Treatment of Early Borderline Lesions in Low Immunological Risk Kidney Transplant Patients: a Spanish Multicenter, Randomized, Controlled Parallel-group Trial: The TRAINING Study - TRAINING

Fundación Canaria Instituto de Investigación Sanitaria de Canarias (FIISC)0 个研究点目标入组 80 人开始时间: 2021年12月17日最近更新: 2022年3月14日

试验速览

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•1) Patients of either sex, older than 18 years, with no immunological risk (PRA<20% and absence of DSA), who receive their first deceased donor or living donor KT.
•2) Presence of BL, excluding isolated inflammation (t0, i>0) and isolated tubulitis (t>0, i0).
•3) Patients receiving tacrolimus in combination with mycophenolic acid (MPA) and steroids.
•4) Absence of clinical or subclinical and histological immunological dysfunction before randomization.
•5) Absence of de novo DSA anti-HLA antibodies at the time of randomization.
•6) Provision of written informed consent.
•7) Acceptance of efficient contraception in women.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

•1) Recipients of a multi-organ transplant.
•2) Re-transplants.
•3) Cold ischemia time >30 hours.
•4) Serum creatinine >2 mg/dl or proteinuria >1 g/day at randomization.
•5) Presence of significant thrombopenia (<100,000/mm3) or leukopenia (<3000 mm/3) at randomization.
•6) Previous episode of clinical or subclinical rejection (=IA) before randomization.
•7) Presence of BL before randomization.
•8) CMV infection or disease in the first three months after transplantation.
•9) BK-polyomavirus nephropathy at randomization.
•10) Recurrent or de novo glomerulonephritis.
•11) Treatment with immunosuppressive drugs other than those in this clinical trial.
•12) Patients who are positive for the human immunodeficiency virus (HIV) or with severe systemic infection, who, in the opinion of the investigator, require continued therapy.
•13) Previous (within the last 5 years) or present malignancy, except excised basal or squamous cell carcinoma.

发起方

Fundación Canaria Instituto de Investigación Sanitaria de Canarias (FIISC)