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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

Page last updated: August 23, 2015

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