Prospective, multicenter, randomized, open-label, parallel-group controlled phase 3 study of tacrolimus minimization in kidney transplant recipients selected according to the AGORA algorithm for their low immunological risk and medium-term graft failure

Phase 1

• Conditions: kidney transplantation; Therapeutic area: Not possible to specify

• Registration Number: CTIS2022-502624-44-00
• Lead Sponsor: Centre Hospitalier Universitaire De Nantes

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-04
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 332

Inclusion Criteria

Adult patient, Patients treated with Tacrolimus (Prograf® or Advagraf®) and MMF / MPS +/- Corticosteroid (CS), First kidney transplantation, Living or a brain death or deceased donor (Maastricht 3), Compatible for ABO group with the donor, One year post kidney transplantation ( between 350 et 515 days after the transplantation), cPRA (ou TGI <20%) the day of the transplantation and no DSA (MFI <500) at pre transplant and at the time of the inclusion at one-year post transplantation (between 350 and 515 days after the transplantation, Normal or IFTA 1-2 histology on one-year surveillance biopsy, Patient insured under a health insurance scheme, according to national regulation., Patient (of childbearing age) with effective contraception (sexual abstinence, use of a condom with spermicide, contraceptive sponge, uterine diaphragm, hormonal contraception, or intrauterine contraceptive device) The contraception should be used throughout the entire study period.

Exclusion Criteria

Deceased donor maastricht 2, Pregnant women (serum or urine test), breastfeeding women, Patient under legal protection (incl. under guardianship or trusteeship), Participation to a drug interventional study within 1 month prior to the inclusion, Any retransplantation and combined transplantations and also other organ previous transplantations, History of lymphoproliferative disorders, Diagnosis of a malignant disease (according to the type of malignancy), Hepatitis C antibody or hepatitis B surface antigen (HbsAg) positive patient or HIV infection

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the AGORAC trial is to demonstrate the impact of TACROLIMUS minimization using AGORA algorithm compared to standard of care on the kidney function 18 months after the minimization period;Secondary Objective: Show that patients in the ultra-minimization arm have a risk of immunological events and of graft loss comparable to those observed in the SOC arm, Show that patients in the ultra-minimization arm have a lower prevalence metabolic disorders, Show that patients in the ultra-minimization arm have a better adhere to the treatment, Show that patients in the ultra-minimization arm have a better quality of life, show that patient in the ultra minimization arm will have an improvement of the renal function;Primary end point(s): The primary endpoint of the AGORAC Trial will be the improvement of the renal function (mGFR) at 18 months after ultra” minimization of Tacrolimus (TAC: Prograf®, Advagraf®) as assessed by iohexol clearance3