Sirolimus Conversions in African-American Renal Transplant Recipients
This trial is active, not recruiting.
|Treatments||rapamune, mycophenolate mofetil and steroid, tacrolimus, sirolimus and steroid|
|Sponsor||Medical University of South Carolina|
|Collaborator||Wyeth is now a wholly owned subsidiary of Pfizer|
|Start date||August 2009|
|End date||July 2013|
|Trial size||40 participants|
|Trial identifier||NCT01005706, HR19042, Wyeth Study - HR 19042|
This study's focus is to compare the level effectiveness and safety of regimens involving Sirolimus, Cellcept and steroid to Prograf, Sirolimus and steroid in African-American recipients of kidney transplants.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Effectiveness and safety of a particular drug regimen to prevent kidney rejection
time frame: 12 months
Male or female participants at least 18 years old.
Inclusion Criteria: - At least 18 years of age and able to give informed consent - African-American ethnicity - Received a first or second non-ECD cadaveric or living donor renal transplant - Transplant occurred during the past 6 to 24 weeks - Patient has stable graft function, defined as no change of greater than 30% of baseline serum creatinine during the past month and no acute rejection in the past 6 weeks - Estimated GFR using the modified MDRD equation of at least 40 mL/min10 at time of enrollment into the study - Currently receiving tacrolimus, mycophenolate mofetil (at least 1 gm per day), and corticosteroids as their immunosuppression regimen. Exclusion Criteria: - Biopsy proven acute rejection episode that occurred within the past 6 weeks - Malignancy within the past 3 years, except for non-melanoma skin cancer - Any known intolerances to current immunosuppressant regimen necessitating withdrawal of the offending agent - Currently enrolled in an investigational trial - Woman of child bearing potential not utilizing an effective form of birth control - Patients with uncontrolled dyslipidemia, defined at serum fasting LDL >200 mg/dL or serum fasting triglycerides >500 mg/dL. - Patients with a spot urine protein to creatinine ratio of > 800 mg of protein per gram of creatinine. - WBC < 3,000 cells/mm3 - Platelets < 100,000 cells/mm3
|Official title||A Pilot Study Comparing Two Different Sirolimus-based Transition Regimens in African-American Renal Transplant Recipients|
|Principal investigator||Charles Bratton, MD|
|Description||A major concern in transplantation is finding a successful regimen of medications to lower the potential for the body to reject the newly transplanted organ. The regimens in kidney transplantation include tacrolimus, sirolimus, mycophenolate mofetil and steroids. This study will compare the effectiveness and safety of a regimen including Sirolimus, Prograf, and steroids compared to a regimen including Sirolimus, Cellcept and steroids. These regimens have already been researched in the Caucasian population, and both drug regimens are FDA approved. This study's focus is on the effectiveness and safety of these regimens in African-Americans.|
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