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Monoclonal Antibodies
Povetacicept for IgA Nephropathy
Phase 3
Recruiting
Research Sponsored by Alpine Immune Sciences Inc, A Subsidiary of Vertex
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Key
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline through week 104
Awards & highlights
Pivotal Trial
Summary
"This trial aims to see if povetacicept is better than placebo in reducing protein leakage in the urine and protecting the kidneys in adults."
Who is the study for?
This trial is for adults with IgA Nephropathy, confirmed by biopsy within the last 10 years. Participants must have significant protein in their urine and a minimum kidney function level. They should be on stable blood pressure medication like ACE inhibitors or ARBs.
What is being tested?
The study tests Povetacicept's effectiveness against a placebo in reducing protein loss in urine and protecting kidney function among IgAN patients. It aims to see if this treatment can help manage the disease better than no active treatment.
What are the potential side effects?
While specific side effects of Povetacicept are not listed here, similar medications may cause immune system changes, injection site reactions, potential infections, and possibly impact blood cell counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline through week 104
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline through week 104
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Time to Kidney Disease Progression Through Week 104
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: PovetaciceptExperimental Treatment1 Intervention
Participants will be randomized to receive Povetacicept.
Group II: PlaceboPlacebo Group1 Intervention
Participants will be randomized to receive placebo matched to Povetacicept.
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Who is running the clinical trial?
Alpine Immune Sciences Inc, A Subsidiary of VertexLead Sponsor
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