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

Nantes University Hospital (NUH)

Status

Active, not recruiting

Conditions

Renal Transplant Failure

Treatments

Other: No intervention

Study type

Observational

Funder types

Other

Identifiers

NCT04945785

RC20_0443

Details and patient eligibility

About

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.

Enrollment

226 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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