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NCT07871669
Efficacy and Safety of TRA16 Administered Orally in Patients With Enteric Hyperoxaluria (EH).
Conditions: Enteric Hyperoxaluria
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 30
Sponsor: Wuhan Kangfude Urolithiasis Research Institute Co., Ltd.
Summary
A Phase II, Multi-center, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of TRA16 Administered Orally in Patients with Enteric Hyperoxaluria (EH).
Eligibility Criteria
Inclusion Criteria:
1. Adult male and female participants with 18 to 75 years of age (inclusive).
2. Participants must have a valid 24-hour urine collection at Screening with UOx ≥50 mg/24 h.
3. Participants have the ability and willingness to sign a written informed consent form (ICF) prior to any study-specific procedures and adequately know about the study content, procedures, and possible adverse reactions.
Exclusion Criteria:
1. Participants who have previously been diagnosed with primary hyperoxaluria or have demonstrated AGXT, GRHPR, or HOGA1 gene mutations.
2. Participants with acute kidney injury (AKI) or estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m2
3. Any other condition that, in the investigator's judgment, would make the participant unsuitable for participation in the study.
Source: ClinicalTrials.gov (NCT07871669). StuddyBuddy aggregates publicly available trial information.