Renal InsufficiencyPhase 1NCT04126538
Pirfenidone Capsule in Patients With Chronic Kidney Disease G2 and G3a Study on Safety and Pharmacokinetics
A Phase 1 study testing pirfenidone capsule in people with Renal Insufficiency, run by Beijing Continent Pharmaceutical Co, Ltd. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Insufficiency
- What is being tested?
- pirfenidone capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 27 Aug 2019to 30 Jun 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with chronic kidney disease, both male and female（Patient group）;
- 18-70 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）;
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- gender: Chinese healthy subjects, male and female（Control group）;
- 18-70 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）;
Who cannot join
- （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）;
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- (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）;
- screening for smoking or using any tobacco products up to admission（Patient group）;
- screening phase physical examination, vital signs measurement, electrocardiogram examination, laboratory examination (hematuria routine, blood coagulation function, blood pregnancy (women of childbearing age only)) and investigator determination of clinically significant abnormalities (excluding abnormalities caused by chronic kidney disease). Abnormal liver function examination (ALT, AST, ALP, gamma GT, TP, Alb, A/G, t-bil, d-bil) suggested liver disease or liver injury. Renal function test SCr > 400 mol/L; Abnormal blood electrolyte examination (K+, Na+, Cl-, Ca2+) suggested high potassium or acidosis.（Patient group）
- nicotine positive test（Patient group）;
- alcohol breath test with test results greater than 0.0mg/100ml（Patient group）;
- positive urine drug screening（Patient group）;
- hepatitis b surface antigen positive, or hepatitis c antibody positive, or syphilis spirochete antibody positive, or HIV antibody positive（Patient group）;
- the investigator considers that there are any circumstances that may affect the subject's informed consent or adherence to the study protocol, or participation in the study may affect the study results or their own safety.（Patient group）;
- （Physician visits）those who participated in any other clinical trials three months prior to the trial（Control group）;
- (preliminary) of any process may affect test security, or drug in the body of the disease, including but not limited to: heart, liver, kidney, endocrine, the digestive tract, immune system and respiratory system always or the existing system diseases (especially cardiovascular diseases including cardiovascular disease risk, 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.)（Control group）;
- (consultation) allergy: if there are two or more drugs, food allergy history (including experimental drugs), lactose intolerance（Control 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); Or have used any medicines (including Chinese herbal medicines) or health supplements within 14 days prior to initial administration（Control group）;
- (consultation) failure to follow a uniform diet (such as intolerance to standard meals, etc.) or difficulty swallowing（Control group）;
- (consultation) unable to tolerate venipuncture and/or having a history of blood or acupuncture（Control 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（Control 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（Control 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（Control group）;
- (consultation) acute disease during the screening phase before study or before study medication（Control 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（Control 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（Control 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（Control group）;
- (consultation) previous history of drug abuse or drug abuse（Control 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（Control group）;
- screening for smoking or using any tobacco products up to admission（Control group）;
- screening phase physical examination, vital signs measurement, electrocardiogram examination, b-mode ultrasound examination, laboratory examination [blood routine, urine routine, blood biochemistry, blood coagulation function, blood pregnancy (women of childbearing age only)], and the investigator judged that abnormalities were clinically significant（Control group）;
- those with positive nicotine test results（Control group）;
- alcohol breath test with test results greater than 0.0mg/100ml（Control group）;
- positive urine drug screening（Control group）;
- hepatitis b surface antigen positive, or hepatitis c antibody positive, or syphilis spirochete antibody positive, or HIV antibody positive（Control group）;
- the investigator considers that there are any circumstances that may affect the subject's informed consent or adherence to the study protocol, or participation in the study may affect the study results or their own safety.（Control group）.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wuhan Union Hospital
Wuhan, Hubei, 430022
Shaojun Shi, Doctor, 027-85726085, sjshicn@163.com
About this study
Official title: Pirfenidone Capsule in Patients With Chronic Kidney Disease G2 and G3a Study on Safety and Pharmacokinetics of Single Dose
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
- Being tested
- pirfenidone capsule
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pirfenidone capsuleDrug
In the patient group, pirfenidone capsule was taken orally once for 400mg
pirfenidone capsuleDrug
Healthy subjects took pirfenidone capsule 400mg once orally
| Study group | Role | What they receive |
|---|---|---|
| Patient group | Experimental | Patients with chronic kidney disease take pirfenidone capsule 400mg once orally Receives: Drug: pirfenidone capsule |
| Control group | Experimental | Healthy subjects take pirfenidone capsule 400mg once orally Receives: Drug: pirfenidone capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma drug concentrations of pirfenidone
Measured: up to 24 weeks
Urine concentration of pirfenidone
Measured: up to 24 weeks
Secondary outcomes (1)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start27 Aug 2019
- Primary completion25 Nov 2021
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Continent Pharmaceutical Co, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shaojun Shaojun, Doctor, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04126538
- Sponsor's protocol ID
- GNI-F647-1703
- Status last verified
- Mar 2021
- First submitted
- 10 Oct 2019
- Last updated
- 29 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pirfenidone Capsule in Patients With Chronic Kidney Disease G2 and G3a Study on Safety and Pharmacokinetics of Single Dose
- ClinicalTrials.gov ID
- NCT04126538
- Acronym / sponsor ID
- GNI-F647-1703
- Conditions
- Renal Insufficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Beijing Continent Pharmaceutical Co, Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Aug 2019 (actual)
- Primary completion
- 25 Nov 2021 (actual)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 15 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient group | Experimental | Drug: pirfenidone capsulePatients with chronic kidney disease take pirfenidone capsule 400mg once orally |
| Control group | Experimental | Drug: pirfenidone capsuleHealthy subjects take pirfenidone capsule 400mg once orally |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- patients with chronic kidney disease, both male and female（Patient group）;
- 18-70 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）;
Key exclusion criteria (44 listed)
- （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）;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pirfenidone capsuleIn the patient group, pirfenidone capsule was taken orally once for 400mg | Drug | Patient group |
| pirfenidone capsuleHealthy subjects took pirfenidone capsule 400mg once orally | Drug | Control group |
Primary outcome
Plasma drug concentrations of pirfenidone
Time frame: up to 24 weeks
Urine concentration of pirfenidone
Time frame: up to 24 weeks
1 secondary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: up to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaojun Shaojun, Doctor principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing pirfenidone capsule in people with Renal Insufficiency, run by Beijing Continent Pharmaceutical Co, Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 44 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shaojun Shi, Doctor (027-85726085, sjshicn@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma drug concentrations of pirfenidone (time frame: up to 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.