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

This is an interventional other trial for Chronic Kidney Disease focused on measuring Fibrosis, Scarring, CKD Read More

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.