Status:
TERMINATED
Mechanisms and Treatment of Chronic Allograft Injury (CAI) Due to Calcineurin Inhibitor (CNI) Toxicity
Lead Sponsor:
Montefiore Medical Center
Conditions:
Chronic Allograft Injury
Calcineurin Inhibitor Toxicity
Eligibility:
All Genders
Phase:
NA
Brief 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 fun...
Detailed Description
Specific Aim 1: To investigate allograft and peripheral blood cell gene expression patterns of patients with CAI by using Affymetrix microarrays. Hypothesis 1: Gene expression patterns of patients wi...
Eligibility Criteria
Inclusion
- All patients with biopsy proven pure chronic allograft injury due to CNI toxicity.
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01473732
Start Date
March 1 2012
End Date
August 1 2012
Last Update
October 16 2018
Active Locations (1)
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1
Montefiore Medical Center
The Bronx, New York, United States, 10467