NCT06235892招募中3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- Improvement of the renal function at 18 months after "ultra" minimization of Tacrolimus
研究概览
简要总结
The goal of this clinical trial is that validation of the non-invasive biomarkers of the AGORA algorithm should make it possible to select patients with a very low immunological risk of graft failure to authorize safe minimization of their immunosuppression for adult patients at one-year post kidney transplantation.
The main question 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First kidney transplantation
- •Living or brain death or
- •Donation after circulatory death (Maastricht 3) donor,Compatible for ABO group with the donor,
- •cPRA (Panel Reactive Antibody Calculated ) (or TGI: Incompatible Graft Rate )<20% on 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.
- •Eplet Mismatchs <= 14
- •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.
- •Patients treated with Tacrolimus (Prograf® or Advagraf®) and MMF / MPS (Mycophenolate Sodium) +/- Corticosteroid (CS)
排除标准
- •Donation after circulatory death maastricht 2 (uncontrolled) and maastricht 1
- •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
研究组 & 干预措施
Ultra-low TACROLIMUS arm
Experimental
Ultra-low TACROLIMUS (TAC) arm based on MMF/MPA (Mycophenolate Mofetil/ Mycophénolic Acid) with or without CS (Cortico Steroid ) and TACROLIMUS to achieve 2-3.5 ng/ml trough levels during all the duration of the study.
干预措施: TACROLIMUS (Drug)
结局指标
主要结局
Improvement of the renal function at 18 months after "ultra" minimization of Tacrolimus
时间窗: Month 18
Improvement will be assessed by measured glomerular filtration rate (mGFR) iohexol clearance.
次要结局
- Appearance of de novo donor-specific alloantibody (DSA) (4 digits and MFI treshold >500)(Month 18)
- Incidence of biopsy-proven acute rejection (BPAR) according to the 2017 Banff classification (including borderline lesions)(Month 18)
- Type, severity and treatment of biopsy-proven acute rejection ( BPAR)(Month 18)
- Appearance or worsening of histological lesions of interstitial fibrosis and inflammatory tubular atrophy (IFTA) of study biopsy by considering that only patients with normal histology or with an IFTA-1 or 2will be randomized(Month 18)
- Prevalence of death, and graft loss (dialysis start or retransplantation) at end of study(Month 18)
- Prevalence of metabolic disorders: post-transplant diabetes mellitus (PTDM), dyslipidaemia and hypertension at end of study(Month 18)
- Treatment adherence consisting in monitoring immunosuppression adherence using Trackyourmed® to monitor individual variability tacrolimus intake(Month 18)
- Change in quality of life estimated using the EQ-5D ( EuroQol instrument - dimensions) questionnaire fulfilled by patients at baseline, Month 3, Month 6, Month 9, Month 12, Month15 and Month18(Month 3, Month 6, Month 9, Month 12, Month15 and Month18)
研究者
研究点 (4)
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