Kidney disease drug trial halted early after only 6 patients
NCT ID NCT04652570
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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6 people
The number who actually took part.
- Started
-
May 2021
- Finished
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Aug 2024
- Lead sponsor
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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
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Anyone
- Healthy volunteers
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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 Hide 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
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Clinical Reserach Site
Los Angeles, California, 91324, United States
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