A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy
A Phase 3 Multicenter, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate Efficacy and Safety of Mezagitamab (TAK-079) in Study Participants With Primary IgA Nephropathy in Combination With Stable Background Therapy
2 other identifiers
interventional
347
25 countries
150
Brief Summary
Immunoglobulin A nephropathy (IgAN) is a kidney condition. It happens when the body's immune system creates groups of proteins (called immune complexes) that build-up in the kidneys causing swelling (inflammation). Over time, this inflammation may lead to kidney damage and cause the kidneys to no longer work properly. The main aim of this study is to check how well mezagitamab changes protein levels in the urine (proteinuria) compared to placebo in adults with primary IgAN. A placebo looks like medicine but doesn't have any active ingredients in it. Other aims are to check how safe mezagitamab is and how well participants with primary IgAN can tolerate it compared to placebo, and to find out if and how well mezagitamab continues to maintain kidney function over the long term compared to placebo. Participants will be placed in 1 of the 2 treatment groups; the main group and the open-label group. In the main group, participants will be placed in 1 of the 2 treatment groups by chance (either mezagitamab or placebo) at a 2:1 ratio. This means that out of 3 participants, 2 will receive mezagitamab and 1 will receive placebo. The participants will receive either mezagitamab or placebo for almost half a year in two 1-year cycles. They will be observed for another half year in each 1-year cycle and will have check-ups about every month during this time. In the open-label group, a small number of participants who have lower levels of protein in their urine or have kidneys that do not filter the blood well, will receive mezagitamab treatment. This will include participants who have previously received mezagitamab in another study, TAK-079-1006. Every participant will receive mezagitamab in the same way as those in the main group receiving mezagitamab. During the study, participants will visit their study clinic several times.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2025
Longer than P75 for phase_3
150 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2025
CompletedFirst Posted
Study publicly available on registry
May 9, 2025
CompletedStudy Start
First participant enrolled
July 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 7, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 14, 2030
May 6, 2026
May 1, 2026
3.2 years
April 30, 2025
May 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline in Proteinuria at Week 36
Proteinuria will be assessed by urine protein to creatinine ratio (UPCR) calculated from a 24-hour urine collection.
From Baseline to Week 36
Secondary Outcomes (5)
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52 and 104, Respectively
From Baseline to Weeks 52 and 104
The Rate of Change in eGFR From Baseline at Week 104
From Baseline to Week 104
Time From Baseline to the First Occurrence of Sustained Decline in eGFR of ≥30 Percent (%) From Baseline Over at Least 4 Weeks
From Baseline to Week 104
Time from Baseline to the First Occurrence of Any of the Pre-specified Kidney Failure Composite Assessment Criteria
From Baseline to Week 104
Change from Baseline in Proteinuria Levels at Weeks 52 and 104
From Baseline to Weeks 52 and 104
Study Arms (3)
Mezagitamab
EXPERIMENTALParticipants will receive mezagitamab injections, subcutaneously (SC), for approximately 22 weeks in each 52-week period.
Placebo
PLACEBO COMPARATORParticipants will receive mezagitamab-matching placebo injections, SC for approximately 22 weeks in each 52-week period.
Open-label Mezagitamab
EXPERIMENTALParticipants will receive mezagitamab injections, SC for approximately 22 weeks in each 52-week period.
Interventions
Mezagitamab injections administered SC.
Eligibility Criteria
You may qualify if:
- To be eligible to participate in this trial, participants must meet all the following criteria:
- Either UPCR greater than or equal to (≥) 0.8 gram per gram (g/g) or urine protein excretion (UPE) ≥1 grams per day (g/day), calculated from at least one 24-hour urine collection during the screening period (or pre-screening, if applicable) (only applicable for the main trial).
- eGFR greater than (\>)30 milliliters per minute per 1.73 meter square (mL/min/1.73m\^2) at screening based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula (only applicable for the main trial).
- The participant is aged ≥ 18 years or the local legal age as applicable.
- The participant (and the participant's legally acceptable representative, as applicable per local regulations or determination) has provided informed consent (that is, in writing, documented via a signed and dated informed consent form \[ICF\]) and any required privacy authorization before the initiation of any clinical trial procedures.
- Diagnosis of primary immunoglobulin A nephropathy (IgAN) supported by a renal biopsy report that is dated more recently than 10 years before the signing of the informed consent for the clinical trial. The redacted report must be made available for review. A renal biopsy must be performed during screening for participants without a biopsy report within 10 years.
- Participants must be on stable renin-angiotensin-aldosterone system (RAAS) inhibitor therapy with an angiotensin-converting enzyme inhibitor (ACE-I) and/or angiotensin receptor blocker (ARB) or endothelin receptor antagonist (ERA) or mineralocorticoid receptor antagonist (MRA) agent for at least 12 weeks before signing the ICF with dosing at the maximally tolerated or labeled dose as determined by the investigator, with the intent to continue stable dosing during the clinical trial. Those intolerant of RAAS inhibitor therapy are potentially eligible after consultation with the medical monitor. Intolerance is defined as a documented side effect causing discontinuation of the therapy.
- Resting blood pressure less than or equal to (≤)150 millimeters of mercury (mmHg) systolic and ≤100 mmHg diastolic.
- Female participants of childbearing potential who are not pregnant during screening (confirmed by negative serum human chorionic gonadotropin \[hCG\]) and on Visit 1 before first dose of trial intervention (confirmed by negative urine pregnancy test).
- Any one of the following (only applicable for participants in the open-label cohort):
- Participants in Trial TAK-079-1006 who completed the Week 96 visit or the retreatment period with either UPCR \>0.5 g/g or UPE \>0.5 g/d calculated from a 24-hour urine collection during the screening period (or pre-screening, if applicable) and eGFR \>30 mL/min/1.73m\^2 at screening based on the CKD-EPI formula.
- UPCR \<0.8 g/g and UPE ≥0.75 and \<1.0 g/day, by 24-hour urine collection during the screening period (or pre-screening, if applicable) and eGFR \> 30 mL/min/1.73m\^2 at screening based on the CKD-EPI formula.
- UPCR ≥ 0.8 g/g or UPE ≥ 1.0 g/d by 24-hour urine collection during the screening period (or pre-screening, if applicable) and eGFR ≥25 and ≤30 mL/min/1.73m\^2 at screening based on the CKD-EPI formula.
You may not qualify if:
- A participant who meets any of the following criteria will be excluded from participation in this trial:
- Kidney biopsy exhibiting significant concomitant renal disease other than IgAN (for example, diabetic nephropathy, lupus nephritis, minimal change disease).
- Secondary IgAN (such as with significant liver disease, inflammatory bowel disease, and seronegative spondyloarthropathies), and immunoglobulin A (IgA) vasculitis.
- Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR within 3 months before the signing of the ICF).
- Diagnosis of nephrotic syndrome defined as 24-hour proteinuria \>3.5 g/day and hypoalbuminemia (\<3.0 grams per deciliter \[g/dL\]) with or without peripheral edema.
- Renal or other organ transplantation prior to or expected during the clinical trial.
- Treatment with oral immunosuppressive agents (including cyclophosphamide, mycophenolate mofetil, cyclosporine, azathioprine, calcineurin inhibitors) or biologic therapy for immunomodulation (including immunomodulatory monoclonal or polyclonal antibodies) within 6 months (both B-cell and non-B-cell directed agents) before signing of the ICF.
- If the participant has received anti-CD20 treatment, the participant is excluded if either of the following apply:
- The last dose was received within 6 months before the signing of the ICF.
- The last dose was received between 6 and 12 months before the signing of the ICF and the participant has a CD19+ count below the lower limit of normal.
- Note: Participants who have received the last dose of anti-CD20 treatment \>12 months before the signing of the ICF are not excluded from clinical trial participation based on this criterion and are not required to undergo CD19+ testing.
- Within 4 months of the screening visit, use of either a) systemic corticosteroids at an average dose of 40 milligrams (mg) prednisone equivalent or higher for more than 14 days or b) oral budesonide delayed release capsules.
- The participant has received a live or live-attenuated vaccine within 4 weeks before signing the ICF or has any live or live-attenuated vaccine planned during the clinical trial.
- Participation in any other investigational drug trial (including vaccine trial) with receipt of at least 1 dose of investigational drug, or has been exposed to another investigational agent within 4 weeks or 5 half-lives, whichever is longer, before Visit 1.
- The participant has active infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (153)
UAB Nephrology Research Clinic at Paula Building
Birmingham, Alabama, 35233-2110, United States
DCR Montgomery
Montgomery, Alabama, 36117, United States
Panoramic Health - Southwest Kidney Institute, PLC
Surprise, Arizona, 85374, United States
Panoramic Health - West Coast Kidney Institute (Fremont)
Fremont, California, 94538, United States
Academic Medical Research Institute
Los Angeles, California, 90022, United States
University of California Irvine
Orange, California, 92868-3201, United States
South Florida Research Institute
Lauderdale Lakes, Florida, 33313-1607, United States
Bioresearch Partners
Miami, Florida, 33127, United States
CTR Oakwater, LLC
Orlando, Florida, 32806, United States
Bioresearch Partners
Pembroke Pines, Florida, 33029, United States
Panoramic Health - Florida Kidney Physicians, LLC (Tampa)
Riverview, Florida, 33578, United States
DCR Columbus
Columbus, Georgia, 31904, United States
CARE Institute - Boise Kidney
Boise, Idaho, 83706, United States
Northwest Louisiana Nephrology
Shreveport, Louisiana, 71101, United States
Ingham Nephrology & Hypertension, P.C.
Lansing, Michigan, 48911, United States
Elixia MKC
Pontiac, Michigan, 48341, United States
DCR Edina
Edina, Minnesota, 55435, United States
Elixia MNA
City of Saint Peters, Missouri, 63376, United States
Clinical Research Consultants a JCCT Company
Kansas City, Missouri, 64111, United States
Brookview Hills Research Associates, LLC
Winston-Salem, North Carolina, 27103, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Panoramic Health - Nephrology Associates, Inc.
East Providence, Rhode Island, 02914, United States
Dallas Renal Group
Dallas, Texas, 75230, United States
DCR - El Paso
El Paso, Texas, 79902, United States
Houston Methodist Research Institute - Department of Medicine
Houston, Texas, 77030, United States
Provecta Research Network
Houston, Texas, 77054, United States
Nephrology Associates of Houston PLLC
Katy, Texas, 77450, United States
Sun Research Institute
San Antonio, Texas, 78215, United States
DCR San Antonio
San Antonio, Texas, 78251, United States
Utah Kidney Research Institute
Salt Lake City, Utah, 84115, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1425AGC, Argentina
Framingham Centro Medico
Buenos Aires, La Plata, 1902, Argentina
Hospital Britanico de Buenos Aires
Ciudad Autonoma Buenos Aires, 1280, Argentina
Clinica Privada Velez Sarsfield
Córdoba, X5016, Argentina
Core Research Group
Milton, Queensland, 4046, Australia
Eastern Health
Box Hill, Victoria, 3128, Australia
Western Health Sunshine Hospital
St Albans, Victoria, 3021, Australia
Johannes Kepler Universitat Linz, Universitatsklinik fur Innere 2
Linz, 4040, Austria
Medizinische Universitat Wien (Medical University of Vienna - Austria)
Vienna, 1090, Austria
Sheldon M. Chumir Health Centre
Calgary, Alberta, T2R 0X7, Canada
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Beijing Tsinghua Changgung Hospital
Changping, Beijing Municipality, 102218, China
Zhongshan Hospital Xiamen University
Xiamen, Fujian, 361004, China
Guangdong General Hospital
Guangzhou, Guangdong, 510080, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518000, China
The Third Xiangya Hospital of Central South University Yuelu District
Changsha, Hunan, 410013, China
The First Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia, 14010, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226001, China
Wuxi People's Hospital
Wuxi, Jiangsu, 214023, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
Shandong University - Qilu Hospital
Jinan, Shandong, 250012, China
Shanghai Jiao Tong University School of Medicine (SJTUSM) - Renji Hospital - Eastern Branch
Shanghai, Shanghai Municipality, 200000, China
Ruijin Hospital of Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
West China Hospital Sichuan University
Chengdu, Sichuan, 610000, China
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
The Second People's Hospital of Yibin
Yibin, Sichuan, 644099, China
The Second Affiliated Hospital, Zhejiang University, School of Medicine
Hangzhou, Zhejiang, 310009, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315010, China
Nemocnice AGEL Novy Jicin a.s
Nový Jičín, Moravskoslezsk Kraj, 741 01, Czechia
Hospital Henri Mondor
Créteil, Paris, 94000, France
CHU Bordeaux, CHU Pellegrin
Bordeaux, 33076, France
CHU Limoges Service de Nephrology
Limoges, 87042, France
Centre Hospitalier Universitaire de Montpellier (CHU Montpellier) - Hopital Lapeyronie
Montpellier, 34090, France
CHU de Nantes
Nantes, 44093, France
Hospital Tenon
Paris, 75020, France
Uniklinik RWTH Aachen
Aachen, North Rhine-Westphalia, 52074, Germany
Universitaetsklinikum Jena
Jena, Thuringia, 7747, Germany
Universitaetsmedizin der Johannes - Gutenberg Universitaet Mainz
Mainz, 55131, Germany
The University of Hong Kong - Department of Medicine
Hong Kong, Hong Kong Island, Hong Kong
Semmelweis Egyetem - Belgyogyaszati es Onkologiai Klinika (I.sz. Belgyogyaszati Klinika)
Budapest, 1083, Hungary
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138, Italy
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
Brescia, 25124, Italy
IRCCS Ospedale Policlinico San Martino
Genoa, 16132, Italy
Az Ospedaliera Universitaria Policlinico G Martino
Messina, 98122, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, 20100, Italy
Istituto Maugeri IRCCS Pavia
Pavia, 27100, Italy
Azienda Unita Sanitaria Locale Piacenza (AUSL) Ospedale "Guglielmo da Saliceto
Piacenza, 29121, Italy
Kasugai Municipal Hospital
Kasugai-Shi, Aichi-ken, 486-8510, Japan
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Nagoya, Aichi-ken, 466-8650, Japan
Fujita Health University Hospital
Toyoake-shi, Aichi-ken, 470-1192, Japan
National Hospital Organization Chiba Medical Center Chibahigashi National Hospital
Chiba, Chiba, 260-8712, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582, Japan
Fukushima Medical University Hospital
Fukushima, Fukushima, 960-1295, Japan
Hiroshima University Hospital
Hiroshima, Hiroshima, 734-8551, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648, Japan
Shonan Kamakura General Hospital
Kamakura-shi, Kanagawa, 247-8533, Japan
Toranomon Hospital Kajigaya
Kawasaki-shi, Kanagawa, 213-8587, Japan
Yokohama City University Hospital
Yokohama, Kanagawa, 236-0004, Japan
Japan Community Health care Organization Sendai Hospital
Sendai, Miyagi, 981-3281, Japan
Nara Medical University Hospital
Kashihara-shi, Nara, 634-8522, Japan
Nara Prefecture General Medical Center
Nara, Nara, 630-8581, Japan
Oita University Hospital
Yufu-shi, Oita Prefecture, 879-5593, Japan
Medical Research Institute KITANO HOSPITAL, PIIF Tazuke-Kofuka
Osaka, Osaka, 530-8480, Japan
Dokkyo Medical University Saitama Medical Center
Koshigaya-shi, Saitama, 343-8555, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-8431, Japan
Tokyo Medical University Hospital
Shinjuku-Ku, Tokyo, 160-0023, Japan
University of Yamanashi Hospital
Chuo-shi, Yamanashi, 409-3898, Japan
Universiti Kebangsaan Malaysia (UKM) - Medical Centre (Pusat Perubatan) (Hospital Canselor Tuanku Muhriz (HCTM))
Kuala Lumpur, Kuala Lumpur, 56000, Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, Pahang, 25100, Malaysia
Hospital Taiping
Taiping, Perak, 34000, Malaysia
Hospital Sultan Idris Shah Serdang (Hospital Serdang)
Kajang, Selangor, 43000, Malaysia
Sunway Medical Centre (SMC)
Subang Jaya, Selangor, 47500, Malaysia
Amsterdam UMC - Locatie AMC (Academisch Medisch Centrum)
Amsterdam, North Holland, 1105 AZ, Netherlands
Leids Universitair Medisch Center
Leiden, 2333 ZA, Netherlands
Sint Antonius ziekenhuis Utrecht/Nieuwegein
Nieuwegein, 3435CM, Netherlands
UMC Utrecht
Utrecht, 3584 CX, Netherlands
Akershus University Hospital
Lorenskog, Akershus, 1478, Norway
Sykehuset I Vestfold
Tønsberg, Vestfold, 4011, Norway
Haukeland Universitetssjukehus
Bergen, 5021, Norway
Sykehuset Ostfold
Grålum, 1714, Norway
Stavanger Universitetssjukehus - Helse Stavanger HF
Stavanger, Norway
Universitetssykehuset I Trondheim - St. Olavs Hospital - Nevroklinikken
Trondheim, 7030, Norway
Nowy Szpital Sp Zo.o
Gmina Świecie, 86-100, Poland
SCM Sp. z o.o.
Krakow, 31-559, Poland
Indywidualna Specjalistyczna Praktyka Lekarska
Lodz, Poland
4th Military Clinical hospital /Polyclinic SP ZOZ
Wroclaw, 50-981, Poland
National University Hospital
Singapore, 119074, Singapore
Singapore General Hospital
Singapore, 169608, Singapore
Tan Tock Seng Hospital
Singapore, 308433, Singapore
University Medical Centre Ljubljana
Ljubljana, 1000, Slovenia
University Clinical Centre Maribor
Maribor, 2000, Slovenia
Ajou University Hospital-Primary Research Location
Suwon, Gyeonggido, 16499, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Seongnam, 13620, South Korea
Seoul National University Hospital
Seoul, 3080, South Korea
Seoul National University Boramae Medical Center
Seoul, 7061, South Korea
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 8915, Spain
Universidad de Navarra - Clinica Universidad de Navarra
Pamplona, Navarre, 31008, Spain
Hospital del Mar
Barcelona, 8003, Spain
Universidad de Navarra - Clinica Universidad de Navarra
Madrid, 28027, Spain
Fundacion Jimenez Diaz
Madrid, 28040, Spain
Hospital Universitario Virgen del Rocio - PPDS
Seville, 41013, Spain
Renal Medicine Linkoping University/ Linkoping University Hospital
Linköping, SE-581 85, Sweden
University Hospital Zurich
Zurich, 8091, Switzerland
Kaohsiung Medical University - Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
Taipei Medical University Shuang Ho Hospital
New Taipei City, 23561, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
National Taiwan University Hospital
Zhongzheng, 100, Taiwan
Turgut Ozal Medical Center
Malatya, Battalgazi, 44280, Turkey (Türkiye)
Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi
Şahinbey, Gaziantep, 27310, Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Fatih, Istanbul, 34098, Turkey (Türkiye)
Kahramanmaras Sutcu Imam Universitesi Tip Fakultesi Avsar Mah
Kahramanmaraş, Onikisubat, 46040, Turkey (Türkiye)
Necmettin Erbakan University
Konya, Selcuklu, 42280, Turkey (Türkiye)
Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
London, Greater London, SE1 9RT, United Kingdom
Birmingham Heartlands Hospital
Birmingham, B95SS, United Kingdom
Kent & Canterbury Hospital, Canterbury
Canterbury, CT1 3PA, United Kingdom
Hull University Teaching Hospitals NHS Trust
Hull, HU3 2JZ, United Kingdom
Leicester General Hospital
Leicester, LE5 4PW, United Kingdom
St George's University Hospitals NHS Foundation Trust
London, SW17 0QT, United Kingdom
King's College Hospital
London, WC2R 2LS, United Kingdom
Nottingham University Hospitals NHS Trust - City Hospital
Nottingham, NG5 1PB, United Kingdom
Related Publications (1)
Ahmad SB, Jefferson JA. Targeting B Cells and Plasma Cells in Glomerular Disease. J Am Soc Nephrol. 2025 Jun 4;36(9):1844-1857. doi: 10.1681/ASN.0000000772.
PMID: 40465397DERIVED
Related Links
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MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2025
First Posted
May 9, 2025
Study Start
July 15, 2025
Primary Completion (Estimated)
September 7, 2028
Study Completion (Estimated)
January 14, 2030
Last Updated
May 6, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.