Kidney Failure, Chronic Clinical Trial
Official title:
Interstitial Fibrosis in Protocol Biopsies of Renal Allografts: A Prospective, Randomised Trial of Sirolimus Versus Cyclosporine.(Fibrasic)
This prospective, randomized study, comparing sirolimus to cyclosporine in renal transplant
recipients, has two major objectives:
1. -To determine the incidence and the degree of interstitialfibrosis and
arteriosclerosis, as wel as the glomerular volume in protocol biopsies at 6 months in
sirolimus-and in cyclosporine-treated renal allograft recipients, by means of
quantitative computerized image analysis.
- To determine the prognostic implication of these morphologic changes.
2. To study the expression of genes, involved in inflammation and fibrosis, in protocol
biopsies at 6 months in sirolimus-and cyclosporine-treated renal allograft recipients.
Calcineurin inhibitors have significantly improved the one-year graft survival of renal
allografts. However, chronic nephrotoxicity caused by calcineurin inhibitors contributes to
the long-term decline in renal function in kidney transplant recipients. Approximately
ninety percent of the protocol biopsies of renal allografts, performed at 18 months post
transplantation, show histological lesions of chronic calcineurin nephrotoxicity . In recent
years, two new non-nephrotoxic immunosuppressive drugs, i.e. mycophenolate mofetil and
sirolimus, have become available for the prophylaxis of graft rejection in renal
transplantation.
Three randomized clinical trials, comparing cyclosporine with sirolimus in combination with
mycophenolate mofetil, reported a superior graft function at one year in sirolimus treated
renal allograft recipients. However, data on long-term graft survival and histological
lesions of protocol biopsies in sirolimus-treated renal transplant recipients, are currently
lacking.
In analogy with previous observations in native kidney disease, Grimm et al. recently
reported that interstitial fibrosis in protocol biopsies of renal allografts, at 6 months
post transplantation, significantly inversely correlates with the subsequent graft survival
One hundred recipients of a first renal allograft will be randomized to an immunosuppressive
protocol based on cyclosporine (50 patients) or sirolimus (50 patients). Concommittant
immunosuppression will be similar in both groups, and consists of Daclizumab as induction
treatment (five iv gifts every two weeks), and mycophenolate mophetil and steroids as
maintenance immunosuppression.
Randomization will be performed by centre to avoid centre-related bias. All patients will
complete a follow-up of 12 months. Two core biopsies of the graft will be obtained in each
recipient, at implantation and at 6 months. Serum creatinine and the estimated creatinine
clearance (by the Nankivell and the Jellife method) will be monthly recorded.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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