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ORIGIN: Atacicept in Subjects With IgA Nephropathy

Sponsor
Vera Therapeutics, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04716231
Collaborator
(none)
116
Enrollment
76
Locations
4
Arms
37.5
Anticipated Duration (Months)
1.5
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of the study is to evaluate the effect of atacicept compared to placebo on change in proteinuria in adult subjects with IGAN.

Condition or Disease Intervention/Treatment Phase
  • Biological: Atacicept
  • Other: Placebo to match Atacicept
 Phase 2

Detailed Description

The study will assess multiple doses of atacicept vs. placebo on impact of renal function as measured by proteinuria. Safety, eGFR, serum immunoglobulins and gd-IgA1 will also be clinically assessed. The clinical study is comprised of a 36wk double-blind treatment period, followed by a 60wk open-label treatment period and a 26wk safety follow-up period.

Study Design

Study Type:
Interventional
Actual Enrollment :
116 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase IIb Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With IgA Nephropathy (IGAN)
Actual Study Start Date :
May 18, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Atacicept Dose A

Atacicept Dose A once weekly subcutaneous (SC) injection

Biological: Atacicept
Once weekly subcutaneous (SC) injections by prefilled syringe
Other Names:
  • VT-001

    		•
    Experimental: Atacicept Dose B

    Atacicept Dose B once weekly subcutaneous (SC) injection

    Biological: Atacicept
    Once weekly subcutaneous (SC) injections by prefilled syringe
    Other Names:
  • VT-001

    		•
    Experimental: Atacicept Dose C

    Atacicept C once weekly subcutaneous (SC) injection

    Biological: Atacicept
    Once weekly subcutaneous (SC) injections by prefilled syringe
    Other Names:
  • VT-001

    		•
    Placebo Comparator: Placebo to match Atacicept

    Placebo to match Atacicept once weekly subcutaneous (SC) injection

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

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in urine protein to creatinine ratio (UPCR) [24 Weeks]

      UPCR based on 24 hour urine collection

    Secondary Outcome Measures

    1. Change from baseline in urine protein to creatinine ratio (UPCR) [36 Weeks]

      UPCR based on 24 hour urine collection

    Other Outcome Measures

    1. Change from baseline in urine protein to creatinine ratio (UPCR) [12, 48, 96 Weeks and Week 26 follow up]

      UPCR based on 24 hour urine collection

    2. Change from baseline in estimated glomerular filtration rage (eGFR) [12, 24, 36, 48, 96 Weeks and 26 Week follow up]

      eGFR calculated by CKD-EPI formula

    3. Change from baseline in IgA, IgG, IgM, C3, C4 and Gd-IgA1 levels [12, 24, 36, 48, 96 Weeks]

      Serum measurement of IgA, IgG, IgM, C3, C4 and Gd-IgA1

    4. Number of participants with adverse events during the double-blind treatment period [Through 36 Weeks]

      Safety and tolerability

    5. Evaluate serum PK of atacicept [Through study completion, an average of 2 years]

      Serum concentration of atacicept

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:

    1. Must have the ability to understand and sign a written informed consent form

    2. Male or female of ≥18 years of age

    3. Diagnosis of IgAN as demonstrated by renal biopsy conducted within 10 years

    4. Total urine protein excretion >0.75g per 24-hour or urine protein to creatinine ratio (UPCR) >0.75 mg/mg based on a 24-hour urine sample during the Screening Period

    5. eGFR ≥ 30 mL/min/1.73 m2, as per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.

    6. On a stable prescribed regimen of RAASi for at least 12 weeks that is at the maximum labeled or tolerated dose

    7. Systolic blood pressure ≤150 mmHg and diastolic blood pressure ≤90 mmHg

    Key Exclusion Criteria:

    1. 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

    2. Evidence of rapidly progressive glomerulonephritis (loss of ≥ 50% of eGFR within 3 months of screening)

    3. Evidence of nephrotic syndrome within 6 months of screening (serum albumin <30g/L in association with UPCR >3.5 mg/mg

    4. 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

    5. Renal or other organ transplantation prior to, or expected during the study

    6. Concomitant chronic renal disease in addition to IgAN

    7. Uncontrolled diabetes, defined as hemoglobin-A1c (HbA1c) >7.5% at screening

    8. History of tuberculosis (TB), untreated latent TB infection (LTBI), or evidence of active TB determined by a positive Quantiferon test

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Vera Site #115 Tucson Arizona United States 85724
    2 Vera Site #106 Palo Alto California United States 94304
    3 Vera Site #120 Salinas California United States 93901
    4 Vera Site #107 Arvada Colorado United States 80002
    5 Vera Site #109 Chicago Illinois United States 60611
    6 Vera Site #103 Iowa City Iowa United States 52242
    7 Vera Site #102 Detroit Michigan United States 48202
    8 Vera Site #114 Albuquerque New Mexico United States 87109
    9 Vera Site #104 Jamaica New York United States 11432
    10 Vera Site #111 New York New York United States 10029
    11 Vera Site #101 Asheville North Carolina United States 28801
    12 Vera Site #119 Greenville North Carolina United States 27834
    13 Vera Site #105 Bethlehem Pennsylvania United States 18017
    14 Vera Site #108 Philadelphia Pennsylvania United States 19104
    15 Vera Site #113 Philadelphia Pennsylvania United States 19107
    16 Vera Site #117 Pittsburgh Pennsylvania United States 15212
    17 Vera Site #112 East Providence Rhode Island United States 02914
    18 Vera Site #122 El Paso Texas United States 79902
    19 Vera Site #121 Houston Texas United States 77054
    20 Vera Site #118 Lufkin Texas United States 75904
    21 Vera Site #123 Saint George Utah United States 84790
    22 Vera Site #110 Burlington Vermont United States 05401
    23 Vera Site #903 Clayton Australia 3168
    24 Vera Site #905 Concord Australia NSW 2139
    25 Vera Site #901 Saint Albans Australia 3021
    26 Vera Site #906 Townsville Australia 4814
    27 Vera Site #904 Westmead Australia 2145
    28 Vera Site #902 Woolloongabba Australia 4102
    29 Vera Site #203 Gent Belgium 9000
    30 Vera Site #201 Liège Belgium 4000
    31 Vera Site #202 Roeselare Belgium 8800
    32 Vera Site #151 Vancouver Canada V5Z 1M9
    33 Vera Site #601 Praha 2 Czechia 128 08
    34 Vera Site #602 Praha Czechia 100 34
    35 Vera Site #303 Dresden Germany D-01307
    36 Vera Site #305 Essen Germany 45147
    37 Vera Site #304 Lübeck Germany 23538
    38 Vera Site #301 Munich Germany 80336
    39 Vera Site #653 Athens Greece 11527
    40 Vera Site #654 Heraklion Greece 71110
    41 Vera Site #656 Ioánnina Greece 45500
    42 Vera Site #655 Níkaia Greece 18454
    43 Vera Site #651 Patras Greece 26504
    44 Vera Site #652 Thessaloníki Greece 54642
    45 Vera Site #712 Ahmedabad India 380052
    46 Vera Site #714 Bengaluru India 560004
    47 Vera Site #719 Jaipur India 302017
    48 Vera Site #707 Kolkata India 700020
    49 Vera Site #704 Nadiād India 387001
    50 Vera Site #717 Nagpur India 440001
    51 Vera Site #708 Pune India 411004
    52 Vera Site #702 Thiruvananthapuram India 695011
    53 Vera Site #706 Vellore India 632004
    54 Vera Site #806 Daegu Korea, Republic of 41944
    55 Vera Site #805 Gyeonggi-do Korea, Republic of 14068
    56 Vera Site #803 Seoul Korea, Republic of 135-720
    57 Vera Site #804 Seoul Korea, Republic of 3080
    58 Vera Site #801 Seoul Korea, Republic of 3312
    59 Vera Site #807 Seoul Korea, Republic of 3722
    60 Vera Site #951 Kuala Lumpur Malaysia 50586
    61 Vera Site #954 Kuala Lumpur Malaysia 59100
    62 Vera Site #952 Kuantan Malaysia 25100
    63 Vera Site #955 Taiping Malaysia 34000
    64 Vera Site #453 Warszawa Poland 02-507
    65 Vera Site #406 Ankara Turkey 6230
    66 Vera Site #408 Ankara Turkey 6340
    67 Vera Site #403 Aydın Turkey 9100
    68 Vera Site #404 Istanbul Turkey 34722
    69 Vera Site #401 Kayseri Turkey 38039
    70 Vera Site #402 Kocaeli Turkey 41000
    71 Vera Site #504 Bristol United Kingdom BS105NB
    72 Vera Site #509 Cambridge United Kingdom CB2 2QQ
    73 Vera Site #503 Canterbury United Kingdom CT1 3NG
    74 Vera Site #508 Glasgow United Kingdom G51 4TF
    75 Vera Site #502 Liverpool United Kingdom L9 7AL
    76 Vera Site #505 Nottingham United Kingdom NG5 1PB

    Sponsors and Collaborators

    • Vera Therapeutics, Inc.

    Investigators

    • Study Director: Joanne Curley, Chief Development Officer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Vera Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT04716231
    Other Study ID Numbers:
    • VT-001-0050
    First Posted:
    Jan 20, 2021
    Last Update Posted:
    Jul 8, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Vera Therapeutics, Inc.
    Berger Disease
    Berger's Disease
    IGA Glomerulonephritis
    IGA Nephropathy
    Iga Nephropathy 1
    Immunoglobulin A Nephropathy Nephritis
    IGA Type Nephropathy, IGA
    Additional relevant MeSH terms:
    Kidney Diseases
    Glomerulonephritis, IGA

    Study Results

    No Results Posted as of Jul 8, 2022