The Comparison of Three Different Immunosuppressant Regimens in Kidney Transplant Recipients.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00275522|
Recruitment Status : Completed
First Posted : January 12, 2006
Last Update Posted : January 20, 2010
|Condition or disease||Intervention/treatment||Phase|
|Kidney Transplant||Drug: Sirolimus||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Open-label Study to Compare the Safety and Efficacy of Two Different Sirolimus Regimens With a Tacrolimus + Mycophenolate Mofetil Regimen in De Novo Renal Allograft Recipients.|
|Study Start Date :||December 2005|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 2007|
- Calculated creatinine clearance at 12 months after transplantation.
- Calculated creatinine clearance at 26, 78, and 104 weeks post transplantation.
- Serum creatinine at 26, 52, 78, and 104 weeks post transplantation.
- Subject and graft survival at 26, 52, 78, and 104 weeks post transplantation.
- Incidence and severity of biopsy-confirmed acute rejection at 26, 52, 78, and 108 weeks post transplantation.
- Severity of rejection, including histological grade of the first acute rejection episode.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00275522
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Mark D. Stegall, M.D.||Mayo Clinic|