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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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00235300
Recruitment Status : Completed
First Posted : October 10, 2005
Last Update Posted : March 18, 2015
Information provided by:

Tracking Information
First Submitted Date  ICMJE October 6, 2005
First Posted Date  ICMJE October 10, 2005
Last Update Posted Date March 18, 2015
Study Start Date  ICMJE May 2000
Actual Primary Completion Date April 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2009)
Freedom from acute rejection, kidney transplant loss, delayed kidney transplant function and death at 6 months after transplant. [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 6, 2005)
Event-free survival, freedom from acute rejection, transplant loss, delayed kidney function
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2009)
12-mo. safety & efficacy assessments including side effects and overall kidney transplant function. [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2005)
Safety assessments include side effects, hospitalizations, infections and cancers
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE 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.
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Cadaveric Donor Renal Transplantation
  • Acute Renal Allograft Rejection
  • Induction Therapy
Intervention  ICMJE
  • Biological: Thymoglobulin [Anti-thymocyte Globulin (rabbit)]
    1.5 mg/kg per day, for a maximum of 5 doses
  • Drug: Simulect (basliximab)
    20 mg per day on 2 days
Study Arms  ICMJE
  • Active Comparator: 1 Control
    Simulect (basiliximab)
    Intervention: Drug: Simulect (basliximab)
  • Experimental: 2
    Thymoglobulin (anti-thymocyte globulin (rabbit))
    Intervention: Biological: Thymoglobulin [Anti-thymocyte Globulin (rabbit)]
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 1, 2009)
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE June 2005
Actual Primary Completion Date April 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany,   Spain,   United Kingdom,   United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00235300
Other Study ID Numbers  ICMJE SMC-101-1010
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical Monitor, Genzyme Corporation
Study Sponsor  ICMJE Genzyme, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Genzyme, a Sanofi Company
PRS Account Sanofi
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP