Pirfenidone Capsule in Patients With Chronic Kidney Disease G2 and G3a Study on Safety and Pharmacokinetics

NCT04126538 | Unknown Phase 1

• 1 other identifier: GNI-F647-1703
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and pharmacokinetic characteristics of pirfenidone capsules in chronic kidney disease G2 and G3a patients, and to provide a basis for the phase II clinical trial program

Conditions

Renal Insufficiency

Outcome Measures

Primary Outcomes (2)

• Plasma drug concentrations of pirfenidone

  up to 24 weeks

• Urine concentration of pirfenidone

  up to 24 weeks

Secondary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  up to 12 weeks

Study Arms (2)

Patient group

EXPERIMENTAL

Patients with chronic kidney disease take pirfenidone capsule 400mg once orally

Drug: pirfenidone capsule

Control group

EXPERIMENTAL

Healthy subjects take pirfenidone capsule 400mg once orally

Drug: pirfenidone capsule

Interventions

pirfenidone capsule DRUG

In the patient group, pirfenidone capsule was taken orally once for 400mg

Patient group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with chronic kidney disease, both male and female（Patient group）;
• years old, including 18 years old and 70 years old（Patient group）;
• weight: male ≥50kg, female ≥45kg, 18≤BMI≤26 (BMI= weight (kg)/height 2 (m2))（Patient group）;
• the stage of chronic kidney disease was G2 or G3a, indicating mild or moderate decrease in GFR, i.e., glomerular filtration rate was 45≤eGFR(ml/min/1.73m2) ≤89 (calculated according to ckd-epi formula)（Patient group）;
• from 24h before the start of the study to the end of the study, subjects who agree to abstain from tobacco, alcohol, fruit juice, caffeine and tea（Patient group）;
• I have had a detailed understanding of the nature, significance, possible benefits, possible inconvenience and potential risks of the trial before the study, and I have volunteered to participate in the clinical trial. I am able to communicate well with the investigator, comply with the requirements of the whole study, and have the ability to understand and sign the written informed consent.（Patient group）;
• gender: Chinese healthy subjects, male and female（Control group）;
• years old, including 18 years old and 70 years old（Control group）;
• weight: male ≥50kg, female ≥45kg, 18≤BMI≤26 (BMI= weight (kg)/height 2 (m2))（Control group）;
• from 24h before the start of the study to the end of the study, subjects who agree to abstain from tobacco, alcohol, fruit juice, caffeine and tea（Control group）;
• those who have detailed understanding of the nature, significance, potential benefits, possible inconveniences and potential risks of the trial before the study, who have volunteered to participate in the clinical trial, who can communicate well with the investigator, comply with the requirements of the whole study, and who are able to understand and sign a written informed consent（Control group）;

You may not qualify if:

• （Physician visits） have participated in any other clinical trials within the first three months of the trial（Patient group）;
• (preliminary) of any process may affect test security, or drug in the body of the disease, not including chronic kidney disease (CKD), including but not limited to: heart, liver, gastrointestinal tract, immune system and respiratory system always or the existing system diseases (especially for any impact on drug absorption of gastrointestinal diseases (such as irritable bowel syndrome symptoms, bowel disease or inflammatory bowel disease), active pathological bleeding (such as peptic ulcer), urticaria, eczema, dermatitis, epilepsy, allergic rhinitis, asthma, etc.)（Patient group）;
• (consultation) allergy: if there are two or more drugs, food allergy history (including experimental drugs), lactose intolerance（Patient group）;
• (consultation) any drugs that inhibit or induce drug metabolism in the liver (common liver enzyme inducers: barbiturates, carbamazepine, aminoximate, griseofulvin, aminopropyl, phenytoin, gromitol, rifampin, dexamethasone; Common liver enzyme inhibitors: chlorpromazine, cimetidine, ciprofloxacin, metronidazole, chloramphenicol, isoniazid, sulfonamide)（Patient group）;
• (consultation) failure to follow a uniform diet (such as intolerance to standard meals, etc.) or difficulty swallowing（Patient group）;
• (consultation) unable to tolerate venipuncture and/or having a history of blood or acupuncture（Patient group）;
• (consultation) patients who have been drinking excessive amounts of tea, coffee or caffeinated drinks (more than 8 cups a day, 1 cup =250mL) for a long time; Or taking any food or beverage containing caffeine (such as coffee, strong tea, chocolate, etc.) within 24 hours before the first administration of the drug（Patient group）;
• (consultation) previous binge drinking (i.e., male drinking more than 28 units per week and female drinking more than 21 units per week (1 unit contains 14g alcohol, such as 360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine); Or who had regularly consumed alcohol (more than 14 units per week) during the 6 months prior to the trial; Or who had taken any alcoholic product within 24 hours of initial administration（Patient group）;
• (consultation) those who had donated blood or suffered massive bleeding (greater than 450 mL) within 3 months before the first administration of the study, or who planned to donate blood or blood components during the study period or within 3 months after the end of the study（Patient group）;
• (consultation) acute disease during the screening phase before study or before study medication（Patient group）;
• (consultation) patients who had taken food or drinks containing enzymes that can induce or inhibit liver metabolism (e.g., grapefruit, mango, pitaya, grape juice, orange juice, etc., rich in flavonoids or citrus glycosides) within 24 hours before the first administration were studied（Patient group）;
• pregnant or lactating women, and subjects (or their partners) who have a pregnancy plan during the trial and within 3 months after the end of the study and who do not agree to use non-drug contraception during the trial（Patient group）;
• (consultation) those who have had surgery within three months before the screening period, or who are planning to have surgery during the study period, and those who have had surgery that will affect drug absorption, distribution, metabolism and excretion（Patient group）;
• (consultation) previous history of drug abuse or drug abuse（Patient group）;
• (consultation) persons who have smoked more than 5 cigarettes per day in the 14 days before screening, or who cannot stop using any tobacco products during the trial（Patient group）;

Sponsors & Collaborators

• Beijing Continent Pharmaceutical Co, Ltd.: lead

Study Sites (1)

Wuhan Union Hospital

Wuhan, Hubei, 430022, China

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency

Interventions

pirfenidone

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Shaojun Shaojun, Doctor

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shaojun Shi, Doctor

CONTACT

027-85726085; sjshicn@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 15, 2019
• Study Start: August 27, 2019
• Primary Completion: November 25, 2021
• Study Completion: June 30, 2022
• Last Updated: March 29, 2022

Record last verified: 2021-03

Locations

CN (1)