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
Conditions
Interventions
Trade Name: Neoral
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: CICLOSPORIN
CAS Number: 59865133
Current Sponsor code: RRK336
Sponsors
University Hospital Birmingham NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The presence of any of the following will preclude patient inclusion • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether complete calcineurin inhibitor withdrawal offers benefits over partial withdrawal (minimisation) in delaying the progression of histological graft damage, in patients with stable short-term allograft function, but who are at risk for progressive histological damage.; Secondary Objective: •To compare patient and graft survival between withdrawal and minimisation groups •To compare renal function between groups •To assess the incidence of allograft rejection (clinical and sub-clinical) between groups •To evaluate effect on proteinuria, where present •To compare changes in anti-HLA antibody profiles between groups •To compare lymphocyte function between groups •To compare cardiovascular risk profile between groups •To compare the incidence of viral and bacterial infection between groups ; Primary end point(s): 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: 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 ) 2)Interstitial fibrosis quantification by Sirius Red staining 3)TGF-beta expression 4)P-selectin expression and leukocyte infiltration (macrophage). 5)Fibroblast function 6)Epithelial mesenchymal transformation markers 7)Markers of apoptosis 8)Electron Microscopy | — |
Countries
United Kingdom
Outcome results
None listed