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Not yet recruitingNCT07871669Updated Oct 13, 2026

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

A Phase 2 interventional study of TRA16 and Placebo in Enteric Hyperoxaluria, sponsored by Wuhan Kangfude Urolithiasis Research Institute Co., Ltd.. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Wuhan Kangfude Urolithiasis Research Institute Co., Ltd. · Phase 2, Interventional, and Treatment

Updated Oct 13, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Enteric Hyperoxaluria

Keywords

  • Urinary Oxalate
  • Kidney Stones
  • Crohn Disease
  • Ulcerative Colitis
  • Short Bowel Syndrome
03

In context

Kidney Calculi

605 studies on the registry are indexed under Kidney Calculi; 164 are open to participants now.

This study's planned enrollment of 30 is below the median of 90 across 464 interventional studies indexed under Kidney Calculi.

Browse Kidney Calculi studies →

Lead sponsor

This is the only study on the registry with Wuhan Kangfude Urolithiasis Research Institute Co., Ltd. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    TRA16 group

    Participants in this arm will receive TRA16 powder, 10000 U, orally, three times daily with meals, for 7 days.

    Drug: TRA16

  • Placebo comparator
    Placebo group

    Participants in this arm will receive a matching placebo (containing no active ingredient) orally, three times daily with meals, for 7 days.

    Drug: Placebo

Interventions

  • DrugTRA16

    TRA16 powder

  • DrugPlacebo

    Matching placebo

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: Days 6 and 7

07

Study locations

No study locations are listed for this record.

08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Mar 2027; primary completion for Mar 2028, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 7, 2026
First posted
Oct 13, 2026
StartEst.
Mar 1, 2027
Primary completionEst.
Mar 1, 2028
CompletionEst.
Apr 2, 2028
Last update
Oct 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07871669
Lead sponsor
Wuhan Kangfude Urolithiasis Research Institute Co., Ltd.
Responsible party
Sponsor
First posted
Oct 13, 2026
Start date
Mar 1, 2027 (estimated)
Primary completion
Mar 1, 2028 (estimated)
Completion
Apr 2, 2028 (estimated)
Last update
Oct 13, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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