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

Phase 1

• Conditions: Renal Transplantation; MedDRA version: 9.1 Level: LLT Classification code 10010185 Term: Complications of transplanted kidney; MedDRA version: 9.1 Level: HLT Classification code 10052779 Term: Transplant rejections

• Registration Number: EUCTR2007-002914-20-GB
• Lead Sponsor: niversity Hospital Birmingham NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-07-31
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 90

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified