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.

March 17, 2015 updated by: Genzyme, a Sanofi Company

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besancon, France, 25000
        • Hopital Saint Jacques
      • Cedex, France, 54511
        • Hopital de Bradois
      • Grenoble, France, 38043
        • Centre Hospitalier Universitaire
      • Lyon, France, 59003
        • Hôpital Edouard Herriot
      • Suresnes, France, 92151
        • Hôpital Foch
  • Germany
      • Erlangen, Germany, 12 91054
        • Unicersitat Erlangen-Numberg
      • Hamburg, Germany, 52 20246
        • University Hospital Eppendorf
  • Spain
      • Baracaldo, Spain
        • Hospital de Cruces
      • Barcelona, Spain, 08036
        • Hospital Clinico Universitario
      • Cordoba, Spain, 14004
        • Hospital Reina Sofia
      • Madrid, Spain, 28041
        • Hospital Occe de Octubre
  • United Kingdom
      • Newcastle upon Tyne, United Kingdom
        • Freeman Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35296
        • University of Alabama
    • California
      • Los Angeles, California, United States, 90095
        • UCLA School of Medicine
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University School of Medicine
    • Florida
      • Orlando, Florida, United States, 32804
        • Florida Hospital Medical Center and Translife
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
      • Augusta, Georgia, United States, 30912
        • Medical College of Georgia
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Transplant Program
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Hospital
    • New Jersey
      • Livingston, New Jersey, United States, 07039
        • St. Barnabas Medical Center
    • New York
      • Valhalla, New York, United States, 10595
        • Westchester Medical Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28232
        • Carolinas Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
    • Texas
      • Galveston, Texas, United States, 77555
        • University of Texas Medical Branch
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1 Control
Simulect (basiliximab)
Drug: Simulect (basliximab)
20 mg per day on 2 days
Experimental: 2
Thymoglobulin (anti-thymocyte globulin (rabbit))
Biological: Thymoglobulin [Anti-thymocyte Globulin (rabbit)]
1.5 mg/kg per day, for a maximum of 5 doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Freedom from acute rejection, kidney transplant loss, delayed kidney transplant function and death at 6 months after transplant.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
12-mo. safety & efficacy assessments including side effects and overall kidney transplant function.
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genzyme, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2000

Primary Completion (Actual)

April 1, 2003

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

October 6, 2005

First Submitted That Met QC Criteria

October 6, 2005

First Posted (Estimate)

October 10, 2005

Study Record Updates

Last Update Posted (Estimate)

March 18, 2015

Last Update Submitted That Met QC Criteria

March 17, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMC-101-1010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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