Phase
Condition
Kidney Disease
Nephritis
Nephropathy
Treatment
Atacicept
Placebo to match Atacicept
Clinical Study ID
Ages > 18 All Genders
Study Summary
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
Study Description
Connect with a study center
Vera Site #903
Clayton, 3168
AustraliaSite Not Available
Vera Site #905
Concord, NSW 2139
AustraliaSite Not Available
Vera Site #901
Saint Albans, 3021
AustraliaSite Not Available
Vera Site #906
Townsville, 4814
AustraliaSite Not Available
Vera Site #904
Westmead, 2145
AustraliaSite Not Available
Vera Site #902
Woolloongabba, 4102
AustraliaSite Not Available
Vera Site #203
Gent, 9000
BelgiumSite Not Available
Vera Site #201
Liège, 4000
BelgiumSite Not Available
Vera Site #202
Roeselare, 8800
BelgiumSite Not Available
Vera Site #151
Vancouver, V5Z 1M9
CanadaSite Not Available
Vera Site #602
Praha, 100 34
CzechiaSite Not Available
Vera Site #601
Praha 2, 128 08
CzechiaSite Not Available
Vera Site #303
Dresden, D-01307
GermanySite Not Available
Vera Site #305
Essen, 45147
GermanySite Not Available
Vera Site #304
Lübeck, 23538
GermanySite Not Available
Vera Site #301
Munich, 80336
GermanySite Not Available
Vera Site #653
Athens, 11527
GreeceSite Not Available
Vera Site #654
Heraklion, 71110
GreeceSite Not Available
Vera Site #656
Ioánnina, 45500
GreeceSite Not Available
Vera Site #655
Níkaia, 18454
GreeceSite Not Available
Vera Site #651
Patras, 26504
GreeceSite Not Available
Vera Site #652
Thessaloníki, 54642
GreeceSite Not Available
Vera Site #712
Ahmedabad, 380052
IndiaSite Not Available
Vera Site #714
Bengaluru, 560004
IndiaSite Not Available
Vera Site #719
Jaipur, 302017
IndiaSite Not Available
Vera Site #707
Kolkata, 700020
IndiaSite Not Available
Vera Site #704
Nadiād, 387001
IndiaSite Not Available
Vera Site #717
Nagpur, 440001
IndiaSite Not Available
Vera Site #708
Pune, 411004
IndiaSite Not Available
Vera Site #702
Thiruvananthapuram, 695011
IndiaSite Not Available
Vera Site #706
Vellore, 632004
IndiaSite Not Available
Vera Site #806
Daegu, 41944
Korea, Republic ofSite Not Available
Vera Site #805
Gyeonggi-do, 14068
Korea, Republic ofSite Not Available
Vera Site #801
Seoul, 3312
Korea, Republic ofSite Not Available
Vera Site #803
Seoul, 135-720
Korea, Republic ofSite Not Available
Vera Site #804
Seoul, 3080
Korea, Republic ofSite Not Available
Vera Site #807
Seoul, 3722
Korea, Republic ofSite Not Available
Vera Site #951
Kuala Lumpur, 50586
MalaysiaSite Not Available
Vera Site #954
Kuala Lumpur, 59100
MalaysiaSite Not Available
Vera Site #952
Kuantan, 25100
MalaysiaSite Not Available
Vera Site #955
Taiping, 34000
MalaysiaSite Not Available
Vera Site #454
Olsztyn, 10-561
PolandSite Not Available
Vera Site #453
Warszawa, 02-507
PolandSite Not Available
Vera Site #451
Łódź, 92-213
PolandSite Not Available
Vera Site #406
Ankara, 6230
TurkeySite Not Available
Vera Site #408
Ankara, 6340
TurkeySite Not Available
Vera Site #403
Aydın, 9100
TurkeySite Not Available
Vera Site #404
Istanbul, 34722
TurkeySite Not Available
Vera Site #405
Istanbul, 34098
TurkeySite Not Available
Vera Site #401
Kayseri, 38039
TurkeySite Not Available
Vera Site #402
Kocaeli, 41000
TurkeySite Not Available
Vera Site #504
Bristol, BS105NB
United KingdomSite Not Available
Vera Site #509
Cambridge, CB2 2QQ
United KingdomSite Not Available
Vera Site #503
Canterbury, CT1 3NG
United KingdomSite Not Available
Vera Site #508
Glasgow, G51 4TF
United KingdomSite Not Available
Vera Site #501
Leicester, LE5 4 PW
United KingdomSite Not Available
Vera Site #502
Liverpool, L9 7AL
United KingdomSite Not Available
Vera Site #505
Nottingham, NG5 1PB
United KingdomSite Not Available
Vera Site #116
Birmingham, Alabama 35294-3412
United StatesSite Not Available
Vera Site #115
Tucson, Arizona 85724
United StatesSite Not Available
ORIGIN 3 Global Site Contact Information
Brisbane, California 94005
United StatesActive - Recruiting
Vera Site #106
Palo Alto, California 94304
United StatesSite Not Available
Vera Site #120
Salinas, California 93901
United StatesSite Not Available
Vera Site #107
Arvada, Colorado 80002
United StatesSite Not Available
Vera Site #109
Chicago, Illinois 60611
United StatesSite Not Available
Vera Site #103
Iowa City, Iowa 52242
United StatesSite Not Available
Vera Site #102
Detroit, Michigan 48202
United StatesSite Not Available
Vera Site #114
Albuquerque, New Mexico 87109
United StatesSite Not Available
Vera Site #104
Jamaica, New York 11432
United StatesSite Not Available
Vera Site #111
New York, New York 10029
United StatesSite Not Available
Vera Site #101
Asheville, North Carolina 28801
United StatesSite Not Available
Vera Site #119
Greenville, North Carolina 27834
United StatesSite Not Available
Vera Site #105
Bethlehem, Pennsylvania 18017
United StatesSite Not Available
Vera Site #108
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Vera Site #113
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Vera Site #117
Pittsburgh, Pennsylvania 15212
United StatesSite Not Available
Vera Site #112
East Providence, Rhode Island 02914
United StatesSite Not Available
Vera Site #122
El Paso, Texas 79902
United StatesSite Not Available
Vera Site #121
Houston, Texas 77054
United StatesSite Not Available
Vera Site #118
Lufkin, Texas 75904
United StatesSite Not Available
Vera Site #123
Saint George, Utah 84790
United StatesSite Not Available
Vera Site #110
Burlington, Vermont 05401
United StatesSite Not Available
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