Calcineurin Inhibitor Minimisation in Renal Transplant recipients with Stable allograft function: A prospective randomised controlled trial

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 90

Inclusion Criteria

1. Adult recipients of a first kidney transplant
2. A functioning kidney allograft (with estimated Glomerular Filtration Rate [eGFR] by Modification of Diet in Renal Disease [MDRD] >30 ml/min/1.73m^ 2) and be between 1 and 5 years post transplantation
3. Stable allograft function, as defined by no greater than 10% rise in serum creatinine in the preceding 6 months, on ciclosporin and azathioprine based immunosuppression
4. Minimal proteinuria, evidenced as urine albumin:creatinine ratio <50mg/mmol

Exclusion Criteria

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> To compare renal allograft markers of damage and evolving injury in biopsies immediately pre study and at the end of the study. The primary tissue assessments will comprise:<br> 1. Index of chronic damage (an objective measure of the amount of chronic damage, shown to be a powerful indicator of prognosis in non-allograft renal biopsies)<br> 2. Interstitial fibrosis quantification by Sirius Red staining<br> 3. TGF-Beta expression<br> 4. P-selectin expression and leukocyte infiltration (macrophage)<br> 5. Fibroblast function<br> 6. Epithelial mesenchymal transformation markers<br> 7. Markers of apoptosis<br> 8. Electron microscopy<br>

Secondary Outcome Measures

Name	Time	Method

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