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A Trial of Hydroxynidone Capsules in Single-dose Administration for Patients With Renal Insufficiency

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Jul 1, 2026 → Dec 1, 2026
See other at-risk trials from Beijing Continent Pharmaceutical Co, Ltd.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Jul 1, 2026 to Dec 1, 2026v4
  2. Eligibility criteria expanded, about 2 wordsv3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Jun 1, 2026 to Jul 1, 2026
    • Start date changed from estimate of Dec 1, 2025 to Dec 25, 2025
    • Study site revised
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07262333
Lead Sponsor Beijing Continent Pharmaceutical Co, Ltd.
Collaborators: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions
(from sponsor)		 Renal Insufficiency Chronic
Related terms Renal Insufficiency, Chronic
Enrollment 56 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov