Monthly Dosing of Atacicept in IgAN

Last updated: June 17, 2025
Sponsor: Vera Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Glomerulonephritis

Treatment

Atacicept

Clinical Study ID

NCT07020923
VT-001-0020
  • Ages > 18
  • All Genders

Study Summary

This is a Phase 2, open-label, multicenter, randomized study comprising parallel groups of participants receiving weekly and/or monthly doses of atacicept

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Must have the ability to understand and sign a written informed consent form, whichmust be obtained prior to initiation of study assessments

  • Adult male or female of ≥18 years of age, or as per country specific legally ornationally recognized adult age, who provides written informed consent prior toperforming any study assessments

  • Diagnosis of IgAN as demonstrated by renal biopsy conducted within 10 years

  • Total urine protein excretion ≥0.75 g per 24-hour or urine protein-to-creatinineratio (UPCR) ≥0.75 mg/mg based on a 24-hour urine sample

  • eGFR ≥30 mL/min/1.73 m2 at screening, as per the Chronic Kidney Disease EpidemiologyCollaboration (CKD-EPI)

  • On a stable prescribed regimen of RASi (angiotensin converting enzyme inhibitor orangiotensin II receptor blocker) for at least 8 weeks that is at the maximum labeledor tolerated dose at screening and from screening to study Day 1

Exclusion

Exclusion Criteria:

  • IgAN secondary to another condition (eg, liver cirrhosis), or other causes ofmesangial IgA deposition including IgA vasculitis (ie, Henoch-Schonlein purpura),systemic lupus erythematosus, dermatitis herpetiformis, ankylosing spondylitis

  • Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR within 3months of screening)

  • Evidence of nephrotic syndrome within 6 months of screening (serum albumin <3.0 g/dLin association with UPCR >3.5 mg/mg)

  • Renal or other organ transplantation prior to or expected during the study, with theexception of corneal transplants

  • Concomitant chronic renal disease in addition to IgAN (eg, diabetic nephropathy,primary focal segmental glomerulosclerosis, membranous nephropathy, C3glomerulopathy, lupus nephritis)

Study Design

Total Participants: 90
Treatment Group(s): 1
Primary Treatment: Atacicept
Phase: 2
Study Start date:
May 29, 2025
Estimated Completion Date:
September 30, 2027

Study Description

This Phase 2 study is to explore the effectiveness, safety and tolerability of different dosing regimens of atacicept. Regimens include monthly and weekly dosing.

Connect with a study center

  • Vera Therapeutics

    Brisbane, California 94005
    United States

    Active - Recruiting

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