Chronic allograft nephropathy is the main cause of long-term renal transplant failure. The pathogenesis involves amongst others calcineurin inhibitors. We performed a multicenter randomized trial to study the effects of withdrawal of ciclosporin (…
ID
Bron
Verkorte titel
Aandoening
renal transplantation, renal failure
ciclosporin, allograft nephropathy, everolimus, mycophenolate mofetyl.
Niertransplantatie, ciclosporine, cardiovasculaire bijwerkingen
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The degree of inflammation and fibrosis and the degree of arteriolar hyalinosis in renal biopsies taken at 6 and 24 months after implantation. Biopsies will be evaluated according to the Banff ‘97 Criteria for Renal Allograft Biopsy Interpretation (appendix II). Quantitative morphometric analysis of interstitial fibrous tissue will be performed using the digital image analysis technique
Doel van het onderzoek
Chronic allograft nephropathy is the main cause of long-term renal transplant failure. The pathogenesis involves amongst others calcineurin inhibitors. We performed a multicenter randomized trial to study the effects of withdrawal of ciclosporin (CsA) from a triple immunosuppressive regimen at 6 months after transplantation. This study is designed to offer the patients “tailored made” immunosuppressive therapy aiming for a very low incidence of acute rejection and a minimum of side effects, such as cardiovascular damage and nefrotoxicity.
Onderzoeksopzet
Pre-Tx1 Week
“2” Week
4-6 Month
3 Month
6 Month
7 Month
12 Month
18 Month
24 Month.
Onderzoeksproduct en/of interventie
The effects of longtime maintenance therapy with everolimus or with MPS in combination with prednisolone will be evaluated. Both drugs will be given orally. Dosages will be guided by calculating drug exposure, using a validated computer model based on a limited sampling strategy. Reference therapy consists of ciclosporin in combination with prednisolone. Drug exposure of ciclosporin will be monitored closely as well.
Publiek
P.O. Box 22660
F. Bemelman
Meibergdreef 9
Amsterdam
The Netherlands
+31 (0)20 5669111
Wetenschappelijk
P.O. Box 22660
F. Bemelman
Meibergdreef 9
Amsterdam
The Netherlands
+31 (0)20 5669111
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Patients, between the age of 18 en 70 years, receiving a first or second renal transplant;
2. Patients had to understand the purpose and risks of the study;
3. Patients had to give written informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Patients with a HLA-identical sibling donor;
2. a third or a fourth transplant;
3. current or historical panel reactive antibodies of more than 50%;
4. female patients unwilling to use adequate contraception during the study;
5. a cholesterol > 8.5 mmol/l despite HMG co-A reductase inhibition.
Opzet
Deelname
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