End-Stage Renal Disease Clinical Trial
Official title:
An Interventional Trial in Established Chronic Renal Allograft Rejection
The purpose of this study is to see how effective 2 drugs, irbesartan and pravastatin, are
at slowing kidney transplant failure.
Many kidney transplant patients have some type of chronic rejection. Chronic rejection is a
disease that causes scarring and damage to the kidney. Over time, chronic rejection can lead
to kidney failure, making it necessary for patients to start dialysis and possibly receive
another kidney transplant. Doctors would like to see whether irbesartan and pravastatin can
slow this damage and prevent kidney failure in patients with signs of chronic rejection.
Status | Completed |
Enrollment | 0 |
Est. completion date | March 2004 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria You may be eligible for this study if you: - Are at least 18 years old. - Received a kidney transplant at least 1 year prior to study entry. - Have been diagnosed with chronic rejection following kidney transplant and within 6 months prior to study entry. - Have been receiving a stable immunosuppressive medication regimen for 1 month prior to study entry that includes at least cyclosporine or tacrolimus and prednisone. - Have high blood pressure. - Agree to use an effective method of birth control during the study. Exclusion Criteria You will not be eligible for this study if you: - Are participating in another study with required tests or treatments. - Cannot take ACE inhibitors or HMG-CoA reductase inhibitors. - Absolutely must take ACE inhibitors or HMG-CoA reductase inhibitors. - Have a serious disease or medical condition. - Are pregnant. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, 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 | death, or renal failure manifested by initiation of dialysis or retransplantation. | Randomization to End of Study | Yes |
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