Effects of Tacrolimus on Blood Sugar Levels in Kidney Transplant Patients
Glucose Disorders Induced by Tacrolimus on Pre Transplantation Endstage Renal Disease Patients
This study is testing whether the medication tacrolimus affects blood sugar levels in kidney transplant patients to see if it leads to diabetes or glucose problems after their surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Departemental Vendee Academic / other |
| Locations | 2 sites (La Roche-sur-Yon and 1 other locations) |
| Trial ID | NCT03640026 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of tacrolimus, an immunosuppressive medication, on glucose metabolism in patients with end-stage renal disease who are preparing for kidney transplantation. The study aims to assess the incidence of diabetes and glucose intolerance following transplantation, as these conditions significantly increase the risk of graft loss and mortality. Eligible participants include adults who are on hemodialysis and meet specific criteria, while those with a history of diabetes or certain health conditions are excluded. The trial is conducted at two hospitals in France.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are eligible for kidney transplantation and currently undergoing hemodialysis.
Not a fit: Patients with a personal history of diabetes or those with certain health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for preventing diabetes in kidney transplant recipients, enhancing patient outcomes.
How similar studies have performed: Previous studies have indicated that tacrolimus can adversely affect glucose metabolism, suggesting that this investigation is building on established findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Patient eligible for kidney transplantation at the Nantes University Hospital * Hemodialysis patient in one of the participating centres * Patient who is able to understand the proposed protocol and has given free and informed consent * Patient with affiliation to the French social security system. Exclusion Criteria: * Personal history of diabetes treated or untreated * Temporary contraindication for carcinological reasons * Immunosuppressive treatment in the 6 months prior to inclusion * Macrolide Allergies * Hypersensitivity to the excipients used in the composition of tacrolimus * Intolerance to the HGPO test * Progressive infectious outbreak * Hepatic insufficiency * Intercurrent infectious pathology * Patient under guardianship, curatorship, legal protection measure, or deprived of liberty * Pregnant women, breastfeeding, or non-menopausal woman who refuses contraception
Where this trial is running
La Roche-sur-Yon and 1 other locations
- Centre Hospitalier Départemental Vendée — La Roche-sur-Yon, France (Recruiting)
- Centre Hospitalier Universitaire Nantes — Nantes, France (Recruiting)
Study contacts
- Principal investigator: Awena LE FUR — CHD Vendée
- Study coordinator: Chloé MOREAU
- Email: chloe.moreau@chd-vendee.fr
- Phone: 0251446572
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.