Clinical trial NCT00089947: A Study to Evaluate the Effect of Thymoglobulin and Reduced Doses of Steroids to Prevent Renal Transplant Rejection
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Transplantation
Graft Rejection
Keywords: Anti-T cell antibodies
Living Donor Renal Transplantation
Acute Renal Allograft Rejection
Induction Therapy with Reduction of Calcineurin inhibitors
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2004-08-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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 outcomes:
measure: To evaluate patient kidney function after transplantation and the overall safety of Thymoglobulin in this patient population.
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Science
state: Arkansas
city: Los Angeles
country: United States
facility: Keck USC School of Medicine
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles Medical Center
state: California
city: San Diego
country: United States
facility: University of California, San Diego Medical Center
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Denver
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: New Orleans
country: United States
facility: Oschner Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University Hospital
state: Maryland
city: Livingston
country: United States
facility: Saint Barnabas Medical Center
state: New Jersey
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Christ Hospital
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: San Antonio
country: United States
facility: Texas Transplant Institute
state: Texas
city: Richmond
country: United States
facility: Medical College of Virginia
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References: