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Clinical Trial Summary

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 If no rejection is detected the calcineurin inhibitor (tacrolimus) is withdrawn.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 If no rejection is detected the calcineurin inhibitor (tacrolimus) is withdrawn.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 If no rejection is detected prednisone is withdrawn.


Clinical Trial Description

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- No differences in number of patients successfully withdrawn from calcineurin inhibitor in the sirolimus and everolimus arm, respectively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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01183247
Study type Interventional
Source University Hospital, Basel, Switzerland
Contact
Status Completed
Phase Phase 4
Start date July 2008
Completion date June 2010

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