A Study to Evaluate the Effect of Thymoglobulin and Reduced Doses of Steroids to Prevent Renal Transplant Rejection
This study has been completed.
Sponsor:
Genzyme
Information provided by:
Genzyme
ClinicalTrials.gov Identifier:
NCT00089947
First received: August 18, 2004
Last updated: August 10, 2012
Last verified: August 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Renal Transplantation Graft Rejection |
Drug: Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)] |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Genzyme:
Primary Outcome Measures:
- 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 Outcome Measures:
- To evaluate patient kidney function after transplantation and the overall safety of Thymoglobulin in this patient population.
| Estimated Enrollment: | 150 |
| Study Start Date: | June 2003 |
| Study Completion Date: | December 2005 |
| Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00089947
Locations
| United States, Arkansas | |
| University of Arkansas for Medical Science | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Keck USC School of Medicine | |
| Los Angeles, California, United States, 90033 | |
| University of California, Los Angeles Medical Center | |
| Los Angeles, California, United States, 90095 | |
| University of California, San Diego Medical Center | |
| San Diego, California, United States, 92103 | |
| University of California, San Francisco | |
| San Francisco, California, United States, 94143 | |
| California Pacific Medical Center | |
| San Francisco, California, United States, 94115 | |
| United States, Colorado | |
| University of Colorado Health Sciences Center | |
| Denver, Colorado, United States, 80262 | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Indiana | |
| Indiana University | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Louisiana | |
| Oschner Medical Center | |
| New Orleans, Louisiana, United States, 70121 | |
| United States, Maryland | |
| Johns Hopkins University Hospital | |
| Baltimore, Maryland, United States, 21287 | |
| United States, New Jersey | |
| Saint Barnabas Medical Center | |
| Livingston, New Jersey, United States, 07039 | |
| United States, New York | |
| Mount Sinai School of Medicine | |
| New York, New York, United States, 10029 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| University of Cincinnati Medical Center | |
| Cincinnati, Ohio, United States, 45267 | |
| Christ Hospital | |
| Cincinnati, Ohio, United States, 45219 | |
| United States, Texas | |
| Texas Transplant Institute | |
| San Antonio, Texas, United States, 78229 | |
| United States, Virginia | |
| Medical College of Virginia | |
| Richmond, Virginia, United States, 23298 | |
| United States, Wisconsin | |
| Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
Sponsors and Collaborators
Genzyme
Investigators
| Study Director: | Medical Monitor | Genzyme |
More Information
Additional Information:
No publications provided
| Responsible Party: | Medical Monitor, Genzyme Corporation |
| ClinicalTrials.gov Identifier: | NCT00089947 History of Changes |
| Other Study ID Numbers: | SMC-101-1025 |
| Study First Received: | August 18, 2004 |
| Last Updated: | August 10, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Genzyme:
|
Anti-T cell antibodies Living Donor Renal Transplantation Acute Renal Allograft Rejection Induction Therapy with Reduction of Calcineurin inhibitors |
Additional relevant MeSH terms:
|
Antilymphocyte Serum Mycophenolate mofetil Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013