SMC1011010: 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

This study has been completed.

Sponsored By:	Genzyme
Information Provided By:	Genzyme
ClinicalTrials.gov Identifier:	NCT00235300

Purpose

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.

Condition	Intervention	Phase
Cadaveric Donor Renal Transplantation Acute Renal Allograft Rejection Induction Therapy	Drug: Thymoglobulin [Anti-thymocyte Globulin (rabbit)]	Phase II

Study Type: Interventional

Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Further Study Details:

Primary Outcomes: Freedom from acute rejection, kidney transplant loss, delayed kidney transplant function and death at 6 months after transplant.

Secondary Outcomes: 12-mo. safety & efficacy assessments including side effects and overall kidney transplant function.

Study start: May 2000; Study Completion: April 2003

Eligibility

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: 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.

Location and Contact Information

Alabama
University of Alabama, Birmingham, Alabama, 35296, United States

California

UCLA School of Medicine, Los Angeles, California, 90095, United States
California Pacific Medical Center, San Francisco, California, 94115, United States

Connecticut
Yale University School of Medicine, New Haven, Connecticut, 06510, United States

Florida
Florida Hospital Medical Center and Translife, Orlando, Florida, 32804, United States

Georgia
Emory University Hospital, Atlanta, Georgia, 30322, United States
Medical College of Georgia, Augusta, Georgia, 30912, United States

Illinois
Rush University Transplant Program, Chicago, Illinois, 60612, United States

Kentucky
University of Kentucky Medical Center, Lexington, Kentucky, 40536, United States

Michigan
University of Michigan Hospital, Ann Arbor, Michigan, 48109, United States

New Jersey
St. Barnabas Medical Center, Livingston, New Jersey, 07039, United States

New York
Westchester Medical Center, Valhalla, New York, 10595, United States

North Carolina
Carolinas Medical Center, Charlotte, North Carolina, 28232, United States

Pennsylvania
Allegheny General Hospital, Pittsburgh, Pennsylvania, 15212, United States

Texas
University of Texas Medical Branch, Galveston, Texas, 77555, United States

Wisconsin
Medical College of Wisconsin, Milwaukee, Wisconsin, 53226, United States

France
Hopital Saint Jacques, Besancon, 25000, France
Hopital Foch, Suresnes, 92151, France
Centre Hospitalier Universitaire, Grenoble, 38043, France
Hopital de Bradois, Cedex, 54511, France
Hopital Edouard Herriot, Lyon, 59003, France

Germany
Unicersitat Erlangen-Numberg, Erlangen, 12 91054, Germany
University Hospital Eppendorf, Hamburg, 52 20246, Germany

Spain
Hospital Reina Sofia, Cordoba, 14004, Spain
Hospital Occe de Octubre, Madrid, 28041, Spain
Hospital Clinico Universitario, Barcelona, 08036, Spain
Hospital de Cruces, Baracaldo, Spain

United Kingdom
Freeman Hospital, Newcastle upon Tyne, United Kingdom

More Information

US FDA Approved Full Prescribing Information for Thymoglobulin®

Literature Citation:

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. PMID: 17093248

Study ID Numbers: SMC1011010
ClinicalTrials.gov Identifier: NCT00235300
Health Authority: United States: Food and Drug Administration