Recruiting
Phase 2

Pirfenidone

Sponsor:

Veterans Medical Research Foundation

Code:

NCT04258397

Conditions

Chronic Kidney Disease

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Pirfenidone

matching placebo

Study Details

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.

Conditions

Chronic Kidney Disease

Study ID

NCT04258397

Start date

Oct 26, 2020

Status verified date

Apr, 2022

Completion date

Dec, 2024

Anticipated

Primary completion date

May, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients with eGFR ≥20 ml/min/1.73m2 using the CKD-EPI Creatinine equation.
  • Four variable Kidney Failure Risk Equation (KFRE) 5 year risk score >1%
  • Age 21 years or older.

Exclusion Criteria:

To be determined at the screening visit or, for laboratory data, within 3 months of the screening visit if available from clinical care.

  • Participants with known autosomal dominant polycystic kidney disease.
  • Use or planned use of drugs that inhibit CYP1A2 which may increase pirfenidone exposure ( for example, artemisin, atazanavir, cimetidine, ciprofloxacin, enoxacin, ethinyl estradiol, fluvoxamine, mexiletine, tacrine, thiabendazole, or zileuton).
  • Liver disease: clinical cirrhosis by imaging or physician diagnosis; alcohol use > 14 drinks/week; or aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin concentrations > 2 times the upper limit of normal (ULN) based on thresholds set at each site's local clinical laboratory.
  • Clinical idiopathic pulmonary fibrosis (IPF) by imaging or physician diagnosis (pirfenidone is indicated for patients with IPF).
  • Electrocardiogram (ECG) with a QTc interval > 500 msec at screening (pirfenidone can prolong QTc).
  • Family or personal history of long QT Syndrome.
  • Known hypersensitivity to pirfenidone.
  • Current use of tobacco, including cigarettes, cigars, chewing tobacco, or vaping products. (Current use is defined as any use in the past 3 months).
  • Physical inability, claustrophobia or other contra-indication to obtaining MRI measurements.
  • Current participation in another clinical trial (observational studies are exempted).
  • Systemic immunosuppressive medications (<10 mg daily prednisone or inhaled steroids are exempted).
  • Malignancy within 2 years (non-melanoma skin and localized prostate carcinoma are exempted).
  • Institutionalized individuals (e.g. prisoners, long term care residents).
  • Pregnancy, planning to become pregnant, or currently breast-feeding; women under 55 will need to either have a reliable method of birth control (IUD {intrauterine device}, oral contraceptive pills {OCPs}) or have no menses in the preceding 2 years.
  • Life expectancy < 12 months as assessed by the site investigator.
  • Plans to leave the immediate area in < 12 months.
  • Anticipated need for dialysis or kidney transplantation within 12 months.
  • Hospitalization within the past 30 days (24-hour observation admissions are exempted).
  • Active alcohol or substance abuse within the last 12 months, as assessed by the site investigator.
  • Active treatment of uncontrolled psychiatric disease, as assessed by the site investigator.
  • Perceived inability to adhere to the medical regimen or comply with recommendations, as determined by the site investigator.
  • Inability or unwillingness to travel to study visits.
  • Any condition that, in the opinion of the site investigator, might be significantly exacerbated by the known side effects associated with the administration of pirfenidone.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Experimental, pirfenidone

Pirfenidone 267 mg capsules

Randomized participants will take 5 capsules (1335 mg pirfenidone): 2 pills in the morning, 1 mid-day, and 2 in the evening, with meals.

placebo comparator: Placebo, pirfenidone

Pirfenidone placebo capsules

Randomized participants will take 5 capsules (1335 mg pirfenidone): 2 pills in the morning, 1 mid-day, and 2 in the evening, with meals.

Interventions

Pirfenidone

Pirfenidone vs. matching placebo

matching placebo

matching placebo

Primary outcome measure

  • Change from baseline in kidney fibrosis, as assessed by diffusion-weighted magnetic resonance imaging (DW-MRI). [ Time Frame: Baseline to Month 12 ]
  • Change from baseline in kidney fibrosis, as assessed by urinary markers of tubulo-interstitial fibrosis. [ Time Frame: Baseline to Month 12 ]

Central Contacts and Locations

Central contacts

Joachim H Ix, MD,MAS

858-552-8585joeix@health.ucsd.edu

Erick O Castro, BS

858-552-8585erick.castro@va.gov

Locations

VA San Diego Healthcare System

Recruiting

San Diego, California, United States, 92161

Contacts

Erick O Castro, BS

858-642-1426

Principal Investigator:

Joachim H Ix, MD

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Lidia J Espino

415-502-5108

Juan Espinoza

415-502-1886

Principal Investigator:

Michael Shlipak, MD

More Information

Sponsor

Veterans Medical Research Foundation

Last update posted

Apr 27, 2022

Last verified

Apr, 2022

Keywords

  • Fibrosis
  • Scarring
  • CKD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Veterans Medical Research Foundation on 2022-04-27.