2024-519895-23-00招募中3 期
Treatment of Early Borderline Lesions in Low Immunological Risk Kidney Transplant Patients: a Spanish Multicenter, Randomized, Controlled Parallel-group Trial: The TRAINING Study
Fundacion Canaria Instituto De Investigacion Sanitaria De Canarias1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年1月29日最近更新:
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Presence of Interstitial Fibrosis and Tubular Atrophy (FIAT) and calculated renal function of the graft with CKD-EPI at 24 months of the study in both therapeutic arms.
研究概览
简要总结
Know in a controlled and randomized clinical trial, carried out in low-risk patients immunological and stable renal function, if the treatment of BL lesions, detected in the third month post-transplant, with rabbit polyclonal antilymphocytic globulin prevents or slows the progression of chronic histological lesions of the graft (FIAT) and the deterioration of its function compared to clinical follow-up conventional, after two years of post-transplant follow-up.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes, over 18 years of age without immunological risk (PRA <20% and absence of DSA), who receive a first kidney graft from a deceased donor or a living donor. b) Presence of BL injuries, which will be defined according to the Banff 2019 classification as the presence of a interstitial inflammation score (i) and tubulitis score (t) of at least 1 point (t>0; i>0), but without reaching the threshold determined for 1A rejection of the Banff'19 classification (i2,t2) and without transmural arteritis (v0), excluding isolated inflammation (t0, i>0) and isolated tubulitis (t>0, i0). c) Patients who are receiving Tacrolimus in combination with mycophenolic acid (MPA) and steroids; d) Absence of clinical or subclinical and histological immunological dysfunction before randomization; e) Absence of anti-HLA de novo DSA antibodies at the time of randomization; f) Patients who wish and who Clinical trial protocol 6 can give written informed consent to participate in the study; g) Acceptance of efficient contraception recommended by the Clinical Trial Facilitation Group in women of childbearing age during the study.
排除标准
- •a)Patients receiving a multi-organ transplant; b) Retransplants; c) Patients without inflammation in the protocol biopsy of the third month (i0, t0), isolated inflammation without tubulitis (t0, i>0) or isolated tubulitis no inflammation (t>0, i0); d) Cold ischemia time >30 hours; e) Patients with higher serum creatinine at 2 mg/dl or proteinuria greater than 1g/day at the time of randomization; f) Presence of significant plateletopenia (<100,000/mm3) or leukopenia (<3,000/mm3) at the time of randomization; g) Previous clinical or subclinical rejection episode (≥AI) of the Banff classification 19 before randomization; h) Presence of borderline lesions detected in a biopsy requested by clinical indication prior to the 3rd month protocol biopsy; i) Patients with infection or CMV disease in the first three months of transplant; j) Patients with BKpoliomavirus nephropathy at the time of randomization: k) Patients with recurrent glomerulonephritis or new; l) Patients who are being treated with immunosuppressive drugs other than those in the trial clinician in question; m) Patients who are positive for the human immunodeficiency virus (HIV) or with severe systemic infection, which in the opinion of the investigator requires continued therapy; n) Patients with any previous (during the last 5 years) or present malignant disease, except carcinoma basal or squamous cell excised; ñ) Pregnant or breastfeeding women.
结局指标
主要结局
Presence of Interstitial Fibrosis and Tubular Atrophy (FIAT) and calculated renal function of the graft with CKD-EPI at 24 months of the study in both therapeutic arms.
Presence of Interstitial Fibrosis and Tubular Atrophy (FIAT) and calculated renal function of the graft with CKD-EPI at 24 months of the study in both therapeutic arms.
次要结局
- Patient and graft survival. Rate of clinical and biopsy-confirmed acute rejection, and proteinuria at 3, 6, 12 and 24 months. Blood pressure figures and number of hypotensive agents, lipid levels and need for lipid-lowering, and weight and BMI increase. Rate of post-transplant diabetes (PTDM) or glucose intolerance at one year and the second year of transplantation according to ADA criteria. Adherence to immunosuppressive treatment evaluated using the Basel scale.
研究者
Consuelo Rodriguez
Scientific
Fundacion Canaria Instituto De Investigacion Sanitaria De Canarias
研究点 (1)
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