Efficacy and Safety of TRA16 Administered Orally in Patients With Enteric Hyperoxaluria (EH).
Phase 2 · Testing TRA16 · Sites not listed yet · Wuhan Kangfude Urolithiasis Research Institute Co., Ltd.
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing TRA16 (a drug) as a possible treatment. Condition(s) listed: Enteric Hyperoxaluria.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- 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.
There are also 3 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 30 participants are expected to take part.
- The study has 2 groups.
- Start date: 2027-03-01 (planned).
- Main results expected around 2028-03-01 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Groups in this study
- TRA16 group (listed as: experimental group)
- Placebo group (listed as: placebo group)
Main thing being measured
- Percent Change from Baseline in 24-hour Urinary Oxalate Excretion (Days 6 and 7)
In the researchers’ words
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).
Words you might see
- Placebo: a look-alike pill or injection with no active drug, used for comparison.
- Randomized: participants are put into groups by chance, like a coin flip.
- eGFR: a blood-test estimate of how well the kidneys filter.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Enteric Hyperoxaluria |
| Lead sponsor | Wuhan Kangfude Urolithiasis Research Institute Co., Ltd. |
| Enrollment | 30 (estimated) |
| Start date | 2027-03-01 |
| Primary completion (est.) | 2028-03-01 |
| First posted | 2026-10-13 |
| Last updated | 2026-10-13 |
| 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). |
| ClinicalTrials.gov ID | NCT07871669 |
Interventions
- TRA16 (Drug)
TRA16 powder - Placebo (Drug)
Matching placebo
Full eligibility criteria (from the record)
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.
Locations (0)
No sites listed yet. The official record has contact information.
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.