Randomized Conversion of Calcineurin-Inhibitors in Renal Allograft Recipients

• Status: Completed
• Trial end date: 2019-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is being done to investigate the impact of changing immunosuppressive medications from tacrolimus (Prograf®) to sirolimus (Rapamune®) between 6 and 24 months post transplant. The primary purpose of this research study is to evaluate whether the use of mycophenolate mofetil(MMF)/Cellcept® and tacrolimus(TAC)/Prograf® (Group 1) or mycophenolate mofetil(MMF)/Cellcept® and sirolimus/Rapamune® (Group 2) impacts the incidence of acute cellular rejection in post kidney transplant patients. This study will examine whether switching from tacrolimus to sirolimus will better preserve long-term kidney function.

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

Details

• Lead Sponsor: Northwestern University
• Collaborator: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Calcineurin Inhibitors; Everolimus; Mycophenolate mofetil; Sirolimus; Tacrolimus

Criteria

Inclusion Criteria:

1. Subjects should be adults ≥ 18- ≤ 70 years of age

2. Subjects can be either gender or of any ethnic background

3. Subjects should be single organ recipients (kidney only)

4. Subjects must be able to understand the protocol and provide informed consent.

Exclusion Criteria:

1. Subjects with end-stage renal disease (ESRD) secondary to primary focal segmental glomerulonephritis (FSGS).

2. Inability to comply with study procedures

3. Inability to sign the informed consent

4. Subjects with a significant or active infection

5. Subjects who are pregnant or nursing females

6. Subjects with a history of severe hyperlipidemia not controlled with statins, patients with at total cholesterol of > 400 mg/dl

7. Subjects with a platelet count <100,000mm3 white blood cell (WBC)< 2,000mm3

8. Subjects with severe proteinuria at the time of randomization (>2gm/day)

9. Subjects with more then 2 episodes of acute cellular rejection post transplantation will be excluded from this study

10. An estimated GFR<40 cc/min

11. A history of malignancy during the post-transplant period (other than treated basal cell cancer and/or squamous cell cancer)

12. Subjects, who, due to the existence of a surgical, medical or psychiatric condition, other than the current transplant, which in the opinion of the investigator, precludes enrollment into this trial

13. A history of albumin-creatinine ratio (ACR) during the most recent previous 3 months prior to randomization