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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.
This study has been completed.
First Received: October 6, 2005   Last Updated: April 1, 2009   History of Changes
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
Biological: Thymoglobulin [Anti-thymocyte Globulin (rabbit)]
Drug: Simulect (basliximab)
Phase II

MedlinePlus related topics: Kidney Transplantation
Drug Information available for: Basiliximab
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Genzyme:

Primary Outcome Measures:
  • Freedom from acute rejection, kidney transplant loss, delayed kidney transplant function and death at 6 months after transplant. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 12-mo. safety & efficacy assessments including side effects and overall kidney transplant function. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 240
Study Start Date: May 2000
Study Completion Date: June 2005
Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Control: Active Comparator
Simulect (basiliximab)
Drug: Simulect (basliximab)
20 mg per day on 2 days
2: Experimental
Thymoglobulin (anti-thymocyte globulin (rabbit))
Biological: Thymoglobulin [Anti-thymocyte Globulin (rabbit)]
1.5 mg/kg per day, for a maximum of 5 doses

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00235300

  Show 28 Study Locations
Sponsors and Collaborators
Genzyme
Investigators
Study Director: Per Lindner, M.D., Ph.D. Genzyme
  More Information

Additional Information:
Publications:
Responsible Party: Genzyme Corporation ( Medical Monitor )
Study ID Numbers: SMC-101-1010
Study First Received: October 6, 2005
Last Updated: April 1, 2009
ClinicalTrials.gov Identifier: NCT00235300     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Genzyme:
Anti-T cells antibodies
Cadaveric Donor Renal Transplantation
Acute Renal Allograft Rejection
Induction Therapy

Study placed in the following topic categories:
Antilymphocyte Serum
Basiliximab
Antibodies
Immunologic Factors
Delayed Graft Function
Immunosuppressive Agents
Immunoglobulins

Additional relevant MeSH terms:
Antilymphocyte Serum
Basiliximab
Pathologic Processes
Immunologic Factors
Physiological Effects of Drugs
Delayed Graft Function
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 06, 2009