Calcineurin Free Immunosuppression in Renal Transplant Recipients
NCT ID: NCT00812123
Last Updated: 2008-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
127 participants
INTERVENTIONAL
2001-01-31
2005-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Calcineurin free
Immunosuppression with Sirolimus, Mycophenolate and Steroids
Sirolimus
Loading dose 30 mg for three days, trough level of 10-20 ng/ml month 1-3, 8-15 ng/ml month 4 - 6
Prednisone
0.5 mg/kg, tapering every two weeks until 0.1 mg/kg
Mycophenolate mofetil
2 x 1000mg, through level above 2ug/ml
Protocol biopsies
protocol kidney biopsies at month one and three
Calcineurin
Immunosuppressive therapy with Cyclosporin A, Mycophenolate and Steroids
Cyclosporine A
Loading dose of 300 mg for three days, trough levels 250-300 ng/ml months 1-3, 150-250 ng/ml months 4 to 6
Prednisone
0.5 mg/kg, tapering every two weeks until 0.1 mg/kg
Mycophenolate mofetil
2 x 1000mg, through level above 2ug/ml
Protocol biopsies
protocol kidney biopsies at month one and three
Interventions
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Sirolimus
Loading dose 30 mg for three days, trough level of 10-20 ng/ml month 1-3, 8-15 ng/ml month 4 - 6
Cyclosporine A
Loading dose of 300 mg for three days, trough levels 250-300 ng/ml months 1-3, 150-250 ng/ml months 4 to 6
Prednisone
0.5 mg/kg, tapering every two weeks until 0.1 mg/kg
Mycophenolate mofetil
2 x 1000mg, through level above 2ug/ml
Protocol biopsies
protocol kidney biopsies at month one and three
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
15 Years
75 Years
ALL
No
Sponsors
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Wyeth is now a wholly owned subsidiary of Pfizer
INDUSTRY
University Hospital, Basel, Switzerland
OTHER
Responsible Party
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University Hospital Basel, Switzerland
Principal Investigators
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Jürg U Steiger, MD
Role: PRINCIPAL_INVESTIGATOR
Clinic for Transplantation Immunology and Nephrology, University Hospital, Basel, Switzerland
Locations
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University Hospital Basel, Clinic for Transplantation Immunology and Nephrology
Basel, , Switzerland
Countries
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References
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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.
Other Identifiers
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Calfree
Identifier Type: -
Identifier Source: org_study_id