No registrations found.
ID
Source
Brief title
Health condition
renal transplantation, renal failure
ciclosporin, allograft nephropathy, everolimus, mycophenolate mofetyl.
Niertransplantatie, ciclosporine, cardiovasculaire bijwerkingen
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
Secondary outcome
1. Cardiovascular (surrogate) endpoints; IMT Intima/Media Thickness of the a. carotis interna;
2. Blood pressure and the number of antihypertensives;
3. Lipid profile;
4. Renal allograft survival and function (Nankivell), and patient survival;
5. The incidence of malignancies;
6. Infectious complications;
7. Miscellaneous;
fasting glucose, HbA1c, uric acid
MPA-levels and IMPDH activity over time, everolimus levels. MPA and everolimus levels over time (AUCs) will be correlated to graft function, rejection episodes and trough levels.
Study objective
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.
Study design
Pre-Tx1 Week
“2” Week
4-6 Month
3 Month
6 Month
7 Month
12 Month
18 Month
24 Month.
Intervention
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.
P.O. Box 22660
F. Bemelman
Meibergdreef 9
Amsterdam
The Netherlands
+31 (0)20 5669111
P.O. Box 22660
F. Bemelman
Meibergdreef 9
Amsterdam
The Netherlands
+31 (0)20 5669111
Inclusion criteria
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.
Exclusion criteria
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1544 |
| NTR-old | NTR1615 |
| Other | : kwkirjjn |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |