View Clinical Trial (Medical Research Study)
A Pilot Study Comparing Two Different Sirolimus-based Transition Regimens in African-American Renal Transplant Recipients
| City: |
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Charleston |
| State: |
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South Carolina |
| Zip Code: |
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29425 |
| Conditions: |
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Kidney Transplantation |
| Purpose: |
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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.
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| Study Summary: |
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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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| Criteria: |
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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
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| NCT ID: |
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NCT01005706 |
| Primary Contact: |
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Principal Investigator
Charles Bratton, MD
Medical University of South Carolina
Charles Bratton, MD
Phone: 843-792-4003
Email: brattocf@musc.edu
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| Backup Contact: |
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Email: cronan@musc.edu
Gail Johnson, BS
Phone: 843-792-1851
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| Location Contact: |
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Charleston, South Carolina 29425
United States
Charles Bratton, MD
Phone: 843-792-4003
Email: brattocf@musc.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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