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NCT07871669Not yet recruitingPhase 2

Efficacy and Safety of TRA16 Administered Orally in Patients With Enteric Hyperoxaluria (EH).

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).

Source: ClinicalTrials.gov · Last updated 13 Oct 2026

Brief summary (registry, in English)

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).

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
30 (estimated)
First submitted
7 Oct 2026
Start date
Mar 2027
Primary completion date
Mar 2028
Lead sponsor
Wuhan Kangfude Urolithiasis Research Institute Co., Ltd.
NCT number
NCT07871669

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 30
  • From Mar 2027 to the primary completion date, Mar 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants who have previously been diagnosed with primary hyperoxaluria or have demonstrated AGXT, GRHPR, or HOGA1 gene mutations.

Other illness

  • Any other condition that, in the investigator's judgment, would make the participant unsuitable for participation in the study.

Lab values

  • Participants with acute kidney injury (AKI) or estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m2

Who the study is looking for

  • Adult male and female participants with 18 to 75 years of age (inclusive).
  • Participants must have a valid 24-hour urine collection at Screening with UOx ≥50 mg/24 h.
  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.