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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00089947
Other study ID # SMC-101-1025
Secondary ID
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


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.
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