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 @ 9:10 PM
Ignite Modification Date:
2025-12-24 @ 9:10 PM
NCT ID:
NCT01817504
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 Years.
* Patients affiliated to health protection system, social security in France or any similar regimen.
* Renal transplant patient with end-stage transplantation, regardless of the number of previous transplants.
* Patient receiving immunosuppressive protocol based on anticalcineurin or mTOR inhibitors
* Patient should have resume hemodialysis within 4 weeks
* Duration of transplantation more than one year
* Patient with asymptomatic graft
* immunogenic potential residual \>50% (calculated PIR during the re-dialysis)
* Patient not covered by any measure of legal protection.
Exclusion Criteria:
* Immunogenic potential residual \<50%
* Graft infection uncontrolled by treatment
* Active infectious pathology
* Inflammatory graft
* Uncontrolled arterial hypertention
* Inflammatory syndrome of undetermined origin with CRP\>50mg/l
* Fever of unknown origin for more than 8 days T\>38°C
* Contra-indication to surgery
* AVK treatment
* Patient candidate for a living donor within 12 months
* Monotherapy with calcineurin inhibitors or mTOR inhibitors
* Treatment directed against the humoral response in the 6 months preceding the recovery of dialysis (Rituximab IV-Ig or high doses)
* Presence of another transplant (pancreas, liver, heart, lung)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01817504
Study Brief:
Protocol Section:
NCT01817504