Atacicept in Subjects With IgA Nephropathy

NCT04716231 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: VT-001-0050
• Study Type: interventional
• Target: 376
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

IgA Nephropathy; Berger Disease

Keywords

Berger Disease; Berger's Disease; IGA Glomerulonephritis; IGA Nephropathy; Iga Nephropathy 1; Immunoglobulin A Nephropathy Nephritis; IGA Type Nephropathy, IGA

Outcome Measures

Primary Outcomes (1)

• Change from baseline in urine protein to creatinine ratio (UPCR)

  UPCR based on 24 hour urine collection

  36 Weeks

Secondary Outcomes (1)

• Annualized rate of change in estimated glomerular filtration rate (eGFR)

  52 and 104 Weeks

Study Arms (2)

Atacicept Dose 150mg

EXPERIMENTAL

Atacicept 150mg once weekly subcutaneous (SC) injections

Biological: Atacicept

Placebo to match Atacicept (Part C/D)

PLACEBO COMPARATOR

Placebo to match Atacicept once weekly subcutaneous (SC) injection

Other: Placebo to match Atacicept

Interventions

Atacicept BIOLOGICAL

Once weekly subcutaneous (SC) injections by prefilled syringe

Also known as: VT-001

Atacicept Dose 150mg

Placebo to match Atacicept OTHER

Once weekly subcutaneous (SC) injections by prefilled syringe

Placebo to match Atacicept (Part C/D)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vera Therapeutics, Inc.: lead

Study Sites (1)

ORIGIN 3 Global Site Contact Information

Brisbane, California, 94005, United States

Location

Related Publications (3)

• Barratt J, Chen K, Lafayette R. A plain language summary: long-term safety and effectiveness of atacicept in individuals with IgA nephropathy. Curr Med Res Opin. 2026 Feb 1:1-15. doi: 10.1080/03007995.2026.2615321. Online ahead of print.

  PMID: 41620980 DERIVED

• Lafayette R, Barbour SJ, Brenner RM, Campbell KN, Doan T, Eren N, Floege J, Jha V, Kim BS, Liew A, Maes B, Pal A, Pecoits-Filho R, Phoon RKS, Rizk DV, Suzuki H, Tesar V, Trimarchi H, Wei X, Zhang H, Barratt J; ORIGIN Phase 3 Trial Investigators. A Phase 3 Trial of Atacicept in Patients with IgA Nephropathy. N Engl J Med. 2025 Nov 6. doi: 10.1056/NEJMoa2510198. Online ahead of print.

  PMID: 41196369 DERIVED

• Barratt J, Barbour SJ, Brenner RM, Cooper K, Wei X, Eren N, Floege J, Jha V, Kim SG, Maes B, Phoon RKS, Singh H, Tesar V, Lafayette R; ORIGIN Phase 2b Investigators. Long-Term Results from an Open-Label Extension Study of Atacicept for the Treatment of IgA Nephropathy. J Am Soc Nephrol. 2025 Apr 1;36(4):679-687. doi: 10.1681/ASN.0000000541. Epub 2024 Oct 26.

  PMID: 39462308 DERIVED

Related Links

• Vera Therapeutics, Inc Company Website

MeSH Terms

Conditions

Glomerulonephritis, IGA

Interventions

TACI receptor-IgG Fc fragment fusion protein

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Zeeshan Khawaja

  Vice President, Clinical Development

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 20, 2021
• Study Start: June 29, 2023
• Primary Completion: May 15, 2025
• Study Completion (Estimated): July 1, 2028
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)