Atacicept in Subjects With IgA Nephropathy

Last updated: September 9, 2026
Sponsor: Vera Therapeutics, Inc.
Overall Status: Active - Not Recruiting

Phase

3

Condition

Kidney Disease

Nephropathy

Nephritis

Treatment

Atacicept

Placebo to match Atacicept

Clinical Study ID

NCT04716231
VT-001-0050
  • Ages > 18
  • All Genders

Study Summary

A Phase 3 Study with Atacicept in Subjects With IgA Nephropathy (ORIGIN 3)

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Must have the ability to understand and sign a written informed consent form

  • Male or female of ≥18 years of age

  • Total urine protein excretion ≥1.0 g per 24-hour or urine protein to creatinineratio (UPCR) ≥1.0 mg/mg based on a 24-hour urine sample during the Screening Period

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

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

  • On a stable prescribed regimen of RAASi for at least 12 weeks that is at the maximumlabeled or tolerated dose at Screening

  • Systolic blood pressure ≤150 mmHg and diastolic blood pressure ≤90 mmHg

Exclusion

Key Exclusion Criteria:

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

  • Total urine protein excretion ≥ 5g per 24-hour or urine protein to creatinine ratio (UPCR) ≥ 5 mg/mg based on a 24-hour urine sample during the Screening Period

  • 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 <30g/L inassociation with UPCR >3.5 mg/mg

  • Renal or other organ transplantation prior to, or expected during the study

  • Concomitant chronic renal disease in addition to IgAN

  • Uncontrolled diabetes, defined as hemoglobin-A1c (HbA1c) >7.5% at screening

  • History of tuberculosis (TB), untreated latent TB infection (LTBI), or evidence ofactive TB determined by a positive Quantiferon test

  • Participation in the Phase 2b (Parts A and B) study or any previous treatment withatacicept

Study Design

Total Participants: 428
Treatment Group(s): 2
Primary Treatment: Atacicept
Phase: 3
Study Start date:
June 29, 2023
Estimated Completion Date:
July 31, 2028

Study Description

This is a multi-part study comprising of the original Phase 2b study and the addition of a separate pivotal Phase 3 study.

After the completion of the primary results for the Ph 2b dose ranging study, the pivotal study will evaluate the efficacy and safety of atacicept compared to placebo in reducing proteinuria in subjects with IgAN and persistent proteinuria despite being on a maximally tolerated dose (MTD) of a RASi. Safety, eGFR, serum immunoglobulins and Gd-IgA1 will also be clinically assessed. The clinical study is comprised of a 104wk double-blind treatment period, followed by a 52wk open-label treatment period and a 26wk safety follow-up period. The UPCR primary endpoint will be assessed after the first 200 patients are randomized.

Connect with a study center

  • ORIGIN 3 Global Site Contact Information

    Brisbane, California 94005
    United States

    Site Not Available

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