A randomized multicenter trial to assess the efficacy of a combined therapy with Sirolimus (Rapamune®), MMF (Cellsept®) and corticosteroids after early elimination of cyclosporin compared to a standard immunosuppression with cyclosporin, MMF and corticosteroids in patients after kidney transplantatio

niversity of Munich - Department of Surgery (Germany)0 sites140 target enrollmentOctober 4, 2005

Overview

Registry

who.int

Start Date

October 4, 2005

End Date

March 31, 2007

Last Updated

4 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity of Munich - Department of Surgery (Germany)

•1\. Male or female patients between 18 and 60 years of age
•2\. Primary or secondary kidney allograft recipients (PRA \<30%)
•3\. No requirement for dialysis since three days before randomization
•4\. Women of childbearing potential must have a negative qualitative pregnancy test before Sirolimus administration and agree to use a medically acceptable method of contraception throughout the treatment period and for three months following discontinuation of Sirolimus. Any woman becoming pregnant during the treatment period must discontinue Sirolimus treatment
•5\. Signed and dated informed consent

•1\. Multiorgan transplant recipients
•2\. Cold ischemia time \>36 hours
•3\. PRA \> 30%
•4\. Postoperative technical complications necessitating re operation (e.g. kidney artery stenosis) or wound healing disturbances (e.g. voluminous lymphoceles)
•5\. Recipients of A\-B\-0 incompatible grafts
•6\. Body mass index \>32
•7\. Patients with cardiac infarction within six months before study entry or actual unstable coronary heart disease
•8\. Total number of neutrophile granulocytes \<1,500/mm^3 or leucocytes \<2,500/mm^3 at screening
•9\. Patients with severe hepatic impairment (glutamic\-oxaloacetic transaminase
•\[GOT], glutamic\-pyruvic transaminase \[GPT], total bilirubin above three times the norm)