Calcineurin Inhibitor Minimisation in Renal Transplant Recipients With Stable Allograft Function

• Status: Unknown status
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to ascertain whether the withdrawal of calcineurin inhibitors (CNI) will lead to less kidney transplant damage when compared with minimisation. The investigators will assess this by comparing the degree of damage on kidney biopsies taken before and after minimisation/withdrawal of CNI.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Birmingham
• Collaborator: Novartis
• Treatments: Calcineurin Inhibitors; Cyclosporine; Cyclosporins

Criteria

Inclusion Criteria:

• The patient must be an adult recipient of a first kidney transplant

• A functioning kidney allograft with estimated (e)GFR by MDRD > 30 ml/min/1.73 m2, and be between 1 and 5 years post transplantation

• Stable allograft function, as defined by no greater than 10% rise in serum creatinine in the preceding 6 months, on cyclosporine and azathioprine based immunosuppression

• Minimal proteinuria, evidenced as urine albumin: creatinine ratio < 50 mg/mmol

Exclusion Criteria:

• > = 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