Enteric HyperoxaluriaPhase 2NCT07871669

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

A Phase 2 study testing TRA16 in people with Enteric Hyperoxaluria, run by Wuhan Kangfude Urolithiasis Research Institute Co., Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

Search all trials

Trial 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). Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Enteric Hyperoxaluria
What is being tested?: TRA16
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: No sites listed yet
Study dates: 1 Mar 2027to 2 Apr 2028
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

Participants who have previously been diagnosed with primary hyperoxaluria or have demonstrated AGXT, GRHPR, or HOGA1 gene mutations.
Participants with acute kidney injury (AKI) or estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2
Any other condition that, in the investigator's judgment, would make the participant unsuitable for participation in the study.

About this study

Official title: 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).

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).

Conditions: Enteric Hyperoxaluria
Being tested: TRA16, Placebo
Keywords: Urinary Oxalate, Kidney Stones, Crohn Disease, Ulcerative Colitis, Short Bowel Syndrome
Medical subject headings: Kidney Calculi, Crohn Disease, Colitis, Ulcerative, Short Bowel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TRA16Drug
TRA16 powder
PlaceboDrug
Matching placebo

Study groups in NCT07871669
Study group	Role	What they receive
TRA16 group	Experimental	Participants in this arm will receive TRA16 powder, 10000 U, orally, three times daily with meals, for 7 days. Receives: Drug: TRA16
Placebo group	Placebo comparator	Participants in this arm will receive a matching placebo (containing no active ingredient) orally, three times daily with meals, for 7 days. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change from Baseline in 24-hour Urinary Oxalate Excretion
Measurements are based on the results of 24-hour urine collection on days 6 and 7. Calculated as the percent change from baseline in the 24-hour UOx excretion.
Measured: Days 6 and 7

Secondary outcomes (1)

Proportion of Participants with a ≥15% Reduction from Baseline in 24-Hour UOx
Percentage of participants achieving a ≥15% reduction in 24-hour UOx compared to baseline.
Measured: Days 6 and 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 20272 Apr 2028

First posted13 Oct 2026
Study start1 Mar 2027 (estimated)
Primary completion1 Mar 2028 (estimated)
Study completion2 Apr 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Enteric HyperoxaluriaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07871669
Sponsor's protocol ID: KFD-TRA16-US-001
Other IDs: IND 163669
Status last verified: Oct 2026
First submitted: 7 Oct 2026
Last updated: 13 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No