" SAVE Study (Switch AdVagraf® to Envarsus®) for Fast Metabolizers Kidney Transplant Recipients"

Recruiting

• Conditions: Renal Transplant Failure
• Interventions: Other: No intervention

• Registration Number: NCT04945785
• Lead Sponsor: Nantes University Hospital

Brief Summary

The use of calcineurin inhibitors (CNIs) in kidney transplantation is the gold standard treatment to prevent episodes of rejection. Nevertheless, CNIs have side effects and are in particular nephrotoxic for the kidney transplant. Monitoring CNI dosages is fundamental for the clinician, in order to find the right balance between toxicity and prevention of rejection. Several recent studies suggest that a Radio Residual Concentration / Dosage (C0 / D) less than 1.05 (patients with rapid metabolizers) is associated with poor graft function (eGFR) and decreased kidney transplant survival. LCPT prolonged-release tacrolimus (Novel Once-Daily Extended-Release Tacrolimus. Prolonged-release tacrolimus: Envarsus®) is a marketed form of tacrolimus with interesting pharmacokinetic properties: daily intake, reduction of the absorption peak (Meltodose® technology ) and reduction of the total CNI dose by 30% to obtain an equivalent CO compared to other molecules on the market (Advagraf®, Prograf®). Thus, the use of LCPT in patients rapid metabolisers in relay of Advagraf® or Prograf® could make it possible to decrease renal toxicity while preserving rejection, by increasing the C0 / D ratio.

The investigators propose a pilot study aiming to study a prospective cohort of rapid metabolisers patients put on Envarsus at one month of transplant compared to a historical cohort, in terms of C0 / D ratio, function and survival of the renal graft.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-01
• Study First Submitted QC: 2021-06-22
• Study First Posted: 2021-06-30
• Study Start: 2021-07-28
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-03
• Last Update Posted: 2023-08-04
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 225

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
control	No intervention	Before switch Advagraf to Envarsus
case	No intervention	After switch Advagraf to Envarsus

Primary Outcome Measures

Name	Time	Method
Improvement of kidney allograft between month 1 and month 12	12 months	comparison of eGFR (estimated Glomerular Filtration Rate) level at M12 by using the MDRD formula between Envarsus® and Advagraf® groups.

Trial Locations

Locations (1)

CHU de Nantes; 🇫🇷 Nantes, France