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 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT01800851
Eligibility Criteria:
Inclusion Criteria:
* Male patient, affiliated to a social security system
* Aged 35 to 65 years
* Renal transplant for more than a year and less than 6 years
* Treated by anticalcineurin
* Patient stopped all treatment with corticosteroids for more than 3 months
* Patient with stable renal function defined by a calculated creatinine clearance between 30 and 90 mL/min/1, 73m according to the Cockcroft and Gault
* Written informed consent after detailed explanation of the protocol.
* Increase in body weight of at least 3kg during the two years prior to the inclusion of 10 patients. Stable or increasing weight less than 1kg for 10 other patients.
* HIV and HCV serology negative
Exclusion Criteria:
* Female patients
* Diabetic (type 1 or type 2) before transplantation or patients who developed diabetes after transplantation and requiring anti-diabetic treatment at the time of inclusion
* Obese patient at the time of transplantation, as defined by a body mass index\> 30%
* Multiple kidney transplant or other organ transplant the kidney
* Patient with lower limb edema, congestive heart failure, and/or uncontrolled hypertension.
* Patient with a change in body weight\> 3 kg in the last 3 months
* Patient with an infection 3 months before inclusion
* Subjects infected with hepatitis B, hepatitis C virus or human immunodeficiency
* Patient with acute rejection within 3 months prior to inclusion
* Patient not treated by anticalcineurin
* Patient with a modification of immunosuppressive therapy within 3 months prior to inclusion
* Patient with unstable psychiatric condition
* Patient smoking\> 5 cigarettes / day
* Alcoholic patient (unweaned)
* Patient with stage 4 renal failure (\<30 mL/min/1, 73m ²) and stage 5 (\<15 mL/min/1, 73m ²)
* hemodialysis patient
* Patient with acute renal failure defined by a 25% increase in creatinine within 3 months prior to inclusion
* Person under guardianship or not subject to social security
* Person in period Exclusion File National Healthy Volunteers
* Person who refuses to give his written consent to participation
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
35 Years
Maximum Age:
65 Years
Study:
NCT01800851
Study Brief:
Protocol Section:
NCT01800851