Kidney Transplantation
Conditions
Keywords
Immunosuppression, JAK3 inhibitor, kidney transplantation.
Brief summary
A new immunosuppressive drug, based on the inhibition of an important enzyme in the immune system called JAK3, is being developed by Pfizer to prevent transplant rejection. In this research study, a JAK3 inhibitor or cyclosporine will be given to new kidney transplant patients for 12 months. Patients will be assigned to one of three treatment groups after receiving a kidney transplant. Two of the treatment groups will receive 2 different dosing regimens of the JAK3 inhibitor that will be taken by mouth. The third treatment group will be a standard-of-care control arm. Patients will continue to take the assigned study medication for 12 months as well as other standard transplant medications such as prednisone.
Interventions
DRUGCyclosporine
Standard of care
DRUGCP-690,550
CP-690,550 15 mg BID for Months 1-6, then 10 mg BID for Months 7-12
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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 Clinical Biopsy Proven Acute Rejection (BPAR) Episode 6 Months Post-Transplant | Baseline up to Month 6 | Clinical BPAR was a BPAR (category acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification) associated with an increase in serum creatinine of \>= 0.3 milligram per deciliter (mg/dL) and \>=20 percent (%) from pre-rejection baseline. The increase in serum creatinine was assessed based on the comparison of baseline and the highest serum creatinine recorded within 24 hours (hrs) of the time of biopsy. |
| Glomerular Filtration Rate (GFR) at Month 12 | 2, 3, 4, and 5 hrs post iohexol intravenous bolus at Month 12 | GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using iohexol serum clearance. For determination of iohexol serum clearance, iohexol was administered as an intravenous bolus over 5 minutes immediately after morning dosing of CP-690,550 or CsA on day of GFR evaluation. A normal GFR is greater than (\>) 90 milliliter per minute (mL/min), although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR less than (\<) 15 mL/min indicated kidney failure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With First Clinical Biopsy Proven Acute Rejection (BPAR) 12 Months Post Transplant | Baseline up to Month 12 | Clinical BPAR was a BPAR (category acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification) associated with an increase in serum creatinine of \>= 0.3 mg/dL and \>=20% from pre-rejection baseline. The increase in serum creatinine was assessed based on the comparison of baseline and the highest serum creatinine recorded within 24 hrs of the time of biopsy. |
| Number of Participants With Treated Clinical Acute Rejection | Month 6, 12 | Treated clinical acute rejection was defined as an acute rejection episode that was diagnosed based on local biopsy readout and received anti-rejection treatment. |
| Number of Participants With Combined Banff Rejection Categories (Categories 2, 3, and 4) | Month 6, 12 | Banff 97: standard classification for scoring and classifying rejection of kidney transplant biopsies in 6 diagnostic categories: normal, antibody-mediated rejection, borderline changes: 'suspicious' for acute cellular rejection, acute/active cellular rejection, chronic/sclerosing allograft nephropathy, and other. Combined Banff rejection calculated from categories of antibody-mediated rejection (Category 2) plus borderline changes (Category 3) plus acute rejection (Category 4), as interpreted by the central pathologist. |
| Number of Participants With Graft Loss | Month 6, 12 | Graft loss was defined as graft nephrectomy, participant death, re-transplantation, or return to dialysis for \>=6 consecutive weeks. |
| Number of Participants With Efficacy Failure | Month 6, 12 | Efficacy failure was the first occurrence of clinical BPAR diagnosed by the central pathologist or graft loss including participant death. |
| Number of Participants Who Died | Month 6, 12 | — |
| Lymphocyte Subset | Month 1, 3, 6, 12 | The absolute cell counts of cluster of differentiation 3 (CD3): T-lymphocytes, cluster of differentiation 19 (CD19): B-lymphocytes, and cluster of differentiation 56 (CD56): assumed natural killer cells, were determined using flow cytometry. |
| Population Pharmacokinetics (PK) | Pre-dose-2(P-2), Pre-dose(P), 0.5,1,2 hr post-dose(PD) on Day14, Month(M) 3; P,1,2 hr PD on M1; P, 0.5, 2, 4 hr PD on M6; P-2, P, 0.5 hr PD on M9, M12 as per randomization in CP-690,550 treated; P on M3 and P, 2, 4 hr PD on M6 in CsA treated participants | 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. |
| Glomerular Filtration Rate (GFR) at Month 6 | 2, 3, 4, and 5 hrs post iohexol intravenous bolus at Month 6 | GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using iohexol serum clearance. For determination of iohexol serum clearance, iohexol was administered as an intravenous bolus over 5 minutes immediately after morning dosing of CP-690,550 or CsA on day of GFR evaluation. 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 The Cockcroft-Gault Equation | Month 1, 3, 6, 9, 12 | GFR: an index of kidney function. GFR 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 The Modification of Diet in Renal Disease (MDRD) Equation | Month 1, 3, 6, 9, 12 | GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. 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).A 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/1.73 m\^2 indicated kidney failure. |
| Glomerular Filtration Rate (GFR) by The Abbreviated Modification of Diet in Renal Disease (MDRD) Equation | Month 1, 3, 6, 9, 12 | GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated using abbreviated MDRD equation. GFR by abbreviated MDRD equation= 186 \* (serum creatinine)\^(-1.154) \* (age in years)\^(-0.203) \* (0.742 if female) \* (1.210 if black). A normal GFR is \>90 mL/min/1.73 m\^2, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR \<15 mL/min/1.73 m\^2 indicated kidney failure. |
| Number of Participants With Clinically Significant Infections | Baseline up to Month 12 | Clinically significant infection was defined as the presence of documented infection confirmed by culture, biopsy, genomic, or serologic findings post-randomization and requiring hospitalization or parenteral anti-infective treatment, or otherwise deemed significant by the investigator. |
| 36-Item Short-Form Health Survey (SF-36) | Baseline, Month 6, 12 | SF-36: 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. Total of 11 variables were analyzed (8 subscales,2 composite subscales and Question(Q) 2 how would you rate your health in general now?(range 1=better, 5=worst). The score for a section (except Q2) is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). |
| End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Baseline, Month 6, 12 | 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. |
| Severity of Dyspepsia Assessment (SODA) | Baseline, Month 6, 12 | SODA:17-item health scale, assessed participant-reported perceptions of dyspepsia;consists of 3 subscales:Pain Intensity (6-items to assess pain and intensity of abdominal \[Ab\] discomfort; Range (Ra):2-47, higher score= greater pain and Ab discomfort), Non-Pain Symptoms (7-items to assess severity and impact of non-pain symptoms:burping/belching,heartburn,bloating,flatulence,sour taste,nausea,and bad breath; Ra:7-35,higher scores = increased symptom severity and influence), and Satisfaction (4-items to assess degree of satisfaction with Ab discomfort; Ra:2-23,higher scores= more satisfaction). |
| Glomerular Filtration Rate (GFR) by The Nankivell Equation | Month 1, 3, 6, 9, 12 | GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated was estimated 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 height square) plus (35 for male/25 for female). 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. |
| Number of Participants With Progression of Chronic Allograft Lesions at Month 12 | Month 12 | Progression of chronic allograft lesions was defined as an increase in the Banff chronicity score (Banff-CS) in biopsy from the implantation (baseline) biopsy in a given participant. Banff-CS was the sum of the Banff scores for the 4 chronic basic lesions (allograft glomerulopathy \[cg\] + interstitial fibrosis \[ci\] + tubular atrophy \[ct\] + vascular intimal thickening \[cv\]).The Banff-CS ranged from 0-12, higher score indicated greater lesions and Month 12 Banff-CS greater than the implantation biopsy score indicated progression of lesions. |
Countries
Australia, Belgium, Brazil, Canada, Czechia, France, Germany, Italy, Netherlands, Norway, Poland, Portugal, South Korea, Spain, United States
Participant flow
Pre-assignment details
Initially 7 participants were enrolled and randomized under original protocol but enrollment was terminated because 2 participants developed Grade 2B rejection. Protocol amendment 1 was implemented to increase aggregate level of immunosuppression and 331 participants were enrolled. Results of participants enrolled under amendment 1 are reported.
Participants by arm
| Arm | Count |
|---|---|
| Cyclosporine Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months. | 109 |
| CP-690,550 15 mg for Months 1 to 6 CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months. | 106 |
| CP-690,550 15 mg for Months 1 to 3 CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months. | 107 |
| Total | 322 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 19 | 38 | 40 |
| Overall Study | Death | 2 | 0 | 1 |
| Overall Study | Lack of Efficacy | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 3 | 1 | 0 |
| Overall Study | Other | 2 | 4 | 3 |
| Overall Study | Randomized, Not Treated | 1 | 4 | 4 |
| Overall Study | Withdrawal by Subject | 5 | 3 | 4 |
Baseline characteristics
| Characteristic | Cyclosporine | CP-690,550 15 mg for Months 1 to 6 | CP-690,550 15 mg for Months 1 to 3 | Total |
|---|---|---|---|---|
| Age, Customized 18 to 44 Years | 45 participants | 43 participants | 46 participants | 134 participants |
| Age, Customized 45 to 64 Years | 57 participants | 54 participants | 56 participants | 167 participants |
| Age, Customized Greater Than or Equal to (>=) 65 Years | 7 participants | 9 participants | 5 participants | 21 participants |
| Sex: Female, Male Female | 39 Participants | 24 Participants | 27 Participants | 90 Participants |
| Sex: Female, Male Male | 70 Participants | 82 Participants | 80 Participants | 232 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 | 105 / 109 | 102 / 106 | 105 / 107 |
| serious Total, serious adverse events | 65 / 109 | 76 / 106 | 74 / 107 |
Outcome results
Primary
Glomerular Filtration Rate (GFR) at Month 12
GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using iohexol serum clearance. For determination of iohexol serum clearance, iohexol was administered as an intravenous bolus over 5 minutes immediately after morning dosing of CP-690,550 or CsA on day of GFR evaluation. A normal GFR is greater than (\>) 90 milliliter per minute (mL/min), although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR less than (\<) 15 mL/min indicated kidney failure.
Time frame: 2, 3, 4, and 5 hrs post iohexol intravenous bolus at Month 12
Population: FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) includes only participants with evaluable data for this measure at Month 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cyclosporine | Glomerular Filtration Rate (GFR) at Month 12 | 54.14 mL/min | Standard Deviation 19.12 |
| CP-690,550 15 mg for Months 1 to 6 | Glomerular Filtration Rate (GFR) at Month 12 | 65.05 mL/min | Standard Deviation 18.81 |
| CP-690,550 15 mg for Months 1 to 3 | Glomerular Filtration Rate (GFR) at Month 12 | 65.37 mL/min | Standard Deviation 20.77 |
Primary
Number of Participants With First Clinical Biopsy Proven Acute Rejection (BPAR) Episode 6 Months Post-Transplant
Clinical BPAR was a BPAR (category acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification) associated with an increase in serum creatinine of \>= 0.3 milligram per deciliter (mg/dL) and \>=20 percent (%) from pre-rejection baseline. The increase in serum creatinine was assessed based on the comparison of baseline and the highest serum creatinine recorded within 24 hours (hrs) of the time of biopsy.
Time frame: Baseline up to Month 6
Population: Full analysis set (FAS) with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cyclosporine | Number of Participants With First Clinical Biopsy Proven Acute Rejection (BPAR) Episode 6 Months Post-Transplant | 9 participants |
| CP-690,550 15 mg for Months 1 to 6 | Number of Participants With First Clinical Biopsy Proven Acute Rejection (BPAR) Episode 6 Months Post-Transplant | 11 participants |
| CP-690,550 15 mg for Months 1 to 3 | Number of Participants With First Clinical Biopsy Proven Acute Rejection (BPAR) Episode 6 Months Post-Transplant | 7 participants |
Secondary
36-Item Short-Form Health Survey (SF-36)
SF-36: 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. Total of 11 variables were analyzed (8 subscales,2 composite subscales and Question(Q) 2 how would you rate your health in general now?(range 1=better, 5=worst). The score for a section (except Q2) is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Time frame: Baseline, Month 6, 12
Population: FAS: 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 who were evaluable at given time point for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cyclosporine | 36-Item Short-Form Health Survey (SF-36) | Baseline: Vitality (n=78,68,72) | 49.77 units on a scale | Standard Deviation 10.81 |
| Cyclosporine | 36-Item Short-Form Health Survey (SF-36) | Month 12: Bodily Pain (n=73,58,56) | 51.12 units on a scale | Standard Deviation 9.23 |
| Cyclosporine | 36-Item Short-Form Health Survey (SF-36) | Month 12: General Health (n=73,57,56) | 48.94 units on a scale | Standard Deviation 8.74 |
| Cyclosporine | 36-Item Short-Form Health Survey (SF-36) | Month 12: Mental Health (n=73,57,56) | 51.93 units on a scale | Standard Deviation 9.24 |
| Cyclosporine | 36-Item Short-Form Health Survey (SF-36) | Baseline: Physical Component (n=78,68,71) | 44.85 units on a scale | Standard Deviation 9.38 |
| Cyclosporine | 36-Item Short-Form Health Survey (SF-36) | Month 12: Physical Functioning (n=73,58,56) | 47.19 units on a scale | Standard Deviation 10.26 |
| Cyclosporine | 36-Item Short-Form Health Survey (SF-36) | Month 12: Role Emotional (n=71,57,56) | 46.13 units on a scale | Standard Deviation 12.36 |
| Cyclosporine | 36-Item Short-Form Health Survey (SF-36) | Baseline: Bodily Pain (n=79,68,71) | 52.89 units on a scale | Standard Deviation 9.45 |
| Cyclosporine | 36-Item Short-Form Health Survey (SF-36) | Month 12: Role Physical (n=71,57,56) | 46.57 units on a scale | Standard Deviation 9.68 |
| Cyclosporine | 36-Item Short-Form Health Survey (SF-36) | Baseline: Mental Component (n=78,68,71) | 49.41 units on a scale | Standard Deviation 9.66 |
| Cyclosporine | 36-Item Short-Form Health Survey (SF-36) | Month 12: Social Functioning (n=73,57,56) | 49.63 units on a scale | Standard Deviation 8.41 |
| Cyclosporine | 36-Item Short-Form Health Survey (SF-36) | Month 12: Vitality (n=73,57,56) | 54.25 units on a scale | Standard Deviation 8.31 |
| Cyclosporine | 36-Item Short-Form Health Survey (SF-36) | Baseline: Physical Functioning (n=79,68,72) | 44.03 units on a scale | Standard Deviation 10.03 |
| Cyclosporine | 36-Item Short-Form Health Survey (SF-36) | Month 12: Physical Component (n=71,57,56) | 47.98 units on a scale | Standard Deviation 8.02 |
| Cyclosporine | 36-Item Short-Form Health Survey (SF-36) | Baseline: Q2-Health in General Now (n=80,68,72) | 2.78 units on a scale | Standard Deviation 0.62 |
| Cyclosporine | 36-Item Short-Form Health Survey (SF-36) | Month 12: Mental Component (n=71,57,56) | 51.12 units on a scale | Standard Deviation 9.34 |
| Cyclosporine | 36-Item Short-Form Health Survey (SF-36) | Month 12: Q2-Health in General Now (n=73,58,56) | 2.75 units on a scale | Standard Deviation 0.62 |
| Cyclosporine | 36-Item Short-Form Health Survey (SF-36) | Month 6: Bodily Pain (n=78,63,65) | 51.87 units on a scale | Standard Deviation 9.55 |
| Cyclosporine | 36-Item Short-Form Health Survey (SF-36) | Baseline: General Health (n=79,68,72) | 44.77 units on a scale | Standard Deviation 9.28 |
| Cyclosporine | 36-Item Short-Form Health Survey (SF-36) | Month 6: General Health (n=78,63,65) | 47.87 units on a scale | Standard Deviation 9 |
| Cyclosporine | 36-Item Short-Form Health Survey (SF-36) | Baseline: Role Emotional (n=79,68,71) | 46.19 units on a scale | Standard Deviation 11.75 |
| Cyclosporine | 36-Item Short-Form Health Survey (SF-36) | Month 6: Mental Health (n=78,63,65) | 50.47 units on a scale | Standard Deviation 10.69 |
| Cyclosporine | 36-Item Short-Form Health Survey (SF-36) | Month 6: Physical Functioning (n=77,63,65) | 47.06 units on a scale | Standard Deviation 9.96 |
| Cyclosporine | 36-Item Short-Form Health Survey (SF-36) | Month 6: Role Emotional (n=77,63,65) | 48.06 units on a scale | Standard Deviation 11.15 |
| Cyclosporine | 36-Item Short-Form Health Survey (SF-36) | Baseline: Role Physical (n=79,68,71) | 41.26 units on a scale | Standard Deviation 11.86 |
| Cyclosporine | 36-Item Short-Form Health Survey (SF-36) | Month 6: Role Physical (n=77,63,65) | 46.48 units on a scale | Standard Deviation 10.44 |
| Cyclosporine | 36-Item Short-Form Health Survey (SF-36) | Month 6: Social Functioning (n=78,63,65) | 50.34 units on a scale | Standard Deviation 8.64 |
| Cyclosporine | 36-Item Short-Form Health Survey (SF-36) | Month 6: Vitality (n=78,63,65) | 54.22 units on a scale | Standard Deviation 9.7 |
| Cyclosporine | 36-Item Short-Form Health Survey (SF-36) | Baseline: Social Functioning (n=79,68,72) | 47.42 units on a scale | Standard Deviation 8.98 |
| Cyclosporine | 36-Item Short-Form Health Survey (SF-36) | Month 6: Physical Component (n=77,63,65) | 47.93 units on a scale | Standard Deviation 8.27 |
| Cyclosporine | 36-Item Short-Form Health Survey (SF-36) | Month 6: Mental Component (n=77,63,65) | 51.60 units on a scale | Standard Deviation 9.43 |
| Cyclosporine | 36-Item Short-Form Health Survey (SF-36) | Baseline: Mental Health (n=78,68,72) | 49.15 units on a scale | Standard Deviation 9.13 |
| Cyclosporine | 36-Item Short-Form Health Survey (SF-36) | Month 6: Q2-Health in General Now (n=78,63,65) | 2.74 units on a scale | Standard Deviation 0.73 |
| CP-690,550 15 mg for Months 1 to 6 | 36-Item Short-Form Health Survey (SF-36) | Baseline: Physical Functioning (n=79,68,72) | 44.46 units on a scale | Standard Deviation 9.58 |
| CP-690,550 15 mg for Months 1 to 6 | 36-Item Short-Form Health Survey (SF-36) | Month 6: Role Physical (n=77,63,65) | 43.11 units on a scale | Standard Deviation 12.14 |
| CP-690,550 15 mg for Months 1 to 6 | 36-Item Short-Form Health Survey (SF-36) | Month 12: Bodily Pain (n=73,58,56) | 51.07 units on a scale | Standard Deviation 10.24 |
| CP-690,550 15 mg for Months 1 to 6 | 36-Item Short-Form Health Survey (SF-36) | Baseline: Vitality (n=78,68,72) | 48.04 units on a scale | Standard Deviation 12.38 |
| CP-690,550 15 mg for Months 1 to 6 | 36-Item Short-Form Health Survey (SF-36) | Month 6: Bodily Pain (n=78,63,65) | 49.76 units on a scale | Standard Deviation 11.49 |
| CP-690,550 15 mg for Months 1 to 6 | 36-Item Short-Form Health Survey (SF-36) | Baseline: Mental Health (n=78,68,72) | 44.85 units on a scale | Standard Deviation 12.75 |
| CP-690,550 15 mg for Months 1 to 6 | 36-Item Short-Form Health Survey (SF-36) | Baseline: Role Physical (n=79,68,71) | 42.28 units on a scale | Standard Deviation 12.56 |
| CP-690,550 15 mg for Months 1 to 6 | 36-Item Short-Form Health Survey (SF-36) | Month 12: Mental Health (n=73,57,56) | 49.43 units on a scale | Standard Deviation 10.98 |
| CP-690,550 15 mg for Months 1 to 6 | 36-Item Short-Form Health Survey (SF-36) | Month 6: Physical Component (n=77,63,65) | 46.22 units on a scale | Standard Deviation 10.76 |
| CP-690,550 15 mg for Months 1 to 6 | 36-Item Short-Form Health Survey (SF-36) | Month 6: General Health (n=78,63,65) | 46.70 units on a scale | Standard Deviation 10.31 |
| CP-690,550 15 mg for Months 1 to 6 | 36-Item Short-Form Health Survey (SF-36) | Month 12: Physical Functioning (n=73,58,56) | 46.88 units on a scale | Standard Deviation 10.16 |
| CP-690,550 15 mg for Months 1 to 6 | 36-Item Short-Form Health Survey (SF-36) | Baseline: Physical Component (n=78,68,71) | 45.85 units on a scale | Standard Deviation 8.35 |
| CP-690,550 15 mg for Months 1 to 6 | 36-Item Short-Form Health Survey (SF-36) | Month 6: Social Functioning (n=78,63,65) | 45.14 units on a scale | Standard Deviation 12.21 |
| CP-690,550 15 mg for Months 1 to 6 | 36-Item Short-Form Health Survey (SF-36) | Month 12: Role Emotional (n=71,57,56) | 47.31 units on a scale | Standard Deviation 9.15 |
| CP-690,550 15 mg for Months 1 to 6 | 36-Item Short-Form Health Survey (SF-36) | Baseline: Bodily Pain (n=79,68,71) | 51.43 units on a scale | Standard Deviation 10.56 |
| CP-690,550 15 mg for Months 1 to 6 | 36-Item Short-Form Health Survey (SF-36) | Month 6: Mental Health (n=78,63,65) | 48.35 units on a scale | Standard Deviation 12.48 |
| CP-690,550 15 mg for Months 1 to 6 | 36-Item Short-Form Health Survey (SF-36) | Month 12: Role Physical (n=71,57,56) | 44.19 units on a scale | Standard Deviation 10.73 |
| CP-690,550 15 mg for Months 1 to 6 | 36-Item Short-Form Health Survey (SF-36) | Baseline: Role Emotional (n=79,68,71) | 43.82 units on a scale | Standard Deviation 13.8 |
| CP-690,550 15 mg for Months 1 to 6 | 36-Item Short-Form Health Survey (SF-36) | Baseline: Social Functioning (n=79,68,72) | 41.14 units on a scale | Standard Deviation 12.42 |
| CP-690,550 15 mg for Months 1 to 6 | 36-Item Short-Form Health Survey (SF-36) | Month 12: Social Functioning (n=73,57,56) | 46.87 units on a scale | Standard Deviation 10.06 |
| CP-690,550 15 mg for Months 1 to 6 | 36-Item Short-Form Health Survey (SF-36) | Baseline: Mental Component (n=78,68,71) | 44.18 units on a scale | Standard Deviation 13.27 |
| CP-690,550 15 mg for Months 1 to 6 | 36-Item Short-Form Health Survey (SF-36) | Month 6: Physical Functioning (n=77,63,65) | 45.74 units on a scale | Standard Deviation 11.08 |
| CP-690,550 15 mg for Months 1 to 6 | 36-Item Short-Form Health Survey (SF-36) | Month 12: Vitality (n=73,57,56) | 51.45 units on a scale | Standard Deviation 11.2 |
| CP-690,550 15 mg for Months 1 to 6 | 36-Item Short-Form Health Survey (SF-36) | Baseline: General Health (n=79,68,72) | 42.46 units on a scale | Standard Deviation 10.63 |
| CP-690,550 15 mg for Months 1 to 6 | 36-Item Short-Form Health Survey (SF-36) | Month 6: Vitality (n=78,63,65) | 52.13 units on a scale | Standard Deviation 11.14 |
| CP-690,550 15 mg for Months 1 to 6 | 36-Item Short-Form Health Survey (SF-36) | Month 12: Physical Component (n=71,57,56) | 46.84 units on a scale | Standard Deviation 8.8 |
| CP-690,550 15 mg for Months 1 to 6 | 36-Item Short-Form Health Survey (SF-36) | Month 6: Role Emotional (n=77,63,65) | 45.40 units on a scale | Standard Deviation 11.82 |
| CP-690,550 15 mg for Months 1 to 6 | 36-Item Short-Form Health Survey (SF-36) | Month 6: Q2-Health in General Now (n=78,63,65) | 2.65 units on a scale | Standard Deviation 0.77 |
| CP-690,550 15 mg for Months 1 to 6 | 36-Item Short-Form Health Survey (SF-36) | Month 12: Mental Component (n=71,57,56) | 49.47 units on a scale | Standard Deviation 9.36 |
| CP-690,550 15 mg for Months 1 to 6 | 36-Item Short-Form Health Survey (SF-36) | Baseline: Q2-Health in General Now (n=80,68,72) | 2.57 units on a scale | Standard Deviation 0.78 |
| CP-690,550 15 mg for Months 1 to 6 | 36-Item Short-Form Health Survey (SF-36) | Month 6: Mental Component (n=77,63,65) | 48.30 units on a scale | Standard Deviation 11.82 |
| CP-690,550 15 mg for Months 1 to 6 | 36-Item Short-Form Health Survey (SF-36) | Month 12: Q2-Health in General Now (n=73,58,56) | 2.69 units on a scale | Standard Deviation 0.71 |
| CP-690,550 15 mg for Months 1 to 6 | 36-Item Short-Form Health Survey (SF-36) | Month 12: General Health (n=73,57,56) | 46.79 units on a scale | Standard Deviation 8.71 |
| CP-690,550 15 mg for Months 1 to 3 | 36-Item Short-Form Health Survey (SF-36) | Month 12: Q2-Health in General Now (n=73,58,56) | 2.84 units on a scale | Standard Deviation 0.56 |
| CP-690,550 15 mg for Months 1 to 3 | 36-Item Short-Form Health Survey (SF-36) | Baseline: Bodily Pain (n=79,68,71) | 49.56 units on a scale | Standard Deviation 10.59 |
| CP-690,550 15 mg for Months 1 to 3 | 36-Item Short-Form Health Survey (SF-36) | Baseline: General Health (n=79,68,72) | 42.39 units on a scale | Standard Deviation 9.68 |
| CP-690,550 15 mg for Months 1 to 3 | 36-Item Short-Form Health Survey (SF-36) | Baseline: Mental Health (n=78,68,72) | 48.69 units on a scale | Standard Deviation 11.33 |
| CP-690,550 15 mg for Months 1 to 3 | 36-Item Short-Form Health Survey (SF-36) | Baseline: Physical Functioning (n=79,68,72) | 45.88 units on a scale | Standard Deviation 9.52 |
| CP-690,550 15 mg for Months 1 to 3 | 36-Item Short-Form Health Survey (SF-36) | Baseline: Role Emotional (n=79,68,71) | 43.79 units on a scale | Standard Deviation 13.62 |
| CP-690,550 15 mg for Months 1 to 3 | 36-Item Short-Form Health Survey (SF-36) | Baseline: Role Physical (n=79,68,71) | 42.51 units on a scale | Standard Deviation 12.32 |
| CP-690,550 15 mg for Months 1 to 3 | 36-Item Short-Form Health Survey (SF-36) | Baseline: Social Functioning (n=79,68,72) | 44.38 units on a scale | Standard Deviation 11.54 |
| CP-690,550 15 mg for Months 1 to 3 | 36-Item Short-Form Health Survey (SF-36) | Baseline: Vitality (n=78,68,72) | 50.29 units on a scale | Standard Deviation 10.57 |
| CP-690,550 15 mg for Months 1 to 3 | 36-Item Short-Form Health Survey (SF-36) | Baseline: Physical Component (n=78,68,71) | 45.05 units on a scale | Standard Deviation 8.58 |
| CP-690,550 15 mg for Months 1 to 3 | 36-Item Short-Form Health Survey (SF-36) | Baseline: Mental Component (n=78,68,71) | 47.13 units on a scale | Standard Deviation 11.54 |
| CP-690,550 15 mg for Months 1 to 3 | 36-Item Short-Form Health Survey (SF-36) | Baseline: Q2-Health in General Now (n=80,68,72) | 2.63 units on a scale | Standard Deviation 0.74 |
| CP-690,550 15 mg for Months 1 to 3 | 36-Item Short-Form Health Survey (SF-36) | Month 6: Bodily Pain (n=78,63,65) | 50.88 units on a scale | Standard Deviation 10.1 |
| CP-690,550 15 mg for Months 1 to 3 | 36-Item Short-Form Health Survey (SF-36) | Month 6: General Health (n=78,63,65) | 47.36 units on a scale | Standard Deviation 9.79 |
| CP-690,550 15 mg for Months 1 to 3 | 36-Item Short-Form Health Survey (SF-36) | Month 6: Mental Health (n=78,63,65) | 48.81 units on a scale | Standard Deviation 10.97 |
| CP-690,550 15 mg for Months 1 to 3 | 36-Item Short-Form Health Survey (SF-36) | Month 6: Physical Functioning (n=77,63,65) | 46.91 units on a scale | Standard Deviation 10.5 |
| CP-690,550 15 mg for Months 1 to 3 | 36-Item Short-Form Health Survey (SF-36) | Month 6: Role Emotional (n=77,63,65) | 46.77 units on a scale | Standard Deviation 11.87 |
| CP-690,550 15 mg for Months 1 to 3 | 36-Item Short-Form Health Survey (SF-36) | Month 6: Role Physical (n=77,63,65) | 45.87 units on a scale | Standard Deviation 10.8 |
| CP-690,550 15 mg for Months 1 to 3 | 36-Item Short-Form Health Survey (SF-36) | Month 6: Social Functioning (n=78,63,65) | 47.88 units on a scale | Standard Deviation 10.15 |
| CP-690,550 15 mg for Months 1 to 3 | 36-Item Short-Form Health Survey (SF-36) | Month 6: Vitality (n=78,63,65) | 51.95 units on a scale | Standard Deviation 10.49 |
| CP-690,550 15 mg for Months 1 to 3 | 36-Item Short-Form Health Survey (SF-36) | Month 6: Physical Component (n=77,63,65) | 47.82 units on a scale | Standard Deviation 9.24 |
| CP-690,550 15 mg for Months 1 to 3 | 36-Item Short-Form Health Survey (SF-36) | Month 6: Mental Component (n=77,63,65) | 49.09 units on a scale | Standard Deviation 10.91 |
| CP-690,550 15 mg for Months 1 to 3 | 36-Item Short-Form Health Survey (SF-36) | Month 6: Q2-Health in General Now (n=78,63,65) | 2.72 units on a scale | Standard Deviation 0.63 |
| CP-690,550 15 mg for Months 1 to 3 | 36-Item Short-Form Health Survey (SF-36) | Month 12: Bodily Pain (n=73,58,56) | 49.48 units on a scale | Standard Deviation 10.95 |
| CP-690,550 15 mg for Months 1 to 3 | 36-Item Short-Form Health Survey (SF-36) | Month 12: General Health (n=73,57,56) | 44.71 units on a scale | Standard Deviation 10.02 |
| CP-690,550 15 mg for Months 1 to 3 | 36-Item Short-Form Health Survey (SF-36) | Month 12: Mental Health (n=73,57,56) | 46.91 units on a scale | Standard Deviation 10.77 |
| CP-690,550 15 mg for Months 1 to 3 | 36-Item Short-Form Health Survey (SF-36) | Month 12: Physical Functioning (n=73,58,56) | 46.99 units on a scale | Standard Deviation 11.01 |
| CP-690,550 15 mg for Months 1 to 3 | 36-Item Short-Form Health Survey (SF-36) | Month 12: Role Emotional (n=71,57,56) | 46.21 units on a scale | Standard Deviation 12.27 |
| CP-690,550 15 mg for Months 1 to 3 | 36-Item Short-Form Health Survey (SF-36) | Month 12: Role Physical (n=71,57,56) | 45.20 units on a scale | Standard Deviation 11.47 |
| CP-690,550 15 mg for Months 1 to 3 | 36-Item Short-Form Health Survey (SF-36) | Month 12: Social Functioning (n=73,57,56) | 47.18 units on a scale | Standard Deviation 10.84 |
| CP-690,550 15 mg for Months 1 to 3 | 36-Item Short-Form Health Survey (SF-36) | Month 12: Vitality (n=73,57,56) | 51.69 units on a scale | Standard Deviation 10.23 |
| CP-690,550 15 mg for Months 1 to 3 | 36-Item Short-Form Health Survey (SF-36) | Month 12: Physical Component (n=71,57,56) | 47.03 units on a scale | Standard Deviation 10.23 |
| CP-690,550 15 mg for Months 1 to 3 | 36-Item Short-Form Health Survey (SF-36) | Month 12: Mental Component (n=71,57,56) | 47.91 units on a scale | Standard Deviation 12.17 |
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, 12
Population: FAS: 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 who were evaluable at given time point for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cyclosporine | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Baseline: SEs of Corticosteroids (n=76,61,71) | 0.45 units on a scale | Standard Deviation 0.53 |
| Cyclosporine | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Baseline: In Growth of Gum and Hair (n=76,61,70) | 0.19 units on a scale | Standard Deviation 0.36 |
| Cyclosporine | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Baseline: Limited Cognitive Capacity (n=77,62,71) | 0.67 units on a scale | Standard Deviation 0.63 |
| Cyclosporine | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Baseline: Limited Physical Capacity (n=76,61,71) | 0.80 units on a scale | Standard Deviation 0.59 |
| Cyclosporine | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Baseline:Cardiac and Renal Dysfunction(n=76,61,71) | 0.76 units on a scale | Standard Deviation 0.55 |
| Cyclosporine | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Baseline: TAPD (n=77,62,71) | 0.98 units on a scale | Standard Deviation 0.68 |
| Cyclosporine | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Month 6:Cardiac and Renal Dysfunction(n=77,63,64) | 0.59 units on a scale | Standard Deviation 0.63 |
| Cyclosporine | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Month 6: In Growth of Gum and Hair (n=77,63,64) | 0.67 units on a scale | Standard Deviation 0.61 |
| Cyclosporine | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Month 6: Limited Cognitive Capacity (n=77,64,65) | 0.64 units on a scale | Standard Deviation 0.68 |
| Cyclosporine | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Month 6: Limited Physical Capacity (n=77,63,64) | 0.69 units on a scale | Standard Deviation 0.6 |
| Cyclosporine | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Month 6: SEs of Corticosteroids (n=77,63,64) | 0.65 units on a scale | Standard Deviation 0.7 |
| Cyclosporine | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Month 6: TAPD (n=77,64,65) | 0.62 units on a scale | Standard Deviation 0.6 |
| Cyclosporine | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Month 12:Cardiac and Renal Dysfunction(n=70,57,55) | 0.51 units on a scale | Standard Deviation 0.46 |
| Cyclosporine | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Month 12: In Growth of Gum and Hair (n=70,57,55) | 0.58 units on a scale | Standard Deviation 0.52 |
| Cyclosporine | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Month 12: Limited Cognitive Capacity (n=71,58,55) | 0.68 units on a scale | Standard Deviation 0.6 |
| Cyclosporine | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Month 12: Limited Physical Capacity (n=70,57,55) | 0.63 units on a scale | Standard Deviation 0.46 |
| Cyclosporine | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Month 12: SEs of Corticosteroids (n=70,56,55) | 0.50 units on a scale | Standard Deviation 0.48 |
| Cyclosporine | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Month 12: TAPD (n=71,57,55) | 0.58 units on a scale | Standard Deviation 0.53 |
| CP-690,550 15 mg for Months 1 to 6 | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Month 12: TAPD (n=71,57,55) | 0.90 units on a scale | Standard Deviation 0.66 |
| CP-690,550 15 mg for Months 1 to 6 | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Baseline:Cardiac and Renal Dysfunction(n=76,61,71) | 0.70 units on a scale | Standard Deviation 0.59 |
| CP-690,550 15 mg for Months 1 to 6 | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Month 6: Limited Physical Capacity (n=77,63,64) | 0.67 units on a scale | Standard Deviation 0.61 |
| CP-690,550 15 mg for Months 1 to 6 | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Month 12:Cardiac and Renal Dysfunction(n=70,57,55) | 0.51 units on a scale | Standard Deviation 0.48 |
| CP-690,550 15 mg for Months 1 to 6 | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Baseline: In Growth of Gum and Hair (n=76,61,70) | 0.16 units on a scale | Standard Deviation 0.31 |
| CP-690,550 15 mg for Months 1 to 6 | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Month 12: Limited Cognitive Capacity (n=71,58,55) | 0.79 units on a scale | Standard Deviation 0.7 |
| CP-690,550 15 mg for Months 1 to 6 | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Month 12: Limited Physical Capacity (n=70,57,55) | 0.69 units on a scale | Standard Deviation 0.5 |
| CP-690,550 15 mg for Months 1 to 6 | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Baseline: Limited Cognitive Capacity (n=77,62,71) | 0.76 units on a scale | Standard Deviation 0.74 |
| CP-690,550 15 mg for Months 1 to 6 | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Month 6: SEs of Corticosteroids (n=77,63,64) | 0.54 units on a scale | Standard Deviation 0.56 |
| CP-690,550 15 mg for Months 1 to 6 | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Month 12: SEs of Corticosteroids (n=70,56,55) | 0.56 units on a scale | Standard Deviation 0.63 |
| CP-690,550 15 mg for Months 1 to 6 | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Baseline: Limited Physical Capacity (n=76,61,71) | 0.79 units on a scale | Standard Deviation 0.65 |
| CP-690,550 15 mg for Months 1 to 6 | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Month 6: Limited Cognitive Capacity (n=77,64,65) | 0.70 units on a scale | Standard Deviation 0.74 |
| CP-690,550 15 mg for Months 1 to 6 | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Month 12: In Growth of Gum and Hair (n=70,57,55) | 0.19 units on a scale | Standard Deviation 0.3 |
| CP-690,550 15 mg for Months 1 to 6 | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Baseline: SEs of Corticosteroids (n=76,61,71) | 0.56 units on a scale | Standard Deviation 0.64 |
| CP-690,550 15 mg for Months 1 to 6 | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Month 6: In Growth of Gum and Hair (n=77,63,64) | 0.23 units on a scale | Standard Deviation 0.47 |
| CP-690,550 15 mg for Months 1 to 6 | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Month 6: TAPD (n=77,64,65) | 0.78 units on a scale | Standard Deviation 0.65 |
| CP-690,550 15 mg for Months 1 to 6 | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Baseline: TAPD (n=77,62,71) | 1.21 units on a scale | Standard Deviation 0.82 |
| CP-690,550 15 mg for Months 1 to 6 | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Month 6:Cardiac and Renal Dysfunction(n=77,63,64) | 0.40 units on a scale | Standard Deviation 0.5 |
| CP-690,550 15 mg for Months 1 to 3 | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Baseline: TAPD (n=77,62,71) | 1.16 units on a scale | Standard Deviation 0.74 |
| CP-690,550 15 mg for Months 1 to 3 | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Month 6:Cardiac and Renal Dysfunction(n=77,63,64) | 0.50 units on a scale | Standard Deviation 0.48 |
| CP-690,550 15 mg for Months 1 to 3 | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Month 6: In Growth of Gum and Hair (n=77,63,64) | 0.24 units on a scale | Standard Deviation 0.35 |
| CP-690,550 15 mg for Months 1 to 3 | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Month 12: Limited Cognitive Capacity (n=71,58,55) | 0.85 units on a scale | Standard Deviation 0.67 |
| CP-690,550 15 mg for Months 1 to 3 | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Month 6: Limited Cognitive Capacity (n=77,64,65) | 0.68 units on a scale | Standard Deviation 0.5 |
| CP-690,550 15 mg for Months 1 to 3 | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Month 12: TAPD (n=71,57,55) | 0.96 units on a scale | Standard Deviation 0.73 |
| CP-690,550 15 mg for Months 1 to 3 | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Month 6: Limited Physical Capacity (n=77,63,64) | 0.62 units on a scale | Standard Deviation 0.49 |
| CP-690,550 15 mg for Months 1 to 3 | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Month 6: SEs of Corticosteroids (n=77,63,64) | 0.69 units on a scale | Standard Deviation 0.63 |
| CP-690,550 15 mg for Months 1 to 3 | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Month 12: Limited Physical Capacity (n=70,57,55) | 0.73 units on a scale | Standard Deviation 0.65 |
| CP-690,550 15 mg for Months 1 to 3 | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Month 6: TAPD (n=77,64,65) | 0.85 units on a scale | Standard Deviation 0.62 |
| CP-690,550 15 mg for Months 1 to 3 | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Baseline:Cardiac and Renal Dysfunction(n=76,61,71) | 0.64 units on a scale | Standard Deviation 0.61 |
| CP-690,550 15 mg for Months 1 to 3 | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Baseline: In Growth of Gum and Hair (n=76,61,70) | 0.18 units on a scale | Standard Deviation 0.32 |
| CP-690,550 15 mg for Months 1 to 3 | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Month 12:Cardiac and Renal Dysfunction(n=70,57,55) | 0.49 units on a scale | Standard Deviation 0.5 |
| CP-690,550 15 mg for Months 1 to 3 | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Baseline: Limited Cognitive Capacity (n=77,62,71) | 0.64 units on a scale | Standard Deviation 0.61 |
| CP-690,550 15 mg for Months 1 to 3 | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Baseline: Limited Physical Capacity (n=76,61,71) | 0.72 units on a scale | Standard Deviation 0.56 |
| CP-690,550 15 mg for Months 1 to 3 | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Baseline: SEs of Corticosteroids (n=76,61,71) | 0.48 units on a scale | Standard Deviation 0.52 |
| CP-690,550 15 mg for Months 1 to 3 | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Month 12: In Growth of Gum and Hair (n=70,57,55) | 0.29 units on a scale | Standard Deviation 0.51 |
| CP-690,550 15 mg for Months 1 to 3 | End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) | Month 12: SEs of Corticosteroids (n=70,56,55) | 0.72 units on a scale | Standard Deviation 0.78 |
Secondary
Glomerular Filtration Rate (GFR) at Month 6
GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using iohexol serum clearance. For determination of iohexol serum clearance, iohexol was administered as an intravenous bolus over 5 minutes immediately after morning dosing of CP-690,550 or CsA on day of GFR evaluation. 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: 2, 3, 4, and 5 hrs post iohexol intravenous bolus at Month 6
Population: FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) includes only participants with evaluable data for this measure at Month 6.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cyclosporine | Glomerular Filtration Rate (GFR) at Month 6 | 57.29 mL/min | Standard Deviation 18.52 |
| CP-690,550 15 mg for Months 1 to 6 | Glomerular Filtration Rate (GFR) at Month 6 | 67.54 mL/min | Standard Deviation 21.86 |
| CP-690,550 15 mg for Months 1 to 3 | Glomerular Filtration Rate (GFR) at Month 6 | 73.93 mL/min | Standard Deviation 23.72 |
Secondary
Glomerular Filtration Rate (GFR) by The Abbreviated Modification of Diet in Renal Disease (MDRD) Equation
GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated using abbreviated MDRD equation. GFR by abbreviated MDRD equation= 186 \* (serum creatinine)\^(-1.154) \* (age in years)\^(-0.203) \* (0.742 if female) \* (1.210 if black). A normal GFR is \>90 mL/min/1.73 m\^2, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR \<15 mL/min/1.73 m\^2 indicated kidney failure.
Time frame: Month 1, 3, 6, 9, 12
Population: FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure. Missing data were imputed using LOCF.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cyclosporine | Glomerular Filtration Rate (GFR) by The Abbreviated Modification of Diet in Renal Disease (MDRD) Equation | Month 9 | 55.39 mL/min per 1.73 m^2 | Standard Deviation 22.09 |
| Cyclosporine | Glomerular Filtration Rate (GFR) by The Abbreviated Modification of Diet in Renal Disease (MDRD) Equation | Month 6 | 55.01 mL/min per 1.73 m^2 | Standard Deviation 20.22 |
| Cyclosporine | Glomerular Filtration Rate (GFR) by The Abbreviated Modification of Diet in Renal Disease (MDRD) Equation | Month 1 | 55.29 mL/min per 1.73 m^2 | Standard Deviation 21.96 |
| Cyclosporine | Glomerular Filtration Rate (GFR) by The Abbreviated Modification of Diet in Renal Disease (MDRD) Equation | Month 3 | 54.36 mL/min per 1.73 m^2 | Standard Deviation 19.28 |
| Cyclosporine | Glomerular Filtration Rate (GFR) by The Abbreviated Modification of Diet in Renal Disease (MDRD) Equation | Month 12 | 54.99 mL/min per 1.73 m^2 | Standard Deviation 24.15 |
| CP-690,550 15 mg for Months 1 to 6 | Glomerular Filtration Rate (GFR) by The Abbreviated Modification of Diet in Renal Disease (MDRD) Equation | Month 6 | 61.49 mL/min per 1.73 m^2 | Standard Deviation 18.1 |
| CP-690,550 15 mg for Months 1 to 6 | Glomerular Filtration Rate (GFR) by The Abbreviated Modification of Diet in Renal Disease (MDRD) Equation | Month 1 | 61.49 mL/min per 1.73 m^2 | Standard Deviation 18.66 |
| CP-690,550 15 mg for Months 1 to 6 | Glomerular Filtration Rate (GFR) by The Abbreviated Modification of Diet in Renal Disease (MDRD) Equation | Month 3 | 62.45 mL/min per 1.73 m^2 | Standard Deviation 18.39 |
| CP-690,550 15 mg for Months 1 to 6 | Glomerular Filtration Rate (GFR) by The Abbreviated Modification of Diet in Renal Disease (MDRD) Equation | Month 9 | 62.52 mL/min per 1.73 m^2 | Standard Deviation 17.86 |
| CP-690,550 15 mg for Months 1 to 6 | Glomerular Filtration Rate (GFR) by The Abbreviated Modification of Diet in Renal Disease (MDRD) Equation | Month 12 | 63.88 mL/min per 1.73 m^2 | Standard Deviation 18.4 |
| CP-690,550 15 mg for Months 1 to 3 | Glomerular Filtration Rate (GFR) by The Abbreviated Modification of Diet in Renal Disease (MDRD) Equation | Month 12 | 64.17 mL/min per 1.73 m^2 | Standard Deviation 19.94 |
| CP-690,550 15 mg for Months 1 to 3 | Glomerular Filtration Rate (GFR) by The Abbreviated Modification of Diet in Renal Disease (MDRD) Equation | Month 9 | 62.76 mL/min per 1.73 m^2 | Standard Deviation 18.55 |
| CP-690,550 15 mg for Months 1 to 3 | Glomerular Filtration Rate (GFR) by The Abbreviated Modification of Diet in Renal Disease (MDRD) Equation | Month 1 | 64.81 mL/min per 1.73 m^2 | Standard Deviation 21.15 |
| CP-690,550 15 mg for Months 1 to 3 | Glomerular Filtration Rate (GFR) by The Abbreviated Modification of Diet in Renal Disease (MDRD) Equation | Month 6 | 63.33 mL/min per 1.73 m^2 | Standard Deviation 19.74 |
| CP-690,550 15 mg for Months 1 to 3 | Glomerular Filtration Rate (GFR) by The Abbreviated Modification of Diet in Renal Disease (MDRD) Equation | Month 3 | 62.27 mL/min per 1.73 m^2 | Standard Deviation 19.71 |
Secondary
Glomerular Filtration Rate (GFR) by The Cockcroft-Gault Equation
GFR: an index of kidney function. GFR 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: Month 1, 3, 6, 9, 12
Population: FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure. Missing data were imputed using LOCF.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cyclosporine | Glomerular Filtration Rate (GFR) by The Cockcroft-Gault Equation | Month 9 | 70.05 mL/min | Standard Deviation 25.15 |
| Cyclosporine | Glomerular Filtration Rate (GFR) by The Cockcroft-Gault Equation | Month 1 | 67.23 mL/min | Standard Deviation 23.84 |
| Cyclosporine | Glomerular Filtration Rate (GFR) by The Cockcroft-Gault Equation | Month 3 | 68.08 mL/min | Standard Deviation 23.19 |
| Cyclosporine | Glomerular Filtration Rate (GFR) by The Cockcroft-Gault Equation | Month 6 | 69.21 mL/min | Standard Deviation 23.66 |
| Cyclosporine | Glomerular Filtration Rate (GFR) by The Cockcroft-Gault Equation | Month 12 | 69.67 mL/min | Standard Deviation 25.64 |
| CP-690,550 15 mg for Months 1 to 6 | Glomerular Filtration Rate (GFR) by The Cockcroft-Gault Equation | Month 3 | 74.41 mL/min | Standard Deviation 25.76 |
| CP-690,550 15 mg for Months 1 to 6 | Glomerular Filtration Rate (GFR) by The Cockcroft-Gault Equation | Month 12 | 78.41 mL/min | Standard Deviation 27.62 |
| CP-690,550 15 mg for Months 1 to 6 | Glomerular Filtration Rate (GFR) by The Cockcroft-Gault Equation | Month 6 | 74.71 mL/min | Standard Deviation 25.87 |
| CP-690,550 15 mg for Months 1 to 6 | Glomerular Filtration Rate (GFR) by The Cockcroft-Gault Equation | Month 9 | 76.41 mL/min | Standard Deviation 25.62 |
| CP-690,550 15 mg for Months 1 to 6 | Glomerular Filtration Rate (GFR) by The Cockcroft-Gault Equation | Month 1 | 71.12 mL/min | Standard Deviation 23.31 |
| CP-690,550 15 mg for Months 1 to 3 | Glomerular Filtration Rate (GFR) by The Cockcroft-Gault Equation | Month 1 | 73.55 mL/min | Standard Deviation 20.62 |
| CP-690,550 15 mg for Months 1 to 3 | Glomerular Filtration Rate (GFR) by The Cockcroft-Gault Equation | Month 3 | 74.16 mL/min | Standard Deviation 22.45 |
| CP-690,550 15 mg for Months 1 to 3 | Glomerular Filtration Rate (GFR) by The Cockcroft-Gault Equation | Month 9 | 76.40 mL/min | Standard Deviation 24.2 |
| CP-690,550 15 mg for Months 1 to 3 | Glomerular Filtration Rate (GFR) by The Cockcroft-Gault Equation | Month 12 | 78.09 mL/min | Standard Deviation 24.69 |
| CP-690,550 15 mg for Months 1 to 3 | Glomerular Filtration Rate (GFR) by The Cockcroft-Gault Equation | Month 6 | 76.30 mL/min | Standard Deviation 23.11 |
Secondary
Glomerular Filtration Rate (GFR) by The Modification of Diet in Renal Disease (MDRD) Equation
GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. 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).A 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/1.73 m\^2 indicated kidney failure.
Time frame: Month 1, 3, 6, 9, 12
Population: FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure. Missing data were imputed using LOCF.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cyclosporine | Glomerular Filtration Rate (GFR) by The Modification of Diet in Renal Disease (MDRD) Equation | Month 9 | 54.11 mL/min/1.73 m^2 | Standard Deviation 20.45 |
| Cyclosporine | Glomerular Filtration Rate (GFR) by The Modification of Diet in Renal Disease (MDRD) Equation | Month 6 | 54.16 mL/min/1.73 m^2 | Standard Deviation 19.21 |
| Cyclosporine | Glomerular Filtration Rate (GFR) by The Modification of Diet in Renal Disease (MDRD) Equation | Month 1 | 52.89 mL/min/1.73 m^2 | Standard Deviation 20.05 |
| Cyclosporine | Glomerular Filtration Rate (GFR) by The Modification of Diet in Renal Disease (MDRD) Equation | Month 3 | 53.55 mL/min/1.73 m^2 | Standard Deviation 18.83 |
| Cyclosporine | Glomerular Filtration Rate (GFR) by The Modification of Diet in Renal Disease (MDRD) Equation | Month 12 | 53.94 mL/min/1.73 m^2 | Standard Deviation 21.36 |
| CP-690,550 15 mg for Months 1 to 6 | Glomerular Filtration Rate (GFR) by The Modification of Diet in Renal Disease (MDRD) Equation | Month 6 | 61.84 mL/min/1.73 m^2 | Standard Deviation 17.71 |
| CP-690,550 15 mg for Months 1 to 6 | Glomerular Filtration Rate (GFR) by The Modification of Diet in Renal Disease (MDRD) Equation | Month 1 | 59.93 mL/min/1.73 m^2 | Standard Deviation 17.54 |
| CP-690,550 15 mg for Months 1 to 6 | Glomerular Filtration Rate (GFR) by The Modification of Diet in Renal Disease (MDRD) Equation | Month 3 | 62.20 mL/min/1.73 m^2 | Standard Deviation 17.16 |
| CP-690,550 15 mg for Months 1 to 6 | Glomerular Filtration Rate (GFR) by The Modification of Diet in Renal Disease (MDRD) Equation | Month 9 | 62.98 mL/min/1.73 m^2 | Standard Deviation 17.5 |
| CP-690,550 15 mg for Months 1 to 6 | Glomerular Filtration Rate (GFR) by The Modification of Diet in Renal Disease (MDRD) Equation | Month 12 | 64.25 mL/min/1.73 m^2 | Standard Deviation 18.28 |
| CP-690,550 15 mg for Months 1 to 3 | Glomerular Filtration Rate (GFR) by The Modification of Diet in Renal Disease (MDRD) Equation | Month 12 | 64.59 mL/min/1.73 m^2 | Standard Deviation 20.35 |
| CP-690,550 15 mg for Months 1 to 3 | Glomerular Filtration Rate (GFR) by The Modification of Diet in Renal Disease (MDRD) Equation | Month 9 | 63.61 mL/min/1.73 m^2 | Standard Deviation 18.82 |
| CP-690,550 15 mg for Months 1 to 3 | Glomerular Filtration Rate (GFR) by The Modification of Diet in Renal Disease (MDRD) Equation | Month 1 | 63.61 mL/min/1.73 m^2 | Standard Deviation 21 |
| CP-690,550 15 mg for Months 1 to 3 | Glomerular Filtration Rate (GFR) by The Modification of Diet in Renal Disease (MDRD) Equation | Month 6 | 64.04 mL/min/1.73 m^2 | Standard Deviation 19.63 |
| CP-690,550 15 mg for Months 1 to 3 | Glomerular Filtration Rate (GFR) by The Modification of Diet in Renal Disease (MDRD) Equation | Month 3 | 62.81 mL/min/1.73 m^2 | Standard Deviation 20.04 |
Secondary
Glomerular Filtration Rate (GFR) by The Nankivell Equation
GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated was estimated 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 height square) plus (35 for male/25 for female). 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: Month 1, 3, 6, 9, 12
Population: FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure. Missing data were imputed using Last Observation Carried Forward (LOCF).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cyclosporine | Glomerular Filtration Rate (GFR) by The Nankivell Equation | Month 1 | 65.85 mL/min | Standard Deviation 19.73 |
| Cyclosporine | Glomerular Filtration Rate (GFR) by The Nankivell Equation | Month 3 | 65.80 mL/min | Standard Deviation 17.88 |
| Cyclosporine | Glomerular Filtration Rate (GFR) by The Nankivell Equation | Month 6 | 66.75 mL/min | Standard Deviation 18.75 |
| Cyclosporine | Glomerular Filtration Rate (GFR) by The Nankivell Equation | Month 12 | 66.88 mL/min | Standard Deviation 21.87 |
| Cyclosporine | Glomerular Filtration Rate (GFR) by The Nankivell Equation | Month 9 | 66.85 mL/min | Standard Deviation 20.33 |
| CP-690,550 15 mg for Months 1 to 6 | Glomerular Filtration Rate (GFR) by The Nankivell Equation | Month 6 | 73.23 mL/min | Standard Deviation 18.26 |
| CP-690,550 15 mg for Months 1 to 6 | Glomerular Filtration Rate (GFR) by The Nankivell Equation | Month 1 | 71.53 mL/min | Standard Deviation 17.72 |
| CP-690,550 15 mg for Months 1 to 6 | Glomerular Filtration Rate (GFR) by The Nankivell Equation | Month 12 | 75.58 mL/min | Standard Deviation 18.54 |
| CP-690,550 15 mg for Months 1 to 6 | Glomerular Filtration Rate (GFR) by The Nankivell Equation | Month 9 | 74.29 mL/min | Standard Deviation 18.23 |
| CP-690,550 15 mg for Months 1 to 6 | Glomerular Filtration Rate (GFR) by The Nankivell Equation | Month 3 | 73.58 mL/min | Standard Deviation 18.46 |
| CP-690,550 15 mg for Months 1 to 3 | Glomerular Filtration Rate (GFR) by The Nankivell Equation | Month 12 | 75.41 mL/min | Standard Deviation 17.5 |
| CP-690,550 15 mg for Months 1 to 3 | Glomerular Filtration Rate (GFR) by The Nankivell Equation | Month 9 | 74.22 mL/min | Standard Deviation 16.78 |
| CP-690,550 15 mg for Months 1 to 3 | Glomerular Filtration Rate (GFR) by The Nankivell Equation | Month 6 | 74.49 mL/min | Standard Deviation 16.81 |
| CP-690,550 15 mg for Months 1 to 3 | Glomerular Filtration Rate (GFR) by The Nankivell Equation | Month 3 | 72.91 mL/min | Standard Deviation 16.9 |
| CP-690,550 15 mg for Months 1 to 3 | Glomerular Filtration Rate (GFR) by The Nankivell Equation | Month 1 | 73.66 mL/min | Standard Deviation 16.53 |
Secondary
Lymphocyte Subset
The absolute cell counts of cluster of differentiation 3 (CD3): T-lymphocytes, cluster of differentiation 19 (CD19): B-lymphocytes, and cluster of differentiation 56 (CD56): assumed natural killer cells, were determined using flow cytometry.
Time frame: Month 1, 3, 6, 12
Population: FAS: 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 who were evaluable at given time point for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cyclosporine | Lymphocyte Subset | CD56: Month 1 (n=60,54,47) | 166.47 cells per microliter | Standard Deviation 93.95 |
| Cyclosporine | Lymphocyte Subset | CD3: Month 1 (n=60,54,47) | 1555.0 cells per microliter | Standard Deviation 925.45 |
| Cyclosporine | Lymphocyte Subset | CD3: Month 3 (n=59,44,34) | 1273.2 cells per microliter | Standard Deviation 742.82 |
| Cyclosporine | Lymphocyte Subset | CD3: Month 6 (n=47,34,31) | 1267.9 cells per microliter | Standard Deviation 693.2 |
| Cyclosporine | Lymphocyte Subset | CD3: Month 12 (n=45,29,26) | 1352.5 cells per microliter | Standard Deviation 647.6 |
| Cyclosporine | Lymphocyte Subset | CD19: Month 1 (n=60,54,47) | 280.58 cells per microliter | Standard Deviation 220.96 |
| Cyclosporine | Lymphocyte Subset | CD19: Month 3 (n=58,44,34) | 154.47 cells per microliter | Standard Deviation 208.07 |
| Cyclosporine | Lymphocyte Subset | CD19: Month 6 (n=47,34,31) | 125.26 cells per microliter | Standard Deviation 164.65 |
| Cyclosporine | Lymphocyte Subset | CD19: Month 12 (n=45,29,26) | 120.18 cells per microliter | Standard Deviation 117.14 |
| Cyclosporine | Lymphocyte Subset | CD56: Month 3 (n=58,44,34) | 143.14 cells per microliter | Standard Deviation 86.42 |
| Cyclosporine | Lymphocyte Subset | CD56: Month 6 (n=47,34,31) | 170.23 cells per microliter | Standard Deviation 123.27 |
| Cyclosporine | Lymphocyte Subset | CD56: Month 12 (n=45,29,26) | 168.91 cells per microliter | Standard Deviation 122.8 |
| CP-690,550 15 mg for Months 1 to 6 | Lymphocyte Subset | CD56: Month 12 (n=45,29,26) | 96.00 cells per microliter | Standard Deviation 100.85 |
| CP-690,550 15 mg for Months 1 to 6 | Lymphocyte Subset | CD56: Month 1 (n=60,54,47) | 116.65 cells per microliter | Standard Deviation 110.62 |
| CP-690,550 15 mg for Months 1 to 6 | Lymphocyte Subset | CD19: Month 3 (n=58,44,34) | 189.41 cells per microliter | Standard Deviation 190.23 |
| CP-690,550 15 mg for Months 1 to 6 | Lymphocyte Subset | CD19: Month 12 (n=45,29,26) | 180.03 cells per microliter | Standard Deviation 235.85 |
| CP-690,550 15 mg for Months 1 to 6 | Lymphocyte Subset | CD3: Month 1 (n=60,54,47) | 1256.7 cells per microliter | Standard Deviation 708.47 |
| CP-690,550 15 mg for Months 1 to 6 | Lymphocyte Subset | CD19: Month 1 (n=60,54,47) | 409.39 cells per microliter | Standard Deviation 339.45 |
| CP-690,550 15 mg for Months 1 to 6 | Lymphocyte Subset | CD56: Month 6 (n=47,34,31) | 68.06 cells per microliter | Standard Deviation 63.85 |
| CP-690,550 15 mg for Months 1 to 6 | Lymphocyte Subset | CD3: Month 3 (n=59,44,34) | 894.20 cells per microliter | Standard Deviation 527.87 |
| CP-690,550 15 mg for Months 1 to 6 | Lymphocyte Subset | CD19: Month 6 (n=47,34,31) | 151.03 cells per microliter | Standard Deviation 129.52 |
| CP-690,550 15 mg for Months 1 to 6 | Lymphocyte Subset | CD3: Month 12 (n=45,29,26) | 796.76 cells per microliter | Standard Deviation 368.51 |
| CP-690,550 15 mg for Months 1 to 6 | Lymphocyte Subset | CD3: Month 6 (n=47,34,31) | 811.74 cells per microliter | Standard Deviation 379.16 |
| CP-690,550 15 mg for Months 1 to 6 | Lymphocyte Subset | CD56: Month 3 (n=58,44,34) | 86.86 cells per microliter | Standard Deviation 97.8 |
| CP-690,550 15 mg for Months 1 to 3 | Lymphocyte Subset | CD3: Month 6 (n=47,34,31) | 970.39 cells per microliter | Standard Deviation 410.28 |
| CP-690,550 15 mg for Months 1 to 3 | Lymphocyte Subset | CD3: Month 12 (n=45,29,26) | 956.04 cells per microliter | Standard Deviation 522.08 |
| CP-690,550 15 mg for Months 1 to 3 | Lymphocyte Subset | CD56: Month 3 (n=58,44,34) | 65.38 cells per microliter | Standard Deviation 38.91 |
| CP-690,550 15 mg for Months 1 to 3 | Lymphocyte Subset | CD19: Month 1 (n=60,54,47) | 416.70 cells per microliter | Standard Deviation 304.95 |
| CP-690,550 15 mg for Months 1 to 3 | Lymphocyte Subset | CD19: Month 3 (n=58,44,34) | 185.68 cells per microliter | Standard Deviation 139.24 |
| CP-690,550 15 mg for Months 1 to 3 | Lymphocyte Subset | CD19: Month 6 (n=47,34,31) | 173.10 cells per microliter | Standard Deviation 136.53 |
| CP-690,550 15 mg for Months 1 to 3 | Lymphocyte Subset | CD56: Month 6 (n=47,34,31) | 65.00 cells per microliter | Standard Deviation 48.86 |
| CP-690,550 15 mg for Months 1 to 3 | Lymphocyte Subset | CD56: Month 1 (n=60,54,47) | 112.23 cells per microliter | Standard Deviation 110.25 |
| CP-690,550 15 mg for Months 1 to 3 | Lymphocyte Subset | CD3: Month 1 (n=60,54,47) | 1327.2 cells per microliter | Standard Deviation 627.74 |
| CP-690,550 15 mg for Months 1 to 3 | Lymphocyte Subset | CD19: Month 12 (n=45,29,26) | 181.46 cells per microliter | Standard Deviation 141.45 |
| CP-690,550 15 mg for Months 1 to 3 | Lymphocyte Subset | CD3: Month 3 (n=59,44,34) | 1007.1 cells per microliter | Standard Deviation 447.91 |
| CP-690,550 15 mg for Months 1 to 3 | Lymphocyte Subset | CD56: Month 12 (n=45,29,26) | 77.23 cells per microliter | Standard Deviation 57.74 |
Secondary
Number of Participants Who Died
Time frame: Month 6, 12
Population: FAS with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed): participants evaluable for this measure; and n: participants who remained at risk at given time point for each group, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cyclosporine | Number of Participants Who Died | Month 6 (n=86,69,69) | 2 participants |
| Cyclosporine | Number of Participants Who Died | Month 12 (n=80,57,55) | 2 participants |
| CP-690,550 15 mg for Months 1 to 6 | Number of Participants Who Died | Month 6 (n=86,69,69) | 2 participants |
| CP-690,550 15 mg for Months 1 to 6 | Number of Participants Who Died | Month 12 (n=80,57,55) | 2 participants |
| CP-690,550 15 mg for Months 1 to 3 | Number of Participants Who Died | Month 6 (n=86,69,69) | 0 participants |
| CP-690,550 15 mg for Months 1 to 3 | Number of Participants Who Died | Month 12 (n=80,57,55) | 0 participants |
Secondary
Number of Participants With Clinically Significant Infections
Clinically significant infection was defined as the presence of documented infection confirmed by culture, biopsy, genomic, or serologic findings post-randomization and requiring hospitalization or parenteral anti-infective treatment, or otherwise deemed significant by the investigator.
Time frame: Baseline up to Month 12
Population: FAS: all randomized participants who received at least 1 dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cyclosporine | Number of Participants With Clinically Significant Infections | 61 participants |
| CP-690,550 15 mg for Months 1 to 6 | Number of Participants With Clinically Significant Infections | 88 participants |
| CP-690,550 15 mg for Months 1 to 3 | Number of Participants With Clinically Significant Infections | 83 participants |
Secondary
Number of Participants With Combined Banff Rejection Categories (Categories 2, 3, and 4)
Banff 97: standard classification for scoring and classifying rejection of kidney transplant biopsies in 6 diagnostic categories: normal, antibody-mediated rejection, borderline changes: 'suspicious' for acute cellular rejection, acute/active cellular rejection, chronic/sclerosing allograft nephropathy, and other. Combined Banff rejection calculated from categories of antibody-mediated rejection (Category 2) plus borderline changes (Category 3) plus acute rejection (Category 4), as interpreted by the central pathologist.
Time frame: Month 6, 12
Population: FAS with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed): participants evaluable for this measure; and n: participants who were evaluable at given time point for each group, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cyclosporine | Number of Participants With Combined Banff Rejection Categories (Categories 2, 3, and 4) | Month 6 (n=100,83,83) | 29 participants |
| Cyclosporine | Number of Participants With Combined Banff Rejection Categories (Categories 2, 3, and 4) | Month 12 (n=96,74,71) | 30 participants |
| CP-690,550 15 mg for Months 1 to 6 | Number of Participants With Combined Banff Rejection Categories (Categories 2, 3, and 4) | Month 6 (n=100,83,83) | 22 participants |
| CP-690,550 15 mg for Months 1 to 6 | Number of Participants With Combined Banff Rejection Categories (Categories 2, 3, and 4) | Month 12 (n=96,74,71) | 24 participants |
| CP-690,550 15 mg for Months 1 to 3 | Number of Participants With Combined Banff Rejection Categories (Categories 2, 3, and 4) | Month 6 (n=100,83,83) | 20 participants |
| CP-690,550 15 mg for Months 1 to 3 | Number of Participants With Combined Banff Rejection Categories (Categories 2, 3, and 4) | Month 12 (n=96,74,71) | 23 participants |
Secondary
Number of Participants With Efficacy Failure
Efficacy failure was the first occurrence of clinical BPAR diagnosed by the central pathologist or graft loss including participant death.
Time frame: Month 6, 12
Population: FAS with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed): participants evaluable for this measure; and n: participants who remained at risk at given time point for each group, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cyclosporine | Number of Participants With Efficacy Failure | Month 6 (n=98,84,80) | 21 participants |
| Cyclosporine | Number of Participants With Efficacy Failure | Month 12 (n=94,74,67) | 22 participants |
| CP-690,550 15 mg for Months 1 to 6 | Number of Participants With Efficacy Failure | Month 6 (n=98,84,80) | 19 participants |
| CP-690,550 15 mg for Months 1 to 6 | Number of Participants With Efficacy Failure | Month 12 (n=94,74,67) | 20 participants |
| CP-690,550 15 mg for Months 1 to 3 | Number of Participants With Efficacy Failure | Month 6 (n=98,84,80) | 14 participants |
| CP-690,550 15 mg for Months 1 to 3 | Number of Participants With Efficacy Failure | Month 12 (n=94,74,67) | 16 participants |
Secondary
Number of Participants With First Clinical Biopsy Proven Acute Rejection (BPAR) 12 Months Post Transplant
Clinical BPAR was a BPAR (category acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification) associated with an increase in serum creatinine of \>= 0.3 mg/dL and \>=20% from pre-rejection baseline. The increase in serum creatinine was assessed based on the comparison of baseline and the highest serum creatinine recorded within 24 hrs of the time of biopsy.
Time frame: Baseline up to Month 12
Population: FAS with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cyclosporine | Number of Participants With First Clinical Biopsy Proven Acute Rejection (BPAR) 12 Months Post Transplant | 9 participants |
| CP-690,550 15 mg for Months 1 to 6 | Number of Participants With First Clinical Biopsy Proven Acute Rejection (BPAR) 12 Months Post Transplant | 11 participants |
| CP-690,550 15 mg for Months 1 to 3 | Number of Participants With First Clinical Biopsy Proven Acute Rejection (BPAR) 12 Months Post Transplant | 7 participants |
Secondary
Number of Participants With Graft Loss
Graft loss was defined as graft nephrectomy, participant death, re-transplantation, or return to dialysis for \>=6 consecutive weeks.
Time frame: Month 6, 12
Population: FAS with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed): participants evaluable for this measure; and n: participants who remained at risk at given time point for each group, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cyclosporine | Number of Participants With Graft Loss | Month 6 (n=85,68,72) | 1 participants |
| Cyclosporine | Number of Participants With Graft Loss | Month 12 (n=79,56,58) | 1 participants |
| CP-690,550 15 mg for Months 1 to 6 | Number of Participants With Graft Loss | Month 6 (n=85,68,72) | 1 participants |
| CP-690,550 15 mg for Months 1 to 6 | Number of Participants With Graft Loss | Month 12 (n=79,56,58) | 1 participants |
| CP-690,550 15 mg for Months 1 to 3 | Number of Participants With Graft Loss | Month 6 (n=85,68,72) | 3 participants |
| CP-690,550 15 mg for Months 1 to 3 | Number of Participants With Graft Loss | Month 12 (n=79,56,58) | 3 participants |
Secondary
Number of Participants With Progression of Chronic Allograft Lesions at Month 12
Progression of chronic allograft lesions was defined as an increase in the Banff chronicity score (Banff-CS) in biopsy from the implantation (baseline) biopsy in a given participant. Banff-CS was the sum of the Banff scores for the 4 chronic basic lesions (allograft glomerulopathy \[cg\] + interstitial fibrosis \[ci\] + tubular atrophy \[ct\] + vascular intimal thickening \[cv\]).The Banff-CS ranged from 0-12, higher score indicated greater lesions and Month 12 Banff-CS greater than the implantation biopsy score indicated progression of lesions.
Time frame: Month 12
Population: Per protocol (PP) population: all randomized participants who received at least 1 dose of study treatment; excluding participants who had a protocol deviation thought to affect the analyses. Here, N (Number of Participants Analyzed) includes only participants with evaluable data for this measure at both baseline and Month 12.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cyclosporine | Number of Participants With Progression of Chronic Allograft Lesions at Month 12 | 29 participants |
| CP-690,550 15 mg for Months 1 to 6 | Number of Participants With Progression of Chronic Allograft Lesions at Month 12 | 18 participants |
| CP-690,550 15 mg for Months 1 to 3 | Number of Participants With Progression of Chronic Allograft Lesions at Month 12 | 19 participants |
Secondary
Number of Participants With Treated Clinical Acute Rejection
Treated clinical acute rejection was defined as an acute rejection episode that was diagnosed based on local biopsy readout and received anti-rejection treatment.
Time frame: Month 6, 12
Population: FAS with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed): participants evaluable for this measure; and n: participants who remained at risk at given time point for each group, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cyclosporine | Number of Participants With Treated Clinical Acute Rejection | Month 6 (n=95,86,80) | 21 participants |
| Cyclosporine | Number of Participants With Treated Clinical Acute Rejection | Month 12 (n=92,76,69) | 25 participants |
| CP-690,550 15 mg for Months 1 to 6 | Number of Participants With Treated Clinical Acute Rejection | Month 6 (n=95,86,80) | 23 participants |
| CP-690,550 15 mg for Months 1 to 6 | Number of Participants With Treated Clinical Acute Rejection | Month 12 (n=92,76,69) | 26 participants |
| CP-690,550 15 mg for Months 1 to 3 | Number of Participants With Treated Clinical Acute Rejection | Month 6 (n=95,86,80) | 18 participants |
| CP-690,550 15 mg for Months 1 to 3 | Number of Participants With Treated Clinical Acute Rejection | Month 12 (n=92,76,69) | 18 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-2(P-2), Pre-dose(P), 0.5,1,2 hr post-dose(PD) on Day14, Month(M) 3; P,1,2 hr PD on M1; P, 0.5, 2, 4 hr PD on M6; P-2, P, 0.5 hr PD on M9, M12 as per randomization in CP-690,550 treated; P on M3 and P, 2, 4 hr PD on M6 in CsA treated participants
Secondary
Severity of Dyspepsia Assessment (SODA)
SODA:17-item health scale, assessed participant-reported perceptions of dyspepsia;consists of 3 subscales:Pain Intensity (6-items to assess pain and intensity of abdominal \[Ab\] discomfort; Range (Ra):2-47, higher score= greater pain and Ab discomfort), Non-Pain Symptoms (7-items to assess severity and impact of non-pain symptoms:burping/belching,heartburn,bloating,flatulence,sour taste,nausea,and bad breath; Ra:7-35,higher scores = increased symptom severity and influence), and Satisfaction (4-items to assess degree of satisfaction with Ab discomfort; Ra:2-23,higher scores= more satisfaction).
Time frame: Baseline, Month 6, 12
Population: Data not analyzed since the SODA instrument was found irrelevant in the treated population.