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

NCT ID: NCT03608033

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-05
• Study Completion Date: 2024-01-12

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

OMS721

Administration of OMS721

Group Type: EXPERIMENTAL

OMS721

Intervention Type: BIOLOGICAL

Biological: OMS721

Placebo

Administration of Vehicle (D5W or Saline Solution)

Group Type: PLACEBO_COMPARATOR

Vehicle (D5W or saline)

Intervention Type: OTHER

5% Dextrose in water or normal saline solution

Interventions

OMS721

Biological: OMS721

Intervention Type: BIOLOGICAL

Vehicle (D5W or saline)

5% Dextrose in water or normal saline solution

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Omeros Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Omeros Investigational Site

Florence, Alabama, United States

Omeros Investigational Site

Mesa, Arizona, United States

Omeros Investigation Sites

Phoenix, Arizona, United States

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Scottsdale, Arizona, United States

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Scottsdale, Arizona, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Northridge, California, United States

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San Dimas, California, United States

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San Francisco, California, United States

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Stanford, California, United States

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Torrance, California, United States

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Denver, Colorado, United States

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Miami, Florida, United States

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Miami Lakes, Florida, United States

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Lawrenceville, Georgia, United States

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Chicago, Illinois, United States

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Iowa City, Iowa, United States

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Boston, Massachusetts, United States

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Springfield, Massachusetts, United States

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Minneapolis, Minnesota, United States

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Rochester, Minnesota, United States

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St Louis, Missouri, United States

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Fresh Meadows, New York, United States

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New York, New York, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Philadelphia, Pennsylvania, United States

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Charleston, South Carolina, United States

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Chattanooga, Tennessee, United States

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Amarillo, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Milwaukee, Wisconsin, United States

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Posadas, Misiones Province, Argentina

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Buenos Aires, , Argentina

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Córdoba, , Argentina

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Salta, , Argentina

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Garran, Australian Capital Territory, Woden, Australia

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Footscray, Saint Albans, Australia

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Adelaide, South Australia, Australia

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Clayton, Victoria, Australia

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Ghent, , Belgium

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Leuven, , Belgium

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Liège, , Belgium

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Plovdiv, , Bulgaria

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Plovdiv, , Bulgaria

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Sofia, , Bulgaria

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Vancouver, British Columbia, Canada

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Vancouver, British Columbia, Canada

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London, Ontario, Canada

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Toronto, Ontario, Canada

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Prague, Prague, Czechia

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Mannheim, Baden-Wrttemberg, Germany

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München, Bavaria, Germany

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Aachen, North Rhine-Westphalia, Germany

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Göttingen, , Germany

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Villingen-Schwenningen, , Germany

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Thessaloniki, Pilea-Chortiatis, Greece

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Athens, , Greece

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Heraklion, , Greece

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Heraklion, , Greece

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Pátrai, , Greece

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Baja, , Hungary

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Budapest, , Hungary

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Győr, , Hungary

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Pécs, , Hungary

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Szeged, , Hungary

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Hyderabad, Ameerpet, India

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Nadiād, Gujarat, India

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Belagavi, Karnataka, India

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Mangalore, Karnataka, India

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Kozhikode, Kerala, India

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New Delhi, New India, India

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Jaipur, Rajasthan, India

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Hyderabad, Telangana, India

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Hyderabad, Telangana, India

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Hyderabad, Telangana, India

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Chandigarh, , India

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Bari, , Italy

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Bergamo, , Italy

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Eboli, , Italy

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Messina, , Italy

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Milan, , Italy

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Modena, , Italy

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Parma, , Italy

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Piacenza, , Italy

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Kaunas, , Lithuania

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Vilnius, , Lithuania

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Lodz, Todzi, Poland

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Krakow, , Poland

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Olsztyn, , Poland

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Warsaw, , Poland

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Singapore, , Singapore

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Singapore, , Singapore

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Banská Bystrica, , Slovakia

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Košice, , Slovakia

Omeros Investigational Site

Seongnam, Geyonggi-do, South Korea

Omeros Investigational Site

Anyang-si, Gyeonggi-do, South Korea

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Busan, , South Korea

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Incheon, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Madrid, San Sebastian de Lost Reyes, Spain

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Almería, , Spain

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Barcelona, , Spain

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Córdoba, , Spain

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Lleida, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Valencia, , Spain

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Zaragoza, , Spain

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Stockholm, , Sweden

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Changhua, , Taiwan

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Hualien City, , Taiwan

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Kaohsiung City, , Taiwan

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New Taipei City, , Taiwan

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New Taipei City, , Taiwan

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Taichung, , Taiwan

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Taoyuan, , Taiwan

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Bangkok, , Thailand

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Bangkok, , Thailand

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Chiang Mai, , Thailand

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Dusit, , Thailand

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Khon Kaen, , Thailand

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Songkhla, , Thailand

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Ankara, , Turkey (Türkiye)

Omeros Investigational Site

Bursa, , Turkey (Türkiye)

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Edirne, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Kocaeli, , Turkey (Türkiye)

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Malatya, , Turkey (Türkiye)

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Leicester, Evington, United Kingdom

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Cambridge, , United Kingdom

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Cardiff, , United Kingdom

Omeros Investigational Site

Dartford, , United Kingdom

Omeros Investigational Site

London, , United Kingdom

Countries

United States; Argentina; Australia; Belgium; Bulgaria; Canada; Czechia; Germany; Greece; Hungary; India; Italy; Lithuania; Poland; Singapore; Slovakia; South Korea; Spain; Sweden; Taiwan; Thailand; Turkey (Türkiye); United Kingdom

References

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.

Reference Type: DERIVED

PMID: 37772889 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35675911 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

OMS721-IGA-001

Identifier Type: -

Identifier Source: org_study_id