Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
2004-03-31
Brief Summary
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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.
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Detailed Description
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Prior to intervention, patients undergo a transplant renal biopsy to: 1) confirm the presence of chronic renal allograft nephropathy and 2) quantify baseline mRNA levels for TGF-beta, PDGF, and selected cytokines and connective tissue components. Patients are randomized to 4 arms: Group 1 receives pravastatin placebo plus irbesartan placebo; Group 2 receives pravastatin plus irbesartan placebo; Group 3 receives pravastatin placebo plus irbesartan; and Group 4 receives pravastatin plus irbesartan. Pravastatin is administered at a dose of 20 mg/day. Irbesartan is initiated at 150 mg/day and is titred to 300 mg/day after 2 weeks. Patients are evaluated routinely for serum creatinine and potassium levels, blood pressure, and other markers of kidney function. In addition, they are monitored for toxicities and adverse events, particularly an early rise in serum creatinine or muscle enzyme changes. At Month 6, or when serum creatinine has risen above 5.0 mg/dl if that is earlier, a repeat transplant kidney biopsy is obtained to compare to baseline. Changes in chronic allograft nephropathy and cytokine mRNA levels are evaluated to determine any correlation between clinical effect and changes in activity of profibrotic pathways. Study endpoints are death or renal failure manifested by initiation of dialysis or retransplantation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Irbesartan
Pravastatin
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Locations
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Ilene Blechman-Krom
Rockville, Maryland, United States
Countries
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Other Identifiers
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DAIT CR01
Identifier Type: -
Identifier Source: org_study_id
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