Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Kidney disease drug trial halted midway

NCT ID NCT03608033

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called OMS721 for people with IgA nephropathy, a kidney disease that can lead to kidney failure. The goal was to see if the drug could reduce protein in the urine, a sign of kidney damage. The trial was stopped early, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

360 people

The number who actually took part.

Started

Apr 2018

Finished

Jan 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for IgA nephropathy are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Omeros Investigation Sites

    Phoenix, Arizona, 85016, United States

  • Omeros Investigational Site

    Florence, Alabama, 35630, United States

  • Omeros Investigational Site

    Mesa, Arizona, 85206, United States

  • Omeros Investigational Site

    Scottsdale, Arizona, 85258, United States

  • Omeros Investigational Site

    Scottsdale, Arizona, 85259, United States

  • Omeros Investigational Site

    Los Angeles, California, 90022-4302, United States

  • Omeros Investigational Site

    Los Angeles, California, 90025, United States

  • Omeros Investigational Site

    Northridge, California, 91324, United States

  • Omeros Investigational Site

    San Dimas, California, 91773, United States

  • Omeros Investigational Site

    San Francisco, California, 94118, United States

  • Omeros Investigational Site

    Stanford, California, 94304, United States

  • Omeros Investigational Site

    Torrance, California, 90509, United States

  • Omeros Investigational Site

    Denver, Colorado, 80230, United States

  • Omeros Investigational Site

    Miami, Florida, 33136, United States

  • Omeros Investigational Site

    Miami Lakes, Florida, 33014, United States

  • Omeros Investigational Site

    Lawrenceville, Georgia, 30046, United States

  • Omeros Investigational Site

    Chicago, Illinois, 60612, United States

  • Omeros Investigational Site

    Iowa City, Iowa, 52242, United States

  • Omeros Investigational Site

    Boston, Massachusetts, 02111, United States

  • Omeros Investigational Site

    Springfield, Massachusetts, 01107, United States

  • Omeros Investigational Site

    Minneapolis, Minnesota, 55414, United States

  • Omeros Investigational Site

    Rochester, Minnesota, 55905, United States

  • Omeros Investigational Site

    St Louis, Missouri, 63110, United States

  • Omeros Investigational Site

    Fresh Meadows, New York, 11365, United States

  • Omeros Investigational Site

    New York, New York, 10029, United States

  • Omeros Investigational Site

    Cincinnati, Ohio, 45220, United States

  • Omeros Investigational Site

    Columbus, Ohio, 43210, United States

  • Omeros Investigational Site

    Philadelphia, Pennsylvania, 19104, United States

  • Omeros Investigational Site

    Charleston, South Carolina, 29425, United States

  • Omeros Investigational Site

    Chattanooga, Tennessee, 37404, United States

  • Omeros Investigational Site

    Amarillo, Texas, 79106, United States

  • Omeros Investigational Site

    Dallas, Texas, 75246, United States

  • Omeros Investigational Site

    Houston, Texas, 77054, United States

  • Omeros Investigational Site

    Milwaukee, Wisconsin, 53226, United States

  • Omeros Investigational Site

    Posadas, Misiones Province, 3300, Argentina

  • Omeros Investigational Site

    Buenos Aires, C1280AEB, Argentina

  • Omeros Investigational Site

    Córdoba, X5016KEH, Argentina

  • Omeros Investigational Site

    Salta, 4400, Argentina

  • Omeros Investigational Site

    Garran, Australian Capital Territory, Woden, 2606, Australia

  • Omeros Investigational Site

    Footscray, Saint Albans, 3021, Australia

  • Omeros Investigational Site

    Adelaide, South Australia, 5000, Australia

  • Omeros Investigational Site

    Clayton, Victoria, 3168, Australia

  • Omeros Investigational Site

    Ghent, 9000, Belgium

  • Omeros Investigational Site

    Leuven, 3000, Belgium

  • Omeros Investigational Site

    Liège, 1-4000, Belgium

  • Omeros Investigational Site

    Plovdiv, 4000, Bulgaria

  • Omeros Investigational Site

    Plovdiv, 4002, Bulgaria

  • Omeros Investigational Site

    Sofia, 1431, Bulgaria

  • Omeros Investigational Site

    Vancouver, British Columbia, V5Z2M9, Canada

  • Omeros Investigational Site

    Vancouver, British Columbia, V6Z1Y6, Canada

  • Omeros Investigational Site

    London, Ontario, N6A545, Canada

  • Omeros Investigational Site

    Toronto, Ontario, M5G2C4, Canada

  • Omeros Investigational Site

    Prague, Prague, 128 08, Czechia

  • Omeros Investigational Site

    Mannheim, Baden-Wrttemberg, 68167, Germany

  • Omeros Investigational Site

    München, Bavaria, 80336, Germany

  • Omeros Investigational Site

    Aachen, North Rhine-Westphalia, 52074, Germany

  • Omeros Investigational Site

    Göttingen, 37075, Germany

  • Omeros Investigational Site

    Villingen-Schwenningen, 78052, Germany

  • Omeros Investigational Site

    Thessaloniki, Pilea-Chortiatis, 57010, Greece

  • Omeros Investigational Site

    Athens, 11527, Greece

  • Omeros Investigational Site

    Heraklion, 71110, Greece

  • Omeros Investigational Site

    Heraklion, 71409, Greece

  • Omeros Investigational Site

    Pátrai, 26504, Greece

  • Omeros Investigational Site

    Baja, H-6500, Hungary

  • Omeros Investigational Site

    Budapest, H-1097, Hungary

  • Omeros Investigational Site

    Győr, H-9024, Hungary

  • Omeros Investigational Site

    Pécs, H-7624, Hungary

  • Omeros Investigational Site

    Szeged, 6720, Hungary

  • Omeros Investigational Site

    Hyderabad, Ameerpet, 500038, India

  • Omeros Investigational Site

    Nadiād, Gujarat, 387001, India

  • Omeros Investigational Site

    Belagavi, Karnataka, 590010, India

  • Omeros Investigational Site

    Mangalore, Karnataka, 575001, India

  • Omeros Investigational Site

    Kozhikode, Kerala, 673008, India

  • Omeros Investigational Site

    New Delhi, New India, 110017, India

  • Omeros Investigational Site

    Jaipur, Rajasthan, 302004, India

  • Omeros Investigational Site

    Hyderabad, Telangana, 500034, India

  • Omeros Investigational Site

    Hyderabad, Telangana, 500038, India

  • Omeros Investigational Site

    Hyderabad, Telangana, 500082, India

  • Omeros Investigational Site

    Chandigarh, 160012, India

  • Omeros Investigational Site

    Bari, 70124, Italy

  • Omeros Investigational Site

    Bergamo, 24127, Italy

  • Omeros Investigational Site

    Eboli, 84025, Italy

  • Omeros Investigational Site

    Messina, 98125, Italy

  • Omeros Investigational Site

    Milan, 20122, Italy

  • Omeros Investigational Site

    Modena, 41124, Italy

  • Omeros Investigational Site

    Parma, 43126, Italy

  • Omeros Investigational Site

    Piacenza, 29121, Italy

  • Omeros Investigational Site

    Kaunas, LT-50161, Lithuania

  • Omeros Investigational Site

    Vilnius, LT-08661, Lithuania

  • Omeros Investigational Site

    Lodz, Todzi, 92-213, Poland

  • Omeros Investigational Site

    Krakow, 30-688, Poland

  • Omeros Investigational Site

    Olsztyn, 10-561, Poland

  • Omeros Investigational Site

    Warsaw, 04-749, Poland

  • Omeros Investigational Site

    Singapore, 119074, Singapore

  • Omeros Investigational Site

    Singapore, 308433, Singapore

  • Omeros Investigational Site

    Banská Bystrica, 97401, Slovakia

  • Omeros Investigational Site

    Košice, 04011, Slovakia

  • Omeros Investigational Site

    Seongnam, Geyonggi-do, 13496, South Korea

  • Omeros Investigational Site

    Anyang-si, Gyeonggi-do, 14068, South Korea

  • Omeros Investigational Site

    Busan, 49241, South Korea

  • Omeros Investigational Site

    Incheon, 21431, South Korea

  • Omeros Investigational Site

    Seoul, 05278, South Korea

  • Omeros Investigational Site

    Seoul, 07061, South Korea

  • Omeros Investigational Site

    Seoul, 3080, South Korea

  • Omeros Investigational Site

    Seoul, 3722, South Korea

  • Omeros Investigational Site

    Madrid, San Sebastian de Lost Reyes, 28702, Spain

  • Omeros Investigational Site

    Almería, 04009, Spain

  • Omeros Investigational Site

    Barcelona, 08025, Spain

  • Omeros Investigational Site

    Córdoba, 14004, Spain

  • Omeros Investigational Site

    Lleida, 25198, Spain

  • Omeros Investigational Site

    Madrid, 28040, Spain

  • Omeros Investigational Site

    Madrid, 28041, Spain

  • Omeros Investigational Site

    Valencia, 46026, Spain

  • Omeros Investigational Site

    Zaragoza, 50009, Spain

  • Omeros Investigational Site

    Stockholm, Sweden

  • Omeros Investigational Site

    Changhua, 500, Taiwan

  • Omeros Investigational Site

    Hualien City, 97002, Taiwan

  • Omeros Investigational Site

    Kaohsiung City, 824, Taiwan

  • Omeros Investigational Site

    New Taipei City, 220, Taiwan

  • Omeros Investigational Site

    New Taipei City, 235, Taiwan

  • Omeros Investigational Site

    Taichung, Taiwan

  • Omeros Investigational Site

    Taoyuan City, 333, Taiwan

  • Omeros Investigational Site

    Bangkok, 10300, Thailand

  • Omeros Investigational Site

    Bangkok, 10700, Thailand

  • Omeros Investigational Site

    Chiang Mai, 50200, Thailand

  • Omeros Investigational Site

    Dusit, Thailand

  • Omeros Investigational Site

    Khon Kaen, 40000, Thailand

  • Omeros Investigational Site

    Songkhla, 90000, Thailand

  • Omeros Investigational Site

    Ankara, 06230, Turkey (Türkiye)

  • Omeros Investigational Site

    Bursa, 16059, Turkey (Türkiye)

  • Omeros Investigational Site

    Edirne, 22130, Turkey (Türkiye)

  • Omeros Investigational Site

    Istanbul, 34899, Turkey (Türkiye)

  • Omeros Investigational Site

    Kocaeli, 41380, Turkey (Türkiye)

  • Omeros Investigational Site

    Malatya, 44200, Turkey (Türkiye)

  • Omeros Investigational Site

    Leicester, Evington, LE5 4PW, United Kingdom

  • Omeros Investigational Site

    Cambridge, CB2 0QQ, United Kingdom

  • Omeros Investigational Site

    Cardiff, CF10 3XQ, United Kingdom

  • Omeros Investigational Site

    Dartford, DA2 8DA, United Kingdom

  • Omeros Investigational Site

    London, NW3 2QG, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.