A Study to Evaluate the Effect of Thymoglobulin and Reduced Doses of Steroids to Prevent Renal Transplant Rejection

Renal Transplantation Clinical Trial

Official title:

Randomized, Prospective, Phase 2 Study Comparing Thymoglobulin in a Rapid Discontinuation of Corticosteroids Protocol With Standard Corticosteroid Therapy in Living Donor Renal Transplantation Using Mycophenolate Mofetil and Tacrolimus Maintenance Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00089947
• Other study ID #: SMC-101-1025
• Status: Completed
• Phase: Phase 2
• First received: August 18, 2004
• Last updated: March 16, 2015
• Start date: June 2003
• Est. completion date: December 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

This study involves the use of a drug called Thymoglobulin, which is approved in the US to treat kidney transplant rejection and in Canada to treat and to prevent kidney transplant rejection.

This study will evaluate the effect of Thymoglobulin and reduced doses of steroids to prevent renal transplant rejection and will provide a basis for future evaluations of Thymoglobulin as an immunosuppressive agent to help prevent renal transplant rejection.

Subjects meeting all inclusion and exclusion criteria are eligible to participate in this study. In addition to standard treatment, study participants will receive either Thymoglobulin with rapid discontinuation of steroids or steroids per hospital standards for at least the first 90 days after transplant. The treatment assignment is random and is not chosen by the subject or their physician.

Subjects will be monitored during treatment with Thymoglobulin and during the transplant hospitalization. Additional subject monitoring occurs at Months 1, 3, 6 and 12 following the transplant.

Approximately 150 study subjects from 15-20 transplant centers in the United States will be enrolled.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult living donor renal transplant recipient

• Age greater than or equal to 18

• If female and of childbearing potential: a) must not be lactating; b) must have a negative serum B-human chorionic gonadotropin (HCG) test within 24 hours prior to Study Day 0 (Day of Transplant) and; c) must agree to practice an acceptable and reliable form of contraception during the study; and

• Signed informed consent

Exclusion Criteria:

• Human Leukocyte Antibody (HLA) identical matched living donor transplant recipient

• > 2 previous transplants

• Current panel reactive antibody (PRA) > 20%

• History of a positive cross-match with the donor

• Active donor or recipient serology positive for human immunodeficiency virus (HIV), Hepatitis B virus (HBV) or Hepatitis C virus (HCV)

• Loss of first kidney transplant in < 1 year

• History of noncompliance in clinical trial(s)

• History of chronic CS or immunosuppressive use except for inhaled CS to treat asthma

• Use of any investigational products during the 90 days prior to screening

• Requirement for multiple organ transplant

• Patient without a functioning urinary bladder prior to transplant (e.g. patients with self catheterization will be excluded)

• Known contraindication to administration of rabbit antithymocyte globulin

• Currently abusing drugs or alcohol

• In the opinion of the investigator, at high risk for poor compliance

• In the opinion of the investigator, has a significant medical or psychosocial problem or unstable disease state that warrants exclusion from the study. Examples of significant problems include, but are not limited to morbid obesity and severe cardiac disease.

Study Design

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

Related Conditions & MeSH terms

• Graft Rejection
• Renal Transplantation

Intervention

Drug:
• Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)]

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Johns Hopkins University Hospital	Baltimore	Maryland
United States	Christ Hospital	Cincinnati	Ohio
United States	University of Cincinnati Medical Center	Cincinnati	Ohio
United States	University of Colorado Health Sciences Center	Denver	Colorado
United States	Duke University Medical Center	Durham	North Carolina
United States	Indiana University	Indianapolis	Indiana
United States	University of Arkansas for Medical Science	Little Rock	Arkansas
United States	Saint Barnabas Medical Center	Livingston	New Jersey
United States	Keck USC School of Medicine	Los Angeles	California
United States	University of California, Los Angeles Medical Center	Los Angeles	California
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Oschner Medical Center	New Orleans	Louisiana
United States	Mount Sinai School of Medicine	New York	New York
United States	Medical College of Virginia	Richmond	Virginia
United States	Texas Transplant Institute	San Antonio	Texas
United States	University of California, San Diego Medical Center	San Diego	California
United States	California Pacific Medical Center	San Francisco	California
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	This study will evaluate the effect of Thymoglobulin and reduced doses of steroids to prevent renal transplant rejection, organ loss and death at 6 months.
Secondary	To evaluate patient kidney function after transplantation and the overall safety of Thymoglobulin in this patient population.

External Links

•   US FDA Approved Full Prescribing Information for Thymoglobulin®