Sirolimus Conversions in African-American Renal Transplant Recipients
NCT01005706
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- 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.
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | Sirolimus Conversions in African-American Renal Transplant Recipients | |||
Official Title ICMJE | A Pilot Study Comparing Two Different Sirolimus-based Transition Regimens in African-American Renal Transplant Recipients | |||
Brief Summary | 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. | |||
Detailed 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. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention | |||
Condition ICMJE | Absence; Kidney | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 40 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | July 2014 | |||
Actual Primary Completion Date | July 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01005706 | |||
Other Study ID Numbers ICMJE | Wyeth Study - HR 19042 HR19042 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Medical University of South Carolina | |||
Study Sponsor ICMJE | Medical University of South Carolina | |||
Collaborators ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Investigators ICMJE |
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PRS Account | Medical University of South Carolina | |||
Verification Date | February 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |