Kidney Transplantation Clinical Trial
Official title:
Evaluation of Antibody Plus Delayed CSA vs CSA in Determining Delayed Graft Function in Cadaver Transplant Recipients
The purpose of this study is to see if kidney function can be improved during transplants by
giving the drug Thymoglobulin with delayed cyclosporine treatment instead of initial
cyclosporine treatment.
There have been improvements for patients receiving kidney transplants, yet acute rejection
is still a problem. This can lead to kidney failure over time. Patients whose graft fails to
function properly in the first week after transplant do not do as well after 5 years as
compared to patients without early problems. This study will see if Thymoglobulin, a drug
that suppresses the immune system, will improve early graft function.
Status | Completed |
Enrollment | 350 |
Est. completion date | March 2004 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years and older |
Eligibility |
Inclusion Criteria Patients may be eligible for this study if they: - Are receiving a first or second kidney transplant. - Are at least 21 years old. - Understand the purposes and risks of the study and have given consent. - Agree to use an acceptable form of birth control for a year following transplant. Exclusion Criteria Patients will not be eligible for this study if they: - Have received a kidney transplant from a living donor. - Have had multiple organ transplants. - Are allergic to Thymoglobulin (contains a rabbit protein). - Are pregnant. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Ilene Blechman-Krom | Rockville | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Graft function measurnment | measured by a calculated creatinine clearance. Creatinine Clearance for males will be computed using the following: [weight in kg * (140 - age in years)]/ [72 * serum creatinine mg/dl]. For females, eighty-five percent of this value will be used. | 3 months | No |
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