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:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-25 @ 3:20 AM
NCT ID:
NCT01663805
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years (black and white subjects);
* End-stage renal disease with indication for transplantation (primary deceased-donor kidney transplant)
* "Standard" traditional (SCD) or extended criteria (ECD) donor;
* Informed consent form duly signed before SCD or ECD kidney transplantation.
Exclusion criteria:
* The subject, in the opinion of the investigator, is not able to complete the study protocol;
* Recipient of live-donor kidney graft;
* Multiple organ transplant recipient;
* Evidence of large systemic or localized infection;
* Evidence of infiltration, cavitation or consolidation on chest X-rays obtained during the evaluation in the screening / baseline visit;
* Use of any drug under investigation or treatment until up to 4 weeks before transplantation;
* Known or suspected hypersensitivity to tacrolimus, everolimus or mycophenolate sodium;
* Immunosuppressive therapies in addition to those described for this study;
* Hypersensitized patients (PRA \> 30%);
* Patients with HIV+ or Hepatitis B or C virus infection.
* Patients for whom T0 and T15 biopsies were not taken.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01663805
Study Brief:
Protocol Section:
NCT01663805