IgA NephropathyPhase 2NCT04042623

Study of Safety and Efficacy of AVB-S6-500 in Patients With IgA Nephropathy

A Phase 2 study testing AVB-S6-500 in people with IgA Nephropathy, run by Aravive, Inc. at 2 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

This is an open-label Phase 2a clinical study designed to evaluate the safety and efficacy of AVB-S6-500 in patients with IgA Nephropathy (IgAN). Approximately 24 patients will be enrolled. Several dose levels of AVB-S6-500 may be evaluated. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: IgA Nephropathy
What is being tested?: AVB-S6-500
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1 participants
Where: 2 sitesin 2 countries
Study dates: 27 Nov 2019to 1 Aug 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of biopsy-proven IgAN
Proteinuria ≥ 1g to 3g/24hr
Stable estimated glomerular filtration rate (eGFR) for at least 3 months prior to screening and ≥ 45 mL/min per 1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration formula
Systolic BP lesser than or equal to 150 mmHg and diastolic BP lesser than or equal to 100 mmHg
Patients who have been on a steady dose of ACE or ARB inhibitors for at least 3 months and throughout screening and who are not expected to have their dose adjusted during the study are allowed on study (patients who are not on ACEi/ARB due to inability to tolerate these therapies are also allowed)
If a sexually-active patient, must agree to use a reliable method of birth control from at least 4 weeks prior to first dose of study drug, during the study and for 1 month following completion of therapy.

Who cannot join

Patients with chronic urinary tract infections (UTIs) or taking prophylactic antibiotics to prevent recurrent UTIs
Treatment with systemic immunosuppressants, including corticosteroids, within 8 weeks of the first dose of study drug
Rapidly progressing nephropathy defined as falling GFR (≥ 15%) over past 3 mos
Clinical or biological evidence of diabetes mellitus, systemic lupus erythematosus, IgA vasculitis (Henoch-Schonlein purpura), secondary IgAN, or other renal disease
Hemoglobin < 9.0 g/dL
History or clinical evidence of cirrhosis, or liver disease with serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3x upper limit of normal

Show all 17Show fewer

Organ transplant recipient (including bone marrow) or a planned transplant during the study
Have a diagnosis of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection, or positive serology at screening
Recent active infection requiring hospitalization or i.v. treatment within 30 days prior to the first dose of study drug
Received transfusion, plasmapheresis or plasma exchange, IV immunoglobulin (IVIg) within 90 days prior to screening
Malignancy within the past 5 years. Exceptions are squamous cell carcinoma of skin, basal cell carcinoma of skin, and cervical carcinoma in situ which have been excised and are considered cured
Females who are nursing, pregnant, or intending to become pregnant during the time of the study, or who have a positive pregnancy test at baseline
Exposure to an investigational drug or device within 90 days or 5 half-lives (whichever is longer) prior to the first dose of study drug
Known sensitivity to any of the products to be administered during dosing
Subject will not be available for follow-up assessment
Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
Prior exposure to AVB-S6-500

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

United States1 site

Moonshine Clinical Research
Doral, Florida, 33166

Other trials in United States

Ukraine1 site

Institute of Nephrology National Academy of Medical Science Ukraine
Kyiv, 04050

Other trials in Ukraine

About this study

Official title: An Open-Label Phase 2a Study to Evaluate the Safety and Efficacy of AVB-S6-500 in Patients With IgA Nephropathy

Conditions: IgA Nephropathy
Being tested: AVB-S6-500
Keywords: IgAN, AXL inhibitor, Berger's Disease, Proteinuria, Kidney Disease
Medical subject headings: Glomerulonephritis, IGA, Proteinuria, Kidney Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AVB-S6-500Drug
AVB-S6-500 is experimental drug

Study groups in NCT04042623
Study group	Role	What they receive
Treatment with AVB-S6-500	Experimental	Patients will receive AVB-S6-500 by intravenous infusion every 2 weeks for total of 6 doses. Receives: Drug: AVB-S6-500

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Adverse Events (AEs)
Measured by the number of patients with AEs
Measured: 14 weeks
The Effect of AVB-S6-500 on Change From Baseline to End of Treatment in 24-hour Urine Protein Excretion (UPE) in g/Day.
Measured: 12 weeks
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.
Measured: 12 weeks
The Effect of AVB-S6-500 on Proportion of Patients With Urinary Protein Equivalent of < 1 g/24 Hours at End of Treatment
Measured: 12 weeks
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.
Measured: 12 weeks
The Effect of AVB-S6-500 on Change From Baseline to End of Treatment in Urine Albumin/Creatinine Ratios (uACRs).
Measured: 12 weeks
The Effect of AVB-S6-500 on Change From Baseline to End of Treatment in Estimated Glomerular Filtration Rate (eGFR).
Measured: 12 weeks

Secondary outcomes (6)

Incidence of Anti-drug Antibody (ADA)
The number of participants with anti-AVB-S6-500 antibodies
Measured: 14 weeks
Titers of Anti-AVB-S6-500 Antibodies
Measured: 14 weeks
Apparent Terminal Half-life (t1/2) of AVB-S6-500
Measured: 12 weeks
Maximum Observed Plasma Concentration of AVB-S6-500 (Cmax)
Measured: 12 weeks
Area Under Time-concentration Curve (AUC)
Measured: 12 weeks
Time of Maximum Observed AVB-S6-500 Concentration (Tmax)
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Nov 20191 Aug 2020

First posted2 Aug 2019
Study start27 Nov 2019
Primary completion1 Aug 2020
Study completion1 Aug 2020

Why it stopped: Business reasons

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for IgA NephropathyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 1 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04042623
Sponsor's protocol ID: AVB500-IGA-001
Status last verified: Jan 2022
First submitted: 31 Jul 2019
Last updated: 10 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 3
A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy
Kidney Disease
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 2
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 to Treat Glomerulonephritis
Glomerulonephritis
RecruitingPhase 3
A Phase 3 Blinded Study of JADE101 in Participants With Immunoglobulin A Nephropathy
IgA Nephropathy (IgAN)

All IgA Nephropathy trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Phase 2a Study to Evaluate the Safety and Efficacy of AVB-S6-500 in Patients With IgA Nephropathy
ClinicalTrials.gov ID: NCT04042623
Acronym / sponsor ID: AVB500-IGA-001
Conditions: IgA Nephropathy
Keywords: IgAN, AXL inhibitor, Berger's Disease, Proteinuria, Kidney Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Business reasons
Enrolment: 1 participants (actual)
Lead sponsor: Aravive, Inc.Industry (pharma, biotech, devices)
Study start: 27 Nov 2019 (actual)
Primary completion: 1 Aug 2020 (actual)
Study completion: 1 Aug 2020 (actual)
First posted: 2 Aug 2019 (actual)
Results: Posted 10 Feb 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment with AVB-S6-500	Experimental	Drug: AVB-S6-500Patients will receive AVB-S6-500 by intravenous infusion every 2 weeks for total of 6 doses.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Diagnosis of biopsy-proven IgAN
Proteinuria ≥ 1g to 3g/24hr
Stable estimated glomerular filtration rate (eGFR) for at least 3 months prior to screening and ≥ 45 mL/min per 1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration formula
Systolic BP lesser than or equal to 150 mmHg and diastolic BP lesser than or equal to 100 mmHg
Patients who have been on a steady dose of ACE or ARB inhibitors for at least 3 months and throughout screening and who are not expected to have their dose adjusted during the study are allowed on study (patients who are not on ACEi/ARB due to inability to tolerate these therapies are also allowed)

Key exclusion criteria (17 listed)

Patients with chronic urinary tract infections (UTIs) or taking prophylactic antibiotics to prevent recurrent UTIs
Treatment with systemic immunosuppressants, including corticosteroids, within 8 weeks of the first dose of study drug
Rapidly progressing nephropathy defined as falling GFR (≥ 15%) over past 3 mos
Clinical or biological evidence of diabetes mellitus, systemic lupus erythematosus, IgA vasculitis (Henoch-Schonlein purpura), secondary IgAN, or other renal disease
Hemoglobin < 9.0 g/dL

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AVB-S6-500AVB-S6-500 is experimental drug	Drug	Treatment with AVB-S6-500

Primary outcome

Incidence of Adverse Events (AEs)
Time frame: 14 weeks
Measured by the number of patients with AEs
The Effect of AVB-S6-500 on Change From Baseline to End of Treatment in 24-hour Urine Protein Excretion (UPE) in g/Day.
Time frame: 12 weeks
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.
Time frame: 12 weeks
The Effect of AVB-S6-500 on Proportion of Patients With Urinary Protein Equivalent of < 1 g/24 Hours at End of Treatment
Time frame: 12 weeks
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.
Time frame: 12 weeks
The Effect of AVB-S6-500 on Change From Baseline to End of Treatment in Urine Albumin/Creatinine Ratios (uACRs).
Time frame: 12 weeks
The Effect of AVB-S6-500 on Change From Baseline to End of Treatment in Estimated Glomerular Filtration Rate (eGFR).
Time frame: 12 weeks

6 secondary outcomes

Incidence of Anti-drug Antibody (ADA)
Time frame: 14 weeks
Titers of Anti-AVB-S6-500 Antibodies
Time frame: 14 weeks
Apparent Terminal Half-life (t1/2) of AVB-S6-500
Time frame: 12 weeks
Maximum Observed Plasma Concentration of AVB-S6-500 (Cmax)
Time frame: 12 weeks
Area Under Time-concentration Curve (AUC)
Time frame: 12 weeks
Time of Maximum Observed AVB-S6-500 Concentration (Tmax)
Time frame: 12 weeks

Results and safety

Results posted to the registry on 10 Feb 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment With AVB-S6-500	1	0

Primary outcome: Incidence of Adverse Events (AEs)

Time frame: 14 weeks. Count of participants. Unit: Participants

Measure	Treatment With AVB-S6-500 n = 1
Value	1

Primary outcome: The Effect of AVB-S6-500 on Change From Baseline to End of Treatment in 24-hour Urine Protein Excretion (UPE) in g/Day.

Time frame: 12 weeks

Population analysed: The subject discontinued the study before data were collected, hence the outcome measure was not analyzed.

Primary outcome: 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.

Time frame: 12 weeks

Population analysed: The subject discontinued the study before data were collected, hence the outcome measure was not analyzed.

Primary outcome: The Effect of AVB-S6-500 on Proportion of Patients With Urinary Protein Equivalent of < 1 g/24 Hours at End of Treatment

Time frame: 12 weeks

Population analysed: The subject discontinued the study before data were collected, hence the outcome measure was not analyzed.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: The adverse events data were collected over 1 month period: the subject consented to participate in this study on 11-Feb-2020. On 12-Mar-2020, AVB-S6-500 10 mg/kg (total dose 670 mg) was administered intravenously . The subject did not receive any subsequent doses of AVB-S6-500, nor did she complete the study. The subject underwent post-treatment assessments through telephone contact, as in-person visits were limited due to COVID. The date of early study discontinuation is noted as 06-Apr-2020.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment With AVB-S6-500	0 of 1 (0%)	1 of 1 (100%)	0 of 1

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for IgA Nephropathy

RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 3
A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy
Kidney Disease
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 2
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 to Treat Glomerulonephritis
Glomerulonephritis
RecruitingPhase 3
A Phase 3 Blinded Study of JADE101 in Participants With Immunoglobulin A Nephropathy
IgA Nephropathy (IgAN)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Francoise Desir study director

Aravive, Inc.

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AVB-S6-500 in people with IgA Nephropathy, run by Aravive, Inc. at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events (AEs) (time frame: 14 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04042623.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2022.