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VB119 for Membranous Glomerulonephritis
Phase 1 & 2
Waitlist Available
Research Sponsored by ACELYRIN Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 18 months
Awards & highlights
Study Summary
This trial is testing a new drug, VB119, to see if it is safe and effective for people with a certain type of cancer.
Who is the study for?
This trial is for adults with a confirmed diagnosis of primary Membranous Nephropathy (kidney disease) within the last 10 years, showing high levels of protein in urine. Participants must have stable blood pressure and agree to use effective contraception. Those with certain infections, diabetes, low white blood cell counts, or other autoimmune diseases like lupus are excluded.Check my eligibility
What is being tested?
The study tests VB119's safety and effectiveness on kidney function in patients with Membranous Nephropathy. It's an early-stage trial where doses increase over time among different groups to find the right balance between benefits and side effects.See study design
What are the potential side effects?
Specific side effects for VB119 aren't listed here but may include typical drug reactions such as nausea, allergic responses, potential impact on blood cells or organ functions which will be closely monitored throughout the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Clinical Laboratory Assessments
Incidence of Treatment-Emergent Adverse Events
Secondary outcome measures
% of Patients with Anti-Drug Antibodies
% of patients achieving complete remission of proteinuria
Anti-PLA2R Antibody Assessment
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: VB119 dose escalationExperimental Treatment1 Intervention
Dose escalation phase followed by a dose expansion phase. VB119 to be administered as intravenous infusions.
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Who is running the clinical trial?
ACELYRIN Inc.Lead Sponsor
8 Previous Clinical Trials
1,052 Total Patients Enrolled
Tenet MedicinesLead Sponsor
1 Previous Clinical Trials
1 Total Patients Enrolled
ValenzaBio, Inc.Lead Sponsor
2 Previous Clinical Trials
39 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function is reduced, with an eGFR below 45.I am using effective birth control and will continue for 125 days after the last study drug dose.I was diagnosed with primary membranous nephropathy through a kidney biopsy in the last 10 years.I have been diagnosed with or have a history of lupus.I have a condition like cancer, hepatitis, HIV, lupus, or thyroiditis causing my kidney disease.I have an ongoing infection, such as TB, hepatitis, HIV, or chronic UTIs.I am a woman who cannot have children due to surgery or being postmenopausal for 2+ years.I have type 1 or type 2 diabetes.I agree not to donate sperm for 125 days after my last dose of the study drug.I am 18 years old or older.My kidney biopsy shows positive for anti-PLA2R and my primary MN diagnosis was between 10 and 20 years ago.
Research Study Groups:
This trial has the following groups:- Group 1: VB119 dose escalation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still an opportunity to join this experiment?
"Affirmative. Clinicaltrials.gov's data shows that the clinical trial, initially posted on May 5th 2021, is presently recruiting patients for participation. 30 participants need to be admitted across 19 medical centres."
Answered by AI
How many healthcare facilities are offering participation in this clinical experiment?
"There are presently 19 sites offering this trial, including locations in Los Angeles, San Antonio and Pontiac. To limit travel needs if you decide to take part, it is advisable to choose the closest centre of research."
Answered by AI
How many participants are enrolled in this investigation?
"Affirmative. The details on clinicaltrials.gov demonstrate that this medical experiment is presently enrolling participants, with the initial post having been made on May 5th 2021 and last updated July 19th 2022. Thirty patients need to be recruited from 19 locations."
Answered by AI
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