Phase
Condition
Collagen Vascular Diseases
Vascular Diseases
Kidney Disease
Treatment
povetacicept
Povetacicept
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria Summary:
- Biopsy-confirmed autoantibody-associated glomerular disease: immunoglobulin A nephropathy (IgAN), primary membranous nephropathy (pMN), or lupus nephritis (LN) 2.
Indication-specific criteria:
a. IgAN
Biopsy-confirmed diagnosis less than or equal to (≤)10 years prior to the start of screening AND Screening UPCR greater than or equal to (≥)0.5 g/g.
No background immunosuppression therapies.
pMN
A historical biopsy-confirmed diagnosis with positive anti-PLA2R1 antibodies or anti-THSD7A antibodies at screening AND Screening UPCR ≥1 g/g
Inadequate reduction of proteinuria determined by the Principal Investigator (PI) despite optimal supportive care for at least 12 weeks.
No background immunosuppression therapies except for optional calcineurin inhibitors.
LN
A Biopsy-confirmed diagnosis of active, proliferative Class III, IV, (with or without Class V) LN ≤6 months prior to the start of screening AND
Screening UPCR ≥1 g/g,
Positive anti-dsDNA at screening
On stable background immunosuppression ≥ 8 weeks prior to Day 1
AAV
•
Past diagnosis of renal AAV, defined as either of the following:
History of renal biopsy consistent with renal AAV.
History of clinically diagnosed renal AAV.
Myeloperoxidase (MPO)-ANCA or proteinase 3 (PR3)-ANCA positive by enzyme-linked immunosorbent assay at screening.
At least 4 weeks since initiation of AAV induction therapy, if applicable.
- On maximal dose or the maximally tolerated dose ACEis/ARBs for ≥12 weeks prior to study Day 1
Key Exclusion Criteria Summary:
Prior diagnosis of, or fulfills diagnostic criteria for, another renal disease
eGFR <30 (milliliter per minute per square meter (mL/min/1.73m^2) or rapidly progressive glomerulonephritis
Recent serious or ongoing infection; risk or history of serious infection
Receipt of B cell depleting therapies or anti-BAFFand/or APRIL therapies within protocol specified timeframes
Study Design
Connect with a study center
Investigational Site (519)
Concord, New South Wales 2139
AustraliaActive - Recruiting
Investigational Site (515)
Saint Albans, Victoria 3021
AustraliaActive - Recruiting
Investigational Site (102)
Nedlands, Western Australia 6009
AustraliaActive - Recruiting
Investigational Site (434)
Vienna, 1090
AustriaSite Not Available
Investigational Site (507)
Cheonan, Chungcheongnam-do 31151
Korea, Republic ofActive - Recruiting
Investigational Site (505)
Anyang-si, Gyeonggi-do 14068
Korea, Republic ofActive - Recruiting
Investigational Site (504)
Goyang-si, Gyeonggi-do 10444
Korea, Republic ofActive - Recruiting
Investigational Site (510)
Guri-si, Gyeonggi-do 11923
Korea, Republic ofActive - Recruiting
Investigational Site (125)
Seoul, Gyeonggi-do 03080
Korea, Republic ofActive - Recruiting
Investigational Site (520)
Seoul, Gyeonggi-do 03181
Korea, Republic ofActive - Recruiting
Investigational Site (521)
Seoul, Gyeonggi-do 05278
Korea, Republic ofActive - Recruiting
Investigational Site (116)
Suwon-si, Gyeonggi-do 16499
Korea, Republic ofActive - Recruiting
Investigational Site (437)
Trondheim, Trondelag 7030
NorwaySite Not Available
Investigational Site (433)
Sarpsborg, 47014
NorwaySite Not Available
Investigational Site (191)
Caguas, 00725
Puerto RicoActive - Recruiting
Investigational Site (436)
Barcelona, Community Of Catalonia 08003
SpainSite Not Available
Investigational Site (439)
London, England E1 1BB
United KingdomSite Not Available
Investigational Site (501)
Phoenix, Arizona 85302
United StatesActive - Recruiting
Investigational Site (523)
Phoenix, Arizona 85016
United StatesActive - Recruiting
Investigational Site (524)
Tucson, Arizona 85712
United StatesActive - Recruiting
Investigational Site (506)
Valencia, California 91335
United StatesActive - Recruiting
Investigational Site (513)
Arvada, Colorado 80002
United StatesActive - Recruiting
Investigational Site (512)
Orlando, Florida 32806
United StatesActive - Recruiting
Investigational Site (525)
Tamarac, Florida 33321
United StatesActive - Recruiting
Investigational Site (502)
Lawrenceville, Georgia 30046
United StatesActive - Recruiting
The Johns Hopkins University School of Medicine
Baltimore, Maryland 21224
United StatesActive - Recruiting
Investigational Site (503)
Boston, Massachusetts 02115
United StatesActive - Recruiting
Washington University School of Medicine in St. Louis
Saint Louis, Missouri 63110
United StatesActive - Recruiting
Investigational Site (509)
Newark, New Jersey 07103
United StatesActive - Recruiting
Investigational Site (511)
Albany, New York 12209
United StatesActive - Recruiting
Investigational Site (508)
Brooklyn, New York 11203
United StatesActive - Recruiting
Investigational Site (518)
Bethlehem, Pennsylvania 18017
United StatesActive - Recruiting
Investigational Site (118)
Colleyville, Texas 76034
United StatesActive - Recruiting
Investigational Site (516)
Houston, Texas 77054
United StatesActive - Recruiting
Investigational Site (526)
Irving, Texas 75061
United StatesActive - Recruiting
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