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IgA NephropathyPhase 3ORIGIN 3NCT04716231

Atacicept in Subjects With IgA Nephropathy

A Phase 3 study testing Atacicept in people with IgA Nephropathy and Berger Disease, run by Vera Therapeutics, Inc. at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

A Phase 3 Study with Atacicept in Subjects With IgA Nephropathy (ORIGIN 3) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
IgA Nephropathy, Berger Disease
What is being tested?
Atacicept
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
428 participants
Where
1 siteUnited States
Study dates
29 Jun 2023to Jul 2028
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • ORIGIN 3 Global Site Contact Information

    Brisbane, California, 94005

Other trials in United States

About this study

Official title: A Phase 2b/3, Multi-part, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With IgA Nephropathy (IgAN)

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

Read the detailed 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.

Being tested
Atacicept, Placebo to match Atacicept
Keywords
Berger Disease, Berger's Disease, IGA Glomerulonephritis, IGA Nephropathy, Iga Nephropathy 1, Immunoglobulin A Nephropathy Nephritis, IGA Type Nephropathy, IGA
Medical subject headings
Glomerulonephritis, IGA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtaciceptBiological

    Also called VT-001

    Once weekly subcutaneous (SC) injections by prefilled syringe

  • Placebo to match AtaciceptOther

    Once weekly subcutaneous (SC) injections by prefilled syringe

Study groups in NCT04716231
Study groupRoleWhat they receive
Atacicept Dose 150mgExperimentalAtacicept 150mg once weekly subcutaneous (SC) injections
Receives: Biological: Atacicept
Placebo to match Atacicept (Part C/D)Placebo comparatorPlacebo to match Atacicept once weekly subcutaneous (SC) injection
Receives: Other: Placebo to match Atacicept

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage Change From Baseline in Urine Protein to Creatinine Ratio (UPCR)

    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.

    Measured: 36 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2021
  2. Study start29 Jun 2023
  3. Primary completion15 May 2025
  4. Study completionJul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
428 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04716231
Sponsor's protocol ID
VT-001-0050
Acronym
ORIGIN 3
Status last verified
Sep 2026
First submitted
11 Jan 2021
Last updated
1 Oct 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Barratt J, Brenner RM, Barbour SJ, Campbell KN, Doan T, Eren N, Floege J, Fordyce MW, Jha V, Khawaja Z, Kim BS, Liew A, Maes B, Pal A, Pecoits-Filho R, Phoon RKS, Rizk DV, Suzuki H, Tesar V, Trimarchi H, Wei X, Yu L, Zhang H, Lafayette R; ORIGIN Phase 3 Trial Investigators. Atacicept in IgA Nephropathy - Phase 3 Trial Final Efficacy Analysis. N Engl J Med. 2026 Oct 22. doi: 10.1056/NEJMoa2610103. Online ahead of print.

    PubMed 42911181

  • Howie AJ, Lalayiannis AD. The Oxford Classification Should Remain the Gold Standard for Classification of IgA Nephropathy: CON. Kidney360. 2026 Oct 1;7(10):2382-2384. doi: 10.34067/KID.0000001083. Epub 2026 Feb 9. No abstract available.

    PubMed 41661687

  • 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. 2025 Dec;41(12):2287-2301. doi: 10.1080/03007995.2026.2615321. Epub 2026 Feb 1.

    PubMed 41620980

  • 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. 2026 Feb 12;394(7):647-657. doi: 10.1056/NEJMoa2510198. Epub 2025 Nov 6.

    PubMed 41196369

  • 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.

    PubMed 39462308

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atacicept in people with IgA Nephropathy and Berger Disease, run by Vera Therapeutics, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage Change From Baseline in Urine Protein to Creatinine Ratio (UPCR) (time frame: 36 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04716231, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.

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