Phase
Condition
Nephrotic Syndrome
Kidney Disease
Nephritis
Treatment
VB119
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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: Itis preferable that subjects enrolled have kidney biopsy tissue samples that arepositive for anti-PLA2R antibody staining. Subjects with kidney biopsy-provendiagnosis of primary MN >10 years and ≤20 years that meet all other eligibilitycriteria may be enrolled after discussion with the Medical Monitor.
- Has a documented laboratory history of nephrotic range proteinuria (defined aseither greater than or equal to 3.5 g total protein per 24-hour urine collection orgreater than or equal to 3.5 g/g UPCR by spot collection) AND has proteinuria with aUPCR greater than or equal to 2.0 g/g based on 2 consecutive spot urine (first morningvoid) sample collections obtained within 14 days of each other during the ScreeningPeriod. Both samples must qualify;
- Has systolic blood pressure (BP) <160 mmHg or diastolic BP <100 mmHg after 5 minutesof 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 oophorectomyat least 26 weeks before the Screening Visit) or postmenopausal, defined asspontaneous amenorrhea for at least 2 years, with follicle-stimulating hormone in thepostmenopausal range at Screening, based on the central laboratory's ranges;
- Female subjects of childbearing potential (ie, ovulating, premenopausal, or notsurgically sterile) and all male subjects must use a medically accepted, highlyeffective contraceptive regimen during their participation in the study and for 125days after the last administration of study drug.
- Male subjects must agree to abstain from sperm donation through 125 days afteradministration of the last dose of study drug.
Exclusion
Exclusion Criteria:
- Has an eGFR <45 mL/min/1.73 m2 at Screening utilizing the Chronic Kidney DiseaseEpidemiology 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 immunodeficiencyvirus [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, orchronic urinary tract infections;
Study Design
Connect with a study center
ValenzaBio Investigative Site
Aguascalientes,
MexicoSite Not Available
ValenzaBio Investigative Site
Monterrey,
MexicoSite Not Available
ValenzaBio Investigative Site
Oaxaca,
MexicoSite Not Available
ValenzaBio Investigative Site
Cambridge, CB2 2QQ
United KingdomSite Not Available
ValenzaBio Investigative Site
Leicester, LE5 4PW
United KingdomSite Not Available
ValenzaBio Investigative Site
London, W12 OHS
United KingdomSite Not Available
ValenzaBio Investigative Site
Sheffield, S5 7AU
United KingdomSite Not Available
ValenzaBio Investigative Site
Birmingham, Alabama 35233
United StatesSite Not Available
ValenzaBio Investigative Site
Granada Hills, California 91344
United StatesSite Not Available
Clinical Reserach Site
Los Angeles, California 91324
United StatesSite Not Available
ValenzaBio Investigative Site
Mission Viejo, California 92691
United StatesSite Not Available
ValenzaBio Investigative Site
Northridge, California 91324
United StatesSite Not Available
ValenzaBio Investigative Site
San Francisco, California 94143
United StatesSite Not Available
ValenzaBio Investigative Site
Vacaville, California 95687
United StatesSite Not Available
ValenzaBio Investigative Site
Washington, District of Columbia 20037
United StatesSite Not Available
ValenzaBio Investigative Site
Chicago, Illinois 60611
United StatesSite Not Available
ValenzaBio Investigative Site
Shreveport, Louisiana 71101
United StatesSite Not Available
ValenzaBio Investigative Site
Ann Arbor, Michigan 48084
United StatesSite Not Available
ValenzaBio Investigative Site
Pontiac, Michigan 48341
United StatesSite Not Available
ValenzaBio Investigative Site
Kansas City, Missouri 64111
United StatesSite Not Available
Clinical Research Site
Albany, New York 12209
United StatesSite Not Available
ValenzaBio Investigative Site
Greenville, North Carolina 27834
United StatesSite Not Available
Clinical Research Site
Bethlehem, Pennsylvania 18017
United StatesSite Not Available
ValenzaBio Investigative Site
Providence, Rhode Island 02903
United StatesSite Not Available
ValenzaBio Investigative Site
Columbia, South Carolina 29201
United StatesSite Not Available
ValenzaBio Investigative Site
Orangeburg, South Carolina 29118
United StatesSite Not Available
Clinical Research Site
Dallas, Texas 75208
United StatesSite Not Available
ValenzaBio Investigative Site
Lewisville, Texas 75057
United StatesSite Not Available
ValenzaBio Investigative Site
San Antonio, Texas 78215
United StatesSite Not Available
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