Kidney disease drug trial halted midway
NCT ID NCT03608033
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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360 people
The number who actually took part.
- Started
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Apr 2018
- Finished
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Jan 2024
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Get notified about this study
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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
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Omeros Investigation Sites
Phoenix, Arizona, 85016, United States
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Omeros Investigational Site
Florence, Alabama, 35630, United States
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Omeros Investigational Site
Mesa, Arizona, 85206, United States
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Omeros Investigational Site
Scottsdale, Arizona, 85258, United States
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Omeros Investigational Site
Scottsdale, Arizona, 85259, United States
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Omeros Investigational Site
Los Angeles, California, 90022-4302, United States
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Omeros Investigational Site
Los Angeles, California, 90025, United States
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Omeros Investigational Site
Northridge, California, 91324, United States
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Omeros Investigational Site
San Dimas, California, 91773, United States
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Omeros Investigational Site
San Francisco, California, 94118, United States
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Omeros Investigational Site
Stanford, California, 94304, United States
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Omeros Investigational Site
Torrance, California, 90509, United States
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Omeros Investigational Site
Denver, Colorado, 80230, United States
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Omeros Investigational Site
Miami, Florida, 33136, United States
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Omeros Investigational Site
Miami Lakes, Florida, 33014, United States
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Omeros Investigational Site
Lawrenceville, Georgia, 30046, United States
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Omeros Investigational Site
Chicago, Illinois, 60612, United States
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Omeros Investigational Site
Iowa City, Iowa, 52242, United States
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Omeros Investigational Site
Boston, Massachusetts, 02111, United States
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Omeros Investigational Site
Springfield, Massachusetts, 01107, United States
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Omeros Investigational Site
Minneapolis, Minnesota, 55414, United States
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Omeros Investigational Site
Rochester, Minnesota, 55905, United States
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Omeros Investigational Site
St Louis, Missouri, 63110, United States
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Omeros Investigational Site
Fresh Meadows, New York, 11365, United States
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Omeros Investigational Site
New York, New York, 10029, United States
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Omeros Investigational Site
Cincinnati, Ohio, 45220, United States
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Omeros Investigational Site
Columbus, Ohio, 43210, United States
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Omeros Investigational Site
Philadelphia, Pennsylvania, 19104, United States
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Omeros Investigational Site
Charleston, South Carolina, 29425, United States
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Omeros Investigational Site
Chattanooga, Tennessee, 37404, United States
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Omeros Investigational Site
Amarillo, Texas, 79106, United States
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Omeros Investigational Site
Dallas, Texas, 75246, United States
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Omeros Investigational Site
Houston, Texas, 77054, United States
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Omeros Investigational Site
Milwaukee, Wisconsin, 53226, United States
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Omeros Investigational Site
Posadas, Misiones Province, 3300, Argentina
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Omeros Investigational Site
Buenos Aires, C1280AEB, Argentina
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Omeros Investigational Site
Córdoba, X5016KEH, Argentina
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Omeros Investigational Site
Salta, 4400, Argentina
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Omeros Investigational Site
Garran, Australian Capital Territory, Woden, 2606, Australia
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Omeros Investigational Site
Footscray, Saint Albans, 3021, Australia
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Omeros Investigational Site
Adelaide, South Australia, 5000, Australia
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Omeros Investigational Site
Clayton, Victoria, 3168, Australia
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Omeros Investigational Site
Ghent, 9000, Belgium
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Omeros Investigational Site
Leuven, 3000, Belgium
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Omeros Investigational Site
Liège, 1-4000, Belgium
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Omeros Investigational Site
Plovdiv, 4000, Bulgaria
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Omeros Investigational Site
Plovdiv, 4002, Bulgaria
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Omeros Investigational Site
Sofia, 1431, Bulgaria
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Omeros Investigational Site
Vancouver, British Columbia, V5Z2M9, Canada
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Omeros Investigational Site
Vancouver, British Columbia, V6Z1Y6, Canada
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Omeros Investigational Site
London, Ontario, N6A545, Canada
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Omeros Investigational Site
Toronto, Ontario, M5G2C4, Canada
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Omeros Investigational Site
Prague, Prague, 128 08, Czechia
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Omeros Investigational Site
Mannheim, Baden-Wrttemberg, 68167, Germany
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Omeros Investigational Site
München, Bavaria, 80336, Germany
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Omeros Investigational Site
Aachen, North Rhine-Westphalia, 52074, Germany
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Omeros Investigational Site
Göttingen, 37075, Germany
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Omeros Investigational Site
Villingen-Schwenningen, 78052, Germany
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Omeros Investigational Site
Thessaloniki, Pilea-Chortiatis, 57010, Greece
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Omeros Investigational Site
Athens, 11527, Greece
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Omeros Investigational Site
Heraklion, 71110, Greece
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Omeros Investigational Site
Heraklion, 71409, Greece
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Omeros Investigational Site
Pátrai, 26504, Greece
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Omeros Investigational Site
Baja, H-6500, Hungary
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Omeros Investigational Site
Budapest, H-1097, Hungary
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Omeros Investigational Site
Győr, H-9024, Hungary
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Omeros Investigational Site
Pécs, H-7624, Hungary
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Omeros Investigational Site
Szeged, 6720, Hungary
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Omeros Investigational Site
Hyderabad, Ameerpet, 500038, India
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Omeros Investigational Site
Nadiād, Gujarat, 387001, India
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Omeros Investigational Site
Belagavi, Karnataka, 590010, India
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Omeros Investigational Site
Mangalore, Karnataka, 575001, India
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Omeros Investigational Site
Kozhikode, Kerala, 673008, India
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Omeros Investigational Site
New Delhi, New India, 110017, India
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Omeros Investigational Site
Jaipur, Rajasthan, 302004, India
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Omeros Investigational Site
Hyderabad, Telangana, 500034, India
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Omeros Investigational Site
Hyderabad, Telangana, 500038, India
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Omeros Investigational Site
Hyderabad, Telangana, 500082, India
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Omeros Investigational Site
Chandigarh, 160012, India
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Omeros Investigational Site
Bari, 70124, Italy
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Omeros Investigational Site
Bergamo, 24127, Italy
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Omeros Investigational Site
Eboli, 84025, Italy
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Omeros Investigational Site
Messina, 98125, Italy
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Omeros Investigational Site
Milan, 20122, Italy
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Omeros Investigational Site
Modena, 41124, Italy
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Omeros Investigational Site
Parma, 43126, Italy
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Omeros Investigational Site
Piacenza, 29121, Italy
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Omeros Investigational Site
Kaunas, LT-50161, Lithuania
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Omeros Investigational Site
Vilnius, LT-08661, Lithuania
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Omeros Investigational Site
Lodz, Todzi, 92-213, Poland
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Omeros Investigational Site
Krakow, 30-688, Poland
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Omeros Investigational Site
Olsztyn, 10-561, Poland
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Omeros Investigational Site
Warsaw, 04-749, Poland
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Omeros Investigational Site
Singapore, 119074, Singapore
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Omeros Investigational Site
Singapore, 308433, Singapore
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Omeros Investigational Site
Banská Bystrica, 97401, Slovakia
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Omeros Investigational Site
Košice, 04011, Slovakia
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Omeros Investigational Site
Seongnam, Geyonggi-do, 13496, South Korea
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Omeros Investigational Site
Anyang-si, Gyeonggi-do, 14068, South Korea
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Omeros Investigational Site
Busan, 49241, South Korea
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Omeros Investigational Site
Incheon, 21431, South Korea
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Omeros Investigational Site
Seoul, 05278, South Korea
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Omeros Investigational Site
Seoul, 07061, South Korea
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Omeros Investigational Site
Seoul, 3080, South Korea
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Omeros Investigational Site
Seoul, 3722, South Korea
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Omeros Investigational Site
Madrid, San Sebastian de Lost Reyes, 28702, Spain
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Omeros Investigational Site
Almería, 04009, Spain
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Omeros Investigational Site
Barcelona, 08025, Spain
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Omeros Investigational Site
Córdoba, 14004, Spain
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Omeros Investigational Site
Lleida, 25198, Spain
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Omeros Investigational Site
Madrid, 28040, Spain
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Omeros Investigational Site
Madrid, 28041, Spain
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Omeros Investigational Site
Valencia, 46026, Spain
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Omeros Investigational Site
Zaragoza, 50009, Spain
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Omeros Investigational Site
Stockholm, Sweden
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Omeros Investigational Site
Changhua, 500, Taiwan
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Omeros Investigational Site
Hualien City, 97002, Taiwan
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Omeros Investigational Site
Kaohsiung City, 824, Taiwan
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Omeros Investigational Site
New Taipei City, 220, Taiwan
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Omeros Investigational Site
New Taipei City, 235, Taiwan
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Omeros Investigational Site
Taichung, Taiwan
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Omeros Investigational Site
Taoyuan City, 333, Taiwan
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Omeros Investigational Site
Bangkok, 10300, Thailand
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Omeros Investigational Site
Bangkok, 10700, Thailand
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Omeros Investigational Site
Chiang Mai, 50200, Thailand
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Omeros Investigational Site
Dusit, Thailand
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Omeros Investigational Site
Khon Kaen, 40000, Thailand
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Omeros Investigational Site
Songkhla, 90000, Thailand
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Omeros Investigational Site
Ankara, 06230, Turkey (Türkiye)
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Omeros Investigational Site
Bursa, 16059, Turkey (Türkiye)
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Omeros Investigational Site
Edirne, 22130, Turkey (Türkiye)
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Omeros Investigational Site
Istanbul, 34899, Turkey (Türkiye)
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Omeros Investigational Site
Kocaeli, 41380, Turkey (Türkiye)
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Omeros Investigational Site
Malatya, 44200, Turkey (Türkiye)
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Omeros Investigational Site
Leicester, Evington, LE5 4PW, United Kingdom
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Omeros Investigational Site
Cambridge, CB2 0QQ, United Kingdom
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Omeros Investigational Site
Cardiff, CF10 3XQ, United Kingdom
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Omeros Investigational Site
Dartford, DA2 8DA, United Kingdom
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Omeros Investigational Site
London, NW3 2QG, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- 10,000 kidneys under the microscope: registry maps IgA Nephropathy's course
- Microbes in the mouth and gut may hold clues to a common kidney disease
- Can a transplant drug tame stubborn kidney disease?
- Blood marker may foretell kidney disease severity
- Can a massive kidney database unlock IgA Nephropathy's secrets?
- Can a new injection slow kidney disease in children?