Pilot Study to Investigate a Steroid Free Immunosuppressive Regimen for Renal Transplant Recipients
Condition: Kidney Transplantation
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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        -  Patients successfully withdrawn from calcineurin inhibitor at three months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.
    

Intervention name(s): Rapamycin
Intervention type(s): Drug
Intervention description(s): Sirolimus perorally following kidney transplantation, randomisation after protocol biopsy at months three to a) Sirolimus - MF- or b) low dose tacrolimus - sirolimus -MMF -
Other intervention name(s): Sirolimus; Rapammune
Intervention MeSH terms: Sirolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Kidney transplantation; Steroid free; Calcineurin inhibitor free; Tacrolimus; Sirolimus