Phase 1 Chronic Kidney Disease Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People of Chinese background who are either healthy with normal kidney function, or who have been diagnosed with mild, moderate, or severe kidney impairment, based on a specific kidney function measurement (eGFR) taken by a doctor.
- People aged 18 to 70 years old (inclusive).
- People whose weight and body mass index (a measure based on height and weight) fall within the required range — men must weigh at least 50 kg and women at least 45 kg, and BMI must be between 18 and 28.
- People who agree to avoid smoking, alcohol, fruit juice, caffeine, and tea for 24 hours before the trial begins and throughout the trial.
- People who have fully understood the trial details, agreed to take part voluntarily, are able to communicate with the research team, and are willing and able to sign a written consent form.
Who may not be able to join:
- People who have taken part in another clinical trial within the past 3 months.
- People (healthy participants) with existing or past conditions affecting the heart, liver, kidneys, hormones, digestive system, immune system, or breathing — including conditions that affect how the body absorbs medicines, such as irritable bowel syndrome, inflammatory bowel disease, active bleeding (e.g. stomach ulcers), hives, epilepsy, allergic rhinitis, eczema, or asthma.
- People (with kidney impairment) who have existing or past conditions — other than kidney disease — affecting the heart, liver, digestive system, immune system, or breathing, including the conditions listed above (confirm with trial site).
- People who have a history of allergic reactions to two or more medicines (including the trial drug), foods, or who are intolerant to lactose.
- People who have taken medicines that affect how the liver breaks down drugs within the past 28 days — this includes certain seizure medicines, antibiotics, and antifungal treatments among others (confirm with trial site for the full list).
- People who have taken medicines that affect specific liver enzymes (SULT and UGT) within the past 7 days and are unable to stop taking them (confirm with trial site).
- People who cannot tolerate blood draws via needle, or who have a history of fainting at the sight of needles.
- People who regularly consume more than 8 cups of tea, coffee, or caffeinated drinks per day, or who have consumed certain fruits or juices (such as grapefruit, mango, dragon fruit, grape juice, or orange juice) or any alcohol within 24 hours before the first dose.
- People who have donated blood or lost more than 450 mL of blood in the 3 months before the trial starts, or who plan to donate blood during or after the study.
- People who have an acute (sudden-onset) illness at the time of screening or before taking the study medication.
- People who are pregnant or breastfeeding, or whose partner is planning a pregnancy during or after the trial, and who are unwilling to use non-medication forms of contraception during the study.
- People who have had surgery in the 3 months before screening, who plan to have surgery during the trial, or who have had surgery that may affect how the body processes medicines.
- People with a history of drug use or substance abuse.
- People who smoked more than 5 cigarettes per day in the 14 days before screening, or who are unable to stop using tobacco products for the duration of the trial.
- People who smoked or used any tobacco products between the screening visit and the admission date.
- People whose physical examination, heart tracing (ECG), or blood and urine test results show significant abnormalities as judged by the trial doctor — including certain liver function, blood fat, or electrolyte abnormalities outside accepted ranges.
- People who test positive for nicotine.
- People whose breath alcohol test shows any detectable alcohol.
- People who test positive for drugs in a urine screen.
- People who test positive for hepatitis B, hepatitis C, syphilis, or HIV.
- People who, in the trial doctor's judgement, have any circumstance that could affect their ability to consent, follow the trial requirements, or that could affect their safety or the trial's results.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: shaojun Shi, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Phone: +86-13501209210
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
The plasma drug concentrations of hydronidone and its metabolites M3 and M4(AUC0-∞); The free plasma concentration of hydronidone; The urine drug concentrations of hydronidone and its metabolites M3 and M4; The plasma drug concentrations of hydronidone and its metabolites M3 and M4(AUC%Extrap); The plasma drug concentrations of hydronidone and its metabolites M3 and M4( AUC0-t); The plasma drug concentrations of hydronidone and its metabolites M3 and M4(CL/F); The plasma drug concentrations of hydronidone and its metabolites M3 and M4(Vd/F); The plasma drug concentrations of hydronidone and it...
Can't join this trial?
Data last synced from ClinicalTrials.gov: 6 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.