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:
Healthy adult section:
- Japanese adult men
- People aged 18 to 45 years at the time of signing consent
- People with a body mass index (a measure of body weight relative to height) between 18.5 and under 25.0 at the screening visit
Chronic kidney disease patient section:
- People who have both chronic kidney disease and type 2 diabetes
- People aged 18 to under 65 years at the time of signing consent
- People whose urine protein levels, measured over a 24-hour urine collection, fall between 300 mg/g and under 3500 mg/g (confirm with trial site)
Who may not be able to join:
Healthy adult section:
- People who are currently being treated for, or have previously had, conditions affecting the lungs, heart, mental health, nervous system, digestive system, immune system, liver, kidneys, blood production, or hormonal systems
- People with a current or past history of a severe allergic reaction to any medicine or food
- People with a current or past history of dependence on alcohol or drugs
Chronic kidney disease patient section:
- People who currently have severe, worsening, or hard-to-control disease affecting the liver, blood, digestive system, lungs, mental health, heart, hormonal system, nerves, or brain
- People who have type 1 diabetes
- People who have previously undergone dialysis treatment
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: Project Leader, Ono Pharmaceutical Co., Ltd.
Phone: +18665877745
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
Adverse event; Maximum plasma observed concentration (Cmax); Time to reach maximum observed concentration (Tmax); Area under the plasma concentration versus time curve from time zero to 24 hours (AUC24h); Area under the plasma concentration versus time curve from time zero to infinity (AUCinf); Area under the plasma concentration versus time curve from time zero to time of last measurable concentration (AUClast); Elimination half-life (T1/2); Apparent total clearance (CL/F); Urinary excretion rate of unchanged drug; Pharmacodynamics (evaluation of Urinary albumin-to-creatinine ratio)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 13 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.