An Open-label, Prospective, Randomized, Multi-center, Phase II Comparative Trial of Thymoglobulin Versus Simulect for the Prevention of Delayed Graft Function and Acute Allograft Rejection in Renal Allograft Recipients.
NCT ID: NCT00235300
Last Updated: 2015-03-18
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
PHASE2
240 participants
INTERVENTIONAL
2000-05-31
2005-06-30
Brief Summary
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Subjects meeting all inclusion and exclusion criteria were eligible to participate in this study. The treatment assignment was random and not chosen by the subject or their physician.
Subjects were monitored during treatment with Thymoglobulin and during the transplant hospitalization. Additional subject monitoring occurred up to 12 months after transplant.
278 study subjects were enrolled at 28 transplant centers in the United States and Europe.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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1 Control
Simulect (basiliximab)
Simulect (basliximab)
20 mg per day on 2 days
2
Thymoglobulin (anti-thymocyte globulin (rabbit))
Thymoglobulin [Anti-thymocyte Globulin (rabbit)]
1.5 mg/kg per day, for a maximum of 5 doses
Interventions
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Thymoglobulin [Anti-thymocyte Globulin (rabbit)]
1.5 mg/kg per day, for a maximum of 5 doses
Simulect (basliximab)
20 mg per day on 2 days
Eligibility Criteria
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Inclusion Criteria
* Patient is classified as "high risk" for acute allograft rejection of DGF. Must have had at least 1 donor or 1 recipient variable for high risk.
* Patient will be a recipient of a solitary cadaveric renal allograft.
* Women of childbearing potential must have had a negative pregnancy test (serum or urine).
* Man or woman agrees to practice medically acceptable contraception (i.e. barrier or pharmacologic) for a minimum of 3 months following study drug administration. In addition, women were recommended to practice contraception for 1 year following transplantation, or per local standard.
* Patient agrees to participate in the study and sign an informed consent.
* Patient has no known contraindication to the administration of rabbit anti-thymocyte globulin or basiliximab. Patient has no history of hypersensitivity to basiliximab.
* Patient is dialysis-dependent at the time immediately prior to transplantation.
Exclusion Criteria
* Patient has a history of malignancy within 2 years, with the exception of adequately treated localized squamous basal cell carcinoma of the skin without evidence of recurrence.
* 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).
* Patient is a multiple organ transplant recipient.
* Patient is on any type of immunosuppression (i.e. prior transplant recipient still on immunosuppression, or patient is receiving systemic steroids for any medical condition).
* Patient, who, in the opinion of the investigator, has significant medical or psychosocial problems or unstable disease states which would preclude enrollment. Examples of significant medical problems include, but are not limited to, morbid obesity or severe cardiac disease.
* Kidneys that are to be implanted en bloc or from donors less than 6 years old.
* Kidneys from donors that are known or suspected to have an active infection with or be seropositive for HBsAg, hepatitis B core antibody (HBcAb), HCV, or HIV.
* Kidneys from donors that have received investigational therapies designed to reduce the impact of ischemia reperfusion, DGF, or other donor-related immune events.
* Donor kidney is preserved by cold storage (with or without machine preservation) for less than 16 hours, with the exception of kidneys from non-heart-beating donors or kidneys from donors greater than 50 years old or donors with a SCr above 2.5mg/dL.
18 Years
ALL
No
Sponsors
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Genzyme, a Sanofi Company
INDUSTRY
Responsible Party
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Genzyme Corporation
Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Genzyme, a Sanofi Company
Locations
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University of Alabama
Birmingham, Alabama, United States
UCLA School of Medicine
Los Angeles, California, United States
California Pacific Medical Center
San Francisco, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Florida Hospital Medical Center and Translife
Orlando, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Medical College of Georgia
Augusta, Georgia, United States
Rush University Transplant Program
Chicago, Illinois, United States
University of Kentucky Medical Center
Lexington, Kentucky, United States
University of Michigan Hospital
Ann Arbor, Michigan, United States
St. Barnabas Medical Center
Livingston, New Jersey, United States
Westchester Medical Center
Valhalla, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Texas Medical Branch
Galveston, Texas, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Hopital Saint Jacques
Besançon, , France
Hopital de Bradois
Cedex, , France
Centre Hospitalier Universitaire
Grenoble, , France
Hopital Edouard Herriot
Lyon, , France
Hopital Foch
Suresnes, , France
Unicersitat Erlangen-Numberg
Erlangen, , Germany
University Hospital Eppendorf
Hamburg, , Germany
Hospital de Cruces
Barakaldo, , Spain
Hospital Clinico Universitario
Barcelona, , Spain
Hospital Reina Sofia
Córdoba, , Spain
Hospital Occe de Octubre
Madrid, , Spain
Freeman Hospital
Newcastle upon Tyne, , United Kingdom
Countries
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References
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Brennan DC, Daller JA, Lake KD, Cibrik D, Del Castillo D; Thymoglobulin Induction Study Group. Rabbit antithymocyte globulin versus basiliximab in renal transplantation. N Engl J Med. 2006 Nov 9;355(19):1967-77. doi: 10.1056/NEJMoa060068.
Lentine KL, Schnitzler MA, Xiao H, Brennan DC. Long-term safety and efficacy of antithymocyte globulin induction: use of integrated national registry data to achieve ten-year follow-up of 10-10 Study participants. Trials. 2015 Aug 19;16:365. doi: 10.1186/s13063-015-0891-y.
Related Links
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US FDA Approved Full Prescribing Information for Thymoglobulin®
Other Identifiers
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SMC-101-1010
Identifier Type: -
Identifier Source: org_study_id
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