Switching kidney transplant medications for fast metabolizers
" SAVE Study (Switch AdVagraf® to Envarsus®) for Fast Metabolizers Kidney Transplant Recipients"
This study is testing whether changing kidney transplant patients who process medications quickly from Advagraf® to Envarsus® can improve their kidney function and help their transplant last longer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 225 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 1 site (Nantes) |
| Trial ID | NCT04945785 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on kidney transplant recipients who are classified as fast metabolizers of calcineurin inhibitors (CNIs). It aims to evaluate the effects of switching from Advagraf® to Envarsus®, a prolonged-release form of tacrolimus, on renal graft function and overall transplant survival. The study will monitor patients with a specific C0/D ratio to assess the impact of this medication switch on kidney health. By analyzing the pharmacokinetic properties of Envarsus®, the study seeks to optimize treatment for patients experiencing poor graft function.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have undergone their first or second kidney transplant and have a specific C0/D ratio indicative of rapid metabolism.
Not a fit: Patients with severely impaired renal function or those who have had multiple transplants may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance kidney transplant outcomes and prolong graft survival for fast metabolizers.
How similar studies have performed: Previous studies have indicated potential benefits of switching to prolonged-release tacrolimus, suggesting this approach may yield positive outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient ≥ 18 years old * 1st or 2nd kidney transplant * Transplantation from a deceased donor (Encephalic death or arrested heart Maastricht III) or living donor * C0 / D ratio \<1.05 at one month of kidney transplant * Renal graft function \<60ml / min (eGFR estimate by CKD-EPI or MDRD). Exclusion Criteria: * Patient ≤ 18 years old, under guardianship or protected * Graft rank ≥ 3 * Renal graft function \<30 ml / min (eGFR estimate by CKD-EPI or MDRD) * Presence of pre-transplant DSA (threshold\> 2000 MFI) * Occurrence of histologically proven rejection during the 1st month of transplant * Presence of another functional transplant (heart / lung / liver / pancreas) or kidney bi-transplant * Transplantation from a living donor * Transplantation from an arrested heart donor Maastricht II
Where this trial is running
Nantes
- CHU de Nantes — Nantes, France (Recruiting)
Study contacts
- Principal investigator: Jacques DANTAL — Nantes University Hospital
- Study coordinator: Jacques DANTAL
- Email: jacques.dantal@chu-nantes.fr
- Phone: (+33) 24 00 87 44 1
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.