Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-24 @ 9:34 PM
NCT ID:
NCT01473732
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01473732
Study Brief:
Protocol Section:
NCT01473732