Efficacy and Safety of VB119 in Subjects With Membranous Nephropathy
Stopped early · Phase 1/Phase 2
Conditions studied: Membranous Nephropathy
In brief
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
Key facts
- Study ID
- NCT04652570
- Run by
- Tenet Medicines
- People needed
- 6
- Starts
- 2021-05-05
- Expected to finish
- 2024-08-15
- Last updated by the study team
- 2026-02-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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;
Where it is running
- Clinical Reserach Site — Los Angeles, California, United States
- Clinical Research Site — Albany, New York, United States
- Clinical Research Site — Bethlehem, Pennsylvania, United States
- Clinical Research Site — Dallas, Texas, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.