Study Of The Safety And Efficacy Of Conversion From A CNI To Sirolimus In Renally-Impaired Heart Transplant Recipients
NCT ID: NCT00369382
Last Updated: 2011-05-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
121 participants
INTERVENTIONAL
2006-09-30
2010-05-31
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
PREVENTION
NONE
Study Groups
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1
Group 1: Continuation of CNI regimen
cyclosporine or tacrolimus
Cyclosporine and tacrolimus are provided by the sites and dosed to achieve a target trough level determined by the investigator; therefore, form, dosage, and frequency are site and patient specific. Duration should be 52 weeks on-therapy.
2
Group 2: (CNI-Free) Conversion to SRL-based regimen
sirolimus
Oral (1 and 2 mg) tablets, dosing should be once daily to achieve a target trough level of 7- 15 ng/mL. Duration should be 52 weeks on-therapy.
Interventions
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cyclosporine or tacrolimus
Cyclosporine and tacrolimus are provided by the sites and dosed to achieve a target trough level determined by the investigator; therefore, form, dosage, and frequency are site and patient specific. Duration should be 52 weeks on-therapy.
sirolimus
Oral (1 and 2 mg) tablets, dosing should be once daily to achieve a target trough level of 7- 15 ng/mL. Duration should be 52 weeks on-therapy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 12 months after cardiac transplantation but less than 96 months post-transplantation.
Exclusion Criteria
* Prior or current use of sirolimus or everolimus unless administration was part of a "CNI holiday" lasting no more than 10 days.
* History of acute rejection within the last 3 months, malignancy within the last 5 years (except for adequately treated basal cell or squamous cell carcinoma of the skin), and human immunodeficiency virus (HIV) patients.
18 Years
ALL
No
Sponsors
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Wyeth is now a wholly owned subsidiary of Pfizer
INDUSTRY
Responsible Party
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Pfizer, Inc
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Tampa, Florida, United States
Pfizer Investigational Site
Rochester, Minnesota, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States
Pfizer Investigational Site
Houston, Texas, United States
Pfizer Investigational Site
Norfolk, Virginia, United States
Pfizer Investigational Site
Darlinghurst, New South Wales, Australia
Pfizer Investigational Site
Vienna, , Austria
Pfizer Investigational Site
Montreal, Quebec, Canada
Pfizer Investigational Site
Québec, Quebec, Canada
Pfizer Investigational Site
Sainte-Foy, Quebec, Canada
Pfizer Investigational Site
Epsom, Auckland, New Zealand
Pfizer Investigational Site
Auckland, New Zealand, New Zealand
Pfizer Investigational Site
L'Hospitalet de Llobregat, Barcelona, Spain
Pfizer Investigational Site
Santander, Cantabria, Spain
Pfizer Investigational Site
La Coru?a, La Coru?a, Spain
Pfizer Investigational Site
Madrid, Madrid, Spain
Pfizer Investigational Site
Seville, Sevilla, Spain
Pfizer Investigational Site
Valencia, Valencia, Spain
Pfizer Investigational Site
Barcelona, , Spain
Pfizer Investigational Site
Bern, , Switzerland
Countries
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References
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Zuckermann A, Keogh A, Crespo-Leiro MG, Mancini D, Vilchez FG, Almenar L, Brozena S, Eisen H, Tai SS, Kushwaha S. Randomized controlled trial of sirolimus conversion in cardiac transplant recipients with renal insufficiency. Am J Transplant. 2012 Sep;12(9):2487-97. doi: 10.1111/j.1600-6143.2012.04131.x. Epub 2012 Jul 9.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B1741006
Identifier Type: OTHER
Identifier Source: secondary_id
0468E7-408
Identifier Type: -
Identifier Source: org_study_id