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.
Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cadaveric Donor Renal Transplantation; Acute Renal Allograft Rejection; Induction Therapy
Intervention: Thymoglobulin [Anti-thymocyte Globulin (rabbit)] (Biological); Simulect (basliximab) (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Genzyme, a Sanofi Company Official(s) and/or principal investigator(s): Medical Monitor, Study Director, Affiliation: Genzyme, a Sanofi Company
Summary
A multicenter clinical study comparing event-free survival at 6 months after transplant
between Thymoglobulin-treated and Simulect-treated adult kidney transplant patients.
Patients received Thymoglobulin or Simulect from Day 0 through Day 4. Day 0 was considered
the day of the transplant procedure.
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.
Clinical Details
Official title: An Open-Label Prospective, Randomized, Multicenter Phase II Comparative Trial of Thymoglobulin® Versus Simulect® for the Prevention of Delayed Graft Function and Acute Allograft Rejection in Renal Allograft Recipients
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Freedom from acute rejection, kidney transplant loss, delayed kidney transplant function and death at 6 months after transplant.
Secondary outcome: 12-mo. safety & efficacy assessments including side effects and overall kidney transplant function.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patient greater than or equal to 18 years old.
- 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 received an investigational medication within the past 30 days.
- 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.
Locations and Contacts
Hopital Saint Jacques, Besancon 25000, France
Hopital de Bradois, Cedex 54511, France
Centre Hospitalier Universitaire, Grenoble 38043, France
Hopital Edouard Herriot, Lyon 59003, France
Hopital Foch, Suresnes 92151, France
Unicersitat Erlangen-Numberg, Erlangen 12 91054, Germany
University Hospital Eppendorf, Hamburg 52 20246, Germany
Hospital de Cruces, Baracaldo, Spain
Hospital Clinico Universitario, Barcelona 08036, Spain
Hospital Reina Sofia, Cordoba 14004, Spain
Hospital Occe de Octubre, Madrid 28041, Spain
Freeman Hospital, Newcastle upon Tyne, United Kingdom
University of Alabama, Birmingham, Alabama 35296, United States
UCLA School of Medicine, Los Angeles, California 90095, United States
California Pacific Medical Center, San Francisco, California 94115, United States
Yale University School of Medicine, New Haven, Connecticut 06510, United States
Florida Hospital Medical Center and Translife, Orlando, Florida 32804, United States
Emory University Hospital, Atlanta, Georgia 30322, United States
Medical College of Georgia, Augusta, Georgia 30912, United States
Rush University Transplant Program, Chicago, Illinois 60612, United States
University of Kentucky Medical Center, Lexington, Kentucky 40536, United States
University of Michigan Hospital, Ann Arbor, Michigan 48109, United States
St. Barnabas Medical Center, Livingston, New Jersey 07039, United States
Westchester Medical Center, Valhalla, New York 10595, United States
Carolinas Medical Center, Charlotte, North Carolina 28232, United States
Allegheny General Hospital, Pittsburgh, Pennsylvania 15212, United States
University of Texas Medical Branch, Galveston, Texas 77555, United States
Medical College of Wisconsin, Milwaukee, Wisconsin 53226, United States
Additional Information
US FDA Approved Full Prescribing Information for Thymoglobulin®
Starting date: May 2000
Last updated: March 17, 2015
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