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Sponsored by: |
University Hospital, Basel, Switzerland |
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Information provided by: | University Hospital, Basel, Switzerland |
ClinicalTrials.gov Identifier: | NCT00306397 |
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.
Condition | Intervention | Phase |
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Kidney Transplantation |
Drug: Rapamycin |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Open, Single Centre, Pilot Study to Investigate a Steroid Free Immunosuppressive Regimen for De Novo Renal Transplant Recipients Followed by Randomisation to Calcineurin Inhibitor Containing or Calcineurin Inhibitor Free Immunosuppression |
Estimated Enrollment: | 100 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | August 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
Rapamycin - MMF after 3 months
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Drug: Rapamycin
Sirolimus perorally following kidney transplantation, randomisation after protocol biopsy at months three to a) Sirolimus - MF- or b) low dose tacrolimus - sirolimus -MMF -
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B: Active Comparator
Low dose tacrolimus - MMF - Rapamycin after 3 months
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Drug: Rapamycin
Sirolimus perorally following kidney transplantation, randomisation after protocol biopsy at months three to a) Sirolimus - MF- or b) low dose tacrolimus - sirolimus -MMF -
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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 rapamycine / 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
Safety:
Long term patient follow up Patients will be followed up for graft and patient survival at 12, 24, and 36 months post-transplantation.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Juerg U Steiger, MD | +41 61 265 44 04 | jsteiger@uhbs.ch |
Contact: Michael Dickenmann, MD | +41 61 265 44 39 | mdickenmann@uhbs.ch |
Switzerland | |
University Hospital Basel, Clinic for Transplantation Immunology and Nephrology | Recruiting |
Basel, Switzerland, 4031 | |
Contact: Juerg U Steiger, MD +41 61 265 44 04 jsteiger@uhbs.ch | |
Contact: Michael Dickenmann, MD +41 61 265 44 39 mdickenmann@uhbs.ch | |
Principal Investigator: Juerg U Steiger, MD |
Principal Investigator: | Juerg U Steiger, MD | University Hospital Basel, Clinic for Transplantation Immunology and Nephrology |
Responsible Party: | University Hospital Basel, Clinic for transplantation immunology and nephrology ( Steiger Juerg / Professor ) |
Study ID Numbers: | CERL-080-CH02, 2004DR3379 |
Study First Received: | March 22, 2006 |
Last Updated: | June 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00306397 |
Health Authority: | Switzerland: Swissmedic |
Kidney transplantation Steroid free Calcineurin inhibitor free Tacrolimus Sirolimus |
Sirolimus Clotrimazole Miconazole Tioconazole Tacrolimus |
Anti-Bacterial Agents Anti-Infective Agents Immunologic Factors Antineoplastic Agents Antifungal Agents |
Therapeutic Uses Physiological Effects of Drugs Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions |