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

Renal Transplant Failure Clinical Trial

— SAVE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04945785
• Other study ID #: RC20_0443
• Status: Recruiting
• Start date: July 28, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: Nantes University Hospital
• Contact: Jacques DANTAL
• Phone: (+33) 24 00 87 44 1
• Email: jacques.dantal[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Renal Transplant Failure

Intervention

Other:
• No intervention
no intervention

Locations

Country	Name	City	State
France	CHU de Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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