Impact of Conversion From Tacrolimus to Sirolimus in African American Renal Transplant Recipients

• Status: Unknown status
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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 tacrolimus-based regimen to a sirolimus-based maintenance immunosuppression regimen.

The investigators hypothesize that the conversion from tacrolimus to sirolimus in African American renal recipients will stabilize or improve renal allograft function, and stabilize the histological progression of CAN. This conversion will have the potential to prolong long-term graft survival in African American renal transplant patients.

GFR measurements, histological parameters on the allograft biopsy, as well as patient and graft survival, incidence of acute rejection, and specific side effects will be monitored and compared between the sirolimus conversion group and the patients who will be maintained on tacrolimus.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Temple University
• Collaborator: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Everolimus; Sirolimus; Tacrolimus

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.