Status:
UNKNOWN
Impact of Conversion From Tacrolimus to Sirolimus in African American Renal Transplant Recipients
Lead Sponsor:
Temple University
Collaborating Sponsors:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Glomerular Filtration Rate
Chronic Allograft Nephropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The objective of this study is to examine the effect on allograft function and histology of converting African American renal transplant recipients with chronic allograft nephropathy (CAN) from a tacr...
Detailed Description
All African American renal transplant recipients (\>3months and \<5 years post-transplant) at our institution that are currently on a tacrolimus based regimen will be screened. Subjects with 10% or mo...
Eligibility Criteria
Inclusion
- African American (self-identified) renal transplant recipients.
- Primary or re-transplant kidney-only recipients.
- Recipients on tacrolimus-based immunosuppression regimen.
- Time interval after transplant: at least 3 months but not greater than 5 years.
- Renal transplant recipients with 10% decrease in GFR from baseline.
- Women of childbearing potential must have a negative pregnancy test upon enrollment, and must consent to receive contraceptive counseling and to use effective contraception while enrolled in the study. Two reliable forms of contraception must be used simultaneously unless abstinence is the chosen method.
Exclusion
- GFR \<40ml/min.
- Urine protein-to-creatinine ratio \>0.5.
- Significant chronic allograft nephropathy grade 3 Banff score.
- Evidence of acute rejection episodes within the past 3 months.
- Evidence of active infection within the past month.
- Any malignancy except treated non-melanoma skin cancer within the past 3 years.
- Leucopenia \<2,000/mm3 within the past month.
- Thrombocytopenia \<100,000/mm3 within the past month.
- Total cholesterol \>300mg/dl, despite adequate treatment.
- Triglycerides \>500mg/dl, despite adequate treatment.
- Non-healed post-surgical or non-surgical wound.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2011
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00999258
Start Date
September 1 2009
End Date
June 1 2011
Last Update
October 21 2009
Active Locations (1)
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1
Temple University
Philadelphia, Pennsylvania, United States, 19140