Rapamycin Versus Mycophenolate Mofetil in Kidney-Pancreas Recipients
NCT ID: NCT00533442
Last Updated: 2017-07-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
170 participants
INTERVENTIONAL
2000-09-30
2016-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Tacrolimus plus MMF plus Steroids
Patients randomized to this arm were scheduled to receive maintenance therapy consisting of Tacrolimus, Mycophenolate Mofetil (MMF), and Steroids. Patients in both treatment arms received dual induction therapy consisting of Rabbit Anti-thymocyte Globulin (Thymoglobulin) plus Daclizumab.
Mycophenolate Mofetil
MMF 1 gm BID beginning 1st day postoperative day
Tacrolimus
Part of standard maintenance.
Steroids
Part of standard maintenance
Tacrolimus plus Rapamycin plus Steroids
Patients randomized to this arm were scheduled to receive maintenance therapy consisting of Tacrolimus, Rapamycin (Sirolimus), and Steroids. Patients in both treatment arms received dual induction therapy consisting of Rabbit Anti-thymocyte Globulin (Thymoglobulin) plus Daclizumab.
Rapamycin
Rapamycin was initiated on day 1 postoperatively, 4mg/day;levels were maintained 5-8ng/ml. Those patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day.
Tacrolimus
Part of standard maintenance.
Steroids
Part of standard maintenance
Interventions
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Rapamycin
Rapamycin was initiated on day 1 postoperatively, 4mg/day;levels were maintained 5-8ng/ml. Those patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day.
Mycophenolate Mofetil
MMF 1 gm BID beginning 1st day postoperative day
Tacrolimus
Part of standard maintenance.
Steroids
Part of standard maintenance
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Women of childbearing potential must have had a negative pregnancy test (serum or urine).
* Patient agrees to participate in the study and sign an informed consent.
* Patient has no known contraindication to the administration of rapamycin or mycophenolate mofetil.
* Patient has no history of hypersensitivity to rapamycin or mycophenolate mofetil.
Exclusion Criteria
* Patient is currently abusing drugs or alcohol.
* Patient is known or suspected to have an active infection or be seropositive for hepatitis B surface antigen (HBsAg), hepatitis C (HCV) or human immunodeficiency virus (HIV).
18 Years
65 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
University of Miami
OTHER
Responsible Party
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George W. Burke
Professor of Surgery
Principal Investigators
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George W Burke, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami, Miller School of Medicine
Miami, Florida, United States
Countries
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References
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Burke GW 3rd, Ciancio G, Figueiro J, Olson L, Gomez C, Rosen A, Suzart K, Miller J. Steroid-resistant acute rejection following SPK: importance of maintaining therapeutic dosing in a triple-drug regimen. Transplant Proc. 2002 Aug;34(5):1918-9. doi: 10.1016/s0041-1345(02)03122-6. No abstract available.
Burke G 3rd, Ciancio G, Figueiro J, Olson L, Gomez C, Rosen A, Suzart K, Miller J. Can acute rejection be prevented in SPK transplantation? Transplant Proc. 2002 Aug;34(5):1913-4. doi: 10.1016/s0041-1345(02)03149-4. No abstract available.
Burke GW 3rd, Ciancio G, Figueiro J, Buigas R, Olson L, Roth D, Kupin W, Miller J. Hypercoagulable state associated with kidney-pancreas transplantation. Thromboelastogram-directed anti-coagulation and implications for future therapy. Clin Transplant. 2004 Aug;18(4):423-8. doi: 10.1111/j.1399-0012.2004.00183.x.
Ciancio G, Sageshima J, Chen L, Gaynor JJ, Hanson L, Tueros L, Montenora-Velarde E, Gomez C, Kupin W, Guerra G, Mattiazzi A, Fornoni A, Pugliese A, Roth D, Wolf M, Burke GW 3rd. Advantage of rapamycin over mycophenolate mofetil when used with tacrolimus for simultaneous pancreas kidney transplants: randomized, single-center trial at 10 years. Am J Transplant. 2012 Dec;12(12):3363-76. doi: 10.1111/j.1600-6143.2012.04235.x. Epub 2012 Sep 4.
Other Identifiers
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20000176
Identifier Type: -
Identifier Source: org_study_id
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