Mechanisms and Treatment of Chronic Allograft Injury (CAI) Due to Calcineurin Inhibitor (CNI) Toxicity

• Status: Terminated
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to find out how well the current drug regimen (including low Prograf dose and Myfortic, which is usually recommended to prevent any further deterioration in the kidney function) works and how safe it is when compared to a combination of Zortress and Myfortic in patients with chronic kidney injury associated with Prograf or Neoral use.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Montefiore Medical Center
• Treatments: Calcineurin Inhibitors; Everolimus; Mycophenolate mofetil; Mycophenolic Acid; Sirolimus; Tacrolimus

Criteria

Inclusion Criteria:

All patients with biopsy proven pure chronic allograft injury due to CNI toxicity.

Exclusion Criteria:

1. 24 hour urine protein or spot urine protein/creatinine ratio > 500 mg/day

2. Estimated glomerular filtration rate (eGFR) < 30 ml/min by modification of Diet in Renal Disease( MDRD) or 24 hour urine collection

3. Patients with Donor-specific antibody (DSA) by Luminex (mean fluorescence intensity values > 1,000)

4. Recipients of multiple organ transplants or ABO-incompatible allograft

5. Current panel reactive antibody (PRA) greater than 30 percent

6. Graft loss at randomization

7. Pregnant women

8. Previous history of acute rejection

9. Previous history of allergy or intolerance to Zortress or Myfortic

10. Platelet count less than 100,000

11. White Blood Cell (WBC) less than 3,000

12. Hb less than 9 g/dL or Htc less than 30%

13. Biopsy findings of

• Chronic antibody mediated rejection

• Acute rejection

• Positive C4d staining

• Interstitial infiltrates more than 25% of the area

• Transplant glomerulopathy

• Recurrent or de novo glomerular disease

• Polyoma nephropathy or positive simian virus 40 (SV40) staining