Trial · NCT04042623
Study of Safety and Efficacy of AVB-S6-500 in Patients With IgA Nephropathy
NCT04042623, Phase 2, Terminated, Aravive, Inc.; results first posted 2022-02-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Safety and Efficacy of AVB-S6-500 in Patients With IgA Nephropathy. Trials, record NCT04042623. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04042623
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Safety and Efficacy of AVB-S6-500 in Patients With IgA Nephropathy
- NCT number
- NCT04042623
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 1 participants, actual
- Lead sponsor
- Aravive, Inc.
- Conditions
- IgA Nephropathy
- Interventions
- AVB-S6-500
- First posted
- 2019-08-02
- Last updated
- 2022-02-10
- Results first posted
- 2022-02-10
- Limitations and caveats
- After enrollment of one subject, the study was paused due to the COVID-19 pandemic. Subsequently, the sponsor terminated the study due to a change in sponsor priorities.
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Adverse Events (AEs) | 14 weeks | Measured by the number of patients with AEs |
| Primary | The Effect of AVB-S6-500 on Change From Baseline to End of Treatment in 24-hour Urine Protein Excretion (UPE) in g/Day. | 12 weeks | |
| Primary | The Effect of AVB-S6-500 on Change From Baseline to End of Treatment in 24-hour Urine Protein Excretion (UPE) in g/Day in the Subset of Patients With Baseline High Proteinuria. | 12 weeks | |
| Primary | The Effect of AVB-S6-500 on Proportion of Patients With Urinary Protein Equivalent of < 1 g/24 Hours at End of Treatment | 12 weeks | |
| Primary | The Effect of AVB-S6-500 on Proportion of Patients Who Had at Least a Decrease of 0.5 g/Day Proteinuria From Baseline to End of Treatment. | 12 weeks | |
| Primary | The Effect of AVB-S6-500 on Change From Baseline to End of Treatment in Urine Albumin/Creatinine Ratios (uACRs). | 12 weeks | |
| Primary | The Effect of AVB-S6-500 on Change From Baseline to End of Treatment in Estimated Glomerular Filtration Rate (eGFR). | 12 weeks | |
| Secondary | Incidence of Anti-drug Antibody (ADA) | 14 weeks | The number of participants with anti-AVB-S6-500 antibodies |
| Secondary | Titers of Anti-AVB-S6-500 Antibodies | 14 weeks | |
| Secondary | Apparent Terminal Half-life (t1/2) of AVB-S6-500 | 12 weeks |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Adverse Events (AEs) | 14 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | The Effect of AVB-S6-500 on Change From Baseline to End of Treatment in 24-hour Urine Protein Excretion (UPE) in g/Day. | 12 weeks | The subject discontinued the study before data were collected, hence the outcome measure was not analyzed. | ||
| PRIMARY | The Effect of AVB-S6-500 on Change From Baseline to End of Treatment in 24-hour Urine Protein Excretion (UPE) in g/Day in the Subset of Patients With Baseline High Proteinuria. | 12 weeks | The subject discontinued the study before data were collected, hence the outcome measure was not analyzed. | ||
| PRIMARY | The Effect of AVB-S6-500 on Proportion of Patients With Urinary Protein Equivalent of < 1 g/24 Hours at End of Treatment | 12 weeks | The subject discontinued the study before data were collected, hence the outcome measure was not analyzed. | ||
| PRIMARY | The Effect of AVB-S6-500 on Proportion of Patients Who Had at Least a Decrease of 0.5 g/Day Proteinuria From Baseline to End of Treatment. | 12 weeks | The subject discontinued the study before data were collected, hence the outcome measure was not analyzed. | ||
| PRIMARY | The Effect of AVB-S6-500 on Change From Baseline to End of Treatment in Urine Albumin/Creatinine Ratios (uACRs). | 12 weeks | The subject discontinued the study before data were collected, hence the outcome measure was not analyzed. | ||
| PRIMARY | The Effect of AVB-S6-500 on Change From Baseline to End of Treatment in Estimated Glomerular Filtration Rate (eGFR). | 12 weeks | The subject discontinued the study before data were collected, hence the outcome measure was not analyzed. | ||
| SECONDARY | Incidence of Anti-drug Antibody (ADA) | 14 weeks | The subject discontinued the study before data were collected, hence the outcome measure was not analyzed. | ||
| SECONDARY | Titers of Anti-AVB-S6-500 Antibodies | 14 weeks | The subject discontinued the study before data were collected, hence the outcome measure was not analyzed. | ||
| SECONDARY | Apparent Terminal Half-life (t1/2) of AVB-S6-500 | 12 weeks | Samples were not analyzed because the study was terminated by the Sponsor. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Adverse Events (AEs) | Treatment With AVB-S6-500 | 1 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment With AVB-S6-500 | 1 | |
| Overall Study | COMPLETED | Treatment With AVB-S6-500 | 0 | |
| Overall Study | NOT COMPLETED | Treatment With AVB-S6-500 | 1 |
Source ClinicalTrials.gov
Adverse events3
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 | Decreased blood pressure | Vascular disorders | Treatment With AVB-S6-500 | 1 | 1 | 1 |
| other | Rigor | General disorders | Treatment With AVB-S6-500 | 1 | 1 | 1 |
| other | Feeling heavy (heaviness) in the back | Musculoskeletal and connective tissue disorders | Treatment With AVB-S6-500 | 1 | 1 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment With AVB-S6-500 | 0 | 1 |
| Total, other adverse events | Treatment With AVB-S6-500 | 1 | 1 |
| Total, serious adverse events | Treatment With AVB-S6-500 | 0 | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT04042623
GET https://conductscience.org/api/trials/v1/NCT04042623/registered