A prospective, open, randomized, single center study comparing the effects of duo therapy with Everolimus and steroids versus triple treatment of low dose calcineurin inhibitor, low-dose MMF and steroids at least one year after renal transplantation.Effects on renal function, tolerability, chronic allograft damage, cardiovascular parameters and malignancies. - STER

MCG0 个研究点目标入组 130 人开始时间: 2009年7月13日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Female or male, aged between 18 and 70 years.
•Recipient of a kidney graft from a deceased donor or living (non-HLA identical) donor.
•The patient understands the purpose and risks of the study and has given written informed consent to participate in the study.
•Acceptable renal function, eGFR > 40 ml/min, Proteinuria = 1, 0 g/24hr.
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Patients with multi-organ transplants.
•Patients who have been receiving a second or subsequent transplant.
•Patients with very low function at 1 year post-transplant, GFR < 40.
•Proteinuria > 1, 0 g/24 hr.
•Patients with a screening/baseline total white blood cell count < 2,0 10Eg/l or ANC < 1,0 10Eg/l, platelet count < 100 10Eg/l.
•Patients with baseline fasting triglycerides > 4.5 mmol/l or fasting total cholesterol > 7.8 mmol/l despite optimal lipid-lowering therapy.
•Presence of sub clinical rejection (Borderline or Banff score >1a) in biopsy taken at approximately month 12
•Vascular or Acute rejection (Banff score = 2a) six months preceding randomization.
•Female patients who are pregnant or unwilling to use adequate contraception during the study.

发起方

MCG