NCT01183247

An Open, Single Centre, Randomised, Parallel Group Study to Investigate Three Different Immunosuppressive Regimens

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 If no rejection is detected the calcineurin inhibitor (tacrolimus) is withdrawn. 2.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 If no rejection is detected the calcineurin inhibitor (tacrolimus) is withdrawn. 3.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 If no rejection is detected prednisone is withdrawn.

Detailed 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.

Conditions

• Comparative Study
• Immunosuppressive Agents

Interventions

Type	Name	Description
DRUG	Rapamycin	Add rapamycin de novo to tacrolimus and MMF
DRUG	Everolimus	Add everolimus de novo to tacrolimus and MMF
DRUG	Prednisone	Add prednisone de novo to tacrolimus and MMF

Timeline

• Start date: 2008-07-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2010-08-17
• Last updated: 2010-08-17

Locations

1 site across 1 country: Switzerland