Image

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

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

Non Recruiting
18 years and older
All
Phase N/A

Powered by AI

Overview

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.

Eligibility

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 details
    Renal Transplant Failure

NCT04945785

Nantes University Hospital

20 August 2025

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.