Kidney disease drug trial halted early after only 6 patients

NCT ID NCT04652570

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tested a new drug called VB119 in 6 adults with primary membranous nephropathy, a kidney disease. The main goal was to check safety and how the body handles the drug, not to cure the disease. The study was terminated early, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

6 people

The number who actually took part.

Started

May 2021

Finished

Aug 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Is ≥ 18 years of age at the time of informed consent; 2. 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. 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; 4. Has systolic blood pressure (BP) \<160 mmHg or diastolic BP \<100 mmHg after 5 minutes of rest at Screening; 5. Is willing and able to provide written informed consent prior to Screening; 6. 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; 7. 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. 8. Male subjects must agree to abstain from sperm donation through 125 days after administration of the last dose of study drug. Exclusion Criteria: 1. Has an eGFR \<45 mL/min/1.73 m2 at Screening utilizing the Chronic Kidney Disease Epidemiology Collaboration formula confirmed by the central laboratory; 2. Has an absolute neutrophil count \<1.5 x 10/L; 3. Has a white blood cell count \<3.0 x 10/L; 4. 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); 5. Has a diagnosis or history of SLE (including non renal disease); 6. Has type 1 or 2 diabetes mellitus; 7. Has an acute, chronic, or latent infection, including tuberculosis, hepatitis, HIV, or chronic urinary tract infections;

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Clinical Research Site

    Albany, New York, 12209, United States

  • Clinical Research Site

    Bethlehem, Pennsylvania, 18017, United States

  • Clinical Research Site

    Dallas, Texas, 75208, United States

  • Clinical Reserach Site

    Los Angeles, California, 91324, United States

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