AzTrials
AzTrials

Primary IgA NephropathyPhase 3IMAGINATIONNCT05797610

A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression

A Phase 3 study testing Sefaxersen (RO7434656) in people with Primary IgA Nephropathy, run by Hoffmann-La Roche at 171 sites in 21 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the efficacy, safety, \& 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Primary IgA Nephropathy
What is being tested?
Sefaxersen (RO7434656)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
459 participants
Where
171 sitesin 21 countries
Study dates
8 Aug 2023to 31 Aug 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 millimetre of mercury (mmHg) or diastolic blood pressure >90 mmHg from the average of two measurements performed at least 1 minute apart during screening
Show all 23Show fewer
  • 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
  • Treatment with a systemic calcineurin inhibitor within 2 months prior to screening or during screening
  • Treatment with anti-CD20 therapy within 9 months of screening or during screening
  • Treatment with other systemic immunosuppressive agents within 6 months of randomization including, but not limited to, complement inhibitors, alkylating agents (e.g., cyclophosphamide or chlorambucil), azathioprine, or mycophenolate
  • Planned major procedure or major surgery during screening or the study
  • Substance abuse within 12 months prior to screening or during screening
  • Any serious medical condition or abnormality in clinical laboratory tests that precludes an individual's safe participation in and completion of the study
  • History of malignancy within < 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
  • Usage of Glucagon-like Peptide-1 (GLP-1)-based therapy (i.e., GLP-1 mono-agonists, GLP-1/GIP dual agonists, etc.) within 90 days prior to screening or during screening, or intent to initiate during the study period

Trial locations and contacts

171 sites in 21 countries.

171 sites in 21 countries

China24 sites

  • Beijing Friendship Hospital, Capital Medical University - PPDS

    Beijing, Beijing Municipality, 000000

  • Peking University First Hospital

    Beijing, 100034

  • Peking University People's Hospital

    Beijing, 100044

  • Cangzhou Central Hospital

    Cangzhou Shi, Hebei, 060001

  • Changzhou First People's Hospital

    Changzhou, 213003

  • West China Hospital, Sichuan University

    Chengdu, 610041

  • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

    Chengdu, 610072

  • Guangdong Provincial People's Hospital

    Guangzhou, 510080

  • Zhejiang Provincial People?s Hospital

    Hangzhou, 310014

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

    Hangzhou, 310016

  • The First Affiliated Hospital of Nanchang University

    Nanchang, 330000

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, 210003

  • Ningbo No.2 Hospital

    Ningbo, 315000

  • Ruijin Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, 200025

  • Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine

    Shanghai

  • Shenzhen People's Hospital

    Shenzhen, 518020

  • The University of Hong Kong - Shenzhen Hospital

    Shenzhen, 518053

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050031

  • The Second Affiliated Hospital of Soochow University

    Suzhou, 215004

  • Renmin Hospital of Wuhan University

    Wuhan, 430060

  • Wuxi People's Hospital

    Wuxi, Jiangsu, 214023

  • The First Affiliated Hospital of Xian Jiao Tong University

    Xi'an, 710061

  • General Hospital of Ningxia Medical University

    Yinchuan, 750004

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, 212001

Other trials in China

Japan23 sites

  • Fujita Health University Hospital

    Aichi, 470-1192

  • Hirosaki University Hospital

    Aomori, 036-8563

  • Juntendo University Urayasu Hospital

    Chiba, 279-0021

  • University of Yamanashi Hospital

    Chūō, 409-3821

  • Matsuyama Red Cross Hospital

    Ehime, 790-8524

  • Japanese Red Cross Fukuoka Hospital

    Fukuoka, 815-8555

  • Hiroshima University Hospital

    Hiroshima, 734-8551

  • Hokkaido University Hospital

    Hokkaido, 060-8648

  • Hyogo Prefectural Nishinomiya General Medical Center

    Hyōgo, 663-8241

  • Kanazawa Medical University Hospital

    Ishikawa, 920-0293

  • Nara Medical University Hospital

    Kashihara, 634-8522

  • Kumamoto University Hospital

    Kumamoto, 860-8556

  • Tohoku University Hospital

    Miyagi, 980-8574

  • Kyoto City Hospital

    Nakagyo-ku, 604-8845

  • Nara Prefecture General Medical Center

    Nara, 630-8054

  • National Hospital Organization Okayama Medical Center

    Okayama, 701-1192

  • Osaka University Hospital

    Suita, 565-0871

  • The Jikei University Hospital

    Tokyo, 105-8471

  • Juntendo University Hospital

    Tokyo, 113-8431

  • Tokyo Women's Medical University Hospital

    Tokyo, 162-8666

  • Juntendo University Nerima Hospital, department of renal and hypertension

    Tokyo, 177-8521

  • University of Tsukuba Hospital

    Tsukuba, 305-8576

  • Yamaguchi University Hospital

    Ube, 755-8505

Other trials in Japan

United States20 sites

  • Cowry Medical Group LLC

    Acworth, Georgia, 30101

  • UAB Nephrology Research Clinic

    Birmingham, Alabama, 35233

  • Massachussets General Hospital

    Boston, Massachusetts, 02114

  • Texas Kidney Institute - Dallas

    Dallas, Texas, 75231

  • Nephrology Associates of Northern Virginia Inc

    Fairfax, Virginia, 22033

  • Kidney Disease Medical Group Inc-1505 Wilson Ter

    Glendale, California, 91206-4032

  • Nephrology Associates of Northern Illinois

    Hinsdale, Illinois, 60521

  • Pioneer Research Solutions

    Houston, Texas, 077099

  • Prolato Clinical Research Center

    Houston, Texas, 77054

  • Care Institute Idaho Kidney Institute

    Idaho Falls, Idaho, 83402

  • R & H Clinical Research

    Katy, Texas, 77449

  • Academic Medical Research Institute - Los Angeles

    Los Angeles, California, 90022

  • UCLA University of California Los Angeles

    Los Angeles, California, 90095-8361

  • Revival Research Institute - McKinney

    McKinney, Texas, 75071

  • Central Florida Kidney Specialists

    Orlando, Florida, 32806

  • North Carolina Nephrology, PA

    Raleigh, North Carolina, 27609

  • Sierra Nevada Nephrology Consultants

    Reno, Nevada, 89511

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • North America Research Institute-San Dimas

    San Dimas, California, 91773

  • L&C Professional Medical Research Institute

    West Miami, Florida, 33144

Other trials in United States

South Korea11 sites

  • Hallym University Sacred Heart Hospital

    Anyang-si, 14068

  • Soon Chun Hyang University Hospital Bucheon

    Bucheon-si, 420-767

  • Chungbuk National University Hospital

    Cheongju-si, 28644

  • Ajou University Hospital

    Gyeonggi-do, 443-380

  • CHA Bundang Medical Center, CHA University

    Seongnam-si, 13496

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

  • Seoul National University Hospital

    Seoul, 03080

  • Konkuk University Medical Center

    Seoul, 05030

  • Gangdong Kyung Hee University Hospital

    Seoul, 05278

  • Samsung Medical Center

    Seoul, 06351

  • SMG-SNU Boramae Medical Center

    Seoul, 156-707

Other trials in South Korea

Germany9 sites

  • Universitatsklinikum der RWTH Aachen

    Aachen, 52074

  • Charite Universitaetsmedizin Berlin - Campus Charite Mitte

    Berlin, 10117

  • St. Joseph-Krankenhaus

    Berlin, 12101

  • Klinikum Koln-Merheim

    Cologne, 51109

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Universitätsklinikum Leipzig

    Leipzig, Saxony, 04103

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55101

  • Robert-Bosch-Krankenhaus

    Stuttgart, 70376

  • Nephrologisches Zentrum Villingen-Schwenningen

    Villingen-Schwenningen, 78052

Other trials in Germany

Malaysia8 sites

  • Hospital Ampang

    Ampang, 68000

  • Hospital Kuala Lumpur

    Kuala Lumpur, FED. Territory of Kuala Lumpur, 50586

  • University Malaya Medical Centre

    Kuala Lumpur, FED. Territory of Kuala Lumpur, 59100

  • Hospital Tengku Ampuan Afzan

    Kuantan, Pahang, 25100

  • Miri Hospital

    Miri, 98000

  • Hospital Seri Manjung

    Seri Manjong, Pahang, 32040

  • Hospital Sibu

    Sibu, Sarawak, 96000

  • Taiping Hospital

    Taiping, Perak, 34000

Other trials in Malaysia

Australia7 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, SA5000

  • Nepean Hospital

    Kingswood, New South Wales, 02747

  • St George Hospital

    Kogarah, New South Wales, 2217

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Sunshine Hospital

    St Albans, Victoria, 3021

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Italy7 sites

  • Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

    Bari, Apulia, 70124

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

    Bologna, Emilia-Romagna, 40138

  • Ospedale Policlinico San Martino

    Genoa, Liguria, 16132

  • Azienda Ospedaliera Universitaria Federico II

    Naples, Campania, 80131

  • IRCCS Pavia - Istituti Clinici Scientifici Maugeri Spa ? Società Benefit

    Pavia, Lombardy, 27100

  • Fondazione Policlinico Universitario A Gemelli

    Rome, Lazio, 00168

  • Ospedale San Giovanni Bosco

    Turin, Piedmont, 10154

Other trials in Italy

Spain7 sites

  • Hospital Universitario Vall d'Hebron - PPDS

    Barcelona, 08035

  • C.H. Regional Reina Sofia - PPDS

    Córdoba, 14004

  • Hospital Universitari Arnau de Vilanova

    Lleida, Lerida, 25198

  • Hospital Ribera Polusa

    Lugo, 27004

  • Hospital Universitario 12 De Octubre

    Madrid, 28041

  • Hospital Universitario La Paz - PPDS

    Madrid, 28046

  • Hospital Universitario Virgen del Rocio - PPDS

    Seville, 41013

Other trials in Spain

Taiwan7 sites

  • Changhua Christian Hospital

    Changhua, 500

  • Chang Gung Medical Foundation

    Kaohsiung City, 83301

  • China Medical University Hospital

    Taichung, 40447

  • Far Eastern Memorial Hospital

    Taipei, 220

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan City, 333

  • Taichung Veterans General Hospital

    Xitun Dist., 40705

  • Mackay Memorial Hospital-Taipei branch

    Zhongshan Dist., 10449

Other trials in Taiwan

Brazil6 sites

  • Santa Casa de Misericordia de Belo Horizonte - PPDS

    Belo Horizonte, Minas Gerais, 30150-221

  • Freire Pesquisa Clinica

    Belo Horizonte, Minas Gerais, 30150

  • Hospital de Clinicas de Porto Alegre HCPA PPDS

    Porto Alegre, Rio Grande do Sul, 90035-903

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

    Rio de Janeiro, 22281

  • Faculdade de Medicina da Universidade de Sao Paulo

    São Paulo, São Paulo, 01246

  • Hospital Do Rim E Hipertensao Fundacao Oswaldo Ramos

    São Paulo, São Paulo, 04038-002

Other trials in Brazil

Canada6 sites

  • London Health Sciences Centre · Victoria Hospital

    London, Ontario, N6A 5W9

  • Montreal General Hospital

    Montreal, Quebec, H3G 1A4

  • Centre Hospitalier Universitaire de Quebec

    Québec, G1R 2J6

  • Cape Breton Regional Hospital

    Sydney, Nova Scotia, B1P 1P3

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

France6 sites

  • Centre Hospitalier

    Annonay, 07103

  • CHU Boulogne sur Mer

    Boulogne-sur-Mer, 62200

  • Hopital Henri Mondor

    Créteil, 94000

  • Hopital Tenon

    Paris, 75020

  • Hopital Bichat - Claude Bernard AP-HP

    Paris, 75877

  • Hôpital de Rangueil

    Toulouse, 31059

Other trials in France

Poland6 sites

  • SCM Clinic - Prywatny Szpital Specjalistyczny

    Krakow, 31-559

  • SPZOZ Centralny Szpital Klin

    Lodz, 92-213

  • Uniwersytecki Szpital Kliniczny w Opolu

    Opole, 45401

  • Uniwersytecki Szpital Kliniczny w Poznaniu - Przybyszewskiego 49

    Poznan, 60-355

  • Szpital Kliniczny Dzieciatka Jezus

    Warsaw, 02-006

  • 4. Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ

    Wroclaw, Lower Silesian Voivodeship, 53-114

Other trials in Poland

United Kingdom6 sites

  • Addenbrookes Hospital

    Cambridge, CB2 0QQ

  • Leicester General Hospital

    Leicester, LE5 4PW

  • Guys and St Thomas Hospital

    London, SE1 9RT

  • Kings College Hospital

    London, SE5 9RS

  • Churchill Hospital

    Oxford, OX3 7LE

  • Salford Royal Hospital

    Salford, M6 8HD

Other trials in United Kingdom

Argentina5 sites

  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

    Ciudad Autonoma Buenos Aires, C1425AGC

  • Consultorios Médicos Dr. Doreski

    Ciudad Autonoma Buenos Aires, C1426ABP

  • Sanatorio Mayo Privado

    Córdoba, 5000

  • Sanatorio Allende

    Córdoba, X5000JHQ

  • Instituto Medico de la Fundacion Estudios Clinicos

    Rosario, S2013DTC

Other trials in Argentina

Singapore4 sites

  • National University Hospital

    Singapore, 119074

  • Singapore General Hospital

    Singapore, 169608

  • Tan Tock Seng Hospital

    Singapore, 308433

  • Changi General Hospital

    Singapore, 529889

Other trials in Singapore

Greece3 sites

  • University General Hospital of Heraklion

    Heraklion, 71110

  • Venizeleio General Hospital of Heraklion

    Heraklion, 714 09

  • University General Hospital of Patras

    Pátrai, 265 04

Other trials in Greece

Mexico3 sites

  • Instituto Mexicano de Trasplantes

    Cuernavaca, Morelos, 62448

  • Clinica San Cosme

    Fracc Lomas Del Campestre, Aguascalientes, 20129

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

    Morelia, Michoacán, 58260

Other trials in Mexico

Czechia2 sites

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • Vseobecna fakultni nemocnice v Praze

    Prague, 12808

Other trials in Czechia

Hong Kong1 site

  • Queen Mary Hospital

    Hong Kong, 999077

Other trials in Hong Kong

About this study

Official title: A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sefaxersen, an Antisense Inhibitor of Complement Factor B, in Patients With Primary IgA Nephropathy at High Risk of Progression

The purpose of this study is to evaluate the efficacy, safety, \& 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.

Being tested
Sefaxersen (RO7434656), Placebo
Medical subject headings
Glomerulonephritis, IGA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sefaxersen (RO7434656)Drug

    Also called Sefaxersen

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

  • PlaceboDrug

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

Study groups in NCT05797610
Study groupRoleWhat they receive
Sefaxersen (RO7434656)ExperimentalParticipants 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 or after the common-close timepoint, whichever occurs first. The common-close timepoint is defined as the data cut-off date for the primary analysis.
Receives: Drug: Sefaxersen (RO7434656)
PlaceboPlacebo comparatorParticipants 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 or after the common-close timepoint, whichever occurs first. The common-close timepoint is defined as the data cut-off date for the primary analysis.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, Week 37

Secondary outcomes (6)

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

    eGFR will be calculated using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation.

    Measured: Baseline, Week 105

  2. Time to the Composite Kidney Failure Endpoint

    Time to the composite kidney failure endpoint is defined as receipt of kidney transplantation, need for kidney replacement therapy, or a sustained decline in eGFR of ≥ 30% or a sustained eGFR < 15 milliliters/minutes/1.73m^2 (mL/min/1.73m^ 2) over at least 4 weeks (both eGFR criteria requires two consecutive central laboratory eGFR values meeting criteria ≥ 4 weeks apart), whichever occurs first.

    Measured: Up to approximately 36 months

  3. Percentage of Participants Achieving Hematuria Resolution at Week 37

    Measured: At Week 37

  4. Change From Baseline in Fatigue at Week 105

    Fatigue will be assessed with the Functional Assessment of Chronic Illness Therapy-Fatigue subscale (FACIT-F). The FACIT-F Scale is a 13-item scale used to measure self-reported fatigue. Items are assessed on a 5-point Likert scale, with responses ranging from 0 for "not at all" to 4 for "very much". Relevant items are reverse scored, and all items are summed up to create a total score ranging from 0 to 52, with higher scores indicative of better functioning (i.e., less fatigue).

    Measured: Baseline, Week 105

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

    Measured: Up to approximately 36 months

  6. Plasma Concentration of Sefaxersen

    Measured: Up to approximately 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2023
  2. Study start8 Aug 2023
  3. Primary completion25 May 2028 (estimated)
  4. Study completion31 Aug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
459 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05797610
Sponsor's protocol ID
WA43966
Other IDs
2022-502102-32-00
Acronym
IMAGINATION
Status last verified
Sep 2026
First submitted
22 Mar 2023
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • Sato T, Fukase H, Ishida T, Karasawa A. A First-in-Japanese Phase 1, Double-Blind, Placebo-Controlled, Parallel-Cohort Study of Sefaxersen, an Antisense Oligonucleotide Targeting Complement Factor B, in Healthy Participants. Clin Pharmacol Drug Dev. 2026 Sep;15(9):e70097. doi: 10.1002/cpdd.70097.

    PubMed 42713733

  • 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.

    PubMed 39331470

  • 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.

    PubMed 38299639

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sefaxersen (RO7434656) in people with Primary IgA Nephropathy, run by Hoffmann-La Roche at 171 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 171 sites in China, Japan, United States, South Korea, Germany and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in the Urine Protein-to-Creatinine Ratio (UPCR) at Week 37 (time frame: Baseline, Week 37). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05797610, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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