Tacrolimus to Sirolimus Conversion for Delayed Graft Function

• Status: Terminated
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to evaluate the safety and efficacy of conversion from tacrolimus to sirolimus early after kidney transplantation in patients with delayed graft function (DGF)and slow graft function (SGF) in improving graft function and delaying chronic allograft nephropathy. The investigators hypothesize that conversion from tacrolimus to sirolimus in renal transplant recipients with DGF/SGF in early months after surgery will improve graft function and decrease the progression of graft fibrosis.

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

Details

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

Criteria

Inclusion Criteria:

1. Age => 18.

2. Recipient of a deceased donor kidney transplant.

3. Delayed graft function, defined as need for dialysis during first week after surgery or slow graft function, defined as creatinine >=3.0 by post-op day 5 without requiring dialysis

4. Stable serum creatinine for 2 weeks prior to enrollment.

5. Able to give informed consent.

6. Compliant with medical regimen and clinic visits.

Exclusion Criteria:

1. Episode of acute rejection within 4 weeks prior to enrollment.

2. Calculated GFR < 30 ml/min.

3. Interstitial fibrosis & tubular atrophy in transplant biopsy higher than grade II (Banff"05 update).

4. Proteinuria > 500 mg/24 h or spot urine protein/creatinine > 0.5.

5. Total fasting cholesterol level > 300 mg/dl or triglyceride > 500 mg/dl despite optimal lipid lowering therapy.

6. Recipient of pancreas or liver allografts.

7. Leukopenia (WBC < 3000 mm3) within 2 weeks prior to enrollment.

8. Leukopenia (WBC < 2000 mm3) within 4 weeks prior to enrollment.

9. Thrombocytopenia (platelets count < 100,000/mm3) within 2 weeks prior to enrollment.

10. Unwilling to comply with study protocol.

11. Enrollment in another drug trial that precludes use of sirolimus.

12. Diagnosis of malignancy within 2 years prior to enrollment, except adequately treated non-melanoma skin cancer.

13. For women, pregnancy.

14. Allergy to iodine