Pilot Study to Investigate a Steroid Free Immunosuppressive Regimen for Renal Transplant Recipients

Overview

The main purpose of this study is to investigate, whether a steroid free immunosuppressive treatment is a valuable alternative in the treatment of de novo kidney transplant recipients and if it is possible to withdraw calcineurin inhibitors after 3 months.

Protocol synopsis Title An open, single centre, pilot study to investigate a steroid free immunosuppressive regimen for de novo renal transplant recipients followed by a two arm randomization to a calcineurin inhibitor containing and a calcineurin inhibitor free maintenance immunosuppression after three months. Study code Sterfree pilot study Project phase An open, single centre, one arm study followed by a 1:1 randomized, parallel group, comparative study after three months. Study objectives To obtain preliminary information on the efficacy and safety of a rapamycin / sodium-mycophenolate (Myfortic) / tacrolimus regimen in the absence of steroids for the prevention of acute rejection following renal transplantation. To compare a low dose tacrolimus / rapamycin / sodium-mycophenolate (Myfortic) regimen to a rapamycin / sodium-mycophenolate regimen in patients without evidence of acute rejection after three months. Efficacy: Primary endpoint * Plasma creatinine (and creatinine clearance (Cockcroft)) Secondary endpoints * Incidence of first acute rejections and total number of acute rejections * Total number of anti-rejection treatments * Patients successfully withdrawn from calcineurin inhibitor at three months * Graft survival * Patient survival Safety: * Graft survival * Patient survival * Protocol biopsies at 3 months( range: day 75 to 105) and 6 months (range day 165 to 195) sub clinical rejection * Incidence of first acute biopsy proven rejection and total number of acute rejection episodes * Total number of anti-rejection treatments * Patients switched from assigned therapy due to rejection or side effects * Patients needing steroids because of rejection * Incidence of selected adverse events: tubulointerstitial nephrotoxicity (TOR inhibitor), leucopenia, thrombocytopenia, elevated fasting blood glucose, dyslipidemia, , electrolyte disturbances, de novo insulin dependency, gastrointestinal disorders (non infectious), neurotoxicity. * Patients withdrawn due to adverse events Long term patient follow up Patients will be followed up for graft and patient survival at 12, 24, and 36 months post-transplantation.

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Eligibility

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Outcomes