Trial · NCT03847090
Establishing the Safety and Efficacy of Reloxaliase in Patients With Enteric Hyperoxaluria
NCT03847090, Phase 3, Terminated, Allena Pharmaceuticals
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Establishing the Safety and Efficacy of Reloxaliase in Patients With Enteric Hyperoxaluria. Trials, record NCT03847090. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03847090
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Establishing the Safety and Efficacy of Reloxaliase in Patients With Enteric Hyperoxaluria
- NCT number
- NCT03847090
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 92 participants, actual
- Lead sponsor
- Allena Pharmaceuticals
- Conditions
- Enteric Hyperoxaluria
- Interventions
- Reloxaliase, Placebo
- First posted
- 2019-02-20
- Last updated
- 2022-06-10
- Other registries' IDs
- eudract:2018-000921-29
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent change from baseline in 24-hour urinary oxalate excretion during Weeks 1 to 4 | 4 weeks | Efficacy will be assessed based on percent change from baseline to the average across Weeks 1 to 4, derived from all 24-hour collections during Weeks 1 to 4 on treatment |
| Primary | Proportion of subjects with kidney stone disease progression (composite of symptomatic kidney stone(s) or finding of new or enlarged kidney stone(s) on imaging) | up to 48 months | Efficacy will be assessed by comparing kidney stone disease progression event rate on reloxaliase vs. placebo |
| Secondary | Percent change from baseline in 24-hour urinary oxalate excretion during Weeks 16-24 | 24 weeks | Efficacy will be assessed based on percent change from baseline to the average across Weeks 16-24, derived from all 24-hour collections during Weeks 16-24 on treatment |
| Secondary | Proportion of subjects with a ≥ 20% reduction from baseline in 24-hour urinary oxalate excretion during Weeks 1-4 | 4 weeks | Efficacy will be assessed based on proportion of subjects with ≥ 20% reduction from baseline to the average across Weeks 1-4, derived from all 24-hour collections during Weeks 1-4 on treatment |
| Secondary | Hospitalizations or emergency room (ER) visits or procedures for the management of kidney stones | up to 48 months | Efficacy will be assessed by comparing utilization on reloxaliase vs. placebo |
| Secondary | Change in estimated glomerular filtration rate (eGFR) from baseline | up to 48 months | Efficacy will be assessed by comparing the rate of change in eGFR on reloxaliase vs. placebo |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03847090
GET https://conductscience.org/api/trials/v1/NCT03847090/registered