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.

Induction Therapy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00235300
• Other study ID #: SMC-101-1010
• Status: Completed
• Phase: Phase 2
• First received: October 6, 2005
• Last updated: March 17, 2015
• Start date: May 2000
• Est. completion date: June 2005

Study information

• Verified date: March 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: June 2005
• Est. primary completion date: April 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Renal Allograft Rejection
• Cadaveric Donor Renal Transplantation
• Delayed Graft Function
• Induction Therapy

Intervention

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

Locations

Country	Name	City	State
France	Hopital Saint Jacques	Besancon
France	Hopital de Bradois	Cedex
France	Centre Hospitalier Universitaire	Grenoble
France	Hopital Edouard Herriot	Lyon
France	Hopital Foch	Suresnes
Germany	Unicersitat Erlangen-Numberg	Erlangen
Germany	University Hospital Eppendorf	Hamburg
Spain	Hospital de Cruces	Baracaldo
Spain	Hospital Clinico Universitario	Barcelona
Spain	Hospital Reina Sofia	Cordoba
Spain	Hospital Occe de Octubre	Madrid
United Kingdom	Freeman Hospital	Newcastle upon Tyne
United States	University of Michigan Hospital	Ann Arbor	Michigan
United States	Emory University Hospital	Atlanta	Georgia
United States	Medical College of Georgia	Augusta	Georgia
United States	University of Alabama	Birmingham	Alabama
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	Rush University Transplant Program	Chicago	Illinois
United States	University of Texas Medical Branch	Galveston	Texas
United States	University of Kentucky Medical Center	Lexington	Kentucky
United States	St. Barnabas Medical Center	Livingston	New Jersey
United States	UCLA School of Medicine	Los Angeles	California
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Florida Hospital Medical Center and Translife	Orlando	Florida
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	California Pacific Medical Center	San Francisco	California
United States	Westchester Medical Center	Valhalla	New York

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Countries where clinical trial is conducted

United States,  France,  Germany,  Spain,  United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from acute rejection, kidney transplant loss, delayed kidney transplant function and death at 6 months after transplant.		6 months	Yes
Secondary	12-mo. safety & efficacy assessments including side effects and overall kidney transplant function.		12 months	Yes

External Links

•   US FDA Approved Full Prescribing Information for Thymoglobulin®