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A Trial of HRS-8427 in the Treatment of Adults With Complicated Urinary Tract Infection, Including Acute Pyelonephritis

StatusCompleted
PhasePhase 3
Started2024-09-25
View on ClinicalTrials.gov ↗

Amendment history

2026-10-01
notable
Trial completed
Primary completion confirmed: September 2026 (last estimated November 2026)
2026-09-24
critical
Enrollment closed, study ongoing
Primary completion pushed: 2025-11 → 2026-11
Completion pushed: 2025-11 → 2026-11
2025-01-21
minor
Study Status, Eligibility v2
Eligibility criteria+24 characters
[...] of renal function with estimated glomerular filtration rate or Creatinine Clearance <15 mL/min ; Laboratory abnormalities in baseline specimens [...]
2024-10-09
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-09→confirmed 2024-09-25
Study sitesdetails revised at 1 of 1 site
2024-08-22
minor
Original filing
The purpose of this study is to evaluate the efficacy and safety of HRS-8427 in patients with complicated urinary tract infection, including acute pyelonephritis.
Trial Details
NCT Number NCT06569056
Lead Sponsor Jiangsu HengRui Medicine Co., Ltd.
Conditions Complicated Urinary Tract Infection(cUTI), Including Acute Pyelonephritis(AP)
Enrollment 579 participants
Start Date 2024-09-25
Primary Completion 2026-09-01 (estimated)
Study Completion 2026-09-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-30