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Monoclonal Antibodies

Low Dose-VIS649 for Glomerulonephritis

Phase 2
Waitlist Available
Research Sponsored by Visterra, 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 16 months
Awards & highlights

Study Summary

This trial will test if VIS649 is an effective and safe treatment for IgA Nephropathy, a kidney disease.

Eligible Conditions
  • Glomerulonephritis
  • IgA Nephropathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy Objective--effect on Proteinuria of repeated doses of VIS649 added to SOC (ACEI/ARB therapy) vs. SOC
Safety Assessment
Secondary outcome measures
Efficacy of repeated doses of VIS649 added to SOC (ACEI/ARB therapy) vs. SOC in achieving ≥ 30% decline from baseline in uPCR
Efficacy of repeated doses of VIS649 added to SOC (ACEI/ARB therapy) vs. SOC on kidney function.
Efficacy of repeated doses of VIS649 added to SOC (ACEI/ARB therapy) vs. SOC on protein excretion
+5 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Medium Dose - VIS649Experimental Treatment1 Intervention
Medium dose of VIS649 administered IV
Group II: Low Dose - VIS649Experimental Treatment1 Intervention
Low dose of VIS649 administered IV
Group III: High Dose - VIS649Experimental Treatment1 Intervention
High dose of VIS649 administered IV
Group IV: PlaceboPlacebo Group1 Intervention
Placebo (0.9% NaCl) will be administered IV
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Medium Dose-VIS649
2020
Completed Phase 2
~160
Low Dose-VIS649
2020
Completed Phase 2
~160
High Dose-VIS649
2020
Completed Phase 2
~160

Find a Location

Who is running the clinical trial?

Visterra, Inc.Lead Sponsor
7 Previous Clinical Trials
497 Total Patients Enrolled
David Oldach, M.D., FIDSAStudy DirectorVisterra, Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment actively recruiting participants?

"Unfortunately, this clinical trial detailed on the clinicaltrials.gov website is not currently recruiting any participants. Initially posted in July 2020 and updated lastly in March 2022, it has yet to begin seeking candidates. Nonetheless, there are 489 other trials actively searching for patients at present."

Answered by AI

Could you provide insight into the potential hazards of Low Dose-VIS649?

"Considering the Phase 2 status of Low Dose-VIS649, it received a safety score of 2. This denotes that while there is some data available to support its security, no trials have been conducted to measure efficacy."

Answered by AI

What are the expected outcomes of this experiment?

"This medical experiment will document the efficacy of VIS649 when added to SOC therapy, over a year-long period. Primary objectives include evaluating Proteinuria levels and potential secondary outcomes may involve assessing ≥ 30% decline from baseline in uPCR, Change from baseline in 24-hour urine protein excretion, or even variation in participant's serum Ig concentrations."

Answered by AI

How many geographic areas are hosting this exploration?

"Currently, 20 different clinical trial sites have been established across the country. These locations include Columbus, Oxnard and Baton Rouge; other cities are also available for patient convenience. It is recommended that individuals select a nearby site to reduce their need to travel extensively if they choose to participate."

Answered by AI
~33 spots leftby Apr 2025