Calcineurin Inhibitor Minimisation in Renal Transplant Recipients with Stable Allograft Function: A Prospective Randomised Controlled Trial - CNIM-SRT

niversity Hospital Birmingham NHS Foundation Trust0 个研究点目标入组 90 人开始时间: 2007年7月31日最近更新: 2019年12月10日

试验速览

暂无简介。

•To be included in the study the patient must be an adult recipient of a first kidney transplant, and have:
•A functioning kidney allograft (with estimated (e)GFR by MDRD >30ml/min/1.73m2) and be between 1 and 10 years post transplantation
•Stable allograft function, as defined by no greater than 10% rise in serum creatinine in the preceding 6 months, on ciclosporin and azathioprine immunosuppression
•Minimal proteinuria, evidenced as urine albumin:creatinine ratio <50mg/mmol
•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

•The presence of any of the following will preclude patient inclusion
•<18 years of age
•Pregnancy or suspicion of pregnancy confirmed by positive b-HCG pregnancy test
•Female patients unwilling to take effective contraception for study duration
•Untreated ureteric obstruction on ultrasound of allograft
•Recurrent urosepsis
•Severe systemic infection
•Untreated significant (>50%) renal artery stenosis on magnetic resonance angiography performed prior to study.
•History of acute allograft rejection
•History of myocardial infarction
•History of malignancy in previous 5 years (excluding non-melanomatous tumours limited to skin)
•Symptomatic ischaemic heart disease
•Hepatitis B surface antigen positive, Hepatitis C positive or HIV positive.
•Recipient of combined organ transplantation (e.g. pancreas/kidney; liver/kidney)
•Recipient of ABO-incompatible kidney
•Greater than 1 HLA mismatch at either the B” or DR” locus
•Peak HLA antibody Panel Reactivity (PRA) greater than 10%
•Recipient who underwent HLA desensitisation procedure prior to transplantation

发起方

niversity Hospital Birmingham NHS Foundation Trust