Renal Insufficiency ChronicPhase 1NCT07262333
A Trial of Hydroxynidone Capsules in Single-dose Administration for Patients With Renal Insufficiency
A Phase 1 study testing Hydronidone capsules in people with Renal Insufficiency Chronic, run by Beijing Continent Pharmaceutical Co, Ltd. at 1 site in China.
Trial summary
Hydronidone capsules are pyridinone-based small molecule compounds. Hydronidone has not been approved for commercial sale both domestically and internationally. The applicant has completed the preliminary Phase I and Phase II clinical trials. 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 Chronic
- What is being tested?
- Hydronidone capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2025to 1 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- The subjects must meet all of the following criteria to be eligible for inclusion:
- (1) Healthy Chinese subjects, with an estimated glomerular filtration rate (absolute eGFR) meeting the following conditions: ≥ 90 mL/min and < 130 mL/min; (limited to healthy subjects)
- (2) Patients diagnosed with renal dysfunction, with the estimated glomerular filtration rate (absolute eGFR) for mild, moderate, and severe renal dysfunction meeting the following standards respectively: 1. Mild renal dysfunction 60-89 mL/min; 2. Moderate renal dysfunction 30-59 mL/min; 3. Severe renal dysfunction 15-29 mL/min; (limited to patients with renal dysfunction)
- (3) Age 18-70 years old, inclusive of 18 years and 70 years old;
- (4) Weight: Male ≥ 50 kg, female ≥ 45 kg, 18 ≤ BMI ≤ 28 (BMI = weight (kg) / height2 (m2));
- (5) During the 24 hours before the start of the trial to the end of the trial, the subjects agree to quit smoking, alcohol, fruit juices, caffeine, and tea;
- (6) Before the trial, they have fully understood the nature, significance, possible benefits, possible inconveniences, and potential risks of the trial, and voluntarily participated in this clinical trial, can communicate well with the researchers, comply with all the requirements of the entire study, and have the ability to understand and sign the written informed consent form.
Who cannot join
- The following conditions must be met for a subject to be eligible for this trial:
- (1) If the subject has participated in any other clinical trial within the three months prior to the trial;
- (2) If the subject has any disease that may affect the safety of the trial or the body's process of the drug, excluding renal insufficiency, including but not limited to: previous or existing diseases of the heart, liver, digestive tract, immune system and respiratory system (especially any gastrointestinal diseases that affect drug absorption, such as irritable bowel syndrome symptoms, intestinal diseases or inflammatory bowel disease history, active pathological bleeding (such as peptic ulcers), urticaria, epilepsy, allergic rhinitis, eczematous dermatitis, asthma, etc.); (limited to patients with renal insufficiency);
- (3) If the subject has any disease that may affect the safety of the trial or the body's process of the drug, including but not limited to: previous or existing diseases of the heart, liver, kidney, endocrine, digestive tract, immune system and respiratory system (especially cardiovascular diseases including those with cardiovascular disease risk, any gastrointestinal diseases that affect drug absorption (such as irritable bowel syndrome symptoms, intestinal diseases or inflammatory bowel disease history), active pathological bleeding (such as peptic ulcers), urticaria, epilepsy, allergic rhinitis, eczematous dermatitis, asthma, etc.); (limited to healthy subjects);
- (4) If the subject has an allergic constitution: if there is a history of allergy to two or more drugs (including the trial drug), food, or lactose intolerance;
- (5) If the subject has used any drugs that inhibit or induce the liver's metabolism of the drug within 28 days before taking the study drug (common liver enzyme inducers: barbiturates, carbamazepine, amiloride, griseofulvin, amitriptyline, phenytoin, grumet, rifampicin, dexamethasone; common liver enzyme inhibitors: chlorpromazine, cimetidine, ciprofloxacin, metronidazole, chloramphenicol, isoniazid, sulfonamide drugs);
Show all 25Show fewer
- (6) If the subject has used drugs that inhibit or induce SULT and UGT enzymes within 7 days before taking the study drug and cannot stop the use;
- (7) If the subject cannot tolerate venipuncture and/or has a history of fainting or needle shock;
- (8) If the subject has long-term excessive consumption of tea, coffee or caffeinated beverages (more than 8 cups per day, 1 cup = 250 mL) in the past; or if within 24 hours before the first administration of the study drug, the subject consumed any food or beverage that inhibits or induces liver metabolic enzymes (such as grapefruit, mango, dragon fruit, grape juice, orange juice, etc., which contain rich flavonoids or citrus glycosides compounds); or if within 24 hours before the first administration of the study drug, the subject took any product containing alcohol;
- (9) If the subject has consumed blood or had a large amount of bleeding (more than 450 mL) within 3 months before the first administration of the study drug, or plans to donate blood or blood components during or after the study;
- (10) If the subject has donated blood or had a large amount of bleeding (more than 450 mL) within 3 months before the first administration of the study drug, or plans to donate blood or blood components during or after the study;
- (11) If the subject has acute diseases during the screening stage of the study or before taking the study drug;
- (12) If the subject has consumed foods or beverages that inhibit or induce liver metabolic enzymes within 24 hours before the first administration of the study drug (such as grapefruit, mango, dragon fruit, grape juice, orange juice, etc., which contain rich flavonoids or citrus glycosides compounds);
- (13) If the subject is pregnant or breastfeeding, and the subject (or their partner) has a pregnancy plan during and after the study, and does not agree to use non-drug measures for contraception during the study period;
- (14) (Medical Inquiry) Those who underwent surgery within three months prior to the screening period, or those planning to undergo surgery during the study period, and those who have undergone surgeries that may affect drug absorption, distribution, metabolism, and excretion;
- (15) Those with a history of drug use or drug abuse;
- (16) Those who smoked more than 5 cigarettes per day within 14 days prior to the screening, or those who cannot stop using any tobacco products during the trial;
- (17) Those who smoked or used any tobacco products during the screening to admission period;
- (18) During the screening period, abnormalities in physical examination, electrocardiogram, and laboratory tests (including routine blood and urine tests, coagulation function, and pregnancy test for women of childbearing potential only) that are judged by the investigator as clinically significant (excluding those caused by renal insufficiency). For liver function tests: ALT > 3×ULN or AST > 3×ULN or T-BIL > 2×ULN or D-BIL > 2×ULN; for lipid tests: TG ≥ 5.6 mmol/L; for serum electrolyte tests (K+, Na+, Cl-, Ca2+): abnormalities indicating hyperkalemia or a tendency toward acidosis (limited to patients with renal insufficiency).
- (19) Those whose physical examination, vital sign measurement, electrocardiogram examination, laboratory tests [blood routine, urine routine, blood biochemistry, coagulation function, blood pregnancy (only for women of childbearing age)] as determined by the researchers show abnormal results with clinical significance; (for healthy subjects)
- (20) Those with positive nicotine test results;
- (21) Those with alcohol breath test results greater than 0.0 mg/100 ml;
- (22) Those with positive urine drug screening results;
- (23) Those with positive hepatitis B surface antigen, or hepatitis C antibody, or syphilis spirochete antibody, or HIV antibody test results positive;
- (24) Those who, as determined by the researchers, have any situation that may affect the subject's provision of informed consent or compliance with the trial protocol, or who participating in the trial may affect the trial results or their own safety.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Hubei, Wuhan
shaojun Shi, sjshicn@163.com
About this study
Official title: Safety and Pharmacokinetics of Single-dose Hydroxynidone Capsules in Patients With Renal Insufficiency
Hydronidone capsules are pyridinone-based small molecule compounds. Hydronidone has not been approved for commercial sale both domestically and internationally. The applicant has completed the preliminary Phase I and Phase II clinical trials. The results showed that Hydronidone is a safe and effective drug for treating liver fibrosis in chronic hepatitis B, and it has good safety and tolerability.
Based on the preliminary clinical research, a special population study has been initiated. The aim is to investigate the pharmacokinetic differences and safety of honginone capsules in patients with renal insufficiency and healthy subjects, in order to provide a basis for the clinical medication of patients with renal dysfunction.
- Conditions
- Renal Insufficiency Chronic
- Being tested
- Hydronidone capsules
- Keywords
- Hydroxynidone
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydronidone capsulesDrug
Take 90mg orally on an empty stomach on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Control group (healthy individuals) | Experimental | On the morning of Day 1, take 90mg of hydronidone capsules on an empty stomach. Receives: Drug: Hydronidone capsules |
| The group of patients with mild renal insufficiency(eGFR 60~89 mL/min) | Experimental | On the morning of Day 1, take 90mg of hydronidone capsules on an empty stomach. Receives: Drug: Hydronidone capsules |
| The group of patients with moderate renal insufficiency(eGFR 30~59 mL/min) | Experimental | On the morning of Day 1, take 90mg of hydronidone capsules on an empty stomach. Receives: Drug: Hydronidone capsules |
| The group of patients with severe renal insufficiency(eGFR 15~29 mL/min) | Experimental | On the morning of Day 1, take 90mg of hydronidone capsules on an empty stomach. Receives: Drug: Hydronidone capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
The plasma drug concentrations of hydronidone and its metabolites M3 and M4(AUC0-∞)
Measured: 48 hours after administration
The free plasma concentration of hydronidone
Measured: 48 hours after administration
The urine drug concentrations of hydronidone and its metabolites M3 and M4
Measured: 48 hours after administration
The plasma drug concentrations of hydronidone and its metabolites M3 and M4(AUC%Extrap)
Measured: 48 hours after administration
The plasma drug concentrations of hydronidone and its metabolites M3 and M4( AUC0-t)
Measured: 48 hours after administration
The plasma drug concentrations of hydronidone and its metabolites M3 and M4(CL/F)
Measured: 48 hours after administration
The plasma drug concentrations of hydronidone and its metabolites M3 and M4(Vd/F)
Measured: 48 hours after administration
The plasma drug concentrations of hydronidone and its metabolites M3 and M4(Cmax)
Measured: 48 hours after administration
The plasma drug concentrations of hydronidone and its metabolites M3 and M4(T1/2)
Measured: 48 hours after administration
The plasma drug concentrations of hydronidone and its metabolites M3 and M4(λz)
Measured: 48 hours after administration
The plasma drug concentrations of hydronidone and its metabolites M3 and M4(Tmax)
Measured: 48 hours after administration
Secondary outcomes (7)
Safety indicator: Any adverse event
Adverse Event (AE) is defined as any untoward medical occurrence during drug clinical trials, drug therapy, or medical procedures, regardless of its causal relationship to the drug used.
Measured: 72 hours after administration
Safety indicator: B-ultrasound examination(liver)
Measured: 72 hours after administration
Safety indicator: B-ultrasound examination(gallbladder)
Measured: 72 hours after administration
Safety indicator: B-ultrasound examination(pancreas)
Measured: 72 hours after administration
Safety indicator: B-ultrasound examination(spleen)
Measured: 72 hours after administration
Safety indicator: B-ultrasound examination(kidneys)
Measured: 72 hours after administration
Safety indicators:12-lead electrocardiogram examination.
The 12-lead electrocardiogram records the electrical activity of the heart through 12 different lead positions, and is the most commonly used and fundamental non-invasive examination method for diagnosing heart diseases.A 12-lead ECG examines P waves, PR intervals, QRS complexes, ST segments, T waves, QT intervals, and other ECG waves and intervals.
Measured: 72 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start25 Dec 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency ChronicStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Continent Pharmaceutical Co, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- shaojun Shi, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07262333
- Sponsor's protocol ID
- KDN-F351-202503
- Status last verified
- Aug 2026
- First submitted
- 17 Nov 2025
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Pharmacokinetics of Single-dose Hydroxynidone Capsules in Patients With Renal Insufficiency
- ClinicalTrials.gov ID
- NCT07262333
- Acronym / sponsor ID
- KDN-F351-202503
- Conditions
- Renal Insufficiency Chronic
- Keywords
- Hydroxynidone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Beijing Continent Pharmaceutical Co, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Study start
- 25 Dec 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 3 Dec 2025 (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.
Hydronidone capsules are pyridinone-based small molecule compounds. Hydronidone has not been approved for commercial sale both domestically and internationally. The applicant has completed the preliminary Phase I and Phase II clinical trials. The results showed that Hydronidone is a safe and effective drug for treating liver fibrosis in chronic hepatitis B, and it has good safety and tolerability.
Based on the preliminary clinical research, a special population study has been initiated. The aim is to investigate the pharmacokinetic differences and safety of honginone capsules in patients with renal insufficiency and healthy subjects, in order to provide a basis for the clinical medication of patients with renal dysfunction.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group (healthy individuals) | Experimental | Drug: Hydronidone capsulesOn the morning of Day 1, take 90mg of hydronidone capsules on an empty stomach. |
| The group of patients with mild renal insufficiency(eGFR 60~89 mL/min) | Experimental | Drug: Hydronidone capsulesOn the morning of Day 1, take 90mg of hydronidone capsules on an empty stomach. |
| The group of patients with moderate renal insufficiency(eGFR 30~59 mL/min) | Experimental | Drug: Hydronidone capsulesOn the morning of Day 1, take 90mg of hydronidone capsules on an empty stomach. |
| The group of patients with severe renal insufficiency(eGFR 15~29 mL/min) | Experimental | Drug: Hydronidone capsulesOn the morning of Day 1, take 90mg of hydronidone capsules on an empty stomach. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The subjects must meet all of the following criteria to be eligible for inclusion:
- (1) Healthy Chinese subjects, with an estimated glomerular filtration rate (absolute eGFR) meeting the following conditions: ≥ 90 mL/min and < 130 mL/min; (limited to healthy subjects)
- (2) Patients diagnosed with renal dysfunction, with the estimated glomerular filtration rate (absolute eGFR) for mild, moderate, and severe renal dysfunction meeting the following standards respectively: 1. Mild renal dysfunction 60-89 mL/min; 2. Moderate renal dysfunction 30-59 mL/min; 3. Severe renal dysfunction 15-29 mL/min; (limited to patients with renal dysfunction)
- (3) Age 18-70 years old, inclusive of 18 years and 70 years old;
- (4) Weight: Male ≥ 50 kg, female ≥ 45 kg, 18 ≤ BMI ≤ 28 (BMI = weight (kg) / height2 (m2));
Key exclusion criteria (25 listed)
- The following conditions must be met for a subject to be eligible for this trial:
- (1) If the subject has participated in any other clinical trial within the three months prior to the trial;
- (2) If the subject has any disease that may affect the safety of the trial or the body's process of the drug, excluding renal insufficiency, including but not limited to: previous or existing diseases of the heart, liver, digestive tract, immune system and respiratory system (especially any gastrointestinal diseases that affect drug absorption, such as irritable bowel syndrome symptoms, intestinal diseases or inflammatory bowel disease history, active pathological bleeding (such as peptic ulcers), urticaria, epilepsy, allergic rhinitis, eczematous dermatitis, asthma, etc.); (limited to patients with renal insufficiency);
- (3) If the subject has any disease that may affect the safety of the trial or the body's process of the drug, including but not limited to: previous or existing diseases of the heart, liver, kidney, endocrine, digestive tract, immune system and respiratory system (especially cardiovascular diseases including those with cardiovascular disease risk, any gastrointestinal diseases that affect drug absorption (such as irritable bowel syndrome symptoms, intestinal diseases or inflammatory bowel disease history), active pathological bleeding (such as peptic ulcers), urticaria, epilepsy, allergic rhinitis, eczematous dermatitis, asthma, etc.); (limited to healthy subjects);
- (4) If the subject has an allergic constitution: if there is a history of allergy to two or more drugs (including the trial drug), food, or lactose intolerance;
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 |
|---|---|---|
| Hydronidone capsulesTake 90mg orally on an empty stomach on Day 1. | Drug | Control group (healthy individuals), The group of patients with mild renal insufficiency(eGFR 60~89 mL/min), The group of patients with moderate renal insufficiency(eGFR 30~59 mL/min), The group of patients with severe renal insufficiency(eGFR 15~29 mL/min) |
Primary outcome
The plasma drug concentrations of hydronidone and its metabolites M3 and M4(AUC0-∞)
Time frame: 48 hours after administration
The free plasma concentration of hydronidone
Time frame: 48 hours after administration
The urine drug concentrations of hydronidone and its metabolites M3 and M4
Time frame: 48 hours after administration
The plasma drug concentrations of hydronidone and its metabolites M3 and M4(AUC%Extrap)
Time frame: 48 hours after administration
The plasma drug concentrations of hydronidone and its metabolites M3 and M4( AUC0-t)
Time frame: 48 hours after administration
The plasma drug concentrations of hydronidone and its metabolites M3 and M4(CL/F)
Time frame: 48 hours after administration
The plasma drug concentrations of hydronidone and its metabolites M3 and M4(Vd/F)
Time frame: 48 hours after administration
The plasma drug concentrations of hydronidone and its metabolites M3 and M4(Cmax)
Time frame: 48 hours after administration
The plasma drug concentrations of hydronidone and its metabolites M3 and M4(T1/2)
Time frame: 48 hours after administration
The plasma drug concentrations of hydronidone and its metabolites M3 and M4(λz)
Time frame: 48 hours after administration
The plasma drug concentrations of hydronidone and its metabolites M3 and M4(Tmax)
Time frame: 48 hours after administration
7 secondary outcomes
Safety indicator: Any adverse event
Time frame: 72 hours after administration
Safety indicator: B-ultrasound examination(liver)
Time frame: 72 hours after administration
Safety indicator: B-ultrasound examination(gallbladder)
Time frame: 72 hours after administration
Safety indicator: B-ultrasound examination(pancreas)
Time frame: 72 hours after administration
Safety indicator: B-ultrasound examination(spleen)
Time frame: 72 hours after administration
Safety indicator: B-ultrasound examination(kidneys)
Time frame: 72 hours after administration
Safety indicators:12-lead electrocardiogram examination.
Time frame: 72 hours after administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
Related trials for Renal Insufficiency Chronic
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
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.
shaojun Shi 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 Hydronidone capsules in people with Renal Insufficiency Chronic, 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 7 inclusion and 25 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: looking for participants now, as of the sponsor's last update on 13 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ling Zhang (+86-13501209210, zhangling@bjcontinent.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The plasma drug concentrations of hydronidone and its metabolites M3 and M4(AUC0-∞) (time frame: 48 hours after administration). The study lists 11 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 13 Aug 2026.