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NCT Number: NCT04945785

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nantes

Nantes, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

no intervention

Primary outcomes

  1. Improvement of kidney allograft between month 1 and month 12

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: SAVE

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Jun 30, 2021
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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