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

NCT03608033 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: OMS721-IGA-001
• Study Type: interventional
• Target: 360
• Locations: 23 countries
• Sites: 139

Brief 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.

Conditions

IgA Nephropathy

Keywords

IgA nephropathy; IgAN; Proteinuria; Chronic kidney disease; IgAN autoantibodies; eGFR; EGFR slope; UPE; Narsoplimab

Outcome Measures

Primary Outcomes (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.

  36 Weeks

Secondary Outcomes (8)

• Change in Annualized eGFR Compared to Baseline.

  96 Weeks

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

  96 Weeks

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

  36 Weeks

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

  36 weeks and 48 weeks

• 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).

  36 weeks and 72 weeks

Study Arms (2)

OMS721

EXPERIMENTAL

Administration of OMS721

Biological: OMS721

Placebo

PLACEBO COMPARATOR

Administration of Vehicle (D5W or Saline Solution)

Other: Vehicle (D5W or saline)

Interventions

OMS721 BIOLOGICAL

Biological: OMS721

OMS721

Vehicle (D5W or saline) OTHER

5% Dextrose in water or normal saline solution

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Omeros Corporation: lead

Study Sites (139)

Omeros Investigational Site

Florence, Alabama, 35630, United States

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Mesa, Arizona, 85206, United States

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Phoenix, Arizona, 85016, United States

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Scottsdale, Arizona, 85258, United States

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Scottsdale, Arizona, 85259, United States

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Los Angeles, California, 90022-4302, United States

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Los Angeles, California, 90025, United States

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Northridge, California, 91324, United States

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San Dimas, California, 91773, United States

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San Francisco, California, 94118, United States

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Stanford, California, 94304, United States

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Torrance, California, 90509, United States

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Denver, Colorado, 80230, United States

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Miami, Florida, 33136, United States

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Miami Lakes, Florida, 33014, United States

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Lawrenceville, Georgia, 30046, United States

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Chicago, Illinois, 60612, United States

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Iowa City, Iowa, 52242, United States

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Boston, Massachusetts, 02111, United States

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Springfield, Massachusetts, 01107, United States

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Minneapolis, Minnesota, 55414, United States

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Rochester, Minnesota, 55905, United States

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St Louis, Missouri, 63110, United States

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Fresh Meadows, New York, 11365, United States

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New York, New York, 10029, United States

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Cincinnati, Ohio, 45220, United States

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Columbus, Ohio, 43210, United States

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Philadelphia, Pennsylvania, 19104, United States

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Charleston, South Carolina, 29425, United States

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Chattanooga, Tennessee, 37404, United States

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Amarillo, Texas, 79106, United States

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Dallas, Texas, 75246, United States

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Houston, Texas, 77054, United States

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Milwaukee, Wisconsin, 53226, United States

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Posadas, Misiones Province, 3300, Argentina

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Buenos Aires, C1280AEB, Argentina

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Córdoba, X5016KEH, Argentina

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Salta, 4400, Argentina

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Garran, Australian Capital Territory, Woden, 2606, Australia

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Footscray, Saint Albans, 3021, Australia

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Adelaide, South Australia, 5000, Australia

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Clayton, Victoria, 3168, Australia

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Ghent, 9000, Belgium

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Leuven, 3000, Belgium

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Liège, 1-4000, Belgium

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Plovdiv, 4000, Bulgaria

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Plovdiv, 4002, Bulgaria

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Sofia, 1431, Bulgaria

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Vancouver, British Columbia, V5Z2M9, Canada

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Vancouver, British Columbia, V6Z1Y6, Canada

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London, Ontario, N6A545, Canada

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Toronto, Ontario, M5G2C4, Canada

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Prague, Prague, 128 08, Czechia

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Mannheim, Baden-Wrttemberg, 68167, Germany

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München, Bavaria, 80336, Germany

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Aachen, North Rhine-Westphalia, 52074, Germany

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Göttingen, 37075, Germany

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Villingen-Schwenningen, 78052, Germany

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Thessaloniki, Pilea-Chortiatis, 57010, Greece

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Athens, 11527, Greece

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Heraklion, 71110, Greece

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Heraklion, 71409, Greece

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Pátrai, 26504, Greece

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Baja, H-6500, Hungary

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Budapest, H-1097, Hungary

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Győr, H-9024, Hungary

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Pécs, H-7624, Hungary

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Szeged, 6720, Hungary

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Hyderabad, Ameerpet, 500038, India

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Nadiād, Gujarat, 387001, India

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Belagavi, Karnataka, 590010, India

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Mangalore, Karnataka, 575001, India

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Kozhikode, Kerala, 673008, India

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New Delhi, New India, 110017, India

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Jaipur, Rajasthan, 302004, India

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Hyderabad, Telangana, 500034, India

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Hyderabad, Telangana, 500038, India

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Hyderabad, Telangana, 500082, India

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Chandigarh, 160012, India

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Bari, 70124, Italy

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Bergamo, 24127, Italy

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Eboli, 84025, Italy

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Messina, 98125, Italy

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Milan, 20122, Italy

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Modena, 41124, Italy

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Parma, 43126, Italy

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Piacenza, 29121, Italy

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Kaunas, LT-50161, Lithuania

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Vilnius, LT-08661, Lithuania

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Lodz, Todzi, 92-213, Poland

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Krakow, 30-688, Poland

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Olsztyn, 10-561, Poland

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Warsaw, 04-749, Poland

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Singapore, 119074, Singapore

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Singapore, 308433, Singapore

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Banská Bystrica, 97401, Slovakia

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Košice, 04011, Slovakia

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Seongnam, Geyonggi-do, 13496, South Korea

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

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Busan, 49241, South Korea

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Incheon, 21431, South Korea

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Seoul, 05278, South Korea

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Seoul, 07061, South Korea

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Seoul, 3080, South Korea

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Seoul, 3722, South Korea

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Madrid, San Sebastian de Lost Reyes, 28702, Spain

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Almería, 04009, Spain

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Barcelona, 08025, Spain

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Córdoba, 14004, Spain

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Lleida, 25198, Spain

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Madrid, 28040, Spain

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Madrid, 28041, Spain

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Valencia, 46026, Spain

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Zaragoza, 50009, Spain

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Stockholm, Sweden

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Changhua, 500, Taiwan

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Hualien City, 97002, Taiwan

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Kaohsiung City, 824, Taiwan

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New Taipei City, 220, Taiwan

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New Taipei City, 235, Taiwan

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Taichung, Taiwan

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Taoyuan, 333, Taiwan

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Bangkok, 10300, Thailand

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Bangkok, 10700, Thailand

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Chiang Mai, 50200, Thailand

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Dusit, Thailand

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Khon Kaen, 40000, Thailand

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Songkhla, 90000, Thailand

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Ankara, 06230, Turkey (Türkiye)

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Bursa, 16059, Turkey (Türkiye)

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Edirne, 22130, Turkey (Türkiye)

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Istanbul, 34899, Turkey (Türkiye)

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Kocaeli, 41380, Turkey (Türkiye)

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Malatya, 44200, Turkey (Türkiye)

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Leicester, Evington, LE5 4PW, United Kingdom

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Cambridge, CB2 0QQ, United Kingdom

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Cardiff, CF10 3XQ, United Kingdom

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Dartford, DA2 8DA, United Kingdom

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London, NW3 2QG, United Kingdom

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Related Publications (2)

• 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.

  PMID: 37772889 DERIVED

• 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.

  PMID: 35675911 DERIVED

MeSH Terms

Conditions

Glomerulonephritis, IGA; Proteinuria; Renal Insufficiency, Chronic

Interventions

narsoplimab; Sodium Chloride

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Skylar Liles
• Organization: Omeros

ctinfo@omeros.com

206-676-5000

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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

Model Details: Eligible patients will be randomized 1:1 to receive OMS721 or placebo

Study Record Dates

• First Submitted: June 21, 2018
• First Posted: July 31, 2018
• Study Start: April 5, 2018
• Primary Completion: January 12, 2024
• Study Completion: January 12, 2024
• Last Updated: December 9, 2025
• Results First Posted: December 9, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (34); PL (4); KR (8); CZ (1); LI (2); SG (2); GR (5); IT (8); BE (3); AR (4); BU (3); SE (1); TW (7); HU (5); GB (5); TU (6); TH (6); ES (9); DE (5); AU (4); IN (11); CA (4); SL (2)