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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

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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

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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.

ListOutcomeTime frameDescription
PrimaryIncidence of Adverse Events (AEs)14 weeksMeasured by the number of patients with AEs
PrimaryThe 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
PrimaryThe 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
PrimaryThe Effect of AVB-S6-500 on Proportion of Patients With Urinary Protein Equivalent of < 1 g/24 Hours at End of Treatment12 weeks
PrimaryThe 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
PrimaryThe Effect of AVB-S6-500 on Change From Baseline to End of Treatment in Urine Albumin/Creatinine Ratios (uACRs).12 weeks
PrimaryThe Effect of AVB-S6-500 on Change From Baseline to End of Treatment in Estimated Glomerular Filtration Rate (eGFR).12 weeks
SecondaryIncidence of Anti-drug Antibody (ADA)14 weeksThe number of participants with anti-AVB-S6-500 antibodies
SecondaryTiters of Anti-AVB-S6-500 Antibodies14 weeks
SecondaryApparent Terminal Half-life (t1/2) of AVB-S6-50012 weeks

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYIncidence of Adverse Events (AEs)14 weeksParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYThe Effect of AVB-S6-500 on Change From Baseline to End of Treatment in 24-hour Urine Protein Excretion (UPE) in g/Day.12 weeksThe subject discontinued the study before data were collected, hence the outcome measure was not analyzed.
PRIMARYThe 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 weeksThe subject discontinued the study before data were collected, hence the outcome measure was not analyzed.
PRIMARYThe Effect of AVB-S6-500 on Proportion of Patients With Urinary Protein Equivalent of < 1 g/24 Hours at End of Treatment12 weeksThe subject discontinued the study before data were collected, hence the outcome measure was not analyzed.
PRIMARYThe 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 weeksThe subject discontinued the study before data were collected, hence the outcome measure was not analyzed.
PRIMARYThe Effect of AVB-S6-500 on Change From Baseline to End of Treatment in Urine Albumin/Creatinine Ratios (uACRs).12 weeksThe subject discontinued the study before data were collected, hence the outcome measure was not analyzed.
PRIMARYThe Effect of AVB-S6-500 on Change From Baseline to End of Treatment in Estimated Glomerular Filtration Rate (eGFR).12 weeksThe subject discontinued the study before data were collected, hence the outcome measure was not analyzed.
SECONDARYIncidence of Anti-drug Antibody (ADA)14 weeksThe subject discontinued the study before data were collected, hence the outcome measure was not analyzed.
SECONDARYTiters of Anti-AVB-S6-500 Antibodies14 weeksThe subject discontinued the study before data were collected, hence the outcome measure was not analyzed.
SECONDARYApparent Terminal Half-life (t1/2) of AVB-S6-50012 weeksSamples were not analyzed because the study was terminated by the Sponsor.

Results by group1

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Incidence of Adverse Events (AEs)Treatment With AVB-S6-5001Participants

Participant flow3

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDTreatment With AVB-S6-5001
Overall StudyCOMPLETEDTreatment With AVB-S6-5000
Overall StudyNOT COMPLETEDTreatment With AVB-S6-5001

Adverse events3

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherDecreased blood pressureVascular disordersTreatment With AVB-S6-500111
otherRigorGeneral disordersTreatment With AVB-S6-500111
otherFeeling heavy (heaviness) in the backMusculoskeletal and connective tissue disordersTreatment With AVB-S6-500111

Adverse event totals3

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityTreatment With AVB-S6-50001
Total, other adverse eventsTreatment With AVB-S6-50011
Total, serious adverse eventsTreatment With AVB-S6-50001

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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