Membranous NephropathyPhase 1/2NCT04652570

Efficacy and Safety of VB119 in Subjects With Membranous Nephropathy

A Phase 1/2 study testing VB119 in people with Membranous Nephropathy, run by Tenet Medicines at 4 sites in United States.

Terminated

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

Official record

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Trial summary

This study is a Phase 1b/2a, open-label, sequential-cohort, dose escalation, and dose expansion study to evaluate the safety, tolerability, PK, and PD of VB119 in subjects with primary MN Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Membranous Nephropathy
What is being tested?: VB119
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 4 sitesUnited States
Study dates: 5 May 2021to 15 Aug 2024
Phase: Phase 1/2
Are there results?: None posted in the registry

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

Is ≥ 18 years of age at the time of informed consent;
Has a kidney biopsy-proven diagnosis of primary MN within the past 10 years; Note: It is preferable that subjects enrolled have kidney biopsy tissue samples that are positive for anti-PLA2R antibody staining. Subjects with kidney biopsy-proven diagnosis of primary MN >10 years and ≤20 years that meet all other eligibility criteria may be enrolled after discussion with the Medical Monitor.
3. Has a documented laboratory history of nephrotic range proteinuria (defined as either greater than or equal to 3.5 g total protein per 24-hour urine collection or greater than or equal to 3.5 g/g UPCR by spot collection) AND has proteinuria with a UPCR greater than or equal to 2.0 g/g based on 2 consecutive spot urine (first morning void) sample collections obtained within 14 days of each other during the Screening Period. Both samples must qualify;
Has systolic blood pressure (BP) <160 mmHg or diastolic BP <100 mmHg after 5 minutes of rest at Screening;
Is willing and able to provide written informed consent prior to Screening;
Female subjects of non-childbearing potential must be either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy at least 26 weeks before the Screening Visit) or postmenopausal, defined as spontaneous amenorrhea for at least 2 years, with follicle-stimulating hormone in the postmenopausal range at Screening, based on the central laboratory's ranges;
Female subjects of childbearing potential (ie, ovulating, premenopausal, or not surgically sterile) and all male subjects must use a medically accepted, highly effective contraceptive regimen during their participation in the study and for 125 days after the last administration of study drug.
Male subjects must agree to abstain from sperm donation through 125 days after administration of the last dose of study drug.

Who cannot join

Has an eGFR <45 mL/min/1.73 m2 at Screening utilizing the Chronic Kidney Disease Epidemiology Collaboration formula confirmed by the central laboratory;
Has an absolute neutrophil count <1.5 x 10/L;
Has a white blood cell count <3.0 x 10/L;
Has secondary causes of MN (eg, malignancy, hepatitis B or C, human immunodeficiency virus [HIV], systemic lupus erythematosus [SLE], or other autoimmune diseases [eg, thyroiditis], drug-induced);
Has a diagnosis or history of SLE (including non renal disease);
Has type 1 or 2 diabetes mellitus;
Has an acute, chronic, or latent infection, including tuberculosis, hepatitis, HIV, or chronic urinary tract infections;

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Clinical Research Site
Albany, New York, 12209
Clinical Research Site
Bethlehem, Pennsylvania, 18017
Clinical Research Site
Dallas, Texas, 75208
Clinical Reserach Site
Los Angeles, California, 91324

Other trials in United States

About this study

Official title: A Phase 1b/2a Study of VB119 in Adult Subjects With Primary Membranous Nephropathy

This study is a Phase 1b/2a, open-label, sequential-cohort, dose escalation, and dose expansion study to evaluate the safety, tolerability, PK, and PD of VB119 in subjects with primary MN

Conditions: Membranous Nephropathy
Being tested: VB119
Medical subject headings: Glomerulonephritis, Membranous

What participants receive

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

VB119Drug
Humanized, immunoglobin (Ig) G1 monoclonal antibody (mAb) to be administered as intravenous infusion at multiple timepoints during the study.

Study groups in NCT04652570
Study group	Role	What they receive
VB119 dose escalation	Experimental	Dose escalation phase followed by a dose expansion phase. VB119 to be administered as intravenous infusions. Receives: Drug: VB119

What is being measured

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

Incidence of Treatment-Emergent Adverse Events
Safety and Tolerability
Measured: Through study completion, an average of 18 months
Incidence of Clinical Laboratory Assessments
Safety and Tolerability
Measured: Through study completion, an average of 18 months

Secondary outcomes (6)

% of Patients with Anti-Drug Antibodies
Measured: Through study completion, an average of 18 months
Maximum Plasma Concentration [Cmax]
Measured: Week 12
Time to Maximum Plasma Concentration [Tmax]
Measured: Week 12
% of patients achieving complete remission of proteinuria
Measured: Through study completion, an average of 18 months
Anti-PLA2R Antibody Assessment
Measured: Through study completion, an average of 18 months
Quality of Life as assessed by PROMIS
Measured: Through study completion, an average of 18 months

Timeline

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

5 May 202115 Aug 2024

First posted3 Dec 2020
Study start5 May 2021
Primary completion21 Nov 2023
Study completion15 Aug 2024

Why it stopped: Sponsor change

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Membranous 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 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04652570
Sponsor's protocol ID: 119-01-01
Status last verified: Feb 2026
First submitted: 23 Nov 2020
Last updated: 12 Feb 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: 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

Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 2
An Open-Label Phase 2 Study of N-Acetyl-D-Mannosamine (ManNAc) in Subjects With Podocyte Diseases
Focal Segmental Glomerulosclerosis, Minimal Change Disease
RecruitingPhase 2/3
Evaluation of Efficacy, Safety, and Tolerability of Povetacicept in Participants With Primary Membranous Nephropathy (pMN)
Primary Membranous Nephropathy
RecruitingPhase 2
Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy
Nephrotic Syndrome, Proteinuria
Not yet recruitingObservational study
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis

All Membranous Nephropathy trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1b/2a Study of VB119 in Adult Subjects With Primary Membranous Nephropathy
ClinicalTrials.gov ID: NCT04652570
Acronym / sponsor ID: 119-01-01
Conditions: Membranous Nephropathy
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor change
Enrolment: 6 participants (actual)
Lead sponsor: Tenet MedicinesIndustry (pharma, biotech, devices)
Study start: 5 May 2021 (actual)
Primary completion: 21 Nov 2023 (actual)
Study completion: 15 Aug 2024 (actual)
First posted: 3 Dec 2020 (actual)
Results: Not posted in the source record

Clinical summary

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

This study is a Phase 1b/2a, open-label, sequential-cohort, dose escalation, and dose expansion study to evaluate the safety, tolerability, PK, and PD of VB119 in subjects with primary MN

Study design

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

Arm	Type	Receives
VB119 dose escalation	Experimental	Drug: VB119Dose escalation phase followed by a dose expansion phase. VB119 to be administered as intravenous infusions.

Who may qualify

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

Key inclusion criteria (8 listed)

Is ≥ 18 years of age at the time of informed consent;
Has a kidney biopsy-proven diagnosis of primary MN within the past 10 years; Note: It is preferable that subjects enrolled have kidney biopsy tissue samples that are positive for anti-PLA2R antibody staining. Subjects with kidney biopsy-proven diagnosis of primary MN >10 years and ≤20 years that meet all other eligibility criteria may be enrolled after discussion with the Medical Monitor.
3. Has a documented laboratory history of nephrotic range proteinuria (defined as either greater than or equal to 3.5 g total protein per 24-hour urine collection or greater than or equal to 3.5 g/g UPCR by spot collection) AND has proteinuria with a UPCR greater than or equal to 2.0 g/g based on 2 consecutive spot urine (first morning void) sample collections obtained within 14 days of each other during the Screening Period. Both samples must qualify;
Has systolic blood pressure (BP) <160 mmHg or diastolic BP <100 mmHg after 5 minutes of rest at Screening;
Is willing and able to provide written informed consent prior to Screening;

Key exclusion criteria (7 listed)

Has an eGFR <45 mL/min/1.73 m2 at Screening utilizing the Chronic Kidney Disease Epidemiology Collaboration formula confirmed by the central laboratory;
Has an absolute neutrophil count <1.5 x 10/L;
Has a white blood cell count <3.0 x 10/L;
Has secondary causes of MN (eg, malignancy, hepatitis B or C, human immunodeficiency virus [HIV], systemic lupus erythematosus [SLE], or other autoimmune diseases [eg, thyroiditis], drug-induced);
Has a diagnosis or history of SLE (including non renal disease);

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
VB119Humanized, immunoglobin (Ig) G1 monoclonal antibody (mAb) to be administered as intravenous infusion at multiple timepoints during the study.	Drug	VB119 dose escalation

Primary outcome

Incidence of Treatment-Emergent Adverse Events
Time frame: Through study completion, an average of 18 months
Safety and Tolerability
Incidence of Clinical Laboratory Assessments
Time frame: Through study completion, an average of 18 months
Safety and Tolerability

6 secondary outcomes

% of Patients with Anti-Drug Antibodies
Time frame: Through study completion, an average of 18 months
Maximum Plasma Concentration [Cmax]
Time frame: Week 12
Time to Maximum Plasma Concentration [Tmax]
Time frame: Week 12
% of patients achieving complete remission of proteinuria
Time frame: Through study completion, an average of 18 months
Anti-PLA2R Antibody Assessment
Time frame: Through study completion, an average of 18 months
Quality of Life as assessed by PROMIS
Time frame: Through study completion, an average of 18 months

Results and safety

The study was stopped early (reason given: Sponsor change). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.

Related trials for Membranous Nephropathy

Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 2
An Open-Label Phase 2 Study of N-Acetyl-D-Mannosamine (ManNAc) in Subjects With Podocyte Diseases
Focal Segmental Glomerulosclerosis, Minimal Change Disease
RecruitingPhase 2/3
Evaluation of Efficacy, Safety, and Tolerability of Povetacicept in Participants With Primary Membranous Nephropathy (pMN)
Primary Membranous Nephropathy
RecruitingPhase 2
Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy
Nephrotic Syndrome, Proteinuria
Not yet recruitingObservational study
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis

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.

Keenan study chair

ValenzaBio, Inc.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing VB119 in people with Membranous Nephropathy, run by Tenet Medicines at 4 sites in United States.

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 8 inclusion and 7 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 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The study was stopped early (reason given: Sponsor change). Results are not available in the source record.

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 Treatment-Emergent Adverse Events (time frame: Through study completion, an average of 18 months). The study lists 2 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 NCT04652570.

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 12 Feb 2026.