Trial · NCT05448755
A Study of ELX-02 in Patients With Alport Syndrome
NCT05448755, Phase 2, Completed, Eloxx Pharmaceuticals, Inc.; results first posted 2026-02-24
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Study of ELX-02 in Patients With Alport Syndrome. Trials, record NCT05448755. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05448755
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of ELX-02 in Patients With Alport Syndrome
- NCT number
- NCT05448755
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 3 participants, actual
- Lead sponsor
- Eloxx Pharmaceuticals, Inc.
- Conditions
- Alport Syndrome
- Interventions
- ELX-02
- First posted
- 2022-07-07
- Last updated
- 2026-02-24
- Results first posted
- 2026-02-24
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events Associated With Administration of 0.75 mg/kg of ELX-02 Once Daily | From the time of first dosing through the end of the follow-up period, a total of 5 months | Treatment Emerging Adverse Events were defined as any adverse events with onset after the first administration of study medication through the end of the study, or any event that was present at baseline but worsened in intensity or was subsequently considered drug-related by the Investigator through the end of the study. Severe Treatment Emerging Adverse Event is a Treatment Emerging Adverse Events with CTCAE Grade 3 or above. Related Treatment Emerging Adverse Events is defined as a Treatment Emerging Adverse Events with a certain, probable/likely, or possible relationship to the study drug. Serious Adverse Events were Adverse Events resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening. |
| Secondary | Change From Baseline in Proteinuria | From screening assessment to end of study treatment, total of 3 timepoints for results at Baseline, Week 4 and End of Treatment at Day 60. | Change from baseline to End Of Treatment. Measurement of urine protein/ creatinine ratio (UPCR) in urine samples |
| Secondary | Change From Baseline to End of Treatment in Collagen IV Expression (Combined Average of Alpha 3 and Alpha 4 Chains) | Baseline to End of Treatment (at Day 60) | Collagen IV expression was assessed by measuring the combined average of alpha 3 and alpha 4 chains, using Immunofluorescence method. Results are reported as percentage change from baseline to End of Treatment. Increase in Collagen IV expression indicate kidney structural improvement. |
| Secondary | Change From Baseline to End of Treatment in Collagen IV Expression (Foot Process Width in Renal Biopsy) | Baseline to End of Treatment (at Day 60) | Collagen IV expression was assessed by measuring podocyte foot process width in renal biopsy specimens, using Transmission Electron Microscopy (TEM) method. Results are reported as percentage change from baseline to End of Treatment. Decrease values indicate kidney structural and morphological improvement. |
| Secondary | Change From Baseline to End of Treatment in Collagen IV Expression (Filtration Slit Density in Renal Biopsy) | Baseline to End of Treatment (at Day 60) | Collagen IV expression was assessed by measuring filtration slit density in renal biopsy specimens, using 3D-Structured Illumination Microscopy method. Results are reported as change from baseline. Increase values indicate improvement and protein recovery. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events Associated With Administration of 0.75 mg/kg of ELX-02 Once Daily | From the time of first dosing through the end of the follow-up period, a total of 5 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change From Baseline in Proteinuria | From screening assessment to end of study treatment, total of 3 timepoints for results at Baseline, Week 4 and End of Treatment at Day 60. | Measurements in 3 enrolled patients. Individual data is repeated due to study sample size. | mg/g | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline to End of Treatment in Collagen IV Expression (Combined Average of Alpha 3 and Alpha 4 Chains) | Baseline to End of Treatment (at Day 60) | Analysis performed with immunofluorescence and light microscopy | percentage of change from baseline | NUMBER |
| SECONDARY | Change From Baseline to End of Treatment in Collagen IV Expression (Foot Process Width in Renal Biopsy) | Baseline to End of Treatment (at Day 60) | Analysis performed with transmission electron microscopy | percentage of change from baseline | NUMBER |
| SECONDARY | Change From Baseline to End of Treatment in Collagen IV Expression (Filtration Slit Density in Renal Biopsy) | Baseline to End of Treatment (at Day 60) | Analysis performed with transmission electron microscopy | Change from baseline in µm-1 | NUMBER |
Source ClinicalTrials.gov
Results by group19
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events Associated With Administration of 0.75 mg/kg of ELX-02 Once Daily | Study Treatment: ELX-02 0.75 mg/kg | 3 | Participants | ||
| Change From Baseline in Proteinuria | ELX-02 Patient 1 | Baseline | 1299.5 | Standard Deviation 1.37 | mg/g |
| Change From Baseline in Proteinuria | ELX-02 Patient 2 | Baseline | 1646.3 | Standard Deviation 1.24 | mg/g |
| Change From Baseline in Proteinuria | ELX-02: Patient 3 | Baseline | 1645.3 | Standard Deviation 1.26 | mg/g |
| Change From Baseline in Proteinuria | ELX-02 Patient 1 | Week 4 | 1943.3 | Standard Deviation 1.13 | mg/g |
| Change From Baseline in Proteinuria | ELX-02 Patient 2 | Week 4 | 706.8 | Standard Deviation 1.25 | mg/g |
| Change From Baseline in Proteinuria | ELX-02: Patient 3 | Week 4 | 3522.2 | Standard Deviation 1.14 | mg/g |
| Change From Baseline in Proteinuria | ELX-02 Patient 1 | End of Treatment | 2465.7 | Standard Deviation 1.7 | mg/g |
| Change From Baseline in Proteinuria | ELX-02 Patient 2 | End of Treatment | 1028.1 | Standard Deviation 1.65 | mg/g |
| Change From Baseline in Proteinuria | ELX-02: Patient 3 | End of Treatment | 2634.7 | Standard Deviation 1.2 | mg/g |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Open Label Study Drug Treatment | 3 | |
| Overall Study | COMPLETED | Open Label Study Drug Treatment | 3 | |
| Overall Study | NOT COMPLETED | Open Label Study Drug Treatment | 0 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Open Label Study Drug Treatment | 2 | 3 | 2 |
| other | postural dizziness | Nervous system disorders | Open Label Study Drug Treatment | 1 | 3 | 1 |
| other | lethargy | Nervous system disorders | Open Label Study Drug Treatment | 1 | 3 | 1 |
| other | Migraine | Nervous system disorders | Open Label Study Drug Treatment | 1 | 3 | 1 |
| other | Injection site erythema | General disorders | Open Label Study Drug Treatment | 2 | 3 | 2 |
| other | Injection site pruritus | General disorders | Open Label Study Drug Treatment | 1 | 3 | 1 |
| other | Chills | General disorders | Open Label Study Drug Treatment | 1 | 3 | 1 |
| other | Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Open Label Study Drug Treatment | 2 | 3 | 4 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Open Label Study Drug Treatment | 0 | 3 |
| Total, other adverse events | Open Label Study Drug Treatment | 3 | 3 |
| Total, serious adverse events | Open Label Study Drug Treatment | 0 | 3 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40938675 | DERIVED |
Source PubMed
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT05448755
GET https://conductscience.org/api/trials/v1/NCT05448755/registered