" SAVE Study (Switch AdVagraf® to Envarsus®) for Fast Metabolizers Kidney Transplant Recipients" (SAVE)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Nantes, France
- CHU de Nantes
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
control
Before switch Advagraf to Envarsus
|
no intervention
|
|
case
After switch Advagraf to Envarsus
|
no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jacques DANTAL, Nantes University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RC20_0443
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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