Evaluation of Efficacy of Povetacicept in Adults With Immunoglobulin A Nephropathy (IgAN)
- Conditions
- Immunoglobulin A Nephropathy
- Interventions
- Drug: Placebo (matched to Povetacicept)
- Registration Number
- NCT06564142
- Lead Sponsor
- Alpine Immune Sciences Inc, A Subsidiary of Vertex
- Brief Summary
The purpose of this study is to evaluate the efficacy of povetacicept in adult participants compared with placebo in reducing proteinuria and preserving renal function.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 480
- Diagnosed IgAN, with biopsy confirmation
- 24-hr proteinuria excretion โฅ1.0 g/day or 24-hour uPCR โฅ0.75 g/g
- Estimated glomerular filtration rate (eGFR) โฅ 30 mL/min/1.73m^2
- Stable angiotensin converting enzyme inhibitor (ACEi) or angiotensin II receptor blocker (ARBs) as per protocol specification
Key
- Have received any immunosuppressive treatment or procedures (including corticosteroids, oral immunosuppressive agents, B cell or plasma cell targeted therapies, complement targeted therapies, herbal medicines per protocol, and tonsillectomy) within a wash-out period per protocol
- Rapidly progressive glomerulonephritis with eGFR reduction >50% within 12 weeks of the start of screening
Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Povetacicept Povetacicept Participants will be randomized to receive Povetacicept. Placebo Placebo (matched to Povetacicept) Participants will be randomized to receive placebo matched to Povetacicept.
- Primary Outcome Measures
Name Time Method Change From Baseline in 24-hour Urine Protein to Creatinine Ratio (uPCR) at Week 36 From Baseline at Week 36 Total Estimated Glomerular Filtration Rate (eGFR) Slope Through Week 104 From Baseline Through Week 104
- Secondary Outcome Measures
Name Time Method Change From Baseline in eGFR at Week 104 From Baseline at Week 104 Time to Kidney Disease Progression Through Week 104 From Baseline Through Week 104 Kidney disease progression defined as greater than or equal to (โฅ) 30% decline in eGFR, end stage kidney disease, or death from kidney failure.
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Score at Week 104 From Baseline at Week 104
Trial Locations
- Locations (246)
The Catholic University of Korea Eunpyeong St. Mary's Hospital
๐ฐ๐ทSeoul, Korea, Republic of
FutureMeds - Soho Road Health Centre
๐ฌ๐งBirmingham, United Kingdom
Southmead Hospital
๐ฌ๐งBristol, United Kingdom
FutureMeds - CPS Research
๐ฌ๐งGlasgow, United Kingdom
Queen Elizabeth University Hospital - Glasgow
๐ฌ๐งGlasgow, United Kingdom
Tokyo Women's Medical University Hospital
๐ฏ๐ตTokyo, Japan
Hypertension & Nephrology Inc.
๐บ๐ธProvidence, Rhode Island, United States
South Carolina Clinical Research, LLC
๐บ๐ธOrangeburg, South Carolina, United States
Knoxville Kidney Center (KKC), PLLC
๐บ๐ธKnoxville, Tennessee, United States
Velocity Clinical Research
๐บ๐ธAbilene, Texas, United States
Introscience Research LLC
๐บ๐ธBellaire, Texas, United States
Dallas Renal Group
๐บ๐ธDallas, Texas, United States
Renal Disease Research Institute - Dallas
๐บ๐ธDallas, Texas, United States
Davita Clinical Research - El Paso
๐บ๐ธEl Paso, Texas, United States
Prolato Clinical Research Center
๐บ๐ธHouston, Texas, United States
Houston Medical Research Institute, LLC (FRENOVA)
๐บ๐ธHouston, Texas, United States
R & H Clinical Research
๐บ๐ธKaty, Texas, United States
North Texas Kidney Disease Associates
๐บ๐ธLewisville, Texas, United States
P&I Clinical Research, LLC
๐บ๐ธLufkin, Texas, United States
Renal Specialists of Houston
๐บ๐ธPasadena, Texas, United States
Utah Kidney Research Institute
๐บ๐ธSalt Lake City, Utah, United States
University of Vermont
๐บ๐ธBurlington, Vermont, United States
Sunshine Coast University Hospital
๐ฆ๐บBirtinya, Australia
YUUAI Medical Center
๐ฏ๐ตTomigusuku, Japan
Virginia Nephrology Group
๐บ๐ธFairfax, Virginia, United States
Toyama Prefectural Central Hospital
๐ฏ๐ตToyama-shi, Japan
Juntendo Uni Urayasu Hospital
๐ฏ๐ตUrayasu-shi, Japan
The Catholic University of Korea, Seoul ST. Mary's Hospital
๐ฐ๐ทSeoul, Korea, Republic of
Ajou University Hospital
๐ฐ๐ทSuwon, Korea, Republic of
Paula Stradina Clinical University Hospital
๐ฑ๐ปRiga, Latvia
Hospital of Lithuanian University of Health Sciences (LSMU) Kauno klinikos
๐ฑ๐นKaunas, Lithuania
Vilnius University Hospital Santaros Klinikos
๐ฑ๐นVilnius, Lithuania
Arke SMO SA de CV
๐ฒ๐ฝVeracruz, Mexico
University Medical Center Groningen
๐ณ๐ฑGroningen, Netherlands
UMC St. Radboud
๐ณ๐ฑNijmegen, Netherlands
Haukeland University Hospital
๐ณ๐ดBergen, Norway
Oslo University Hospital - Ulleval Hospital
๐ณ๐ดOslo, Norway
SCM Sp. Z o.o
๐ต๐ฑKrakow, Poland
Panstwowy Instytut Medyczny MSWiA - Klinika Chorob Wewnetrznych, Nefrologii i Transplantologii
๐ต๐ฑWarszawa, Poland
Velocity Zamosc
๐ต๐ฑZamosc, Poland
Hospital Universitari Arnau de Vilanova - Lleida
๐ช๐ธLleida, Spain
Clinica Universidad de Navarra - Madrid
๐ช๐ธMadrid, Spain
Hospital Fundacion Jimenez Diaz
๐ช๐ธMadrid, Spain
Hospital Universitario Puerta de Hierro
๐ช๐ธMadrid, Spain
Hospital Universitario Ramon y Cajal
๐ช๐ธMadrid, Spain
Clinica Universidad de Navarra - Pamplona
๐ช๐ธPamplona, Spain
Hospital Clinico Universitario de Santiago
๐ช๐ธSantiago de Compostela, Spain
Hospital Universitario Virgen Macarena
๐ช๐ธSevilla, Spain
Kidney and Hypertension Specialist PLLC
๐บ๐ธManassas, Virginia, United States
Grampians Health Ballarat
๐ฆ๐บBallarat, Australia
Bendigo Hospital
๐ฆ๐บBendigo, Australia
Core Research Group Pty Ltd
๐ฆ๐บBrisbane, Australia
Royal Prince Alfred Hospital
๐ฆ๐บCamperdown, Australia
Monash Health
๐ฆ๐บClayton, Australia
Concord Repatriation General Hospital
๐ฆ๐บConcord, Australia
Renal Research Gosford
๐ฆ๐บGosford, Australia
Austin Hospital
๐ฆ๐บHeidelberg, Australia
Western Health (Sunshine Hospital)
๐ฆ๐บMelbourne, Australia
Fiona Stanley Hospital
๐ฆ๐บMurdoch, Australia
John Hunter Hospital
๐ฆ๐บNewcastle, Australia
Melbourne Renal Research
๐ฆ๐บReservoir, Australia
Medizinische Universitaet Wien
๐ฆ๐นVienna, Austria
LKH Feldkirch
๐ฆ๐นFeldkirch, Austria
Hallym University Sacred Heart Hospital
๐ฐ๐ทAnyang, Korea, Republic of
Seoul National University Hospital
๐ฐ๐ทCheonan, Korea, Republic of
Klinikum Wels- Grieskirchen
๐ฆ๐นWels-Grieskirchen, Austria
Hospital Evangelico de Belo Horizonte
๐ง๐ทBelo Horizonte, Brazil
St. Josephs Healthcare - Hamilton
๐จ๐ฆHamilton, Canada
Taian City Central Hospital
๐จ๐ณTaian, China
Beijing Tsinghua Changgung Hospital
๐จ๐ณBeijing, China
Peking University First Hos
๐จ๐ณBeijing, China
Cangzhou People's Hospital
๐จ๐ณCangzhou, China
Yichang central people Hos
๐จ๐ณYichang, China
Soon Chun Hyang University Cheonan Hospital
๐ฐ๐ทCheonan, Korea, Republic of
Keimyung University Dongsan Medical Center
๐ฐ๐ทDaegu, Korea, Republic of
Kyungpook National University Hospital
๐ฐ๐ทDaegu, Korea, Republic of
Hacettepe University Hospital
๐น๐ทAnkara, Turkey
The Second Norman Bethune Hospital of Jilin University
๐จ๐ณChangchun, China
Heping Hospital Affiliated to Changzhi Medical College
๐จ๐ณChangzhi, China
Sichuan People s Hospital
๐จ๐ณChengdu, China
Hospital Universitario Doctor Peset
๐ช๐ธValencia, Spain
Nephrology Clinic, Danderyd University Hospital
๐ธ๐ชDanderyd, Sweden
Sahlgrenska University Hospital
๐ธ๐ชGoteborg, Sweden
Karolinska University Hospital Huddinge
๐ธ๐ชHuddinge, Sweden
Shuang Ho Hospital
๐จ๐ณNew Taipei City, Taiwan
Tungs' Taichung Metroharbour Hospital
๐จ๐ณTaichung, Taiwan
Bishan Hospital of Chongqing
๐จ๐ณChongqing, China
The Second Affiliated Hospital of Chongqing Medical University
๐จ๐ณChongqing, China
Dongguan People s Hospital
๐จ๐ณDongguan, China
Konyang University Hospital
๐ฐ๐ทDaejeon, Korea, Republic of
Hallym University Chuncheon Sacred Heart Hospital
๐ฐ๐ทGangwon-do, Korea, Republic of
Wonju Severance Christian Hospital
๐ฐ๐ทGangwon-do, Korea, Republic of
The First People's Hospital of Foshan
๐จ๐ณFoshan, China
Fuyang People's Hospital
๐จ๐ณFuyang City, China
Fujian Medical University Union Hospital
๐จ๐ณFuzhou, China
Barts Health NHS Trust
๐ฌ๐งLondon, United Kingdom
Guangdong Provincial People's Hospital
๐จ๐ณGuangzhou, China
The First Affiliated Hospital of Guangzhou Medical University
๐จ๐ณGuangzhou, China
Third Affiliated Hospital of Southern Medical University
๐จ๐ณGuangzhou, China
Zhujiang Hospital, Southern Medical University
๐จ๐ณGuangzhou, China
Affiliated Hospital of Guilin Medical University
๐จ๐ณGuilin, China
Guizhou Provincial People's Hospital
๐จ๐ณGuiyang, China
King's College Hospital
๐ฌ๐งLondon, United Kingdom
St Pancras Clinical Research
๐ฌ๐งLondon, United Kingdom
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
๐จ๐ณHangzhou, China
The First Affiliated Hospital of Anhui Medical University
๐จ๐ณHefei, China
The Second Affiliated Hospital of Anhui Medical University
๐จ๐ณHefei, China
The Affiliated Hospital of Inner Mongolia Medical University
๐จ๐ณHohhot, China
NHIS Ilsan Hospital
๐ฐ๐ทGoyang-si, Korea, Republic of
Linkoping University Hospital
๐ธ๐ชLinkรถping, Sweden
Taipei Medical University Hospital
๐จ๐ณTaipei, Taiwan
Kocaeli University Medical School
๐น๐ทKocaeli, Turkey
FutureMeds Liverpool
๐ฌ๐งWirral (Liverpool), United Kingdom
The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)
๐จ๐ณJinan, China
The Second Hospital of Shandong University
๐จ๐ณJinan, China
Linyi People's Hospital
๐จ๐ณLin Yi City, China
The First Affiliated Hospital of Nanchang University
๐จ๐ณNanchang, China
Affiliated Hospital of Nantong University
๐จ๐ณNantong City, China
Ningbo No.2 Hospital
๐จ๐ณNingbo, China
The First Affiliated Hospital of Ningbo University
๐จ๐ณNingbo, China
Uppsala University Hospital
๐ธ๐ชUppsala, Sweden
The First Affiliated Hospital of Xian JiaoTong University
๐จ๐ณShaanxi, China
Shanghai General Hospital
๐จ๐ณShanghai, China
Shengjing Hospital of China Medical University
๐จ๐ณShenyang, China
The University of Hong Kong - Shenzhen Hospital
๐จ๐ณShenzhen, China
The Second Hospital of Hebei Medical University
๐จ๐ณShijiazhuang, China
Seoul National University Bundang Hospital
๐ฐ๐ทSeongnam-si, Korea, Republic of
Asan Medical Center
๐ฐ๐ทSeoul, Korea, Republic of
Chung-Ang University Hospital
๐ฐ๐ทSeoul, Korea, Republic of
Konkuk University Medical Center
๐ฐ๐ทSeoul, Korea, Republic of
Second Hospital of Shanxi Medical University
๐จ๐ณTaiyuan, China
The Second Hospital of Tianjin Medical University
๐จ๐ณTianjin, China
Wuxi People s Hospital
๐จ๐ณWuxi, China
Xuancheng People s Hospital
๐จ๐ณXuancheng, China
Yancheng No. 1 People's Hospital
๐จ๐ณYancheng City, China
Affiliated Hospital Yangzhou University
๐จ๐ณYangzhou City, China
Yantai YuHuangDing Hospital
๐จ๐ณYantai, China
Clinical Hospital Dubrava
๐ญ๐ทZagreb, Croatia
Vseobecna fakultni nemocnice v Praze
๐จ๐ฟNove Mesto, Czechia
Nemocnice AGEL Novy Jicin a.s.
๐จ๐ฟNovรฝ Jiฤรญn, Czechia
Aalborg University Hospital
๐ฉ๐ฐAalborg, Denmark
Center for Cancer and Organ Diseases - Rigshospitalet - Hornum Mads
๐ฉ๐ฐCopenhagen, Denmark
North Estonia Medical Centre Foundation
๐ช๐ชTallin, Estonia
Tartu University Hospital
๐ช๐ชTartu, Estonia
Groupe Hospitalier Pellegrin, CHU De Bordeaux
๐ซ๐ทBordeaux, France
Hopitaux Universitaires Henri Mondor
๐ซ๐ทCreteil, France
Centre Hospitalier Emile Roux
๐ซ๐ทLe Puy-en-Velay, France
AP-HM - Hopital de La Conception
๐ซ๐ทMarseille, France
CHU de Nantes - Hotel-Dieu
๐ซ๐ทNantes, France
Hopital Necker - Enfants Malades
๐ซ๐ทParis, France
Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord
๐ซ๐ทSt Priest en Jarez, France
Centre Hospitalier de Valencienes
๐ซ๐ทValenciennes, France
Charite Universitaetsnedizin Berlin
๐ฉ๐ชBerlin, Germany
Queen Mary Hospital
๐ญ๐ฐHong Kong, Hong Kong
Apogee Clinical Research, LLC
๐บ๐ธHuntsville, Alabama, United States
Arizona Kidney Disease and Hypertension Center - Thomas Office
๐บ๐ธPhoenix, Arizona, United States
Prince Wales Hospital
๐ญ๐ฐShatin, Hong Kong
Tung Wah Hospital
๐ญ๐ฐSheung Wan, Hong Kong
FutureMeds Newcastle
๐ฌ๐งNewcastle-Upon-Tyne, United Kingdom
Pecsi Tudomanyegyetem Klinikai Kozpont
๐ญ๐บPecs, Hungary
Barzilai Medical Center
๐ฎ๐ฑAshkelon, Israel
Rabin Medical Center
๐ฎ๐ฑPetah Tivka, Israel
Arizona Kidney Disease and Hypertension Center - Tuscon
๐บ๐ธTucson, Arizona, United States
West Coast Kidney
๐บ๐ธFremont, California, United States
CARE Institute - Carabello Kidney
๐บ๐ธLos Angeles, California, United States
Sheba Medical Center
๐ฎ๐ฑTel Hashomer, Israel
Shamir Medical Center
๐ฎ๐ฑZerifin, Israel
Providence Medical Foundation - Orange
๐บ๐ธOrange, California, United States
Ospedale Policlinico San Martino IRCCS
๐ฎ๐นGenova, Italy
Istituti Clinici Scientifici Maugeri-IRCCS Pavia
๐ฎ๐นPavia, Italy
Fujita Health University Hos
๐ฏ๐ตAichi, Japan
Hyogo Amagasaki Gen Med Ctr
๐ฏ๐ตAmagasaki, Japan
Western Nephrology
๐บ๐ธArvada, Colorado, United States
Colorado Kidney Care
๐บ๐ธDenver, Colorado, United States
Fukuoka University Hospital
๐ฏ๐ตFukuoka, Japan
Dokkyo Medical University Saitama Medical Center
๐ฏ๐ตKoshigaya, Japan
National Taiwan University Hospital (NTUH)
๐จ๐ณTaipei, Taiwan
Japanese Red Cross Fukuoka Hospital
๐ฏ๐ตFukuoka, Japan
Nephrology Associates Delaware Kidney
๐บ๐ธNewark, Delaware, United States
FutureMeds Tesside
๐ฌ๐งStockton on Tees, United Kingdom
South Florida Nephrology Group PA, Research Div.
๐บ๐ธCoral Springs, Florida, United States
Nihon University Itabashi Hospital
๐ฏ๐ตItabashi-ku, Japan
Kanazawa Medical Uni Hospital
๐ฏ๐ตKahoku, Japan
Kokura Memorial Hospital
๐ฏ๐ตKitakyushu-shi, Japan
Kobe University Hospital
๐ฏ๐ตKobe, Japan
Korea University Guro Hospital
๐ฐ๐ทSeoul, Korea, Republic of
Korea University Medical Center (KUMC)-Korea University Anam Hospital
๐ฐ๐ทSeoul, Korea, Republic of
Dolphin Medical Research
๐บ๐ธDoral, Florida, United States
Nephrology Associates of Central Florida
๐บ๐ธHollywood, Florida, United States
Kanazawa University Hospital
๐ฏ๐ตKanazawa, Japan
Nara Med University Hos
๐ฏ๐ตKashihara, Japan
Tectum Medical Research, LLC
๐บ๐ธHollywood, Florida, United States
South Florida Research Institute
๐บ๐ธLauderdale Lakes, Florida, United States
Florida Kidney Physicians - Melbourne
๐บ๐ธMelbourne, Florida, United States
Med-Care Research
๐บ๐ธMiami, Florida, United States
Professional Research Center
๐บ๐ธMiami, Florida, United States
Nephrology Associates of South Miami
๐บ๐ธMiami, Florida, United States
Kasugai Municipal Hospital
๐ฏ๐ตKasugai, Japan
On Health Research Center
๐บ๐ธMiami, Florida, United States
Combined Research Orlando Phase I-IV
๐บ๐ธOrlando, Florida, United States
BioResearch Partner
๐บ๐ธPembroke Pines, Florida, United States
D&H Pompano Research Center
๐บ๐ธPompano Beach, Florida, United States
Cordova Research Institute, LLC
๐บ๐ธSweetwater, Florida, United States
SciMerge Clinical Research
๐บ๐ธAtlanta, Georgia, United States
Georgia Nephrology - Lawrenceville
๐บ๐ธLawrenceville, Georgia, United States
Randomize Now - Midtown
๐บ๐ธNewnan, Georgia, United States
Care Institute - Chubbuck, ID
๐บ๐ธChubbuck, Idaho, United States
Care Institute - Idaho Falls
๐บ๐ธIdaho Falls, Idaho, United States
CARE - Boise Kidney Institute
๐บ๐ธMeridian, Idaho, United States
Okayama University Hospital
๐ฏ๐ตKita-ku, Japan
Japanese Red Cross Kyoto Daini Hospital
๐ฏ๐ตKyoto-shi, Japan
Kyoto University Hospital
๐ฏ๐ตKyoto, Japan
University of Miyazaki Hos
๐ฏ๐ตMiyazaki, Japan
Bioluminux Clinical Research
๐บ๐ธNaperville, Illinois, United States
Rockford Nephrology Associates
๐บ๐ธRockford, Illinois, United States
Nephrology Associates of Northern Illinois and Indiana (NANI)
๐บ๐ธIndianapolis, Indiana, United States
Nephrology Physicians LLC
๐บ๐ธMishawaka, Indiana, United States
Nephrology Associates of Kentuckiana
๐บ๐ธLouisville, Kentucky, United States
Renal Associates of Baton Rouge
๐บ๐ธBaton Rouge, Louisiana, United States
Velocity Clinical Research - Metairie
๐บ๐ธMetairie, Louisiana, United States
St. Clair Nephrology Research
๐บ๐ธShelby, Michigan, United States
Kyung Hee University Hospital at Gangdong (KUIMS)
๐ฐ๐ทSeoul, Korea, Republic of
InterMed Consultants / DaVita Clinical Research, Edina
๐บ๐ธEdina, Minnesota, United States
Mayo Clinic - Rochester
๐บ๐ธRochester, Minnesota, United States
Osaka City General Hospital
๐ฏ๐ตOsaka, Japan
Samsung Medical Center
๐ฐ๐ทSeoul, Korea, Republic of
Nephrology and Hypertension Associates, LTD
๐บ๐ธTupelo, Mississippi, United States
Somnos Clinical Research
๐บ๐ธLincoln, Nebraska, United States
DaVita Clinical Research Nevada - Las Vegas
๐บ๐ธLas Vegas, Nevada, United States
Bioluminux Clinical Research New Jersey
๐บ๐ธHamilton, New Jersey, United States
New Jersey Kidney Care, LLC (FRENOVA)
๐บ๐ธJersey City, New Jersey, United States
Renal Medicine Associates
๐บ๐ธAlbuquerque, New Mexico, United States
New York Nephrology Vasculitis and Glomerular Center
๐บ๐ธAlbany, New York, United States
Queens Hospital Center
๐บ๐ธJamaica, New York, United States
Metrolina Nephrology Associates
๐บ๐ธCharlotte, North Carolina, United States
Nephrology Associates Inc
๐บ๐ธEast Providence, Rhode Island, United States
Severance Hospital, Yonsei University Health System
๐ฐ๐ทSeoul, Korea, Republic of
Taipei Veterans General Hospital (TP-VGH)
๐จ๐ณTaipei, Taiwan
Osaka General Medical Center
๐ฏ๐ตOsaka, Japan
Sapporo City General Hospital
๐ฏ๐ตSapporo-shi, Japan
Tohoku University Tohoku University Hospital
๐ฏ๐ตSendai-shi, Japan
Juntendo Hospital Affiliated to Juntendo University School of Medicine
๐ฏ๐ตTokyo, Japan
Juntendo University Nerima Hospital
๐ฏ๐ตTokyo, Japan
The Jikei Uni Daisan Hospital
๐ฏ๐ตTokyo, Japan
The Jikei University Hospital
๐ฏ๐ตTokyo, Japan
Tokyo Med University Hospital
๐ฏ๐ตTokyo, Japan