Kidney Biopsy Controlled Trial of Calcineurin Inhibitor Withdrawal

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Current therapy to prevent organ rejection relies on the use of calcineurin inhibitors either cyclosporine or tacrolimus. Although these agents have been very successful in preventing early acute rejection, this success has not translated into improved long-term kidney transplant function. One of the important factors that leads to premature kidney transplant failure is chronic allograft nephropathy (CAN). CAN is characterized by progressive interstitial fibrosis or "scarring", vascular wall thickening, and finally glomerular sclerosis leading to slow progressive loss of kidney function. Calcineurin inhibitors have been shown to play an important role in the pathogens of CAN. Renal transplant recipients in whom calcineurin inhibitors are discontinued enjoy better and longer kidney function. Therefore, immunosuppressive strategies are being designed with the intention of withdrawing calcineurin inhibitors.

The purpose of this trial is to test if tacrolimus can be safely substituted by sirolimus (Rapamycin) and this substitution will yield improved renal function, less CAN and better graft survival rates over the first year.

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

Details

• Lead Sponsor: University at Buffalo
• Collaborators: Novartis; University of Washington
• Treatments: Calcineurin Inhibitors; Everolimus; Mycophenolate mofetil; Mycophenolic Acid; Sirolimus; Tacrolimus

Criteria

Inclusion Criteria:

1. All patients receiving their first renal allograft transplant will be considered eligible for study

2. Patients receiving both living and cadaveric donors will be eligible

Exclusion Criteria:

1. If less than 18 years of age

2. Severe hyperlipidemia

3. If pregnant or cannot comply with proper birth control during the study

4. Recipients of kidney together with another solid organ or bone marrow transplant

5. Patients receiving any investigational medications or participating in a clinical trial

6. Patients receiving a second or third renal allograft

7. PRA > 30%

8. Active infections

9. Chronic antiarrhythmic therapy for ventricular arrhythmia

10. Malignancy except for basal cell carcinoma

11. HIV

12. ANC count < 1,000/ mm3, Platelet count < 100,00/mm3

13. Fasting triglycerides > 400 mg/dl and cholesterol > 300 mg/dl

14. HCV-positive, HBVSAg-positive, HBVCoreAb-positive and HBVSAntibody negative or HCV/HBV co-infected patients

15. Breastfeeding women