Study Evaluating A Planned Transition From Tacrolimus To Sirolimus In Kidney Transplant Recipients
This study has been completed.
Information provided by (Responsible Party):
First received: April 29, 2009
Last updated: September 16, 2013
Last verified: September 2013
This study will look at the effect on long-term kidney function using tacrolimus right after a transplant and then switching to sirolimus at 3 to 5 months after the transplant.
Renal Allograft Recipients
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Planned Transition To Sirolimus-Based Therapy Versus Continued Tacrolimus-Based Therapy In Renal Allograft Recipients|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Percent of subjects who demonstrate a greater than or equal to 5 ml/min/1.73m2 improvement in calculated glomerular filtration rate (GFR). [ Time Frame: From randomization to 24 months post-transplant ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Composite rate of the first occurrence of biopsy-confirmed acute rejection (BCAR), graft loss, or death. [ Time Frame: From randomization to 24 months post-transplant ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2009|
|Study Completion Date:||August 2013|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
|Experimental: Group I - Planned transition to sirolimus from tacrolimus||
During the screening phase, tacrolimus is provided by the investigator (not the Sponsor) and is dosed to achieve a target trough level determined by the investigator. Therefore, the dosage form, dosage, and frequency are determined by the investigator. Duration of treatment is from transplantation until randomization (from 90 to 150 days).
Other Name: Prograf, AdagrafDrug: Sirolimus
Following randomization, sirolimus is provided by the Sponsor in 1 and 2 mg oral tablets. Sirolimus is dosed once daily to achieve a target trough level of 7 to 15 ng/mL in the 1st year post-transplant and 5 - 15 ng/mL in the 2nd year post-transplant. Duration of treatment is from randomization through 2 years post-transplant (19 to 21 months).
Other Name: Rapamune
|Active Comparator: Group II - Continuation of tacrolimus||
During the study, tacrolimus is provided by the investigator (not the Sponsor) and is dosed to achieve a target trough level determined by the investigator. Therefore, the dosage form, dosage, and frequency are determined by the investigator. Duration of treatment is 2 years post-transplant.
Other Name: Prograf, adagraf
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00895583
Show 44 Study Locations
Show 44 Study Locations
Sponsors and Collaborators
|Study Director:||Pfizer CT.gov Call Center||Pfizer|