Immunosuppressive Agents Clinical Trial
Official title:
An Open, Single Centre, Randomised, Parallel Group Study to Investigate Three Different Immunosuppressive Regimens for de Novo Renal Transplant Recipients: A Comparison of a Sirolimus / EC-MPS (Myfortic) / Tacrolimus Regimen, an Everolimus / EC-MPS / Tacrolimus Regimen and a EC-MPS / Tacrolimus Prednisone Regimen
An open, single center, randomised study to investigate three different immunosuppressive
regimens for de novo renal transplant recipients:
1. st sirolimus / EC-MPS / tacrolimus regimen
- After 3 months a protocol biopsy is performed. If no rejection is detected the
calcineurin inhibitor (tacrolimus) is withdrawn.
2. nd everolimus / EC-MPS / tacrolimus regimen
- After 3 months a protocol biopsy is performed. If no rejection is detected the
calcineurin inhibitor (tacrolimus) is withdrawn.
3. rd tacrolimus / EC-MPS / prednisone regimen - After 3 months a protocol biopsy is
performed. If no rejection is detected prednisone is withdrawn.
This study is designed to show similar efficacy but a different adverse event profile
between the three regimens. Its main purpose is to provide more information, if steroid free
immunosuppressive treatment is a valuable alternative in the treatment of de novo kidney
transplant recipients and that it is possible to withdraw calcineurin inhibitors after 3
months in this steroid free protocol. A secondary rationale of the study is to compare
sirolimus with everolimus directly to better differentiate these two mTOR-inhibitors in
terms of compound-specific effects and class-effects. This should allow for early
conclusions on the usage of these two mTOR-inhibitors in CNI-free regimens.
Basis for this study are the following hypotheses regarding the first 6 months of treatment
following kidney transplantation:
- Similar graft function in the three treatment groups after 6 months
- No difference in graft and patient survival in the three groups
- No differences in incidence of first, total number, type of acute rejections, and
number of anti-rejection treatments in the three groups
- No differences in number of patients successfully withdrawn from calcineurin inhibitor
in the sirolimus and everolimus arm, respectively
- A different adverse event profile with regard to the incidence of dyslipidemias,
impaired fasting glucose, new onset diabetes mellitus, de novo post-transplant insulin
dependency, histological signs of calcineurin inhibitor toxicity, and
tubulointerstitial nephrotoxicity in the three groups. In addition to this the
incidence of mTOR-inhibitor specific adverse events will be analysed.
These hypotheses are the basis for the study objectives.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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