Evaluation of Efficacy of Povetacicept in Adults With Immunoglobulin A Nephropathy (IgAN)
NCT ID: NCT06564142
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
605 participants
INTERVENTIONAL
2024-08-30
2028-01-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Povetacicept
Participants will be randomized to receive Povetacicept.
Povetacicept
Subcutaneous injection administration.
Placebo
Participants will be randomized to receive placebo matched to Povetacicept.
Placebo (matched to Povetacicept)
Placebo matched to Povetacicept subcutaneous injection administration.
Interventions
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Povetacicept
Subcutaneous injection administration.
Placebo (matched to Povetacicept)
Placebo matched to Povetacicept subcutaneous injection administration.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 24-hr proteinuria excretion ≥1.0 g/day or 24-hour uPCR ≥0.75 g/g
* Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m\^2
* Stable angiotensin converting enzyme inhibitor (ACEi) or angiotensin II receptor blocker (ARBs) as per protocol specification
Exclusion Criteria
* Rapidly progressive glomerulonephritis with eGFR reduction \>50% within 12 weeks of the start of screening
18 Years
ALL
No
Sponsors
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Alpine Immune Sciences Inc, A Subsidiary of Vertex
INDUSTRY
Responsible Party
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Locations
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Apogee Clinical Research, LLC
Huntsville, Alabama, United States
Arizona Kidney Disease and Hypertension Center - Thomas Office
Phoenix, Arizona, United States
Arizona Kidney Disease and Hypertension Center - Tuscon
Tucson, Arizona, United States
West Coast Kidney
Fremont, California, United States
The Medical Research Group, Inc. (FRENOVA)
Fresno, California, United States
CARE Institute - Carabello Kidney
Los Angeles, California, United States
Providence Medical Foundation - Orange
Orange, California, United States
National Nephrology Alliance Research
Riverside, California, United States
UC Davis Health
Sacramento, California, United States
Zuckerberg San Francisco General Hospital and Trauma Center
San Francisco, California, United States
University of California San Francisco (UCSF)
San Francisco, California, United States
Western Nephrology
Arvada, Colorado, United States
Colorado Kidney Care
Denver, Colorado, United States
Nephrology Associates Delaware Kidney (FRENOVA)
Newark, Delaware, United States
South Florida Nephrology Group PA, Research Div.
Coral Springs, Florida, United States
Dolphin Medical Research
Doral, Florida, United States
Nephrology Associates of Central Florida
Hollywood, Florida, United States
Tectum Medical Research, LLC
Hollywood, Florida, United States
South Florida Research Institute
Lauderdale Lakes, Florida, United States
Florida Kidney Physicians - Melbourne
Melbourne, Florida, United States
Med-Care Research
Miami, Florida, United States
Professional Research Center
Miami, Florida, United States
Nephrology Associates of South Miami
Miami, Florida, United States
On Health Research Center
Miami, Florida, United States
Combined Research Orlando Phase I-IV
Orlando, Florida, United States
BioResearch Partner
Pembroke Pines, Florida, United States
D&H Pompano Research Center
Pompano Beach, Florida, United States
Cordova Research Institute, LLC
Sweetwater, Florida, United States
SciMerge Clinical Research
Atlanta, Georgia, United States
Georgia Nephrology - Lawrenceville
Lawrenceville, Georgia, United States
Randomize Now - Midtown
Newnan, Georgia, United States
Care Institute - Chubbuck, ID
Chubbuck, Idaho, United States
Care Institute - Idaho Falls
Idaho Falls, Idaho, United States
CARE - Boise Kidney Institute
Meridian, Idaho, United States
Bioluminux Clinical Research
Naperville, Illinois, United States
Rockford Nephrology Associates
Rockford, Illinois, United States
Nephrology Associates of Northern Illinois and Indiana (NANI)
Indianapolis, Indiana, United States
Nephrology Physicians LLC
Mishawaka, Indiana, United States
Nephrology Associates of Kentuckiana
Louisville, Kentucky, United States
Renal Associates of Baton Rouge
Baton Rouge, Louisiana, United States
Velocity Clinical Research - Metairie
Metairie, Louisiana, United States
Johns Hopkins School of Medicine
Baltimore, Maryland, United States
St. Clair Nephrology Research
Shelby, Michigan, United States
InterMed Consultants / DaVita Clinical Research, Edina
Edina, Minnesota, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Nephrology and Hypertension Associates, LTD
Tupelo, Mississippi, United States
Washington University in St. Louis
St Louis, Missouri, United States
Somnos Clinical Research
Lincoln, Nebraska, United States
DaVita Clinical Research Nevada - Las Vegas
Las Vegas, Nevada, United States
Bioluminux Clinical Research New Jersey
Hamilton, New Jersey, United States
New Jersey Kidney Care, LLC (FRENOVA)
Jersey City, New Jersey, United States
Renal Medicine Associates
Albuquerque, New Mexico, United States
New York Nephrology Vasculitis and Glomerular Center
Albany, New York, United States
Queens Hospital Center
Jamaica, New York, United States
The Rogosin Institute
New York, New York, United States
Metrolina Nephrology Associates
Charlotte, North Carolina, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Nephrology Associates Inc
East Providence, Rhode Island, United States
Hypertension & Nephrology Inc.
Providence, Rhode Island, United States
South Carolina Clinical Research, LLC
Orangeburg, South Carolina, United States
Knoxville Kidney Center (KKC), PLLC
Knoxville, Tennessee, United States
Velocity Clinical Research
Abilene, Texas, United States
Introscience Research LLC
Bellaire, Texas, United States
Dallas Renal Group
Dallas, Texas, United States
Renal Disease Research Institute - Dallas
Dallas, Texas, United States
Davita Clinical Research - El Paso
El Paso, Texas, United States
Prolato Clinical Research Center
Houston, Texas, United States
Houston Medical Research Institute, LLC (FRENOVA)
Houston, Texas, United States
R & H Clinical Research
Katy, Texas, United States
North Texas Kidney Disease Associates
Lewisville, Texas, United States
P&I Clinical Research, LLC
Lufkin, Texas, United States
Renal Specialists of Houston
Pasadena, Texas, United States
Utah Kidney Research Institute
Salt Lake City, Utah, United States
University of Vermont
Burlington, Vermont, United States
Virginia Nephrology Group
Fairfax, Virginia, United States
Kidney and Hypertension Specialist PLLC
Manassas, Virginia, United States
Grampians Health Ballarat
Ballarat, , Australia
Bendigo Hospital
Bendigo, , Australia
Sunshine Coast University Hospital
Birtinya, , Australia
Core Research Group Pty Ltd
Brisbane, , Australia
Royal Prince Alfred Hospital
Camperdown, , Australia
Monash Health
Clayton, , Australia
Concord Repatriation General Hospital
Concord, , Australia
Canberra Hospital
Garran, , Australia
Renal Research Gosford
Gosford, , Australia
Austin Hospital
Heidelberg, , Australia
Western Health (Sunshine Hospital)
Melbourne, , Australia
Fiona Stanley Hospital
Murdoch, , Australia
John Hunter Hospital
Newcastle, , Australia
Sir Charles Gairdner Hospital
Perth, , Australia
Melbourne Renal Research
Reservoir, , Australia
Gold Coast University Clinical Trials Unit
Southport, , Australia
Princess Alexandra Hospital
Woolloongabba, , Australia
LKH Feldkirch
Feldkirch, , Austria
Medizinische Universitaet Innsbruck
Innsbruck, , Austria
Ordensklinikum Linz GmbH Elisabethinen
Linz, , Austria
Medizinische Universitaet Wien
Vienna, , Austria
Klinikum Wels- Grieskirchen
Wels-Grieskirchen, , Austria
Ziekenhuis Oost-Limburg
Genk, , Belgium
Universitaire Ziekenhuizen Leuven
Leuven, , Belgium
Centro de Pesquisa Clinica do Coracao
Aracaju, , Brazil
Freire Pesquisa Clinica
Belo Horizonte, , Brazil
Hospital Evangelico de Belo Horizonte
Belo Horizonte, , Brazil
Associacao Ampara a Saude
Brasília, , Brazil
HU Hospital Walter Cantidio
Fortaleza, , Brazil
UFG Hospital de Clinicas da Universidad Federal de Golas
Goiânia, , Brazil
Hospital de Caridade de Ijui
Ijuí, , Brazil
Fundacao Pro-Rim Santa Catarina
Joinville, , Brazil
Centro Mineiro de Pesquisa
Juiz de Fora, , Brazil
Hospital das Clinicas Riberao Preto
Monte Alegre, , Brazil
Hospital das Clinicas da Universidade Federal de Pernambuco (UFPE)
Recife, , Brazil
Hospital Universitario Pedro Ernesto - UERJ
Rio de Janeiro, , Brazil
Clinica Senhor do Bonfim
Salvador, , Brazil
Universidade Federal da Bahia
Salvador, , Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, , Brazil
Hospital do Rim Fundacao Oswaldo Ramos
São Paulo, , Brazil
Hospital Nove de Julho - DASA
São Paulo, , Brazil
A2z Clinical Centro Avancedo de Pesquisa Clinica
Valinhos, , Brazil
St. Josephs Healthcare - Hamilton
Hamilton, , Canada
Beijing Tsinghua Changgung Hospital
Beijing, , China
Peking University First Hos
Beijing, , China
Cangzhou People's Hospital
Cangzhou, , China
The Second Norman Bethune Hospital of Jilin University
Changchun, , China
Heping Hospital Affiliated to Changzhi Medical College
Changzhi, , China
Sichuan People s Hospital
Chengdu, , China
Bishan Hospital of Chongqing
Chongqing, , China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, , China
Dongguan People s Hospital
Dongguan, , China
The First People's Hospital of Foshan
Foshan, , China
Fuyang People's Hospital
Fuyang, , China
Fujian Medical University Union Hospital
Fuzhou, , China
Guangdong Provincial People's Hospital
Guangzhou, , China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, , China
Third Affiliated Hospital of Southern Medical University
Guangzhou, , China
Zhujiang Hospital, Southern Medical University
Guangzhou, , China
Affiliated Hospital of Guilin Medical University
Guilin, , China
Guizhou Provincial People's Hospital
Guiyang, , China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, , China
The First Affiliated Hospital of Anhui Medical University
Hefei, , China
The Second Affiliated Hospital of Anhui Medical University
Hefei, , China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, , China
The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)
Jinan, , China
The Second Hospital of Shandong University
Jinan, , China
Linyi People's Hospital
Linyi, , China
The First Affiliate Hospital of Henan University of Science and Technology
Luoyang, , China
The First Affiliated Hospital of Nanchang University
Nanchang, , China
Affiliated Hospital of Nantong University
Nantong, , China
Ningbo No.2 Hospital
Ningbo, , China
The First Affiliated Hospital of Ningbo University
Ningbo, , China
The First Affiliated Hospital of Xian JiaoTong University
Shaanxi, , China
Shanghai General Hospital
Shanghai, , China
Shengjing Hospital of China Medical University
Shenyang, , China
The University of Hong Kong - Shenzhen Hospital
Shenzhen, , China
The Second Hospital of Hebei Medical University
Shijiazhuang, , China
Taian City Central Hospital
Taian, , China
Second Hospital of Shanxi Medical University
Taiyuan, , China
The Second Hospital of Tianjin Medical University
Tianjin, , China
Wuxi People s Hospital
Wuxi, , China
Xuancheng People s Hospital
Xuancheng, , China
Yancheng No. 1 People's Hospital
Yancheng, , China
Affiliated Hospital Yangzhou University
Yangzhou, , China
Yantai YuHuangDing Hospital
Yantai, , China
Yichang central people Hos
Yichang, , China
General Hospital of Ningxia Medical University
Yinchuan, , China
Clinical Hospital Dubrava
Zagreb, , Croatia
Clinical Hospital Merkur
Zagreb, , Croatia
Polyclinic Somed
Zagreb, , Croatia
Fakultni Nemocnice Brno
Brno, , Czechia
Vseobecna fakultni nemocnice v Praze
New Town, , Czechia
Nemocnice AGEL Novy Jicin a.s.
Nový Jičín, , Czechia
Aalborg University Hospital
Aalborg, , Denmark
Center for Cancer and Organ Diseases - Rigshospitalet - Hornum Mads
Copenhagen, , Denmark
Hillerod Hospital
Hillerød, , Denmark
Sygehus Lillebaelt - Kolding
Kolding, , Denmark
North Estonia Medical Centre Foundation
Tallinn, , Estonia
Tartu University Hospital
Tartu, , Estonia
Tampere University Hospital
Tampere, , Finland
Groupe Hospitalier Pellegrin, CHU De Bordeaux
Bordeaux, , France
Hopitaux Universitaires Henri Mondor
Créteil, , France
Centre Hospitalier Emile Roux
Le Puy-en-Velay, , France
AP-HM - Hopital de La Conception
Marseille, , France
CHU de Nantes - Hotel-Dieu
Nantes, , France
Hopital Necker - Enfants Malades
Paris, , France
Université Paris-Descartes / Hôpital Européen Georges Pompidou
Paris, , France
Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord
Saint-Priest-en-Jarez, , France
Centre Hospitalier de Valencienes
Valenciennes, , France
Medizinische Klinik II
Aachen, , Germany
Charite Universitaetsnedizin Berlin
Berlin, , Germany
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, , Germany
Klinikum St Georg
Leipzig, , Germany
Universitaetsklinikum Leipzig
Leipzig, , Germany
Queen Mary Hospital
Hong Kong, , Hong Kong
Prince Wales Hospital
Shatin, , Hong Kong
Tung Wah Hospital
Sheung Wan, , Hong Kong
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, , Hungary
Cork University Hospital
Cork, , Ireland
Beaumont Hospital
Dublin, , Ireland
University Hospital Galway
Galway, , Ireland
University Hospital Waterford
Waterford, , Ireland
Barzilai Medical Center
Ashkelon, , Israel
Rabin Medical Center
Petah Tivka, , Israel
Sheba Medical Center
Tel Litwinsky, , Israel
Shamir Medical Center
Ẕerifin, , Israel
Azienda Ospedaliera Universitaria Consorziale - policlinicio Bari
Bari, , Italy
Ospedale Policlinico San Martino IRCCS
Genova, , Italy
AOU Policlinico di Modena
Modena, , Italy
Istituti Clinici Scientifici Maugeri-IRCCS Pavia
Pavia, , Italy
Fondazione Policlinico Universitario A. Gemelli
Rome, , Italy
Fujita Health University Hos
Aichi, , Japan
Hyogo Amagasaki Gen Med Ctr
Amagasaki, , Japan
Fukuoka University Hospital
Fukuoka, , Japan
Japanese Red Cross Fukuoka Hospital
Fukuoka, , Japan
Nihon University Itabashi Hospital
Itabashi-ku, , Japan
Kanazawa Medical Uni Hospital
Kahoku, , Japan
Kanazawa University Hospital
Kanazawa, , Japan
Nara Med University Hos
Kashihara, , Japan
Kasugai Municipal Hospital
Kasugai, , Japan
Okayama University Hospital
Kita-ku, , Japan
Kokura Memorial Hospital
Kitakyushu-shi, , Japan
Kobe University Hospital
Kobe, , Japan
Dokkyo Medical University Saitama Medical Center
Koshigaya, , Japan
Japanese Red Cross Kyoto Daini Hospital
Kyoto, , Japan
Kyoto University Hospital
Kyoto, , Japan
University of Miyazaki Hos
Miyazaki, , Japan
Osaka City General Hospital
Osaka, , Japan
Osaka General Medical Center
Osaka, , Japan
Sapporo City General Hospital
Sapporo, , Japan
Tohoku University Tohoku University Hospital
Sendai, , Japan
Juntendo Hospital Affiliated to Juntendo University School of Medicine
Tokyo, , Japan
Juntendo University Nerima Hospital
Tokyo, , Japan
The Jikei Uni Daisan Hospital
Tokyo, , Japan
The Jikei University Hospital
Tokyo, , Japan
Tokyo Med University Hospital
Tokyo, , Japan
Tokyo Women's Medical University Hospital
Tokyo, , Japan
YUUAI Medical Center
Tomigusuku, , Japan
Toyama Prefectural Central Hospital
Toyama, , Japan
Juntendo Uni Urayasu Hospital
Urayasu-shi, , Japan
Paula Stradina Clinical University Hospital
Riga, , Latvia
Vidzemes Hospital
Valmiera, , Latvia
Hospital of Lithuanian University of Health Sciences (LSMU) Kauno klinikos
Kaunas, , Lithuania
Vilnius University Hospital Santaros Klinikos
Vilnius, , Lithuania
Arke SMO SA de CV
Veracruz, , Mexico
University Medical Center Groningen
Groningen, , Netherlands
UMC St. Radboud
Nijmegen, , Netherlands
Haukeland University Hospital
Bergen, , Norway
Oslo University Hospital - Ulleval Hospital
Oslo, , Norway
SCM Sp. Z o.o
Krakow, , Poland
Klinika Nefrologii, Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi
Lodzkie, , Poland
Uniwersytecki Szpital Kliniczny nr 2 PUM w Szczecinie
Szczecin, , Poland
Panstwowy Instytut Medyczny MSWiA - Klinika Chorob Wewnetrznych, Nefrologii i Transplantologii
Warsaw, , Poland
Velocity Zamosc
Zamość, , Poland
King Fahad Specialist Hospital, Dammam
Dammam, , Saudi Arabia
King Saud University, King Saud University Medical City
Riyadh, , Saudi Arabia
Hallym University Sacred Heart Hospital
Anyang, , South Korea
Seoul National University Hospital
Cheonan, , South Korea
Soon Chun Hyang University Cheonan Hospital
Cheonan, , South Korea
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Kyungpook National University Hospital
Daegu, , South Korea
Konyang University Hospital
Daejeon, , South Korea
Hallym University Chuncheon Sacred Heart Hospital
Gangwon-do, , South Korea
Wonju Severance Christian Hospital
Gangwon-do, , South Korea
NHIS Ilsan Hospital
Goyang-si, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Asan Medical Center
Seoul, , South Korea
Chung-Ang University Hospital
Seoul, , South Korea
Konkuk University Medical Center
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Korea University Medical Center (KUMC)-Korea University Anam Hospital
Seoul, , South Korea
Kyung Hee University Hospital at Gangdong (KUIMS)
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
The Catholic University of Korea Eunpyeong St. Mary's Hospital
Seoul, , South Korea
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
Yongin Severance Hospital
Yongin-si, , South Korea
Hospital Universitari de Bellvitge
Barcelona, , Spain
Hospital Universitatio Vall d'Hebron
Barcelona, , Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Hospital Universitari Arnau de Vilanova - Lleida
Lleida, , Spain
Clinica Universidad de Navarra - Madrid
Madrid, , Spain
Hospital Fundacion Jimenez Diaz
Madrid, , Spain
Hospital Universitario Puerta de Hierro
Madrid, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Clinica Universidad de Navarra - Pamplona
Pamplona, , Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Universitario Doctor Peset
Valencia, , Spain
Nephrology Clinic, Danderyd University Hospital
Danderyd, , Sweden
Sahlgrenska University Hospital
Gothenburg, , Sweden
Karolinska University Hospital Huddinge
Huddinge, , Sweden
Linkoping University Hospital
Linköping, , Sweden
Uppsala University Hospital
Uppsala, , Sweden
Shuang Ho Hospital
New Taipei City, , Taiwan
Tungs' Taichung Metroharbour Hospital
Taichung, , Taiwan
National Taiwan University Hospital (NTUH)
Taipei, , Taiwan
Taipei Medical University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital (TP-VGH)
Taipei, , Taiwan
Hacettepe University Hospital
Ankara, , Turkey (Türkiye)
Istanbul University Cerrahpasa Medical Faculty
Istanbul, , Turkey (Türkiye)
Kocaeli University Medical School
Kocaeli, , Turkey (Türkiye)
Belfast Health and Social Care Trust
Belfast, , United Kingdom
FutureMeds - Soho Road Health Centre
Birmingham, , United Kingdom
Southmead Hospital
Bristol, , United Kingdom
Cambridge University - Addenbrooke's Hospital
Cambridge, , United Kingdom
FutureMeds - CPS Research
Glasgow, , United Kingdom
Queen Elizabeth University Hospital - Glasgow
Glasgow, , United Kingdom
Gloucestershire Royal Hospital
Gloucester, , United Kingdom
Leicester General Hospital
Leicester, , United Kingdom
Barts Health NHS Trust
London, , United Kingdom
Imperial College Healthcare NHS Trust
London, , United Kingdom
King's College Hospital
London, , United Kingdom
St Pancras Clinical Research
London, , United Kingdom
University of Manchester, Manchester Royal Infirmary
Manchester, , United Kingdom
FutureMeds Newcastle
Newcastle upon Tyne, , United Kingdom
FutureMeds Tesside
Stockton-on-Tees, , United Kingdom
FutureMeds Liverpool
Wirral (Liverpool), , United Kingdom
Royal Wolverhampton NHS Trust
Wolverhampton, , United Kingdom
Countries
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Other Identifiers
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2024-514135-17-00
Identifier Type: OTHER
Identifier Source: secondary_id
VX24-AIS-D08
Identifier Type: -
Identifier Source: org_study_id