Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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

Official Title

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

Keywords

Membranous Nephropathy Kidney Diseases Glomerulonephritis, Membranous

Eligibility

You can join if…

Open to people ages 18 years and up

  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.
    1. 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;
  3. Has systolic blood pressure (BP) <160 mmHg or diastolic BP <100 mmHg after 5 minutes of rest at Screening;
  4. Is willing and able to provide written informed consent prior to Screening;
  5. 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;
  6. 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.
  7. Male subjects must agree to abstain from sperm donation through 125 days after administration of the last dose of study drug.

You CAN'T join if...

  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;

Locations

  • ValenzaBio Investigative Site not yet accepting patients
    San Francisco California 94143 United States
  • ValenzaBio Investigative Site accepting new patients
    Los Angeles California 91324 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
ValenzaBio, Inc.
ID
NCT04652570
Phase
Phase 1/2 Membranous Nephropathy Research Study
Study Type
Interventional
Participants
Expecting 30 study participants
Last Updated