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

  • STATUS
    Recruiting
  • End date
    Dec 16, 2024
  • participants needed
    200
  • sponsor
    Veterans Medical Research Foundation
Updated on 16 May 2022
cardiovascular disease
heart failure
renal failure
nephropathy

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.

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.

Details
Condition Chronic Kidney Disease
Treatment Pirfenidone, Matching Placebo
Clinical Study IdentifierNCT04258397
SponsorVeterans Medical Research Foundation
Last Modified on16 May 2022

Eligibility

Yes No Not Sure

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
Family or personal history of long QT Syndrome
total bilirubin concentrations > 2 times the upper limit of normal (ULN) based on
Known hypersensitivity to pirfenidone
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)
Current participation in another clinical trial (observational studies are exempted)
Electrocardiogram (ECG) with a QTc interval > 500 msec at screening (pirfenidone can
prolong QTc)
Institutionalized individuals (e.g. prisoners, long term care residents)
Life expectancy < 12 months as assessed by the site investigator
Current use of tobacco, including cigarettes, cigars, chewing tobacco, or vaping
Plans to leave the immediate area in < 12 months
products. (Current use is defined as any use in the past 3 months)
Anticipated need for dialysis or kidney transplantation within 12 months
Physical inability, claustrophobia or other contra-indication to obtaining MRI
Hospitalization within the past 30 days (24-hour observation admissions are exempted)
measurements
Systemic immunosuppressive medications (<10 mg daily prednisone or inhaled steroids
are exempted)
Inability or unwillingness to travel to study visits
Malignancy within 2 years (non-melanoma skin and localized prostate carcinoma are
exempted)
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
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
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
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