Calcineurin Free Immunosuppression in Renal Transplant Recipients
NCT00812123
ABOUT THIS STUDY
FOR MORE INFORMATION
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1-800-718-1021
- Male or female patients between 15 and 75 years of age, regardless of race.
- Female patients of child bearing age agree to maintain effective birth control practice during the study.
- Patient has end stage kidney disease and is a suitable candidate for primary renal transplantation or retransplantation as assessed by the transplantation center.
- Patient has been fully informed and has given written or independent person witnessed oral informed consent.
- Patient is pregnant or breastfeeding.
- Patient has a low immunological risk constellation, defined by receiving a kidney from
a HLA-identical related living donor.
- Patient has a high immunological risk constellation, defined as having within the
previous three years a measured PRA grade of ≥25% and/or having a previous graft
survival shorter than 3 years due to rejection.
- Patient and donor have a positive T or B-cell crossmatch.
- Patient and donor are ABO incompatible.
- Age of donor > 68 years.
- Cold ischemia time > 36 hours.
- Patient has leucopenia, defined as having at transplantation less than 3000/mm3
leukocytes.
- Patient has thrombocytopenia, defined as having at transplantation less than 75000/mm3
thrombocytes.
- Patient is allergic or intolerant to cremophor RH 60 or structurally related
compounds, steroids, Cyclosporine A Neoral, Rapamycin or MMF.
- Patient requires initial sequential or parallel therapy with immunosuppressive
antibody preparation(s).
- Patient or donor is known to be HIV positive.
- Patient has significant liver disease, defined as having during the past 28 days
continuously ASAT (SGOT) and/or ALAT (SGPT) levels greater than 3 fold of the upper
value of the normal range of the investigational site.
- Patient with malignancy or history of malignancy ≥ 2 years, except non metastatic
basal or squamous cell carcinoma of the skin that has been treated successfully.
- Patient has significant, uncontrolled concomitant infections and/or severe diarrhea,
vomiting, or active peptic ulcer.
- Patient is taking or has been taking an investigational drug in the past 28 days.
- Patient has previously received or is receiving another organ transplant other than
kidney.
- Patient is unlikely to comply with the visits schedule in the protocol.
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Descriptive Information | ||||
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Brief Title ICMJE | Calcineurin Free Immunosuppression in Renal Transplant Recipients | |||
Official Title ICMJE | Open, Single Center, Randomised, Parallel Group Pilot Study to Investigate a Calcineurin Free Immunosuppressive Treatment for de Novo Renal Transplant Recipients: A Comparison of a Rapamycin/MMF/Steroids Regime to a Cyclosporine A Neoral/MMF/Steroids Regimen in the Prevention of Acute Rejection Following Renal Transplantation | |||
Brief Summary | The main purpose of this study is to obtain preliminary information on the efficacy, safety and cost of two regimens, Rapamycin / MMF / steroid therapy and Cyclosporine A Neoral / MMF / steroid therapy, used in the prevention of acute rejection following renal transplantation. | |||
Detailed Description | This pilot study is designed to show differences in efficacy, safety and cost between the two regimens. Its main purpose is to provide information, if calcineurin free immunosuppressive treatment is a valuable alternative in the treatment of de novo kidney transplant recipients. Furthermore, by investigating the side effects in both arms it will be possible to decide, if the absence of calcineurin inhibition and lack of nephrotoxicity will outweigh the adverse effects of Rapamycin. With the obtained information it will be possible to plan a larger trial, which is warranted to compare the mentioned treatment regimens in more detail. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Franz S, Regeniter A, Hopfer H, Mihatsch M, Dickenmann M. Tubular toxicity in sirolimus- and cyclosporine-based transplant immunosuppression strategies: an ancillary study from a randomized controlled trial. Am J Kidney Dis. 2010 Feb;55(2):335-43. doi: 10.1053/j.ajkd.2009.09.004. Epub 2009 Nov 17. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 127 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | July 2005 | |||
Actual Primary Completion Date | July 2005 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 15 Years to 75 Years (Child, Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Switzerland | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00812123 | |||
Other Study ID Numbers ICMJE | Calfree | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Prof. Dr. J. Steiger, University Hospital Basel, Switzerland | |||
Study Sponsor ICMJE | University Hospital, Basel, Switzerland | |||
Collaborators ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Investigators ICMJE |
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PRS Account | University Hospital, Basel, Switzerland | |||
Verification Date | December 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |