A RANDOMISED CONTROLLED TRIAL COMPARING THE USE OF SIROLIMUS BASED BIPHASIC IMMUNOSUPRESSION WITH MYFORTIC TO ALLOW EARLY CNI WITHDRAWAL IN RENAL TRNASPLANTATION - Effects of Myfortic and Rapamycin on the Early Development of Chronic allograft Nephropathy: A Rando

niversity Hospitals Leicester0 个研究点开始时间: 2007年6月14日最近更新: 2017年8月21日

试验速览

暂无简介。

•Patients will be eligible for the trial if all of the following criteria are met:
•1.Age greater than or equal to 18 years.
•2.Patients receiving a primary or secondary renal allograft from a living related, living unrelated or heart-beating cadaveric donor.
•3.Patients with second transplants must have maintained their primary graft for at least six months after transplantation (with the exception of graft failure due to technical reasons).
•4.Stable renal allograft function over the first 3 months post transplant.
•5.An absence of subclinical rejection on the 3 month protocol biopsy.
•6.Signed written informed consent.
•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 will not be eligible for the trial if any of the following criteria apply:
•1.Kidney transplantation from a non heart-beating donor.
•2.Patients suffering an acute rejection episode in the first 3 months post transplant with a Banff classification of 1b or above.
•3.Sub-clinical rejection seen in the 3 month protocol biopsy.
•4.Proteinuria >500mg/24hours
•5.eGFR <40mls/min (Cockcroft-Gault formula).
•6.Evidence of active systemic or localised major infection at study entry.
•7.Known hypersensitivity to Tacrolimus, macrolide antibiotics or Myfortic.
•8.Use of any investigational drug or treatments within 28 days before study entry.
•9.Known or suspected malignancy within five years before study entry.
•10.Any condition which in the opinion of the investigator makes the patient unsuitable for entry into the study.

发起方

niversity Hospitals Leicester