Atacicept in Subjects with IgA Nephropathy

Last updated: September 10, 2024
Sponsor: Vera Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Kidney Disease

Nephritis

Nephropathy

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: 376
Treatment Group(s): 2
Primary Treatment: Atacicept
Phase: 3
Study Start date:
May 23, 2023
Estimated Completion Date:
July 31, 2028

Study Description

This is a multi-part study comprising of the original Phase 2b study (active, no longer recruiting) and the addition of a separate pivotal Phase 3 study (active, recruiting).

After the completion of the primary results for the Ph 2b dose ranging study, the pivotal study (active, recruiting) 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

  • Vera Site #903

    Clayton, 3168
    Australia

    Site Not Available

  • Vera Site #905

    Concord, NSW 2139
    Australia

    Site Not Available

  • Vera Site #901

    Saint Albans, 3021
    Australia

    Site Not Available

  • Vera Site #906

    Townsville, 4814
    Australia

    Site Not Available

  • Vera Site #904

    Westmead, 2145
    Australia

    Site Not Available

  • Vera Site #902

    Woolloongabba, 4102
    Australia

    Site Not Available

  • Vera Site #203

    Gent, 9000
    Belgium

    Site Not Available

  • Vera Site #201

    Liège, 4000
    Belgium

    Site Not Available

  • Vera Site #202

    Roeselare, 8800
    Belgium

    Site Not Available

  • Vera Site #151

    Vancouver, V5Z 1M9
    Canada

    Site Not Available

  • Vera Site #602

    Praha, 100 34
    Czechia

    Site Not Available

  • Vera Site #601

    Praha 2, 128 08
    Czechia

    Site Not Available

  • Vera Site #303

    Dresden, D-01307
    Germany

    Site Not Available

  • Vera Site #305

    Essen, 45147
    Germany

    Site Not Available

  • Vera Site #304

    Lübeck, 23538
    Germany

    Site Not Available

  • Vera Site #301

    Munich, 80336
    Germany

    Site Not Available

  • Vera Site #653

    Athens, 11527
    Greece

    Site Not Available

  • Vera Site #654

    Heraklion, 71110
    Greece

    Site Not Available

  • Vera Site #656

    Ioánnina, 45500
    Greece

    Site Not Available

  • Vera Site #655

    Níkaia, 18454
    Greece

    Site Not Available

  • Vera Site #651

    Patras, 26504
    Greece

    Site Not Available

  • Vera Site #652

    Thessaloníki, 54642
    Greece

    Site Not Available

  • Vera Site #712

    Ahmedabad, 380052
    India

    Site Not Available

  • Vera Site #714

    Bengaluru, 560004
    India

    Site Not Available

  • Vera Site #719

    Jaipur, 302017
    India

    Site Not Available

  • Vera Site #707

    Kolkata, 700020
    India

    Site Not Available

  • Vera Site #704

    Nadiād, 387001
    India

    Site Not Available

  • Vera Site #717

    Nagpur, 440001
    India

    Site Not Available

  • Vera Site #708

    Pune, 411004
    India

    Site Not Available

  • Vera Site #702

    Thiruvananthapuram, 695011
    India

    Site Not Available

  • Vera Site #706

    Vellore, 632004
    India

    Site Not Available

  • Vera Site #806

    Daegu, 41944
    Korea, Republic of

    Site Not Available

  • Vera Site #805

    Gyeonggi-do, 14068
    Korea, Republic of

    Site Not Available

  • Vera Site #801

    Seoul, 3312
    Korea, Republic of

    Site Not Available

  • Vera Site #803

    Seoul, 135-720
    Korea, Republic of

    Site Not Available

  • Vera Site #804

    Seoul, 3080
    Korea, Republic of

    Site Not Available

  • Vera Site #807

    Seoul, 3722
    Korea, Republic of

    Site Not Available

  • Vera Site #951

    Kuala Lumpur, 50586
    Malaysia

    Site Not Available

  • Vera Site #954

    Kuala Lumpur, 59100
    Malaysia

    Site Not Available

  • Vera Site #952

    Kuantan, 25100
    Malaysia

    Site Not Available

  • Vera Site #955

    Taiping, 34000
    Malaysia

    Site Not Available

  • Vera Site #454

    Olsztyn, 10-561
    Poland

    Site Not Available

  • Vera Site #453

    Warszawa, 02-507
    Poland

    Site Not Available

  • Vera Site #451

    Łódź, 92-213
    Poland

    Site Not Available

  • Vera Site #406

    Ankara, 6230
    Turkey

    Site Not Available

  • Vera Site #408

    Ankara, 6340
    Turkey

    Site Not Available

  • Vera Site #403

    Aydın, 9100
    Turkey

    Site Not Available

  • Vera Site #404

    Istanbul, 34722
    Turkey

    Site Not Available

  • Vera Site #405

    Istanbul, 34098
    Turkey

    Site Not Available

  • Vera Site #401

    Kayseri, 38039
    Turkey

    Site Not Available

  • Vera Site #402

    Kocaeli, 41000
    Turkey

    Site Not Available

  • Vera Site #504

    Bristol, BS105NB
    United Kingdom

    Site Not Available

  • Vera Site #509

    Cambridge, CB2 2QQ
    United Kingdom

    Site Not Available

  • Vera Site #503

    Canterbury, CT1 3NG
    United Kingdom

    Site Not Available

  • Vera Site #508

    Glasgow, G51 4TF
    United Kingdom

    Site Not Available

  • Vera Site #501

    Leicester, LE5 4 PW
    United Kingdom

    Site Not Available

  • Vera Site #502

    Liverpool, L9 7AL
    United Kingdom

    Site Not Available

  • Vera Site #505

    Nottingham, NG5 1PB
    United Kingdom

    Site Not Available

  • Vera Site #116

    Birmingham, Alabama 35294-3412
    United States

    Site Not Available

  • Vera Site #115

    Tucson, Arizona 85724
    United States

    Site Not Available

  • ORIGIN 3 Global Site Contact Information

    Brisbane, California 94005
    United States

    Active - Recruiting

  • Vera Site #106

    Palo Alto, California 94304
    United States

    Site Not Available

  • Vera Site #120

    Salinas, California 93901
    United States

    Site Not Available

  • Vera Site #107

    Arvada, Colorado 80002
    United States

    Site Not Available

  • Vera Site #109

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Vera Site #103

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Vera Site #102

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Vera Site #114

    Albuquerque, New Mexico 87109
    United States

    Site Not Available

  • Vera Site #104

    Jamaica, New York 11432
    United States

    Site Not Available

  • Vera Site #111

    New York, New York 10029
    United States

    Site Not Available

  • Vera Site #101

    Asheville, North Carolina 28801
    United States

    Site Not Available

  • Vera Site #119

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Vera Site #105

    Bethlehem, Pennsylvania 18017
    United States

    Site Not Available

  • Vera Site #108

    Philadelphia, Pennsylvania 19104
    United States

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  • Vera Site #113

    Philadelphia, Pennsylvania 19107
    United States

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  • Vera Site #117

    Pittsburgh, Pennsylvania 15212
    United States

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  • Vera Site #112

    East Providence, Rhode Island 02914
    United States

    Site Not Available

  • Vera Site #122

    El Paso, Texas 79902
    United States

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  • Vera Site #121

    Houston, Texas 77054
    United States

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  • Vera Site #118

    Lufkin, Texas 75904
    United States

    Site Not Available

  • Vera Site #123

    Saint George, Utah 84790
    United States

    Site Not Available

  • Vera Site #110

    Burlington, Vermont 05401
    United States

    Site Not Available

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