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.
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
1 other identifier
interventional
240
5 countries
28
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2000
Longer than P75 for phase_2
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 6, 2005
CompletedFirst Posted
Study publicly available on registry
October 10, 2005
CompletedMarch 18, 2015
March 1, 2015
2.9 years
October 6, 2005
March 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Freedom from acute rejection, kidney transplant loss, delayed kidney transplant function and death at 6 months after transplant.
6 months
Secondary Outcomes (1)
12-mo. safety & efficacy assessments including side effects and overall kidney transplant function.
12 months
Study Arms (2)
1 Control
ACTIVE COMPARATORSimulect (basiliximab)
2
EXPERIMENTALThymoglobulin (anti-thymocyte globulin (rabbit))
Interventions
1.5 mg/kg per day, for a maximum of 5 doses
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
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
Hopital Saint Jacques
Besançon, 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
Barakaldo, Spain
Hospital Clinico Universitario
Barcelona, 08036, Spain
Hospital Reina Sofia
Córdoba, 14004, Spain
Hospital Occe de Octubre
Madrid, 28041, Spain
Freeman Hospital
Newcastle upon Tyne, United Kingdom
Related Publications (2)
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.
PMID: 17093248RESULTLentine 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.
PMID: 26285695DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Genzyme, a Sanofi Company
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 6, 2005
First Posted
October 10, 2005
Study Start
May 1, 2000
Primary Completion
April 1, 2003
Study Completion
June 1, 2005
Last Updated
March 18, 2015
Record last verified: 2015-03