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 - RC22-0525

Centre Hospitalier Universitaire De Nantes0 个研究点目标入组 332 人开始时间: 2023年9月4日最近更新: 2024年7月22日

适应症

试验速览

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•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.

•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

发起方

Centre Hospitalier Universitaire De Nantes