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Active, not recruiting Phase 3

Atacicept in Subjects With IgA Nephropathy

NCT04716231 · tracked via the Priya Life Science USA tracker
Phase
Phase 3
Started
2023-06-29
Last updated
2026-10-01

Condition(s) studied

IgA NephropathyBerger Disease

Investigational drug(s) / intervention(s)

Atacicept →Placebo to match Atacicept

Atacicept: Once weekly subcutaneous (SC) injections by prefilled syringe

Placebo to match Atacicept: Once weekly subcutaneous (SC) injections by prefilled syringe

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 creatinine ratio (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 Epidemiology Collaboration (CKD-EPI) equation. * On a stable prescribed regimen of RAASi for at least 12 weeks that is at the maximum labeled or tolerated dose at Screening * Systolic blood pressure ≤150 mmHg and diastolic blood pressure ≤90 mmHg Key Exclusion Criteria: * IgAN secondary to another condition (e.g., liver cirrhosis), or other causes of mesangial 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 3 months of screening) * Evidence of nephrotic syndrome within 6 months of screening (serum albumin \<30g/L in association 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 of active TB determined by a positive Quantiferon test * Participation in the Phase 2b (Parts A and B) study or any previous treatment with atacicept

Primary outcome measure(s)

  • Percentage Change From Baseline in Urine Protein to Creatinine Ratio (UPCR) — 36 Weeks
    Percentage reduction in UPCR was obtained from geometric mean ratios. The natural log-transformed ratio of UPCR to its baseline value was analyzed using a Mixed Model for Repeated Measures (MMRM), adjusted by baseline variables specified in the Statistical Analysis Plan (SAP), including data from baseline up to Week 36 during the Double-Blind period.

Trial sites (1)

FacilityCityRegionStatus
ORIGIN 3 Global Site Contact Information Brisbane California

More Vera Therapeutics, Inc. trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04716231 on ClinicalTrials.gov ↗ ← All trials in the USA