Kidney Transplantation
Conditions
Brief summary
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of escalating doses of TCD601 when compared to rATG in de novo renal transplant patients.
Interventions
BIOLOGICALTCD601
Investigational Product
DRUGTacrolimus (TAC)
Standard of Care Concomitant Immunosuppression
Standard of Care Concomitant Immunosuppression
DRUGMycophenolate Mofetil (MMF)
Standard of Care Concomitant Immunosuppression
DRUGATG
Standard of Care induction therapy in solid organ transplantation
Sponsors
ITB-Med LLC
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Able to understand the study requirements and provide written informed consent before and study assessment is performed. * Male or female patients ≥ 18 to 70 years of age. * Recipients of a de novo renal allograft from a heart-beating deceased, living unrelated, or non-HLA identical living related donor. * Recipients of a kidney with a cold ischemia time (CIT) less than 30 hours. Key
Exclusion criteria
* Multiple-organ transplant recipients * Subjects who have received a kidney allograft previously * Recipient of a kidney from an HLA identical living related donor * Recipient of a kidney from a donor after cardiac death * Subjects at high immunological risk for rejection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | 12 months | — |
| Measure Peak Plasma Concentration (Cmax) Over Time. | 12 months | The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration. |
| Measure the Area Under the Plasma Concentration Versus Time Curve (AUC). | 12 months | The AUC from time zero to the last measurable concentration sampling time. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Incidence of Rejection at 12 Months Post-transplant. | 12 months | The incidence of treated biopsy-proven acute rejection (tBPAR) and antibody medication rejection (AMR) at 12 months post-transplant. |
| To Assess the Change in Renal Function Over Time. | 12 months | Estimated glomerular filtration rate (eGFR) was calculated using the MDRD4 equation. Mean+-SD eGFR values are presented at 3, 6, and 12. and compared against baseline (1 Month post-transplant). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 TCD601 (0.2mg/kg) administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
TCD601: Investigational Product
Tacrolimus (TAC): Standard of Care Concomitant Immunosuppression
Corticosteroids (CS): Standard of Care Concomitant Immunosuppression
Mycophenolate Mofetil (MMF): Standard of Care Concomitant Immunosuppression | 2 |
| Arm 2 TCD601 (0.6mg/kg) administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
TCD601: Investigational Product
Tacrolimus (TAC): Standard of Care Concomitant Immunosuppression
Corticosteroids (CS): Standard of Care Concomitant Immunosuppression
Mycophenolate Mofetil (MMF): Standard of Care Concomitant Immunosuppression | 4 |
| Arm 3 ATG administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
ATG: Standard of Care induction therapy in solid organ transplantation
Tacrolimus (TAC): Standard of Care Concomitant Immunosuppression
Corticosteroids (CS): Standard of Care Concomitant Immunosuppression
Mycophenolate Mofetil (MMF): Standard of Care Concomitant Immunosuppression | 7 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Arm 2 | Total | Arm 1 | Arm 3 |
|---|---|---|---|---|
| Age, Continuous | 42 years STANDARD_DEVIATION 10.8 | 45 years STANDARD_DEVIATION 10.6 | 29 years STANDARD_DEVIATION 5.7 | 51.3 years STANDARD_DEVIATION 4.7 |
| BMI | 30.5 kg/m^2 STANDARD_DEVIATION 2.9 | 29.0 kg/m^2 STANDARD_DEVIATION 5.3 | 22.1 kg/m^2 STANDARD_DEVIATION 6.6 | 30.6 kg/m^2 STANDARD_DEVIATION 4.6 |
| Current Dialysis Hemodialysis | 2 Participants | 5 Participants | 0 Participants | 3 Participants |
| Current Dialysis None | 1 Participants | 5 Participants | 2 Participants | 2 Participants |
| Current Dialysis Peritoneal Dialysis | 1 Participants | 3 Participants | 0 Participants | 2 Participants |
| End Stage Disease Leading to Transplantation Diabetes Mellitus | 1 Participants | 4 Participants | 0 Participants | 3 Participants |
| End Stage Disease Leading to Transplantation Glomerular Disease | 0 Participants | 2 Participants | 1 Participants | 1 Participants |
| End Stage Disease Leading to Transplantation Hypertension/ Nephrosclerosis | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| End Stage Disease Leading to Transplantation IgA Nephropathy | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| End Stage Disease Leading to Transplantation Other: Congenital Obstructive Uropathy | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| End Stage Disease Leading to Transplantation Polycystic Disease | 3 Participants | 3 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 12 Participants | 2 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Height | 188.0 centimeters STANDARD_DEVIATION 4.4 | 179.1 centimeters STANDARD_DEVIATION 10.4 | 171.0 centimeters STANDARD_DEVIATION 16.9 | 177.7 centimeters STANDARD_DEVIATION 8.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 10 Participants | 2 Participants | 5 Participants |
| Region of Enrollment United States | 4 participants | 13 participants | 2 participants | 7 participants |
| Sex: Female, Male Female | 0 Participants | 3 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 4 Participants | 10 Participants | 1 Participants | 5 Participants |
| Viral Serology Cytomegalovirus Negative | 2 Participants | 7 Participants | 1 Participants | 4 Participants |
| Viral Serology Cytomegalovirus Positive | 2 Participants | 6 Participants | 1 Participants | 3 Participants |
| Viral Serology Epstein-Barr Virus Negative | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Viral Serology Epstein-Barr Virus Positive | 4 Participants | 13 Participants | 2 Participants | 7 Participants |
| Viral Serology Hepatitis B Surface Antigen Negative | 4 Participants | 13 Participants | 2 Participants | 7 Participants |
| Viral Serology Hepatitis B Surface Antigen Positive | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Viral Serology Hepatitis C Virus Antibody Negative | 4 Participants | 13 Participants | 2 Participants | 7 Participants |
| Viral Serology Hepatitis C Virus Antibody Positive | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Viral Serology Human Immunodeficiency Virus Negative | 4 Participants | 13 Participants | 2 Participants | 7 Participants |
| Viral Serology Human Immunodeficiency Virus Positive | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Weight | 115.5 kilograms STANDARD_DEVIATION 16.5 | 97.9 kilograms STANDARD_DEVIATION 24.8 | 66.8 kilograms STANDARD_DEVIATION 32.4 | 96.8 kilograms STANDARD_DEVIATION 19.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 4 | 0 / 7 |
| other Total, other adverse events | 2 / 2 | 4 / 4 | 7 / 7 |
| serious Total, serious adverse events | 2 / 2 | 1 / 4 | 5 / 7 |
Outcome results
Primary
Measure Peak Plasma Concentration (Cmax) Over Time.
The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | Measure Peak Plasma Concentration (Cmax) Over Time. | 5.0 ug/mL | Standard Deviation 0.2 |
| Arm 2 | Measure Peak Plasma Concentration (Cmax) Over Time. | 17.5 ug/mL | Standard Deviation 1.1 |
Primary
Measure the Area Under the Plasma Concentration Versus Time Curve (AUC).
The AUC from time zero to the last measurable concentration sampling time.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | Measure the Area Under the Plasma Concentration Versus Time Curve (AUC). | 23.0 ug/mL*day | Standard Deviation 0.5 |
| Arm 2 | Measure the Area Under the Plasma Concentration Versus Time Curve (AUC). | 162.0 ug/mL*day | Standard Deviation 53.4 |
Primary
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0.
Time frame: 12 months
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Arm 1 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 Infection | Yes | 2 Participants |
| Arm 1 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 TEAE leading to Study Discontinuation | No | 2 Participants |
| Arm 1 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 SAE related to Study Medication | Yes | 1 Participants |
| Arm 1 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 TEAE leading to Study Medication Discontinuation | No | 2 Participants |
| Arm 1 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 TEAE leading to Dose Adjustment | Yes | 0 Participants |
| Arm 1 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 TEAE Related to Study Medication | Yes | 2 Participants |
| Arm 1 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 TEAE leading to Study Medication Discontinuation | Yes | 0 Participants |
| Arm 1 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 TEAE leading to Dose Adjustment | No | 2 Participants |
| Arm 1 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 SAE | Yes | 2 Participants |
| Arm 1 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 TEAE leading to Dose Interruption | No | 2 Participants |
| Arm 1 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 TEAE leading to Dose Interruption | Yes | 0 Participants |
| Arm 1 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 Serious Infection | No | 1 Participants |
| Arm 1 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 TEAE Related to Study Medication | No | 0 Participants |
| Arm 1 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 SAE related to Study Medication | No | 1 Participants |
| Arm 1 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 Serious Infection | Yes | 1 Participants |
| Arm 1 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 SAE | No | 0 Participants |
| Arm 1 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 TEAE | No | 0 Participants |
| Arm 1 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 Infection | No | 0 Participants |
| Arm 1 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 TEAE leading to Study Discontinuation | Yes | 0 Participants |
| Arm 1 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 TEAE | Yes | 2 Participants |
| Arm 2 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 Serious Infection | No | 4 Participants |
| Arm 2 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 SAE | Yes | 1 Participants |
| Arm 2 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 TEAE | Yes | 4 Participants |
| Arm 2 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 TEAE | No | 0 Participants |
| Arm 2 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 TEAE Related to Study Medication | Yes | 3 Participants |
| Arm 2 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 TEAE Related to Study Medication | No | 1 Participants |
| Arm 2 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 SAE | No | 3 Participants |
| Arm 2 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 TEAE leading to Study Discontinuation | Yes | 0 Participants |
| Arm 2 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 TEAE leading to Study Discontinuation | No | 4 Participants |
| Arm 2 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 TEAE leading to Dose Adjustment | Yes | 0 Participants |
| Arm 2 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 TEAE leading to Dose Adjustment | No | 4 Participants |
| Arm 2 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 TEAE leading to Dose Interruption | Yes | 0 Participants |
| Arm 2 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 TEAE leading to Dose Interruption | No | 4 Participants |
| Arm 2 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 TEAE leading to Study Medication Discontinuation | Yes | 0 Participants |
| Arm 2 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 TEAE leading to Study Medication Discontinuation | No | 4 Participants |
| Arm 2 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 Infection | Yes | 3 Participants |
| Arm 2 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 Infection | No | 1 Participants |
| Arm 2 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 Serious Infection | Yes | 0 Participants |
| Arm 2 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 SAE related to Study Medication | Yes | 0 Participants |
| Arm 2 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 SAE related to Study Medication | No | 4 Participants |
| Arm 3 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 TEAE | No | 0 Participants |
| Arm 3 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 TEAE leading to Study Medication Discontinuation | No | 7 Participants |
| Arm 3 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 TEAE leading to Study Discontinuation | Yes | 0 Participants |
| Arm 3 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 SAE related to Study Medication | No | 7 Participants |
| Arm 3 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 Infection | Yes | 6 Participants |
| Arm 3 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 SAE | No | 2 Participants |
| Arm 3 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 SAE related to Study Medication | Yes | 0 Participants |
| Arm 3 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 Infection | No | 1 Participants |
| Arm 3 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 TEAE Related to Study Medication | No | 3 Participants |
| Arm 3 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 TEAE | Yes | 7 Participants |
| Arm 3 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 Serious Infection | Yes | 1 Participants |
| Arm 3 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 TEAE Related to Study Medication | Yes | 4 Participants |
| Arm 3 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 TEAE leading to Dose Interruption | Yes | 1 Participants |
| Arm 3 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 TEAE leading to Dose Adjustment | No | 7 Participants |
| Arm 3 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 SAE | Yes | 5 Participants |
| Arm 3 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 TEAE leading to Dose Interruption | No | 6 Participants |
| Arm 3 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 TEAE leading to Dose Adjustment | Yes | 0 Participants |
| Arm 3 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 Serious Infection | No | 6 Participants |
| Arm 3 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 TEAE leading to Study Medication Discontinuation | Yes | 0 Participants |
| Arm 3 | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. | At least 1 TEAE leading to Study Discontinuation | No | 7 Participants |
Secondary
The Incidence of Rejection at 12 Months Post-transplant.
The incidence of treated biopsy-proven acute rejection (tBPAR) and antibody medication rejection (AMR) at 12 months post-transplant.
Time frame: 12 months
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Arm 1 | The Incidence of Rejection at 12 Months Post-transplant. | AMR | Yes | 0 Participants |
| Arm 1 | The Incidence of Rejection at 12 Months Post-transplant. | tBPAR | Yes | 1 Participants |
| Arm 1 | The Incidence of Rejection at 12 Months Post-transplant. | AMR | No | 2 Participants |
| Arm 1 | The Incidence of Rejection at 12 Months Post-transplant. | tBPAR | No | 1 Participants |
| Arm 2 | The Incidence of Rejection at 12 Months Post-transplant. | AMR | Yes | 0 Participants |
| Arm 2 | The Incidence of Rejection at 12 Months Post-transplant. | tBPAR | No | 4 Participants |
| Arm 2 | The Incidence of Rejection at 12 Months Post-transplant. | tBPAR | Yes | 0 Participants |
| Arm 2 | The Incidence of Rejection at 12 Months Post-transplant. | AMR | No | 4 Participants |
| Arm 3 | The Incidence of Rejection at 12 Months Post-transplant. | tBPAR | No | 6 Participants |
| Arm 3 | The Incidence of Rejection at 12 Months Post-transplant. | tBPAR | Yes | 1 Participants |
| Arm 3 | The Incidence of Rejection at 12 Months Post-transplant. | AMR | No | 7 Participants |
| Arm 3 | The Incidence of Rejection at 12 Months Post-transplant. | AMR | Yes | 0 Participants |
Secondary
To Assess the Change in Renal Function Over Time.
Estimated glomerular filtration rate (eGFR) was calculated using the MDRD4 equation. Mean+-SD eGFR values are presented at 3, 6, and 12. and compared against baseline (1 Month post-transplant).
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 | To Assess the Change in Renal Function Over Time. | Month 6 | 39.0 mL/minute/1.73m^2 | Standard Deviation 5.6 |
| Arm 1 | To Assess the Change in Renal Function Over Time. | Month 12 | 44.0 mL/minute/1.73m^2 | Standard Deviation 7 |
| Arm 1 | To Assess the Change in Renal Function Over Time. | Month 3 | 40.5 mL/minute/1.73m^2 | Standard Deviation 0.3 |
| Arm 1 | To Assess the Change in Renal Function Over Time. | Baseline | 40.4 mL/minute/1.73m^2 | Standard Deviation 5 |
| Arm 2 | To Assess the Change in Renal Function Over Time. | Baseline | 50.2 mL/minute/1.73m^2 | Standard Deviation 21.1 |
| Arm 2 | To Assess the Change in Renal Function Over Time. | Month 3 | 48.2 mL/minute/1.73m^2 | Standard Deviation 9.4 |
| Arm 2 | To Assess the Change in Renal Function Over Time. | Month 12 | 53.7 mL/minute/1.73m^2 | Standard Deviation 14.1 |
| Arm 2 | To Assess the Change in Renal Function Over Time. | Month 6 | 51.4 mL/minute/1.73m^2 | Standard Deviation 8.9 |
| Arm 3 | To Assess the Change in Renal Function Over Time. | Month 12 | 46.0 mL/minute/1.73m^2 | Standard Deviation 14.3 |
| Arm 3 | To Assess the Change in Renal Function Over Time. | Baseline | 45.9 mL/minute/1.73m^2 | Standard Deviation 5.8 |
| Arm 3 | To Assess the Change in Renal Function Over Time. | Month 3 | 48.2 mL/minute/1.73m^2 | Standard Deviation 10 |
| Arm 3 | To Assess the Change in Renal Function Over Time. | Month 6 | 47.2 mL/minute/1.73m^2 | Standard Deviation 17 |