NCT05797610

Brief Summary

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of sefaxersen (RO7434656), a novel Antisense Oligonucleotide (ASO) therapy in participants with primary IgA nephropathy (IgAN) who are at high risk of progressive kidney disease despite optimized supportive care.

Trial Health

88
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
428

participants targeted

Target at P50-P75 for phase_3

Timeline
36mo left

Started Aug 2023

Longer than P75 for phase_3

Geographic Reach
21 countries

202 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Aug 2023Mar 2029

First Submitted

Initial submission to the registry

March 22, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 4, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

August 8, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2029

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

3.1 years

First QC Date

March 22, 2023

Last Update Submit

April 10, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in the Urine Protein-to-Creatinine Ratio (UPCR) at Week 37

    UPCR will be assessed in urine sampled over 24 hours.

    Baseline, Week 37

Secondary Outcomes (5)

  • Estimated Glomerular Filtration Rate (eGFR) Slope at Week 105 from Baseline

    Baseline, Week 105

  • Time to the Composite Kidney Failure Endpoint

    Up to approximately 36 months

  • Change From Baseline in Fatigue at Week 105

    Baseline, Week 105

  • Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs)

    Up to approximately 36 months

  • Plasma Concentration of Sefaxersen

    Up to approximately 36 months

Other Outcomes (1)

  • Change From Baseline in Symptoms and Health-Related Quality of Life at Week 105 as Assessed Using the RAND Kidney Disease and Quality of Life 36-Item (KDQOL-36) Short Form

    Baseline, Week 105

Study Arms (2)

Sefaxersen (RO7434656)

EXPERIMENTAL

Participants will receive subcutaneous (SC) doses of sefaxersen (RO7434656) on Days 1, 15, and 29 followed by once every 4 weeks (Q4W) until Week 105. Participants may be eligible to switch to open-label treatment after Week 105 at the investigator's discretion until up to 1 year after the common-close timepoint, the date when the last participant completes the Week 105 assessment, withdraws, or is discontinued from the study.

Drug: Sefaxersen (RO7434656)

Placebo

PLACEBO COMPARATOR

Participants will receive SC doses of sefaxersen (RO7434656) matching placebo on Days 1, 15, and 29 followed by once Q4W until Week 105. Participants may be eligible to switch to open-label treatment after Week 105 at the investigator's discretion until up to 1 year after the common-close timepoint, the date when the last participant completes the Week 105 assessment, withdraws, or is discontinued from the study.

Drug: Placebo

Interventions

Sefaxersen (RO7434656) will be administered as SC injection per schedule as specified.

Also known as: Sefaxersen
Sefaxersen (RO7434656)

Matching placebo will be administered as SC injection per schedule as specified.

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary IgAN, as evidenced by a kidney biopsy performed within 10 years prior to or during screening, without known secondary cause
  • Treatment with maximum tolerated doses of angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs) for at least 90 days immediately prior to screening, and without an intent to modify the dose during the study, except for interruptions due to illness (not greater than 7 consecutive days), unless the potential participant is intolerant to these medications
  • Urine Protein-to-Creatinine Ratio (UPCR) ≥ 1 gram per gram (g/g) or urine protein excretion ≥ 1 gram per day (g/day) (with UPCR ≥ 0.8 g/g), all measured from a 24-hour urine collection during screening
  • eGFR ≥ 20 mL/min/1.73 m\^2, as calculated by the 2021 CKD-EPI creatinine equation (Inker et al. 2021a)
  • Vaccination against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae according to national vaccination recommendations
  • Female participants of childbearing potential must use adequate contraception

You may not qualify if:

  • Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 12 weeks after the final dose of sefaxersen
  • Histopathologic or other evidence of another autoimmune glomerular disease
  • Presence of ≥ 50% crescents on kidney biopsy, sustained doubling of serum creatinine within 3 months prior to screening, or rapidly progressive glomerulonephritis in the opinion of the investigator
  • History of kidney transplantation
  • Glycated Hemoglobin (HbA1c) ≥ 6.5% or a clinical diagnosis of diabetes mellitus of any type
  • Systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg from the average of two measurements performed at least 1 minute apart during screening
  • Initiation of sodium-glucose cotransporter-2 (SGLT2) inhibitors within 16 weeks prior to screening or during screening
  • Initiation of endothelin receptor antagonists within 90 days prior to screening or during screening
  • Initiation of mineralocorticoid receptor antagonists or non-dihydropyridine calcium channel blockers within 90 days prior to screening or during screening
  • Use of herbal therapies within 90 days prior to or during screening
  • Treatment with investigational therapy within 28 days prior to screening or 5.5 drug-elimination half-lives of that investigational product prior to screening
  • Treatment with an investigational therapy planned during the treatment period
  • Previous treatment with sefaxersen
  • Treatment with oral or intravenous (IV) corticosteroids with a dose equivalent to ≥ 7.5 milligrams per day (mg/day) of prednisone for 7 days or equivalent to ≥ 5 mg/day of prednisone for 14 days within 90 days prior to screening
  • Treatment with corticosteroids with systemic effects during screening
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (202)

Alabama Kidney Research - ERN - PPDS

Alabaster, Alabama, 35007-8823, United States

RECRUITING

UAB Nephrology Research Clinic

Birmingham, Alabama, 35233, United States

RECRUITING

Sunrise Medical Management LLC

Surprise, Arizona, 85374-8644, United States

RECRUITING

Tucson Neuroscience Research - M3 WR

Tucson, Arizona, 85710, United States

WITHDRAWN

Kidney Disease Medical Group Inc-1505 Wilson Ter

Glendale, California, 91206-4032, United States

RECRUITING

Southern California Medical Research Center

La Palma, California, 90623, United States

WITHDRAWN

Academic Medical Research Institute - Los Angeles

Los Angeles, California, 90022, United States

RECRUITING

University of California, Los Angeles (UCLA) - Hematology/Oncology Santa Monica

Los Angeles, California, 90025-4837, United States

RECRUITING

Los Angeles County Nephrology

Montebello, California, 90640-2217, United States

RECRUITING

North America Research Institute-San Dimas

San Dimas, California, 91773, United States

RECRUITING

Kaiser Permanente Skyport Medical Offices

San Jose, California, 95110, United States

RECRUITING

Hope Clinic & Research Center

Hialeah, Florida, 33010, United States

WITHDRAWN

LCC Medical Research - Miami - ClinEdge - PPDS

Miami, Florida, 33126, United States

RECRUITING

Central Florida Kidney Specialists

Orlando, Florida, 32806, United States

RECRUITING

L&C Professional Medical Research Institute

West Miami, Florida, 33144, United States

RECRUITING

Cowry Medical Group LLC

Acworth, Georgia, 30101, United States

RECRUITING

Care Institute Idaho Kidney Institute

Chubbuck, Idaho, 83202, United States

RECRUITING

Care Institute Idaho Kidney Institute

Idaho Falls, Idaho, 83402, United States

RECRUITING

Nephrology Associates of Northern Illinois

Hinsdale, Illinois, 60521, United States

RECRUITING

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

Massachussets General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

RECRUITING

Sierra Nevada Nephrology Consultants

Reno, Nevada, 89511, United States

RECRUITING

NYU Langone Nephrology Associates - Mineola

Mineola, New York, 11501, United States

RECRUITING

North Carolina Nephrology, PA

Raleigh, North Carolina, 27609, United States

RECRUITING

Ohio State University Wexner Medical Center - Outpatient Care East

Columbus, Ohio, 43203, United States

RECRUITING

Kidney and Hypertension Center

Roseburg, Oregon, 97471, United States

WITHDRAWN

Austin Diagnostic Clinic - Frenova F1

Austin, Texas, 78751-3014, United States

RECRUITING

Global Medical Research - M3 WR

Dallas, Texas, 75224, United States

WITHDRAWN

Texas Kidney Institute - Dallas

Dallas, Texas, 75231, United States

RECRUITING

Pioneer Research Solutions

Houston, Texas, 077099, United States

RECRUITING

Prolato Clinical Research Center

Houston, Texas, 77054, United States

RECRUITING

R & H Clinical Research

Katy, Texas, 77449, United States

RECRUITING

Revival Research Institute - McKinney

McKinney, Texas, 75071, United States

RECRUITING

Utah Kidney Research Institute

Salt Lake City, Utah, 84115, United States

RECRUITING

Nephrology Associates of Northern Virginia Inc

Fairfax, Virginia, 22033, United States

RECRUITING

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

Milwaukee Nephrologists, Sc

Wauwatosa, Wisconsin, 53226, United States

WITHDRAWN

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

Ciudad Autonoma Buenos Aires, C1425AGC, Argentina

RECRUITING

Consultorios Médicos Dr. Doreski

Ciudad Autonoma Buenos Aires, C1426ABP, Argentina

RECRUITING

Sanatorio Mayo Privado

Córdoba, 5000, Argentina

RECRUITING

Sanatorio Allende

Córdoba, X5000JHQ, Argentina

RECRUITING

Instituto Medico de la Fundacion Estudios Clinicos

Rosario, S2013DTC, Argentina

RECRUITING

Nepean Hospital

Kingswood, New South Wales, 02747, Australia

RECRUITING

St George Hospital

Kogarah, New South Wales, 2217, Australia

RECRUITING

Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

RECRUITING

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

RECRUITING

Royal Adelaide Hospital

Adelaide, South Australia, SA5000, Australia

RECRUITING

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

RECRUITING

Sunshine Hospital

St Albans, Victoria, 3021, Australia

RECRUITING

Santa Casa de Misericordia de Belo Horizonte - PPDS

Belo Horizonte, Minas Gerais, 30150-221, Brazil

RECRUITING

Freire Pesquisa Clinica

Belo Horizonte, Minas Gerais, 30150, Brazil

RECRUITING

Hospital de Clinicas de Porto Alegre HCPA PPDS

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

RECRUITING

Centro de Pesquisa Clinica da Fundação Pró Rim

Joinville, Santa Catarina, 89227-680, Brazil

RECRUITING

Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, São Paulo, 01246, Brazil

RECRUITING

Hospital Do Rim E Hipertensao Fundacao Oswaldo Ramos

São Paulo, São Paulo, 04038-002, Brazil

RECRUITING

Instituto D?Or Pesquisa e Ensino - Hospital Gloria D?Or

Rio de Janeiro, 22281, Brazil

RECRUITING

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

Cape Breton Regional Hospital

Sydney, Nova Scotia, B1P 1P3, Canada

RECRUITING

London Health Sciences Centre · Victoria Hospital

London, Ontario, N6A 5W9, Canada

RECRUITING

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

RECRUITING

Centre Hospitalier Universitaire de Quebec

Québec, G1R 2J6, Canada

RECRUITING

Beijing Friendship Hospital, Capital Medical University - PPDS

Beijing, Beijing Municipality, 000000, China

RECRUITING

Cangzhou Central Hospital

Cangzhou Shi, Hebei, 060001, China

RECRUITING

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050031, China

RECRUITING

Wuxi People's Hospital

Wuxi, Jiangsu, 214023, China

RECRUITING

Peking University First Hospital

Beijing, 100034, China

RECRUITING

Peking University People's Hospital

Beijing, 100044, China

RECRUITING

Changzhou First People's Hospital

Changzhou, 213003, China

RECRUITING

West China Hospital, Sichuan University

Chengdu, 610041, China

RECRUITING

Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

Chengdu, 610072, China

RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, 510080, China

RECRUITING

Zhejiang Provincial People?s Hospital

Hangzhou, 310014, China

RECRUITING

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

Hangzhou, 310016, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, 330000, China

RECRUITING

The Second Affiliated Hospital of Nanchang University

Nanchang, 330008, China

RECRUITING

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, 210003, China

RECRUITING

Ningbo No.2 Hospital

Ningbo, 315000, China

RECRUITING

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, 200025, China

RECRUITING

Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine

Shanghai, China

RECRUITING

Shenzhen People's Hospital

Shenzhen, 518020, China

RECRUITING

The University of Hong Kong - Shenzhen Hospital

Shenzhen, 518053, China

RECRUITING

The Second Affiliated Hospital of Soochow University

Suzhou, 215004, China

RECRUITING

Renmin Hospital of Wuhan University

Wuhan, 430060, China

RECRUITING

The First Affiliated Hospital of Xian Jiao Tong University

Xi'an, 710061, China

RECRUITING

General Hospital of Ningxia Medical University

Yinchuan, 750004, China

RECRUITING

Affiliated Hospital of Jiangsu University

Zhenjiang, 212001, China

RECRUITING

Fakultni nemocnice Hradec Kralove

Hradec Králové, 500 05, Czechia

RECRUITING

Vseobecna fakultni nemocnice v Praze

Prague, 12808, Czechia

RECRUITING

Centre Hospitalier

Annonay, 07103, France

RECRUITING

CHU Boulogne sur Mer

Boulogne-sur-Mer, 62200, France

RECRUITING

Hopital Henri Mondor

Créteil, 94000, France

RECRUITING

Hopital Tenon

Paris, 75020, France

RECRUITING

Hopital Bichat - Claude Bernard AP-HP

Paris, 75877, France

RECRUITING

Hôpital de Rangueil

Toulouse, 31059, France

RECRUITING

Universitätsklinikum Leipzig

Leipzig, Saxony, 04103, Germany

RECRUITING

Universitatsklinikum der RWTH Aachen

Aachen, 52074, Germany

RECRUITING

Charite Universitaetsmedizin Berlin - Campus Charite Mitte

Berlin, 10117, Germany

RECRUITING

St. Joseph-Krankenhaus

Berlin, 12101, Germany

RECRUITING

Klinikum Koln-Merheim

Cologne, 51109, Germany

RECRUITING

Medizinische Hochschule Hannover

Hanover, 30625, Germany

RECRUITING

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, 55101, Germany

RECRUITING

Robert-Bosch-Krankenhaus

Stuttgart, 70376, Germany

RECRUITING

Nephrologisches Zentrum Villingen-Schwenningen

Villingen-Schwenningen, 78052, Germany

RECRUITING

University General Hospital of Heraklion

Heraklion, 71110, Greece

RECRUITING

Venizeleio General Hospital of Heraklion

Heraklion, 714 09, Greece

RECRUITING

University General Hospital of Patras

Pátrai, 265 04, Greece

RECRUITING

Ippokratio General Hospital of Thessaloniki

Thessaloniki, 546 42, Greece

WITHDRAWN

Queen Mary Hospital

Hong Kong, 999077, Hong Kong

RECRUITING

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

Bari, Apulia, 70124, Italy

RECRUITING

Azienda Ospedaliera Universitaria Federico II

Naples, Campania, 80131, Italy

RECRUITING

Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi-Via Massarenti

Bologna, Emilia-Romagna, 40138, Italy

RECRUITING

Fondazione Policlinico Universitario A Gemelli

Rome, Lazio, 00168, Italy

RECRUITING

Ospedale Policlinico San Martino

Genoa, Liguria, 16132, Italy

RECRUITING

IRCCS Pavia - Istituti Clinici Scientifici Maugeri Spa ? Società Benefit

Pavia, Lombardy, 27100, Italy

RECRUITING

Ospedale San Giovanni Bosco

Turin, Piedmont, 10154, Italy

RECRUITING

Fujita Health University Hospital

Aichi, 470-1192, Japan

RECRUITING

Hirosaki University Hospital

Aomori, 036-8563, Japan

RECRUITING

Juntendo University Urayasu Hospital

Chiba, 279-0021, Japan

RECRUITING

University of Yamanashi Hospital

Chūō, 409-3821, Japan

RECRUITING

Matsuyama Red Cross Hospital

Ehime, 790-8524, Japan

RECRUITING

Japanese Red Cross Fukuoka Hospital

Fukuoka, 815-8555, Japan

RECRUITING

Hiroshima University Hospital

Hiroshima, 734-8551, Japan

RECRUITING

Hokkaido University Hospital

Hokkaido, 060-8648, Japan

RECRUITING

Tokyo Medical University Ibaraki Medical Center

Inashiki-Gun, 300-0395, Japan

RECRUITING

Kanazawa Medical University Hospital

Ishikawa, 920-0293, Japan

RECRUITING

Nara Medical University Hospital

Kashihara, 634-8522, Japan

RECRUITING

Kumamoto University Hospital

Kumamoto, 860-8556, Japan

RECRUITING

Tohoku University Hospital

Miyagi, 980-8574, Japan

RECRUITING

Kyoto City Hospital

Nakagyo-ku, 604-8845, Japan

RECRUITING

Nara Prefecture General Medical Center

Nara, 630-8054, Japan

RECRUITING

Hyogo Prefectural Nishinomiya Hospital

Nishinomiya, 662-0918, Japan

RECRUITING

Iwate Medical University Hospital

Numakunai, 028-3695, Japan

RECRUITING

National Hospital Organization Okayama Medical Center

Okayama, 701-1192, Japan

RECRUITING

Okayama University Hospital

Okayama-Shi Kita-Ku, 700-0914, Japan

RECRUITING

University of the Ryukyus Hospital

Okinawa, 903-0125, Japan

RECRUITING

Saitama Medical University Hospital

Saitama, 350-0451, Japan

RECRUITING

Osaka University Hospital

Suita, 565-0871, Japan

RECRUITING

Jichi Medical University Hospital

Tochigi, 329-0498, Japan

RECRUITING

Tokushima University Hospital

Tokushima, 770-8503, Japan

RECRUITING

The Jikei University Hospital

Tokyo, 105-8471, Japan

RECRUITING

Juntendo University Hospital

Tokyo, 113-8431, Japan

RECRUITING

Tokyo Women's Medical University Hospital

Tokyo, 162-8666, Japan

RECRUITING

Juntendo University Nerima Hospital, department of renal and hypertension

Tokyo, 177-8521, Japan

RECRUITING

University of Tsukuba Hospital

Tsukuba, 305-8576, Japan

RECRUITING

Yamaguchi University Hospital

Ube, 755-8505, Japan

RECRUITING

Hospital Kuala Lumpur

Kuala Lumpur, FED. Territory of Kuala Lumpur, 50586, Malaysia

RECRUITING

University Malaya Medical Centre

Kuala Lumpur, FED. Territory of Kuala Lumpur, 59100, Malaysia

RECRUITING

Hospital Tengku Ampuan Afzan

Kuantan, Pahang, 25100, Malaysia

RECRUITING

Hospital Seri Manjung

Seri Manjong, Pahang, 32040, Malaysia

RECRUITING

Taiping Hospital

Taiping, Perak, 34000, Malaysia

RECRUITING

Hospital Sibu

Sibu, Sarawak, 96000, Malaysia

RECRUITING

Hospital Ampang

Ampang, 68000, Malaysia

RECRUITING

Miri Hospital

Miri, 98000, Malaysia

RECRUITING

Clinica San Cosme

Fracc Lomas Del Campestre, Aguascalientes, 20129, Mexico

RECRUITING

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Barrio Belisario Domínguez Secc XVI, Mexico CITY (federal District), 14080, Mexico

RECRUITING

Centro de Investigacion Clinica Chapultepec S. A. de C. V.

Morelia, Michoacán, 58260, Mexico

RECRUITING

Instituto Mexicano de Trasplantes

Cuernavaca, Morelos, 62448, Mexico

RECRUITING

Christus Latam Hub Center Of Excellence & Innovation

Monterrey, Nuevo León, 64000, Mexico

RECRUITING

4. Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ

Wroclaw, Lower Silesian Voivodeship, 53-114, Poland

RECRUITING

SCM Clinic - Prywatny Szpital Specjalistyczny

Krakow, 31-559, Poland

RECRUITING

SPZOZ Centralny Szpital Klin

Lodz, 92-213, Poland

RECRUITING

Uniwersytecki Szpital Kliniczny w Opolu

Opole, 45401, Poland

RECRUITING

Szpital Kliniczny im. H.Swiecickiego UM w Poznaniu

Późna, 60-355, Poland

RECRUITING

Szpital Kliniczny Dzieciatka Jezus

Warsaw, 02-006, Poland

RECRUITING

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu

Wroc?aw, 50-556, Poland

RECRUITING

National University Hospital

Singapore, 119074, Singapore

RECRUITING

Singapore General Hospital

Singapore, 169608, Singapore

RECRUITING

Tan Tock Seng Hospital

Singapore, 308433, Singapore

RECRUITING

Changi General Hospital

Singapore, 529889, Singapore

RECRUITING

Hallym University Sacred Heart Hospital

Anyang-si, 14068, South Korea

RECRUITING

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, 420-767, South Korea

RECRUITING

Chungbuk National University Hospital

Cheongju-si, 28644, South Korea

RECRUITING

Ajou University Hospital

Gyeonggi-do, 443-380, South Korea

RECRUITING

CHA Bundang Medical Center, CHA University

Seongnam-si, 13496, South Korea

RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, 13620, South Korea

RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Konkuk University Medical Center

Seoul, 05030, South Korea

RECRUITING

Gangdong Kyung Hee University Hospital

Seoul, 05278, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

SMG-SNU Boramae Medical Center

Seoul, 156-707, South Korea

RECRUITING

Hospital Universitari Arnau de Vilanova

Lleida, Lerida, 25198, Spain

RECRUITING

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, 08035, Spain

RECRUITING

C.H. Regional Reina Sofia - PPDS

Córdoba, 14004, Spain

RECRUITING

Hospital Ribera Polusa

Lugo, 27004, Spain

RECRUITING

Hospital Universitario 12 De Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Universitario La Paz - PPDS

Madrid, 28046, Spain

RECRUITING

Hospital Universitario Virgen del Rocio - PPDS

Seville, 41013, Spain

RECRUITING

Changhua Christian Hospital

Changhua, 500, Taiwan

RECRUITING

Chang Gung Medical Foundation

Kaohsiung City, 83301, Taiwan

RECRUITING

China Medical University Hospital

Taichung, 40447, Taiwan

RECRUITING

Far Eastern Memorial Hospital

Taipei, 220, Taiwan

RECRUITING

Chang Gung Memorial Hospital, Linkou

Taoyuan, 333, Taiwan

RECRUITING

Taichung Veterans General Hospital

Xitun Dist., 40705, Taiwan

RECRUITING

Mackay Memorial Hospital-Taipei branch

Zhongshan Dist., 10449, Taiwan

RECRUITING

Addenbrookes Hospital

Cambridge, CB2 0QQ, United Kingdom

RECRUITING

Leicester General Hospital

Leicester, LE5 4PW, United Kingdom

RECRUITING

Guys and St Thomas Hospital

London, SE1 9RT, United Kingdom

RECRUITING

Kings College Hospital

London, SE5 9RS, United Kingdom

RECRUITING

Churchill Hospital

Oxford, OX3 7LE, United Kingdom

RECRUITING

Salford Royal Hospital

Salford, M6 8HD, United Kingdom

RECRUITING

Related Publications (2)

  • Tekendo-Ngongang C, Gleeson JG, Mignon L. Treating the Untreatable: Antisense Oligonucleotides as an Individualized Therapy for Rare Genetic Kidney Diseases. J Am Soc Nephrol. 2024 Dec 1;35(12):1774-1777. doi: 10.1681/ASN.0000000532. Epub 2024 Sep 27. No abstract available.

  • Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.

MeSH Terms

Conditions

Glomerulonephritis, IGA

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Central Study Contacts

WA43966 https://forpatients.roche.com/

CONTACT

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

March 22, 2023

First Posted

April 4, 2023

Study Start

August 8, 2023

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

March 31, 2029

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Locations