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IgA NephropathyPhase 3NCT03608033

Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy

A Phase 3 study testing OMS721 in people with IgA Nephropathy, run by Omeros Corporation at 139 sites in 23 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The primary objective of this study is to evaluate the effect of OMS721 on 24-hour urine protein excretion (UPE) in IgA nephropathy (IgAN) patients with high baseline proteinuria (high-risk proteinuria group; 24-hour UPE ≥ 2 g/day) assessed at 36 weeks from baseline. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
IgA Nephropathy
What is being tested?
OMS721
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
360 participants
Where
139 sitesin 23 countries
Study dates
5 Apr 2018to 12 Jan 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Age 18 years or older at the onset of Screening
  • Biopsy confirmed diagnosis of IgAN within 8 years prior to Screening or Run-in Visit 1
  • Documented history of proteinuria of > 1 g/day within 6 months prior to Screening or uPCR > 0.75 by spot urine at Screening
  • Mean of two proteinuria measurements > 1 g/day at baseline
  • Estimated glomerular filtration rate of ≥ 30 mL/min/1.73 m² at Screening and baseline

Who cannot join

  • Treatment with immunosuppressants (e.g., azathioprine or cyclophosphamide), Chinese traditional medicine with immunosuppressive function, cytotoxic drugs, or eculizumab within 8 weeks prior to Screening, unless such treatment is given for indications other than IgA.
  • Treatment with systemic corticosteroids within 8 weeks prior to Screening
  • Uncontrolled BP, a systolic BP of > 150 mmHg and a diastolic BP of > 100 mmHg at rest despite the combination of two or more anti-hypertensives including ACE inhibitors, ARBs, or direct renin inhibitors
  • Female patients who are pregnant, breast feeding, or planning to become pregnant up through 12 weeks after the last dose of study drug, including possible retreatments. Males who are planning to father children up through 12 weeks after the last dose of study drug, including possible retreatments
  • Clinical or biological evidence of Type 1 diabetes mellitus (DM), or poorly controlled DM with hemoglobin A1c > 7.5 or with evidence of diabetic nephropathy on biopsy, systemic lupus erythematosus, IgA vasculitis (Henoch-Schonlein purpura), secondary IgAN, or other renal disease during Screening and Run-In
  • Presence of significant morbidity or other major illness or disease that may confound the interpretation of the clinical trial results or may result in death within 2 years of Screening
Show all 17Show fewer
  • History of renal transplantation
  • Have a known hypersensitivity to any constituent of the investigational product
  • Rapidly progressive glomerulonephritis, defined as a fall in eGFR of > 30 mL/min/1.73 m^2 within 24 weeks or > 15 mL/min/1.73 m^2 within 12 weeks prior to Screening
  • Significant abnormalities in clinical laboratory values
  • History of human immunodeficiency virus (HIV), evidence of immune suppression, active hepatitis C virus (HCV) infection (patients with positive anti-HCV antibody but a non-detected HCV RNA PCR can enroll), hepatitis B virus (HBV) infection (patients with positive HBsAg are excluded; for patients with isolated positive anti-HBc antibody, HBV DNA test by PCR must be non-detectable to enroll).
  • Diagnosis of a malignancy except for adequately treated and cured basal or squamous cell skin cancer, curatively treated in situ disease, or other cancer from which the patient has been disease-free for ≥ 5 years
  • Have received any other investigational drug or device or experimental procedures within 30 days of the Screening Visit (SV) or within 5 times the plasma half-life of the administered experimental drug, whichever is longer
  • Initiation or change in dosing of sodium glucose co-transporter 2 inhibitors (SGLT2i) during Screening and Run-In Periods. However, a stable dose regimen established at least 8 weeks prior to screening is acceptable
  • Treatment with Tarpeyo™ (budesonide) or other approved treatments for IgAN within 6 months prior to screening. Treatment with Tarpeyo is not allowed during Screening and Run-In Periods
  • Treatment with Kerendia® (finerenone) within 6 months prior to screening. Treatment with Kerendia is not allowed during Screening and Run-In Periods
  • Initiation of treatment with Filspari™ (sparsentan), a dual Endothelin Angiotensin Receptor Antagonist (dEARA) or similar medication within three months prior to screening. A stable dose initiated at minimum 3 months before screening is acceptable and will take the place of ACEi/ARB as background therapy

Trial locations and contacts

139 sites in 23 countries.

139 sites in 23 countries

United States34 sites

  • Omeros Investigational Site

    Amarillo, Texas, 79106

  • Omeros Investigational Site

    Boston, Massachusetts, 02111

  • Omeros Investigational Site

    Charleston, South Carolina, 29425

  • Omeros Investigational Site

    Chattanooga, Tennessee, 37404

  • Omeros Investigational Site

    Chicago, Illinois, 60612

  • Omeros Investigational Site

    Cincinnati, Ohio, 45220

  • Omeros Investigational Site

    Columbus, Ohio, 43210

  • Omeros Investigational Site

    Dallas, Texas, 75246

  • Omeros Investigational Site

    Denver, Colorado, 80230

  • Omeros Investigational Site

    Florence, Alabama, 35630

  • Omeros Investigational Site

    Fresh Meadows, New York, 11365

  • Omeros Investigational Site

    Houston, Texas, 77054

  • Omeros Investigational Site

    Iowa City, Iowa, 52242

  • Omeros Investigational Site

    Lawrenceville, Georgia, 30046

  • Omeros Investigational Site

    Los Angeles, California, 90022-4302

  • Omeros Investigational Site

    Los Angeles, California, 90025

  • Omeros Investigational Site

    Mesa, Arizona, 85206

  • Omeros Investigational Site

    Miami, Florida, 33136

  • Omeros Investigational Site

    Miami Lakes, Florida, 33014

  • Omeros Investigational Site

    Milwaukee, Wisconsin, 53226

  • Omeros Investigational Site

    Minneapolis, Minnesota, 55414

  • Omeros Investigational Site

    New York, New York, 10029

  • Omeros Investigational Site

    Northridge, California, 91324

  • Omeros Investigational Site

    Philadelphia, Pennsylvania, 19104

  • Omeros Investigation Sites

    Phoenix, Arizona, 85016

  • Omeros Investigational Site

    Rochester, Minnesota, 55905

  • Omeros Investigational Site

    San Dimas, California, 91773

  • Omeros Investigational Site

    San Francisco, California, 94118

  • Omeros Investigational Site

    Scottsdale, Arizona, 85258

  • Omeros Investigational Site

    Scottsdale, Arizona, 85259

  • Omeros Investigational Site

    Springfield, Massachusetts, 01107

  • Omeros Investigational Site

    St Louis, Missouri, 63110

  • Omeros Investigational Site

    Stanford, California, 94304

  • Omeros Investigational Site

    Torrance, California, 90509

Other trials in United States

India11 sites

  • Omeros Investigational Site

    Belagavi, Karnataka, 590010

  • Omeros Investigational Site

    Chandigarh, 160012

  • Omeros Investigational Site

    Hyderabad, Ameerpet, 500038

  • Omeros Investigational Site

    Hyderabad, Telangana, 500034

  • Omeros Investigational Site

    Hyderabad, Telangana, 500038

  • Omeros Investigational Site

    Hyderabad, Telangana, 500082

  • Omeros Investigational Site

    Jaipur, Rajasthan, 302004

  • Omeros Investigational Site

    Kozhikode, Kerala, 673008

  • Omeros Investigational Site

    Mangalore, Karnataka, 575001

  • Omeros Investigational Site

    Nadiād, Gujarat, 387001

  • Omeros Investigational Site

    New Delhi, New India, 110017

Other trials in India

Spain9 sites

  • Omeros Investigational Site

    Almería, 04009

  • Omeros Investigational Site

    Barcelona, 08025

  • Omeros Investigational Site

    Córdoba, 14004

  • Omeros Investigational Site

    Lleida, 25198

  • Omeros Investigational Site

    Madrid, San Sebastian de Lost Reyes, 28702

  • Omeros Investigational Site

    Madrid, 28040

  • Omeros Investigational Site

    Madrid, 28041

  • Omeros Investigational Site

    Valencia, 46026

  • Omeros Investigational Site

    Zaragoza, 50009

Other trials in Spain

Italy8 sites

  • Omeros Investigational Site

    Bari, 70124

  • Omeros Investigational Site

    Bergamo, 24127

  • Omeros Investigational Site

    Eboli, 84025

  • Omeros Investigational Site

    Messina, 98125

  • Omeros Investigational Site

    Milan, 20122

  • Omeros Investigational Site

    Modena, 41124

  • Omeros Investigational Site

    Parma, 43126

  • Omeros Investigational Site

    Piacenza, 29121

Other trials in Italy

South Korea8 sites

  • Omeros Investigational Site

    Anyang-si, Gyeonggi-do, 14068

  • Omeros Investigational Site

    Busan, 49241

  • Omeros Investigational Site

    Incheon, 21431

  • Omeros Investigational Site

    Seongnam, Geyonggi-do, 13496

  • Omeros Investigational Site

    Seoul, 05278

  • Omeros Investigational Site

    Seoul, 07061

  • Omeros Investigational Site

    Seoul, 3080

  • Omeros Investigational Site

    Seoul, 3722

Other trials in South Korea

Taiwan7 sites

  • Omeros Investigational Site

    Changhua, 500

  • Omeros Investigational Site

    Hualien City, 97002

  • Omeros Investigational Site

    Kaohsiung City, 824

  • Omeros Investigational Site

    New Taipei City, 220

  • Omeros Investigational Site

    New Taipei City, 235

  • Omeros Investigational Site

    Taichung

  • Omeros Investigational Site

    Taoyuan City, 333

Other trials in Taiwan

Thailand6 sites

  • Omeros Investigational Site

    Bangkok, 10300

  • Omeros Investigational Site

    Bangkok, 10700

  • Omeros Investigational Site

    Chiang Mai, 50200

  • Omeros Investigational Site

    Dusit

  • Omeros Investigational Site

    Khon Kaen, 40000

  • Omeros Investigational Site

    Songkhla, 90000

Other trials in Thailand

Turkey (Türkiye)6 sites

  • Omeros Investigational Site

    Ankara, 06230

  • Omeros Investigational Site

    Bursa, 16059

  • Omeros Investigational Site

    Edirne, 22130

  • Omeros Investigational Site

    Istanbul, 34899

  • Omeros Investigational Site

    Kocaeli, 41380

  • Omeros Investigational Site

    Malatya, 44200

Other trials in Turkey (Türkiye)

Germany5 sites

  • Omeros Investigational Site

    Aachen, North Rhine-Westphalia, 52074

  • Omeros Investigational Site

    Göttingen, 37075

  • Omeros Investigational Site

    Mannheim, Baden-Wrttemberg, 68167

  • Omeros Investigational Site

    München, Bavaria, 80336

  • Omeros Investigational Site

    Villingen-Schwenningen, 78052

Other trials in Germany

Greece5 sites

  • Omeros Investigational Site

    Athens, 11527

  • Omeros Investigational Site

    Heraklion, 71110

  • Omeros Investigational Site

    Heraklion, 71409

  • Omeros Investigational Site

    Pátrai, 26504

  • Omeros Investigational Site

    Thessaloniki, Pilea-Chortiatis, 57010

Other trials in Greece

Hungary5 sites

  • Omeros Investigational Site

    Baja, H-6500

  • Omeros Investigational Site

    Budapest, H-1097

  • Omeros Investigational Site

    Győr, H-9024

  • Omeros Investigational Site

    Pécs, H-7624

  • Omeros Investigational Site

    Szeged, 6720

Other trials in Hungary

United Kingdom5 sites

  • Omeros Investigational Site

    Cambridge, CB2 0QQ

  • Omeros Investigational Site

    Cardiff, CF10 3XQ

  • Omeros Investigational Site

    Dartford, DA2 8DA

  • Omeros Investigational Site

    Leicester, Evington, LE5 4PW

  • Omeros Investigational Site

    London, NW3 2QG

Other trials in United Kingdom

Argentina4 sites

  • Omeros Investigational Site

    Buenos Aires, C1280AEB

  • Omeros Investigational Site

    Córdoba, X5016KEH

  • Omeros Investigational Site

    Posadas, Misiones Province, 3300

  • Omeros Investigational Site

    Salta, 4400

Other trials in Argentina

Australia4 sites

  • Omeros Investigational Site

    Adelaide, South Australia, 5000

  • Omeros Investigational Site

    Clayton, Victoria, 3168

  • Omeros Investigational Site

    Footscray, Saint Albans, 3021

  • Omeros Investigational Site

    Garran, Australian Capital Territory, Woden, 2606

Other trials in Australia

Canada4 sites

  • Omeros Investigational Site

    London, Ontario, N6A545

  • Omeros Investigational Site

    Toronto, Ontario, M5G2C4

  • Omeros Investigational Site

    Vancouver, British Columbia, V5Z2M9

  • Omeros Investigational Site

    Vancouver, British Columbia, V6Z1Y6

Other trials in Canada

Poland4 sites

  • Omeros Investigational Site

    Krakow, 30-688

  • Omeros Investigational Site

    Lodz, Todzi, 92-213

  • Omeros Investigational Site

    Olsztyn, 10-561

  • Omeros Investigational Site

    Warsaw, 04-749

Other trials in Poland

Belgium3 sites

  • Omeros Investigational Site

    Ghent, 9000

  • Omeros Investigational Site

    Leuven, 3000

  • Omeros Investigational Site

    Liège, 1-4000

Other trials in Belgium

Bulgaria3 sites

  • Omeros Investigational Site

    Plovdiv, 4000

  • Omeros Investigational Site

    Plovdiv, 4002

  • Omeros Investigational Site

    Sofia, 1431

Other trials in Bulgaria

Lithuania2 sites

  • Omeros Investigational Site

    Kaunas, LT-50161

  • Omeros Investigational Site

    Vilnius, LT-08661

Other trials in Lithuania

Singapore2 sites

  • Omeros Investigational Site

    Singapore, 119074

  • Omeros Investigational Site

    Singapore, 308433

Other trials in Singapore

Slovakia2 sites

  • Omeros Investigational Site

    Banská Bystrica, 97401

  • Omeros Investigational Site

    Košice, 04011

Other trials in Slovakia

Czechia1 site

  • Omeros Investigational Site

    Prague, Prague, 128 08

Other trials in Czechia

Sweden1 site

  • Omeros Investigational Site

    Stockholm

Other trials in Sweden

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy (ARTEMIS - IGAN)

The primary objective of this study is to evaluate the effect of OMS721 on 24-hour urine protein excretion (UPE) in IgA nephropathy (IgAN) patients with high baseline proteinuria (high-risk proteinuria group; 24-hour UPE ≥ 2 g/day) assessed at 36 weeks from baseline.

Read the detailed description

This is a Phase 3, double-blind, randomized, placebo-controlled, study in patients aged 18 years and above with a biopsy-confirmed diagnosis of IgAN and with 24-hour UPE that is > 1 g/day. The purpose of this study is to evaluate the efficacy and safety of narsoplimab (OMS721) compared to placebo on proteinuria and whether narsoplimab has the ability to slow disease progression in primary IgAN patients. The primary objective of the study is to evaluate proteinuria reduction as assessed by 24-hour UPE at 36 weeks from baseline. The trial will continue beyond 36 weeks in a blinded fashion to provide confirmatory evidence of long-term efficacy based on the annualized slope of eGFR over 24 months. The trial will enroll approximately 450 patients with 225 patients per arm, all having biopsy-proven IgAN with eGFR≥30 mL/min/1.73m^2 and 24 hour UPE >1g/day. The study duration for each patient is expected to last approximately 112 weeks.

Conditions
IgA Nephropathy
Being tested
OMS721, Vehicle (D5W or saline)
Keywords
IgA nephropathy, IgAN, Proteinuria, Chronic kidney disease, IgAN autoantibodies, eGFR, EGFR slope, UPE, Narsoplimab
Medical subject headings
Glomerulonephritis, IGA, Proteinuria, Renal Insufficiency, Chronic

What participants receive

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

  • OMS721Biological

    Biological: OMS721

  • Vehicle (D5W or saline)Other

    5% Dextrose in water or normal saline solution

Study groups in NCT03608033
Study groupRoleWhat they receive
OMS721ExperimentalAdministration of OMS721
Receives: Biological: OMS721
PlaceboPlacebo comparatorAdministration of Vehicle (D5W or Saline Solution)
Receives: Other: Vehicle (D5W or saline)

What is being measured

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

  1. Percent Change in 24-hour UPE in g/Day Compared to Baseline

    The Primary Endpoint of this Study is the Percent Change from Baseline in Log-transformed 24-hour UPE in g/Day at 36 Weeks in Patients with High Baseline Proteinuria (High-risk Proteinuria Group; 24-hour UPE ≥ 2 g/day.

    Measured: 36 Weeks

Secondary outcomes (8)

  1. Change in Annualized eGFR Compared to Baseline.

    The Rate of Change in eGFR up to 96 Weeks from Baseline in Patients with High Baseline Proteinuria (High-risk Proteinuria Group; 24-hour UPE ≥ 2 g/Day)

    Measured: 96 Weeks

  2. Change in Annualized eGFR Compared to Baseline in All Patients.

    The Rate of Change in eGFR up to 96 Weeks from Baseline in the All-patients Population (24-hour UPE > 1 g/Day)

    Measured: 96 Weeks

  3. Change in 24-hour UPE in g/Day Compared to Baseline in All Patients

    Change From Baseline in Log-transformed 24-hour UPE at Week 36 in the All-patients Population. (24-hour UPE > 1 g/Day)

    Measured: 36 Weeks

  4. Change in 24-hour UPE in g/Day Between 36 Weeks and 48 Weeks.

    Change From Baseline in the Log-transformed 24-hour UPE Between 36 Weeks and 48 Weeks in Patients With ≥ 2 g/Day UPE at Baseline (High-risk Proteinuria Group)

    Measured: 36 weeks and 48 weeks

  5. Change in 24-hour UPE in g/Day Between 36 Weeks and 72 Weeks in Patients With >= 2 g/Day UPE at Baseline (High-risk Proteinuria Group).

    Time-averaged Change from Baseline in the Log-transformed 24-hour UPE Between 36 Weeks and 72 Weeks in Patients with ≥ 2 g/Day UPE at Baseline (High-risk Proteinuria Group)

    Measured: 36 weeks and 72 weeks

  6. Change in 24-hour UPE in g/Day Between 36 Weeks and 48 Weeks in All Patients

    Time-averaged Change from Baseline in the Log-transformed 24-hour UPE Between 36 Weeks and 48 Weeks in the All-patients Population

    Measured: 36 weeks and 48 weeks

  7. Change in 24-hour UPE in g/Day Between 36 Weeks and 72 Weeks in All Patients

    Time-averaged Change from Baseline in the Log-transformed 24-hour UPE between 36 Weeks and 72 Weeks in the All-patients Population

    Measured: 36 weeks and 72 weeks

  8. Safety and Tolerability of Narsoplimab for the Treatment of IgAN as Assessed by AEs, Vital Signs, Clinical Laboratory Tests, and ECGs

    As assessed by the incidence of adverse events through study completion (Week 112) in the patient group in the all-patients population. Clinically meaningful abnormalities in vital signs, clinical laboratory tests, and ECGs were collected as AEs.

    Measured: Week 112

Timeline

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

  1. First posted31 Jul 2018
  2. Study start5 Apr 2018
  3. Primary completion12 Jan 2024
  4. Study completion12 Jan 2024

Why it stopped: IA did not meet the prespecified primary endpoint.

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
Model description
Eligible patients will be randomized 1:1 to receive OMS721 or placebo
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
360 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03608033
Sponsor's protocol ID
OMS721-IGA-001
Status last verified
Nov 2025
First submitted
21 Jun 2018
Last updated
9 Dec 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • El Karoui K, Fervenza FC, De Vriese AS. Treatment of IgA Nephropathy: A Rapidly Evolving Field. J Am Soc Nephrol. 2024 Jan 1;35(1):103-116. doi: 10.1681/ASN.0000000000000242. Epub 2023 Sep 29.

    PubMed 37772889

  • Reich HN, Floege J. How I Treat IgA Nephropathy. Clin J Am Soc Nephrol. 2022 Aug;17(8):1243-1246. doi: 10.2215/CJN.02710322. Epub 2022 Jun 8. No abstract available.

    PubMed 35675911

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing OMS721 in people with IgA Nephropathy, run by Omeros Corporation at 139 sites in 23 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 5 inclusion and 17 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: stopped early, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 139 sites in United States, India, Spain, Italy, South Korea and 18 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?

Yes. Results are posted in the registry (first posted 9 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percent Change in 24-hour UPE in g/Day Compared to Baseline (time frame: 36 Weeks). 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 NCT03608033, which also lists 2 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 9 Dec 2025.

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