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

Stopped early · Not applicable

Conditions studied: Chronic Allograft Injury, Calcineurin Inhibitor Toxicity

In brief

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.

Key facts

Study ID

NCT01473732

Run by

Montefiore Medical Center

People needed

2

Starts

2012-03-01

Expected to finish

2012-08-01

Last updated by the study team

2018-10-16

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 24 hour urine protein or spot urine protein/creatinine ratio > 500 mg/day
• Estimated glomerular filtration rate (eGFR) < 30 ml/min by modification of Diet in Renal Disease( MDRD) or 24 hour urine collection
• Patients with Donor-specific antibody (DSA) by Luminex (mean fluorescence intensity values > 1,000)
• Recipients of multiple organ transplants or ABO-incompatible allograft
• Current panel reactive antibody (PRA) greater than 30 percent
• Graft loss at randomization
• Pregnant women
• Previous history of acute rejection
• Previous history of allergy or intolerance to Zortress or Myfortic
• Platelet count less than 100,000
• White Blood Cell (WBC) less than 3,000
• Hb less than 9 g/dL or Htc less than 30%
• 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

Where it is running

• Montefiore Medical Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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