Trial of Pirfenidone to Prevent Progression in Chronic Kidney Disease (TOP-CKD)

Trial of Pirfenidone to Prevent Progression in Chronic Kidney Disease (TOP-CKD)

Brief 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.

Detailed Description:
The TOP-CKD clinical trial is a randomized, double-blind, placebo-controlled interventional study, phase 2 trial of pirfenidone vs. placebo in 200 persons with Chronic Kidney Disease (CKD) with an eGFR ≥ 20 ml/min/1.73 m² and a risk of progression to End Stage Renal Disease (ESRD) of at least 1% over five years. Participants receive treatment for 12 months, followed by a 6 month off-treatment follow-up period. Kidney scarring, also known as fibrosis, is a dominant factor in the development of kidney disease. This study will evaluate 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. We will use these measures to evaluate pirfenidone as a promising potential new treatment for patients with CKD.


Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: Trial of Pirfenidone to Prevent Progression in Chronic Kidney Disease (TOP-CKD)
Actual Study Start Date: October 26, 2020
Estimated Primary Completion Date: May 2024
Estimated Study Completion Date: December 2024

Arms:
- Active Comparator: Experimental, pirfenidone
- Placebo Comparator: Placebo, pirfenidone

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