Study Evaluating Rapamune® Maintenance Regimen
|ClinicalTrials.gov Identifier: NCT00478608|
Recruitment Status : Completed
First Posted : May 25, 2007
Results First Posted : January 7, 2010
Last Update Posted : April 28, 2010
Primary : To evaluate the efficacy of sirolimus assessed by the incidence of biopsy-confirmed acute rejection episode at 6 months after transplantation in Korean renal transplantation recipients.
- To evaluate the safety of sirolimus over 12 months after transplantation in Korean renal transplantation recipients.
- To evaluate graft function, patient survival and graft survival at 6 and 12 months after transplantation, and to investigate the incidence of biopsy-confirmed acute rejection episode at 12 months after transplantation.
|Condition or disease||Intervention/treatment||Phase|
|Renal Transplant||Drug: Sirolimus (Rapamune®)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||79 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Clinical Study to Evaluate the Efficacy and Safety of Cyclosporine (CsA) and Sirolimus (SRL) Induction Followed by Cyclosporine Withdrawal in Korean Renal Allograft Recipients|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||November 2008|
|Actual Study Completion Date :||November 2008|
Drug: Sirolimus (Rapamune®)
- Number of Patients Experiencing Biopsy Confirmed Acute Rejection Through Month 6 After Transplantation. [ Time Frame: 6 months after transplantation ]The diagnosis of acute rejection required a kidney biopsy. Biopsies were assessed using the Banff criteria, standardized diagnostic categories based on histological assessments (e.g., cell types and distributions).
- Glomerular Filtration Rate (GFR) (Nankivell Method) [ Time Frame: 6 and 12 months ]GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. For this study, GFR was calculated using the Nankivell formula. A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poorer kidney function. A GFR <15 is consistent with kidney failure.
- Serum Creatinine [ Time Frame: Baseline, 6 and 12 months ]Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. An increased level of creatinine in the blood indicates decreased kidney function. Normal adult blood levels of creatinine are 0.5 to 1.1 mg/dL for females and 0.6 to 1.2 mg/dL for males; however, the normal values are age-dependent as elderly patients typically have smaller muscle mass.
- Patient and Graft Survival [ Time Frame: 12 months ]Patient survival defined as patients living with or without a functioning graft. Graft survival defined as those patients who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 weeks), retransplant or death during the first 12 months after randomization.
- Number of Patients Experiencing Biopsy Confirmed Acute Rejection Through Month 12 After Transplantation [ Time Frame: 12 months after transplantation ]The diagnosis of acute rejection required a kidney biopsy. Biopsies were assessed using the Banff criteria, standardized diagnostic categories based on histological assessments (e.g., cell types and distributions).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00478608
|Korea, Republic of|
|Deagu, Korea, Republic of, 700-712|
|Deagu, Korea, Republic of, 700-721|
|Pusan, Korea, Republic of, 614-735|
|Seoul, Korea, Republic of, 110-744|
|Seoul, Korea, Republic of, 120-752|
|Seoul, Korea, Republic of, 135-710|
|Seoul, Korea, Republic of, 137-701|
|Seoul, Korea, Republic of, 138-736|
|Suwon, Korea, Republic of, 443-721|
|Study Director:||Medical Monitor||Wyeth is now a wholly owned subsidiary of Pfizer|