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Clinical Trials in the USA / NCT04716231
Active, not recruiting Phase 3

Atacicept in Subjects With IgA Nephropathy

NCT04716231 · tracked via the Priya Life Science USA tracker
Sponsor
Vera Therapeutics, Inc.
Phase
Phase 3
Started
2023-06-29
Last updated
2025-09-30

Condition(s) studied

IgA NephropathyBerger Disease

Investigational drug(s) / intervention(s)

AtaciceptPlacebo 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)

Trial sites (1)

FacilityCityRegionStatus
ORIGIN 3 Global Site Contact Information Brisbane California

More Vera Therapeutics, Inc. trials in the USA

Other trials for the same condition

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