No registrations found.
ID
Source
Brief title
Health condition
prospective, open, randomized multicenter
Sponsors and support
Chair: S.Surachno/F.Bemelman
Intervention
Outcome measures
Primary outcome
Degree of inflammation and fibrosis and degree of arteriolar hyalinosis in renal biopsies taken at 6 and 24 months after implantation.
Secondary outcome
1. Vascular assesments by IMT and M-mode of carotis interna;
2. Bloodpressure and number of antihypertensive drugs;
3. Lipid profile;
4. Renal allograft survival and function;
5. Patient survival;
6. Incidence of malignancies;
7. Infectious complications.
Background summary
This study compares the results on changes of renal allograft histology by optimal use of ciclosporin, mycophenolate sodium and everolimus ( primary endpoints). Furthermore cardiovascular, infectious and oncologic endpoints will be assessed in each group and compared to each other.
Study objective
By achieving optimal immunosuppression with minimal sideeffects due to controled drugexposure by target AUC's we expect reduction of druginduced damage on kidney and cardiovascular system. Three drugs will be subject of study: ciclosporin, mycophenolate and everolimus.
Study design
N/A
Intervention
By achieving stable state 6 months after renal transplantation a baseline renal allograft biopsy is performed and randomisation in one of the three arms of the study takes place.
Arm 1: prednisolon and AUC guided ciclosporin treatment;
Arm 2 : prednisolon and AUC guided mycophenolate mofetil sodium treatment;
Arm 3: prednisolon and AUC guided everolimus treatment. All treatment arm have a duration of 18 month whereafter a final renal allograft biopsy is performed.
It has to be noted that for the 3 treatmentarms no separate control group is defined because no data exists adressing the "golden standard" treatment after renal transplantation.
P.O. Box 22660
S. Surachno
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5664170 / +31 (0)20 5669111
s.surachno@amc.uva.nl
P.O. Box 22660
S. Surachno
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5664170 / +31 (0)20 5669111
s.surachno@amc.uva.nl
Inclusion criteria
1. First or second renal transplant;
2. Female or male 18-70 years;
3. Cadaveric or non-HLA identical living donor;
4. Understands risks and purpose of study;
5. written informed consent.
Exclusion criteria
1. Double kidney transplants, kidney-pancreas transplants, 3rd or 4th transplant;
2. PRA > 50% historic or current;
3. Pregnancy or unwilling to use contraception during the study;
4. Cholesterol > 8,5 mmol/l;
5. History of therapy resistance against HMG co-reductase inhibitors.
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 | NL523 |
| NTR-old | NTR567 |
| Other | : N/A |
| ISRCTN | ISRCTN69188731 |