Trial of Pirfenidone to Prevent Progression in Chronic Kidney Disease
NCT04258397 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2022-04-27
Summary
Kidney disease is a global health problem, affecting more than 10% of the world's population and more than half of adults over 70 years of age in the United States. Persons with kidney disease are at higher risk for cardiovascular disease, heart failure, physical function decline, and mortality. Kidney scarring is a dominant factor in the development of kidney disease. Our group has evaluated several tests to determine the severity of scarring without requiring kidney biopsies, using MRI imaging scans and evaluating markers of scarring that we can measure in the urine. In this study we will use these measures to evaluate pirfenidone as a promising potential new treatment for patients with kidney disease.
Conditions
Interventions
- DRUG
-
Pirfenidone vs. matching placebo
- DRUG
-
matching placebo
matching placebo
Sponsors & Collaborators
-
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
collaborator NIH -
San Diego Veterans Healthcare System
collaborator FED -
University of California, San Diego
collaborator OTHER -
University of California, San Francisco
collaborator OTHER -
Genentech, Inc.
collaborator INDUSTRY -
Veterans Medical Research Foundation
lead OTHER
Principal Investigators
-
Joachim H Ix, MD,MAS · Veterans Medical Research Foundation at VASDHS
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-10-26
- Primary Completion
- 2024-05-31
- Completion
- 2024-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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