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

NCT04945785 | Active Not Recruiting

• 1 other identifier: RC20_0443
• Study Type: observational
• Target: 226
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Transplant Failure

Outcome Measures

Primary Outcomes (1)

• Improvement of kidney allograft between month 1 and month 12

  comparison of eGFR (estimated Glomerular Filtration Rate) level at M12 by using the MDRD formula between Envarsus® and Advagraf® groups.

  12 months

Study Arms (2)

control

Before switch Advagraf to Envarsus

Other: No intervention

case

After switch Advagraf to Envarsus

Other: No intervention

Interventions

No intervention OTHER

no intervention

case; control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Major patients with row 1 or 2 renal transplants (1st or 2nd transplant) rapid metabolizers defined by a C0 / D ratio \<1.05 at one month post transplant, with impaired function of the graft. 75 patients will be prospectively included in the Advagraf® or Prograf® switch cohort for Envarsus® during their renal transplant follow-up. 150 patients matched on age, graft rank, type of donor (standard criteria / expanded criteria) and C0 / D at one month of grafting will constitute the retrospective control cohort extracted from the database in Nantes.

You may qualify if:

• Patient ≥ 18 years old
• st 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

CHU de Nantes

Nantes, France

Location

Study Officials

• Jacques DANTAL

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 30, 2021
• Study Start: July 28, 2021
• Primary Completion: May 28, 2025
• Study Completion (Estimated): May 28, 2026
• Last Updated: July 18, 2025

Record last verified: 2025-07

Locations

FR (1)