical Severity of First Biopsy Proven Chronic Allograft Nephropathy (BPCAN)	Month 6: I	0 participants

Secondary

Number of Participants With Rejection

Rejection was defined as first occurrence of BPAR, antibody mediated rejection, or suspicious for acute rejection.

Time frame: Month 3, 6

Population: FAS included all randomized participants who received at least 1 dose of study medication.

Arm	Measure	Group	Value (NUMBER)
CP-690,550 15 mg	Number of Participants With Rejection	Month 3	1 participants
CP-690,550 15 mg	Number of Participants With Rejection	Month 6	2 participants
CP-690,550 30 mg	Number of Participants With Rejection	Month 3	4 participants
CP-690,550 30 mg	Number of Participants With Rejection	Month 6	4 participants
Tacrolimus	Number of Participants With Rejection	Month 3	1 participants
Tacrolimus	Number of Participants With Rejection	Month 6	1 participants

Secondary

Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 2 months after last dose that were absent before treatment or that worsened relative to pretreatment state.

Time frame: Baseline up to Month 8 (2 months follow-up)

Population: Safety analysis set included all randomized participants who received at least 1 dose of study medication.

Arm	Measure	Group	Value (NUMBER)
CP-690,550 15 mg	Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)	AEs	20 participants
CP-690,550 15 mg	Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)	SAEs	8 participants
CP-690,550 30 mg	Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)	AEs	18 participants
CP-690,550 30 mg	Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)	SAEs	10 participants
Tacrolimus	Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)	AEs	21 participants
Tacrolimus	Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)	SAEs	6 participants

Secondary

Number of Participants With Treatment Failure

Treatment failure was defined as the first occurrence of BPAR, graft loss, participant's death or premature discontinuation of study medication for any reason.

Time frame: Month 3, 6

Population: FAS included all randomized participants who received at least 1 dose of study medication.

Arm	Measure	Group	Value (NUMBER)
CP-690,550 15 mg	Number of Participants With Treatment Failure	Month 3	1 participants
CP-690,550 15 mg	Number of Participants With Treatment Failure	Month 6	3 participants
CP-690,550 30 mg	Number of Participants With Treatment Failure	Month 3	7 participants
CP-690,550 30 mg	Number of Participants With Treatment Failure	Month 6	9 participants
Tacrolimus	Number of Participants With Treatment Failure	Month 3	2 participants
Tacrolimus	Number of Participants With Treatment Failure	Month 6	3 participants

Secondary

Population Pharmacokinetics (PK)

Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.

Time frame: Pre-dose on Day 1, 3, 7, 14, Month 1, 3, 6, between 1 to 2 hours post-dose at Month 3 and between 3 to 4 hours post-dose at Month 6

Secondary

Reticulocyte Count

Reticulocytes are slightly immature red blood cells in the blood. Reticulocyte counts are reported as cells\*10\^3 per cubic millimeter (cells\*10\^3/mm\^3).

Time frame: Baseline, Day 14, Month 1, 3, 6

Arm	Measure	Group	Value (MEAN)	Dispersion
CP-690,550 15 mg	Reticulocyte Count	Month 1 (n= 19, 18, 19)	94.37 cells*10^3/mm^3	Standard Deviation 31.58
CP-690,550 15 mg	Reticulocyte Count	Day 14 (n= 18, 19, 18)	93.06 cells*10^3/mm^3	Standard Deviation 50.13
CP-690,550 15 mg	Reticulocyte Count	Month 3 (n= 19, 17, 20)	83.00 cells*10^3/mm^3	Standard Deviation 41.52
CP-690,550 15 mg	Reticulocyte Count	Month 6 (n= 16, 14, 18)	79.81 cells*10^3/mm^3	Standard Deviation 43.02
CP-690,550 15 mg	Reticulocyte Count	Baseline (n= 20, 20, 21)	81.75 cells*10^3/mm^3	Standard Deviation 58.39
CP-690,550 30 mg	Reticulocyte Count	Month 1 (n= 19, 18, 19)	87.39 cells*10^3/mm^3	Standard Deviation 33.55
CP-690,550 30 mg	Reticulocyte Count	Month 3 (n= 19, 17, 20)	90.94 cells*10^3/mm^3	Standard Deviation 31.64
CP-690,550 30 mg	Reticulocyte Count	Baseline (n= 20, 20, 21)	68.50 cells*10^3/mm^3	Standard Deviation 30.4
CP-690,550 30 mg	Reticulocyte Count	Month 6 (n= 16, 14, 18)	73.07 cells*10^3/mm^3	Standard Deviation 12.46
CP-690,550 30 mg	Reticulocyte Count	Day 14 (n= 18, 19, 18)	109.47 cells*10^3/mm^3	Standard Deviation 73.6
Tacrolimus	Reticulocyte Count	Day 14 (n= 18, 19, 18)	81.61 cells*10^3/mm^3	Standard Deviation 39.43
Tacrolimus	Reticulocyte Count	Month 1 (n= 19, 18, 19)	101.37 cells*10^3/mm^3	Standard Deviation 50.3
Tacrolimus	Reticulocyte Count	Month 6 (n= 16, 14, 18)	71.89 cells*10^3/mm^3	Standard Deviation 30.85
Tacrolimus	Reticulocyte Count	Baseline (n= 20, 20, 21)	75.67 cells*10^3/mm^3	Standard Deviation 38.96
Tacrolimus	Reticulocyte Count	Month 3 (n= 19, 17, 20)	85.90 cells*10^3/mm^3	Standard Deviation 30.19

Secondary

Supine Systolic and Diastolic Blood Pressure (BP)

Time frame: Baseline, Day 2, 3, 14, Month 1, 3, 6

Arm	Measure	Group	Value (MEAN)	Dispersion
CP-690,550 15 mg	Supine Systolic and Diastolic Blood Pressure (BP)	SBP: Day 14 (n= 20, 19, 20)	135.90 millimeter of mercury	Standard Deviation 24.43
CP-690,550 15 mg	Supine Systolic and Diastolic Blood Pressure (BP)	DBP: Month 3 (n= 19, 18, 21)	80.42 millimeter of mercury	Standard Deviation 10.91
CP-690,550 15 mg	Supine Systolic and Diastolic Blood Pressure (BP)	DBP: Day 3 (n= 18, 19, 18)	82.50 millimeter of mercury	Standard Deviation 10.59
CP-690,550 15 mg	Supine Systolic and Diastolic Blood Pressure (BP)	SBP: Day 3 (n= 18, 19, 18)	146.78 millimeter of mercury	Standard Deviation 17.33
CP-690,550 15 mg	Supine Systolic and Diastolic Blood Pressure (BP)	DBP: Month 6 (n= 17, 13, 19)	77.24 millimeter of mercury	Standard Deviation 10.46
CP-690,550 15 mg	Supine Systolic and Diastolic Blood Pressure (BP)	DBP: Day 2 (n= 19, 20, 20)	79.05 millimeter of mercury	Standard Deviation 13.62
CP-690,550 15 mg	Supine Systolic and Diastolic Blood Pressure (BP)	SBP: Day 2 (n= 19, 20, 20)	141.16 millimeter of mercury	Standard Deviation 18.66
CP-690,550 15 mg	Supine Systolic and Diastolic Blood Pressure (BP)	Systolic BP (SBP): Baseline (n= 20, 20, 21)	139.65 millimeter of mercury	Standard Deviation 23.22
CP-690,550 15 mg	Supine Systolic and Diastolic Blood Pressure (BP)	SBP: Month 1 (n= 20, 18, 19)	129.05 millimeter of mercury	Standard Deviation 19.06
CP-690,550 15 mg	Supine Systolic and Diastolic Blood Pressure (BP)	DBP: Day 14 (n= 20, 19, 20)	78.45 millimeter of mercury	Standard Deviation 11.83
CP-690,550 15 mg	Supine Systolic and Diastolic Blood Pressure (BP)	SBP: Month 6 (n= 17, 13, 19)	135.76 millimeter of mercury	Standard Deviation 17.08
CP-690,550 15 mg	Supine Systolic and Diastolic Blood Pressure (BP)	Diastolic BP (DBP) : Baseline (n= 20, 20, 21)	77.10 millimeter of mercury	Standard Deviation 14.04
CP-690,550 15 mg	Supine Systolic and Diastolic Blood Pressure (BP)	DBP: Month 1 (n= 20, 18, 19)	78.95 millimeter of mercury	Standard Deviation 11.08
CP-690,550 15 mg	Supine Systolic and Diastolic Blood Pressure (BP)	SBP: Month 3 (n= 19, 18, 21)	140.32 millimeter of mercury	Standard Deviation 20.58
CP-690,550 30 mg	Supine Systolic and Diastolic Blood Pressure (BP)	SBP: Day 14 (n= 20, 19, 20)	141.16 millimeter of mercury	Standard Deviation 19.48
CP-690,550 30 mg	Supine Systolic and Diastolic Blood Pressure (BP)	Diastolic BP (DBP) : Baseline (n= 20, 20, 21)	75.25 millimeter of mercury	Standard Deviation 9.95
CP-690,550 30 mg	Supine Systolic and Diastolic Blood Pressure (BP)	DBP: Day 2 (n= 19, 20, 20)	80.20 millimeter of mercury	Standard Deviation 9.68
CP-690,550 30 mg	Supine Systolic and Diastolic Blood Pressure (BP)	DBP: Day 3 (n= 18, 19, 18)	88.05 millimeter of mercury	Standard Deviation 9.45
CP-690,550 30 mg	Supine Systolic and Diastolic Blood Pressure (BP)	DBP: Day 14 (n= 20, 19, 20)	81.21 millimeter of mercury	Standard Deviation 8.15
CP-690,550 30 mg	Supine Systolic and Diastolic Blood Pressure (BP)	DBP: Month 1 (n= 20, 18, 19)	80.83 millimeter of mercury	Standard Deviation 9.29
CP-690,550 30 mg	Supine Systolic and Diastolic Blood Pressure (BP)	DBP: Month 3 (n= 19, 18, 21)	76.06 millimeter of mercury	Standard Deviation 12.66
CP-690,550 30 mg	Supine Systolic and Diastolic Blood Pressure (BP)	DBP: Month 6 (n= 17, 13, 19)	83.23 millimeter of mercury	Standard Deviation 10.21
CP-690,550 30 mg	Supine Systolic and Diastolic Blood Pressure (BP)	Systolic BP (SBP): Baseline (n= 20, 20, 21)	139.45 millimeter of mercury	Standard Deviation 18.98
CP-690,550 30 mg	Supine Systolic and Diastolic Blood Pressure (BP)	SBP: Day 2 (n= 19, 20, 20)	143.55 millimeter of mercury	Standard Deviation 13.87
CP-690,550 30 mg	Supine Systolic and Diastolic Blood Pressure (BP)	SBP: Day 3 (n= 18, 19, 18)	152.42 millimeter of mercury	Standard Deviation 14.47
CP-690,550 30 mg	Supine Systolic and Diastolic Blood Pressure (BP)	SBP: Month 1 (n= 20, 18, 19)	136.22 millimeter of mercury	Standard Deviation 15.01
CP-690,550 30 mg	Supine Systolic and Diastolic Blood Pressure (BP)	SBP: Month 3 (n= 19, 18, 21)	133.44 millimeter of mercury	Standard Deviation 20.05
CP-690,550 30 mg	Supine Systolic and Diastolic Blood Pressure (BP)	SBP: Month 6 (n= 17, 13, 19)	134.31 millimeter of mercury	Standard Deviation 14.82
Tacrolimus	Supine Systolic and Diastolic Blood Pressure (BP)	SBP: Month 3 (n= 19, 18, 21)	124.00 millimeter of mercury	Standard Deviation 14.65
Tacrolimus	Supine Systolic and Diastolic Blood Pressure (BP)	SBP: Day 3 (n= 18, 19, 18)	139.94 millimeter of mercury	Standard Deviation 18.13
Tacrolimus	Supine Systolic and Diastolic Blood Pressure (BP)	DBP: Month 1 (n= 20, 18, 19)	76.32 millimeter of mercury	Standard Deviation 11.61
Tacrolimus	Supine Systolic and Diastolic Blood Pressure (BP)	DBP: Day 14 (n= 20, 19, 20)	75.20 millimeter of mercury	Standard Deviation 7.29
Tacrolimus	Supine Systolic and Diastolic Blood Pressure (BP)	SBP: Day 14 (n= 20, 19, 20)	121.45 millimeter of mercury	Standard Deviation 17.01
Tacrolimus	Supine Systolic and Diastolic Blood Pressure (BP)	DBP: Day 3 (n= 18, 19, 18)	82.61 millimeter of mercury	Standard Deviation 9.67
Tacrolimus	Supine Systolic and Diastolic Blood Pressure (BP)	Diastolic BP (DBP) : Baseline (n= 20, 20, 21)	76.52 millimeter of mercury	Standard Deviation 17.71
Tacrolimus	Supine Systolic and Diastolic Blood Pressure (BP)	SBP: Month 1 (n= 20, 18, 19)	128.21 millimeter of mercury	Standard Deviation 13.57
Tacrolimus	Supine Systolic and Diastolic Blood Pressure (BP)	DBP: Day 2 (n= 19, 20, 20)	78.50 millimeter of mercury	Standard Deviation 10.37
Tacrolimus	Supine Systolic and Diastolic Blood Pressure (BP)	Systolic BP (SBP): Baseline (n= 20, 20, 21)	136.24 millimeter of mercury	Standard Deviation 27.68
Tacrolimus	Supine Systolic and Diastolic Blood Pressure (BP)	DBP: Month 6 (n= 17, 13, 19)	79.00 millimeter of mercury	Standard Deviation 9.99
Tacrolimus	Supine Systolic and Diastolic Blood Pressure (BP)	SBP: Month 6 (n= 17, 13, 19)	128.00 millimeter of mercury	Standard Deviation 17.94
Tacrolimus	Supine Systolic and Diastolic Blood Pressure (BP)	SBP: Day 2 (n= 19, 20, 20)	136.05 millimeter of mercury	Standard Deviation 20.14
Tacrolimus	Supine Systolic and Diastolic Blood Pressure (BP)	DBP: Month 3 (n= 19, 18, 21)	77.33 millimeter of mercury	Standard Deviation 10.88

Secondary

Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels

Time frame: Baseline, Day 14, Month 1, 3, 6

Arm	Measure	Group	Value (MEAN)	Dispersion
CP-690,550 15 mg	Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels	LDL: Baseline (n=18,18,19)	93.17 mg/dL	Standard Deviation 28.08
CP-690,550 15 mg	Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels	Total serum cholesterol: Month 1 (n=20,18,19)	245.20 mg/dL	Standard Deviation 48.51
CP-690,550 15 mg	Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels	HDL: Baseline (n=18,19,21)	43.89 mg/dL	Standard Deviation 13.01
CP-690,550 15 mg	Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels	LDL: Day 14 (n=17,19,20)	114.71 mg/dL	Standard Deviation 36.6
CP-690,550 15 mg	Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels	Total serum cholesterol: Day 14 (n=19,19,20)	217.21 mg/dL	Standard Deviation 44.79
CP-690,550 15 mg	Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels	LDL: Month 6 (n=17,14,18)	117.00 mg/dL	Standard Deviation 27.2
CP-690,550 15 mg	Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels	LDL: Month 1 (n=18,18,19)	139.28 mg/dL	Standard Deviation 35.85
CP-690,550 15 mg	Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels	HDL: Month 1 (n=20,18,19)	75.65 mg/dL	Standard Deviation 19.26
CP-690,550 15 mg	Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels	LDL: Month 3 (n=18,18,20)	118.72 mg/dL	Standard Deviation 33.15
CP-690,550 15 mg	Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels	Total serum cholesterol: Month 3 (n=18,18,20)	216.17 mg/dL	Standard Deviation 38.92
CP-690,550 15 mg	Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels	HDL: Month 6 (n=17,14,18)	59.53 mg/dL	Standard Deviation 18.43
CP-690,550 15 mg	Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels	Total serum cholesterol: Baseline (n=18,19,21)	168.78 mg/dL	Standard Deviation 34.33
CP-690,550 15 mg	Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels	Total serum cholesterol: Month 6 (n=17,14,18)	207.88 mg/dL	Standard Deviation 36.01
CP-690,550 15 mg	Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels	HDL: Month 3 (n=18,18,20)	66.17 mg/dL	Standard Deviation 16.51
CP-690,550 15 mg	Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels	HDL: Day 14 (n=19,19,20)	61.58 mg/dL	Standard Deviation 13.2
CP-690,550 30 mg	Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels	HDL: Day 14 (n=19,19,20)	64.16 mg/dL	Standard Deviation 16.54
CP-690,550 30 mg	Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels	Total serum cholesterol: Baseline (n=18,19,21)	159.79 mg/dL	Standard Deviation 39.2
CP-690,550 30 mg	Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels	Total serum cholesterol: Day 14 (n=19,19,20)	208.05 mg/dL	Standard Deviation 56.37
CP-690,550 30 mg	Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels	Total serum cholesterol: Month 1 (n=20,18,19)	232.17 mg/dL	Standard Deviation 66.17
CP-690,550 30 mg	Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels	Total serum cholesterol: Month 3 (n=18,18,20)	203.00 mg/dL	Standard Deviation 49.34
CP-690,550 30 mg	Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels	Total serum cholesterol: Month 6 (n=17,14,18)	206.07 mg/dL	Standard Deviation 38.72
CP-690,550 30 mg	Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels	LDL: Baseline (n=18,18,19)	87.78 mg/dL	Standard Deviation 27.85
CP-690,550 30 mg	Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels	LDL: Day 14 (n=17,19,20)	113.05 mg/dL	Standard Deviation 38.08
CP-690,550 30 mg	Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels	LDL: Month 1 (n=18,18,19)	130.50 mg/dL	Standard Deviation 48.8
CP-690,550 30 mg	Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels	LDL: Month 3 (n=18,18,20)	114.06 mg/dL	Standard Deviation 35.1
CP-690,550 30 mg	Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels	LDL: Month 6 (n=17,14,18)	119.00 mg/dL	Standard Deviation 28.21
CP-690,550 30 mg	Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels	HDL: Baseline (n=18,19,21)	36.84 mg/dL	Standard Deviation 12.76
CP-690,550 30 mg	Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels	HDL: Month 1 (n=20,18,19)	69.06 mg/dL	Standard Deviation 21.29
CP-690,550 30 mg	Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels	HDL: Month 3 (n=18,18,20)	56.11 mg/dL	Standard Deviation 17.88
CP-690,550 30 mg	Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels	HDL: Month 6 (n=17,14,18)	51.50 mg/dL	Standard Deviation 12.78
Tacrolimus	Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels	LDL: Baseline (n=18,18,19)	90.74 mg/dL	Standard Deviation 31.76
Tacrolimus	Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels	HDL: Month 3 (n=18,18,20)	54.05 mg/dL	Standard Deviation 13.8
Tacrolimus	Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels	HDL: Baseline (n=18,19,21)	46.00 mg/dL	Standard Deviation 11.75
Tacrolimus	Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels	Total serum cholesterol: Month 6 (n=17,14,18)	195.50 mg/dL	Standard Deviation 43.28
Tacrolimus	Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels	Total serum cholesterol: Month 3 (n=18,18,20)	193.90 mg/dL	Standard Deviation 39.74
Tacrolimus	Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels	HDL: Day 14 (n=19,19,20)	55.05 mg/dL	Standard Deviation 16.77
Tacrolimus	Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels	Total serum cholesterol: Month 1 (n=20,18,19)	202.89 mg/dL	Standard Deviation 31.94
Tacrolimus	Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels	Total serum cholesterol: Baseline (n=18,19,21)	166.86 mg/dL	Standard Deviation 38.25
Tacrolimus	Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels	HDL: Month 1 (n=20,18,19)	62.16 mg/dL	Standard Deviation 19.66
Tacrolimus	Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels	LDL: Month 1 (n=18,18,19)	110.32 mg/dL	Standard Deviation 26.78
Tacrolimus	Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels	Total serum cholesterol: Day 14 (n=19,19,20)	184.95 mg/dL	Standard Deviation 36.79
Tacrolimus	Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels	LDL: Month 3 (n=18,18,20)	111.50 mg/dL	Standard Deviation 34.87
Tacrolimus	Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels	LDL: Day 14 (n=17,19,20)	98.70 mg/dL	Standard Deviation 25.81
Tacrolimus	Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels	HDL: Month 6 (n=17,14,18)	55.00 mg/dL	Standard Deviation 14.97
Tacrolimus	Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels	LDL: Month 6 (n=17,14,18)	114.50 mg/dL	Standard Deviation 36.61

Secondary

Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil

Time frame: Baseline, Day 14, Month 1, 3, 6

Population: Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here 'n' signifies those participants evaluable at specific time points.

Arm	Measure	Group	Value (MEAN)	Dispersion
CP-690,550 15 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Eosinophil: Baseline (n= 20, 20, 21)	0.08 cells*10^3/mm^3	Standard Deviation 0.08
CP-690,550 15 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Neutrophil: Day 14 (n= 18, 19, 18)	10.01 cells*10^3/mm^3	Standard Deviation 3.14
CP-690,550 15 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Monocyte: Baseline (n= 20, 20, 21)	0.58 cells*10^3/mm^3	Standard Deviation 0.44
CP-690,550 15 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Eosinophil: Day 14 (n= 18, 19, 18)	0.17 cells*10^3/mm^3	Standard Deviation 0.13
CP-690,550 15 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	WBC: Month 6 (n= 16, 14, 18)	5.57 cells*10^3/mm^3	Standard Deviation 1.95
CP-690,550 15 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Lymphocyte: Month 6 (n= 16, 14, 18)	1.44 cells*10^3/mm^3	Standard Deviation 0.61
CP-690,550 15 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Eosinophil: Month 1 (n= 19,18, 19)	0.14 cells*10^3/mm^3	Standard Deviation 0.1
CP-690,550 15 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Neutrophil: Month 3 (n= 19, 17, 20)	3.68 cells*10^3/mm^3	Standard Deviation 2.21
CP-690,550 15 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Lymphocyte: Month 3 (n= 19, 17, 20)	1.26 cells*10^3/mm^3	Standard Deviation 0.57
CP-690,550 15 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Eosinophil: Month 3 (n= 19, 17, 20)	0.10 cells*10^3/mm^3	Standard Deviation 0.03
CP-690,550 15 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Neutrophil: Baseline (n= 20, 20, 21)	11.63 cells*10^3/mm^3	Standard Deviation 3.73
CP-690,550 15 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Lymphocyte: Month 1 (n= 19,18, 19)	1.96 cells*10^3/mm^3	Standard Deviation 1.22
CP-690,550 15 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Eosinophil: Month 6 (n= 16, 14, 18)	0.11 cells*10^3/mm^3	Standard Deviation 0.05
CP-690,550 15 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Basophil: Baseline (n= 20, 20, 21)	0.04 cells*10^3/mm^3	Standard Deviation 0.05
CP-690,550 15 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Lymphocyte: Day 14 (n= 18, 19, 18)	2.03 cells*10^3/mm^3	Standard Deviation 1.43
CP-690,550 15 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Lymphocyte: Baseline (n= 20, 20, 21)	0.61 cells*10^3/mm^3	Standard Deviation 0.41
CP-690,550 15 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	WBC: Month 1 (n= 19,18, 19)	7.33 cells*10^3/mm^3	Standard Deviation 1.85
CP-690,550 15 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Monocyte: Month 6 (n= 16, 14, 18)	0.31 cells*10^3/mm^3	Standard Deviation 0.15
CP-690,550 15 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Basophil: Day 14 (n= 18, 19, 18)	0.09 cells*10^3/mm^3	Standard Deviation 0.07
CP-690,550 15 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	WBC: Day 14 (n= 18, 19, 18)	12.76 cells*10^3/mm^3	Standard Deviation 3.68
CP-690,550 15 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Monocyte: Month 3 (n= 19, 17, 20)	0.31 cells*10^3/mm^3	Standard Deviation 0.17
CP-690,550 15 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Basophil: Month 1 (n= 19,18, 19)	0.05 cells*10^3/mm^3	Standard Deviation 0.08
CP-690,550 15 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Neutrophil: Month 1 (n= 19,18, 19)	4.85 cells*10^3/mm^3	Standard Deviation 1.86
CP-690,550 15 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	WBC: Baseline (n= 20, 20, 21)	12.75 cells*10^3/mm^3	Standard Deviation 3.79
CP-690,550 15 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Basophil: Month 3 (n= 19, 17, 20)	0.04 cells*10^3/mm^3	Standard Deviation 0.05
CP-690,550 15 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	WBC: Month 3 (n= 19, 17, 20)	5.47 cells*10^3/mm^3	Standard Deviation 2.52
CP-690,550 15 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Monocyte: Month 1 (n= 19,18, 19)	0.26 cells*10^3/mm^3	Standard Deviation 0.12
CP-690,550 15 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Basophil: Month 6 (n= 16, 14, 18)	0.04 cells*10^3/mm^3	Standard Deviation 0.05
CP-690,550 15 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Neutrophil: Month 6 (n= 16, 14, 18)	3.68 cells*10^3/mm^3	Standard Deviation 1.67
CP-690,550 15 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Monocyte: Day 14 (n= 18, 19, 18)	0.36 cells*10^3/mm^3	Standard Deviation 0.16
CP-690,550 30 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Monocyte: Month 1 (n= 19,18, 19)	0.32 cells*10^3/mm^3	Standard Deviation 0.13
CP-690,550 30 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	WBC: Baseline (n= 20, 20, 21)	11.09 cells*10^3/mm^3	Standard Deviation 3.57
CP-690,550 30 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	WBC: Day 14 (n= 18, 19, 18)	13.81 cells*10^3/mm^3	Standard Deviation 3.49
CP-690,550 30 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	WBC: Month 1 (n= 19,18, 19)	7.41 cells*10^3/mm^3	Standard Deviation 2.8
CP-690,550 30 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	WBC: Month 3 (n= 19, 17, 20)	6.15 cells*10^3/mm^3	Standard Deviation 2.82
CP-690,550 30 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	WBC: Month 6 (n= 16, 14, 18)	5.11 cells*10^3/mm^3	Standard Deviation 2.22
CP-690,550 30 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Basophil: Baseline (n= 20, 20, 21)	0.01 cells*10^3/mm^3	Standard Deviation 0.03
CP-690,550 30 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Basophil: Day 14 (n= 18, 19, 18)	0.11 cells*10^3/mm^3	Standard Deviation 0.08
CP-690,550 30 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Basophil: Month 1 (n= 19,18, 19)	0.07 cells*10^3/mm^3	Standard Deviation 0.06
CP-690,550 30 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Basophil: Month 3 (n= 19, 17, 20)	0.05 cells*10^3/mm^3	Standard Deviation 0.05
CP-690,550 30 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Basophil: Month 6 (n= 16, 14, 18)	0.04 cells*10^3/mm^3	Standard Deviation 0.05
CP-690,550 30 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Eosinophil: Baseline (n= 20, 20, 21)	0.06 cells*10^3/mm^3	Standard Deviation 0.08
CP-690,550 30 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Eosinophil: Day 14 (n= 18, 19, 18)	0.21 cells*10^3/mm^3	Standard Deviation 0.12
CP-690,550 30 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Eosinophil: Month 1 (n= 19,18, 19)	0.19 cells*10^3/mm^3	Standard Deviation 0.16
CP-690,550 30 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Eosinophil: Month 3 (n= 19, 17, 20)	0.11 cells*10^3/mm^3	Standard Deviation 0.07
CP-690,550 30 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Eosinophil: Month 6 (n= 16, 14, 18)	0.11 cells*10^3/mm^3	Standard Deviation 0.08
CP-690,550 30 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Lymphocyte: Baseline (n= 20, 20, 21)	0.52 cells*10^3/mm^3	Standard Deviation 0.23
CP-690,550 30 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Lymphocyte: Day 14 (n= 18, 19, 18)	2.48 cells*10^3/mm^3	Standard Deviation 1.4
CP-690,550 30 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Lymphocyte: Month 1 (n= 19,18, 19)	1.77 cells*10^3/mm^3	Standard Deviation 0.79
CP-690,550 30 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Lymphocyte: Month 3 (n= 19, 17, 20)	1.61 cells*10^3/mm^3	Standard Deviation 0.97
CP-690,550 30 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Lymphocyte: Month 6 (n= 16, 14, 18)	1.28 cells*10^3/mm^3	Standard Deviation 0.81
CP-690,550 30 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Monocyte: Baseline (n= 20, 20, 21)	0.39 cells*10^3/mm^3	Standard Deviation 0.22
CP-690,550 30 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Monocyte: Day 14 (n= 18, 19, 18)	0.41 cells*10^3/mm^3	Standard Deviation 0.19
CP-690,550 30 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Monocyte: Month 3 (n= 19, 17, 20)	0.34 cells*10^3/mm^3	Standard Deviation 0.19
CP-690,550 30 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Monocyte: Month 6 (n= 16, 14, 18)	0.25 cells*10^3/mm^3	Standard Deviation 0.15
CP-690,550 30 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Neutrophil: Baseline (n= 20, 20, 21)	10.06 cells*10^3/mm^3	Standard Deviation 3.53
CP-690,550 30 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Neutrophil: Day 14 (n= 18, 19, 18)	10.48 cells*10^3/mm^3	Standard Deviation 3.05
CP-690,550 30 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Neutrophil: Month 1 (n= 19,18, 19)	4.93 cells*10^3/mm^3	Standard Deviation 2.5
CP-690,550 30 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Neutrophil: Month 3 (n= 19, 17, 20)	3.96 cells*10^3/mm^3	Standard Deviation 2.01
CP-690,550 30 mg	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Neutrophil: Month 6 (n= 16, 14, 18)	3.37 cells*10^3/mm^3	Standard Deviation 1.65
Tacrolimus	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Eosinophil: Baseline (n= 20, 20, 21)	0.12 cells*10^3/mm^3	Standard Deviation 0.2
Tacrolimus	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	WBC: Month 1 (n= 19,18, 19)	7.43 cells*10^3/mm^3	Standard Deviation 2.08
Tacrolimus	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Monocyte: Baseline (n= 20, 20, 21)	0.44 cells*10^3/mm^3	Standard Deviation 0.26
Tacrolimus	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Basophil: Month 6 (n= 16, 14, 18)	0.06 cells*10^3/mm^3	Standard Deviation 0.06
Tacrolimus	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	WBC: Baseline (n= 20, 20, 21)	11.82 cells*10^3/mm^3	Standard Deviation 5.16
Tacrolimus	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Monocyte: Day 14 (n= 18, 19, 18)	0.34 cells*10^3/mm^3	Standard Deviation 0.14
Tacrolimus	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Basophil: Month 3 (n= 19, 17, 20)	0.04 cells*10^3/mm^3	Standard Deviation 0.05
Tacrolimus	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Basophil: Month 1 (n= 19,18, 19)	0.06 cells*10^3/mm^3	Standard Deviation 0.05
Tacrolimus	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Monocyte: Month 1 (n= 19,18, 19)	0.28 cells*10^3/mm^3	Standard Deviation 0.09
Tacrolimus	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Basophil: Day 14 (n= 18, 19, 18)	0.05 cells*10^3/mm^3	Standard Deviation 0.05
Tacrolimus	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Neutrophil: Month 1 (n= 19,18, 19)	5.05 cells*10^3/mm^3	Standard Deviation 1.82
Tacrolimus	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Monocyte: Month 3 (n= 19, 17, 20)	0.28 cells*10^3/mm^3	Standard Deviation 0.09
Tacrolimus	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Basophil: Baseline (n= 20, 20, 21)	0.02 cells*10^3/mm^3	Standard Deviation 0.04
Tacrolimus	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	WBC: Day 14 (n= 18, 19, 18)	10.24 cells*10^3/mm^3	Standard Deviation 3.1
Tacrolimus	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Monocyte: Month 6 (n= 16, 14, 18)	0.34 cells*10^3/mm^3	Standard Deviation 0.12
Tacrolimus	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	WBC: Month 6 (n= 16, 14, 18)	6.06 cells*10^3/mm^3	Standard Deviation 2.89
Tacrolimus	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Neutrophil: Month 6 (n= 16, 14, 18)	3.94 cells*10^3/mm^3	Standard Deviation 2.27
Tacrolimus	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Lymphocyte: Baseline (n= 20, 20, 21)	0.75 cells*10^3/mm^3	Standard Deviation 0.45
Tacrolimus	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Eosinophil: Month 6 (n= 16, 14, 18)	0.17 cells*10^3/mm^3	Standard Deviation 0.12
Tacrolimus	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Neutrophil: Baseline (n= 20, 20, 21)	10.37 cells*10^3/mm^3	Standard Deviation 4.84
Tacrolimus	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Lymphocyte: Day 14 (n= 18, 19, 18)	1.84 cells*10^3/mm^3	Standard Deviation 0.93
Tacrolimus	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Eosinophil: Month 3 (n= 19, 17, 20)	0.11 cells*10^3/mm^3	Standard Deviation 0.07
Tacrolimus	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	WBC: Month 3 (n= 19, 17, 20)	5.48 cells*10^3/mm^3	Standard Deviation 1.85
Tacrolimus	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Lymphocyte: Month 1 (n= 19,18, 19)	1.81 cells*10^3/mm^3	Standard Deviation 0.76
Tacrolimus	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Eosinophil: Month 1 (n= 19,18, 19)	0.13 cells*10^3/mm^3	Standard Deviation 0.09
Tacrolimus	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Neutrophil: Month 3 (n= 19, 17, 20)	3.72 cells*10^3/mm^3	Standard Deviation 1.9
Tacrolimus	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Lymphocyte: Month 3 (n= 19, 17, 20)	1.29 cells*10^3/mm^3	Standard Deviation 0.56
Tacrolimus	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Eosinophil: Day 14 (n= 18, 19, 18)	0.13 cells*10^3/mm^3	Standard Deviation 0.08
Tacrolimus	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Neutrophil: Day 14 (n= 18, 19, 18)	7.78 cells*10^3/mm^3	Standard Deviation 2.99
Tacrolimus	Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil	Lymphocyte: Month 6 (n= 16, 14, 18)	1.47 cells*10^3/mm^3	Standard Deviation 0.68

Secondary

Trough Levels of Tacrolimus (TAC)

Time frame: Pre-dose on Day 14, Month 1, 3, 6

Arm	Measure	Group	Value (MEAN)	Dispersion
CP-690,550 15 mg	Trough Levels of Tacrolimus (TAC)	Day 14 (n= 18)	11.17 nanogram/milliliter (ng/mL)	Standard Deviation 4.15
CP-690,550 15 mg	Trough Levels of Tacrolimus (TAC)	Month 1 (n= 18)	9.11 nanogram/milliliter (ng/mL)	Standard Deviation 3.2
CP-690,550 15 mg	Trough Levels of Tacrolimus (TAC)	Month 3 (n= 17)	8.82 nanogram/milliliter (ng/mL)	Standard Deviation 4.05
CP-690,550 15 mg	Trough Levels of Tacrolimus (TAC)	Month 6 (n= 15)	8.33 nanogram/milliliter (ng/mL)	Standard Deviation 4.06

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

A 6-Month Study Of CP-690,550 Versus Tacrolimus In Kidney Transplant Patients

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Glomerular Filtration Rate (GFR) by Nankivell Equation at Month 6

Number of Participants With First Biopsy Proven Acute Rejection (BPAR) at Month 6

36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)

Absolute Platelet Levels

Alanine Aminotransferase (ALT) Level

BK Virus (BKV) Deoxyribonucleic Acid (DNA) Load

Electrocardiogram (ECG) Parameters

End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL)

Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load

Fasting Serum Glucose Levels

Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets

Glomerular Filtration Rate (GFR) by Cockcroft-Gault

Glomerular Filtration Rate (GFR) by Modification of Diet in Renal Disease (MDRD) Equation

Glomerular Filtration Rate (GFR) by Reciprocal of Serum Creatinine (1/sCr)

Healthcare Resource Utilization Questionnaire (HCRUQ)

Healthcare Resource Utilization Questionnaire (HCRUQ) - 5th Question

Hematocrit Level

Hemoglobin Level

Number of Participants Who Died

Number of Participants With Cytomegalovirus (CMV) Disease

Number of Participants With Discontinuation

Number of Participants With Drug Usage

Number of Participants With Efficacy Failure

Number of Participants With First Biopsy Proven Acute Rejection (BPAR) at Month 3

Number of Participants With First Biopsy Proven Chronic Allograft Nephropathy (BPCAN)

Number of Participants With First Clinically Significant Infection

Number of Participants With Graft Loss

Number of Participants With Hypercholesterolemia

Number of Participants With Hypertriglyceridemia

Number of Participants With New Onset Diabetes Mellitus (NODM)

Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR)

Number of Participants With Ordered Categorical Severity of First Biopsy Proven Chronic Allograft Nephropathy (BPCAN)

Number of Participants With Rejection

Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

Number of Participants With Treatment Failure

Population Pharmacokinetics (PK)

Reticulocyte Count

Supine Systolic and Diastolic Blood Pressure (BP)

Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels

Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil

Trough Levels of Tacrolimus (TAC)