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

November 25, 2025 updated by: Omeros Corporation

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
360

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1280AEB
        • Omeros Investigational Site
      • Córdoba, Argentina, X5016KEH
        • Omeros Investigational Site
      • Salta, Argentina, 4400
        • Omeros Investigational Site
    • Misiones Province
      • Posadas, Misiones Province, Argentina, 3300
        • Omeros Investigational Site
  • Australia
    • Australian Capital Territory, Woden
      • Garran, Australian Capital Territory, Woden, Australia, 2606
        • Omeros Investigational Site
    • Saint Albans
      • Footscray, Saint Albans, Australia, 3021
        • Omeros Investigational Site
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Omeros Investigational Site
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Omeros Investigational Site
  • Belgium
      • Ghent, Belgium, 9000
        • Omeros Investigational Site
      • Leuven, Belgium, 3000
        • Omeros Investigational Site
      • Liège, Belgium, 1-4000
        • Omeros Investigational Site
  • Bulgaria
      • Plovdiv, Bulgaria, 4000
        • Omeros Investigational Site
      • Plovdiv, Bulgaria, 4002
        • Omeros Investigational Site
      • Sofia, Bulgaria, 1431
        • Omeros Investigational Site
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z2M9
        • Omeros Investigational Site
      • Vancouver, British Columbia, Canada, V6Z1Y6
        • Omeros Investigational Site
    • Ontario
      • London, Ontario, Canada, N6A545
        • Omeros Investigational Site
      • Toronto, Ontario, Canada, M5G2C4
        • Omeros Investigational Site
  • Czechia
    • Prague
      • Prague, Prague, Czechia, 128 08
        • Omeros Investigational Site
  • Germany
      • Göttingen, Germany, 37075
        • Omeros Investigational Site
      • Villingen-Schwenningen, Germany, 78052
        • Omeros Investigational Site
    • Baden-Wrttemberg
      • Mannheim, Baden-Wrttemberg, Germany, 68167
        • Omeros Investigational Site
    • Bavaria
      • München, Bavaria, Germany, 80336
        • Omeros Investigational Site
    • North Rhine-Westphalia
      • Aachen, North Rhine-Westphalia, Germany, 52074
        • Omeros Investigational Site
  • Greece
      • Athens, Greece, 11527
        • Omeros Investigational Site
      • Heraklion, Greece, 71110
        • Omeros Investigational Site
      • Heraklion, Greece, 71409
        • Omeros Investigational Site
      • Pátrai, Greece, 26504
        • Omeros Investigational Site
    • Pilea-Chortiatis
      • Thessaloniki, Pilea-Chortiatis, Greece, 57010
        • Omeros Investigational Site
  • Hungary
      • Baja, Hungary, H-6500
        • Omeros Investigational Site
      • Budapest, Hungary, H-1097
        • Omeros Investigational Site
      • Győr, Hungary, H-9024
        • Omeros Investigational Site
      • Pécs, Hungary, H-7624
        • Omeros Investigational Site
      • Szeged, Hungary, 6720
        • Omeros Investigational Site
  • India
      • Chandigarh, India, 160012
        • Omeros Investigational Site
    • Ameerpet
      • Hyderabad, Ameerpet, India, 500038
        • Omeros Investigational Site
    • Gujarat
      • Nadiād, Gujarat, India, 387001
        • Omeros Investigational Site
    • Karnataka
      • Belagavi, Karnataka, India, 590010
        • Omeros Investigational Site
      • Mangalore, Karnataka, India, 575001
        • Omeros Investigational Site
    • Kerala
      • Kozhikode, Kerala, India, 673008
        • Omeros Investigational Site
    • New India
      • New Delhi, New India, India, 110017
        • Omeros Investigational Site
    • Rajasthan
      • Jaipur, Rajasthan, India, 302004
        • Omeros Investigational Site
    • Telangana
      • Hyderabad, Telangana, India, 500034
        • Omeros Investigational Site
      • Hyderabad, Telangana, India, 500038
        • Omeros Investigational Site
      • Hyderabad, Telangana, India, 500082
        • Omeros Investigational Site
  • Italy
      • Bari, Italy, 70124
        • Omeros Investigational Site
      • Bergamo, Italy, 24127
        • Omeros Investigational Site
      • Eboli, Italy, 84025
        • Omeros Investigational Site
      • Messina, Italy, 98125
        • Omeros Investigational Site
      • Milan, Italy, 20122
        • Omeros Investigational Site
      • Modena, Italy, 41124
        • Omeros Investigational Site
      • Parma, Italy, 43126
        • Omeros Investigational Site
      • Piacenza, Italy, 29121
        • Omeros Investigational Site
  • Lithuania
      • Kaunas, Lithuania, LT-50161
        • Omeros Investigational Site
      • Vilnius, Lithuania, LT-08661
        • Omeros Investigational Site
  • Poland
      • Krakow, Poland, 30-688
        • Omeros Investigational Site
      • Olsztyn, Poland, 10-561
        • Omeros Investigational Site
      • Warsaw, Poland, 04-749
        • Omeros Investigational Site
    • Todzi
      • Lodz, Todzi, Poland, 92-213
        • Omeros Investigational Site
  • Singapore
      • Singapore, Singapore, 119074
        • Omeros Investigational Site
      • Singapore, Singapore, 308433
        • Omeros Investigational Site
  • Slovakia
      • Banská Bystrica, Slovakia, 97401
        • Omeros Investigational Site
      • Košice, Slovakia, 04011
        • Omeros Investigational Site
  • South Korea
      • Busan, South Korea, 49241
        • Omeros Investigational Site
      • Incheon, South Korea, 21431
        • Omeros Investigational Site
      • Seoul, South Korea, 05278
        • Omeros Investigational Site
      • Seoul, South Korea, 07061
        • Omeros Investigational Site
      • Seoul, South Korea, 3080
        • Omeros Investigational Site
      • Seoul, South Korea, 3722
        • Omeros Investigational Site
    • Geyonggi-do
      • Seongnam, Geyonggi-do, South Korea, 13496
        • Omeros Investigational Site
    • Gyeonggi-do
      • Anyang-si, Gyeonggi-do, South Korea, 14068
        • Omeros Investigational Site
  • Spain
      • Almería, Spain, 04009
        • Omeros Investigational Site
      • Barcelona, Spain, 08025
        • Omeros Investigational Site
      • Córdoba, Spain, 14004
        • Omeros Investigational Site
      • Lleida, Spain, 25198
        • Omeros Investigational Site
      • Madrid, Spain, 28040
        • Omeros Investigational Site
      • Madrid, Spain, 28041
        • Omeros Investigational Site
      • Valencia, Spain, 46026
        • Omeros Investigational Site
      • Zaragoza, Spain, 50009
        • Omeros Investigational Site
    • San Sebastian de Lost Reyes
      • Madrid, San Sebastian de Lost Reyes, Spain, 28702
        • Omeros Investigational Site
  • Sweden
      • Stockholm, Sweden
        • Omeros Investigational Site
  • Taiwan
      • Changhua, Taiwan, 500
        • Omeros Investigational Site
      • Hualien City, Taiwan, 97002
        • Omeros Investigational Site
      • Kaohsiung City, Taiwan, 824
        • Omeros Investigational Site
      • New Taipei City, Taiwan, 220
        • Omeros Investigational Site
      • New Taipei City, Taiwan, 235
        • Omeros Investigational Site
      • Taichung, Taiwan
        • Omeros Investigational Site
      • Taoyuan, Taiwan, 333
        • Omeros Investigational Site
  • Thailand
      • Bangkok, Thailand, 10300
        • Omeros Investigational Site
      • Bangkok, Thailand, 10700
        • Omeros Investigational Site
      • Chiang Mai, Thailand, 50200
        • Omeros Investigational Site
      • Dusit, Thailand
        • Omeros Investigational Site
      • Khon Kaen, Thailand, 40000
        • Omeros Investigational Site
      • Songkhla, Thailand, 90000
        • Omeros Investigational Site
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06230
        • Omeros Investigational Site
      • Bursa, Turkey (Türkiye), 16059
        • Omeros Investigational Site
      • Edirne, Turkey (Türkiye), 22130
        • Omeros Investigational Site
      • Istanbul, Turkey (Türkiye), 34899
        • Omeros Investigational Site
      • Kocaeli, Turkey (Türkiye), 41380
        • Omeros Investigational Site
      • Malatya, Turkey (Türkiye), 44200
        • Omeros Investigational Site
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Omeros Investigational Site
      • Cardiff, United Kingdom, CF10 3XQ
        • Omeros Investigational Site
      • Dartford, United Kingdom, DA2 8DA
        • Omeros Investigational Site
      • London, United Kingdom, NW3 2QG
        • Omeros Investigational Site
    • Evington
      • Leicester, Evington, United Kingdom, LE5 4PW
        • Omeros Investigational Site
  • United States
    • Alabama
      • Florence, Alabama, United States, 35630
        • Omeros Investigational Site
    • Arizona
      • Mesa, Arizona, United States, 85206
        • Omeros Investigational Site
      • Phoenix, Arizona, United States, 85016
        • Omeros Investigation Sites
      • Scottsdale, Arizona, United States, 85258
        • Omeros Investigational Site
      • Scottsdale, Arizona, United States, 85259
        • Omeros Investigational Site
    • California
      • Los Angeles, California, United States, 90022-4302
        • Omeros Investigational Site
      • Los Angeles, California, United States, 90025
        • Omeros Investigational Site
      • Northridge, California, United States, 91324
        • Omeros Investigational Site
      • San Dimas, California, United States, 91773
        • Omeros Investigational Site
      • San Francisco, California, United States, 94118
        • Omeros Investigational Site
      • Stanford, California, United States, 94304
        • Omeros Investigational Site
      • Torrance, California, United States, 90509
        • Omeros Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80230
        • Omeros Investigational Site
    • Florida
      • Miami, Florida, United States, 33136
        • Omeros Investigational Site
      • Miami Lakes, Florida, United States, 33014
        • Omeros Investigational Site
    • Georgia
      • Lawrenceville, Georgia, United States, 30046
        • Omeros Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Omeros Investigational Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Omeros Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Omeros Investigational Site
      • Springfield, Massachusetts, United States, 01107
        • Omeros Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55414
        • Omeros Investigational Site
      • Rochester, Minnesota, United States, 55905
        • Omeros Investigational Site
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Omeros Investigational Site
    • New York
      • Fresh Meadows, New York, United States, 11365
        • Omeros Investigational Site
      • New York, New York, United States, 10029
        • Omeros Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Omeros Investigational Site
      • Columbus, Ohio, United States, 43210
        • Omeros Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Omeros Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Omeros Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Omeros Investigational Site
    • Texas
      • Amarillo, Texas, United States, 79106
        • Omeros Investigational Site
      • Dallas, Texas, United States, 75246
        • Omeros Investigational Site
      • Houston, Texas, United States, 77054
        • Omeros Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Omeros Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: OMS721
Administration of OMS721
Biological: OMS721
Biological: OMS721
Placebo Comparator: Placebo
Administration of Vehicle (D5W or Saline Solution)
Other: Vehicle (D5W or saline)
5% Dextrose in water or normal saline solution

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent Change in 24-hour UPE in g/Day Compared to Baseline
Time Frame: 36 Weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Annualized eGFR Compared to Baseline.
Time Frame: 96 Weeks
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)
96 Weeks
Change in Annualized eGFR Compared to Baseline in All Patients.
Time Frame: 96 Weeks
The Rate of Change in eGFR up to 96 Weeks from Baseline in the All-patients Population (24-hour UPE > 1 g/Day)
96 Weeks
Change in 24-hour UPE in g/Day Compared to Baseline in All Patients
Time Frame: 36 Weeks
Change From Baseline in Log-transformed 24-hour UPE at Week 36 in the All-patients Population. (24-hour UPE > 1 g/Day)
36 Weeks
Change in 24-hour UPE in g/Day Between 36 Weeks and 48 Weeks.
Time Frame: 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)
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).
Time Frame: 36 weeks and 72 weeks
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)
36 weeks and 72 weeks
Change in 24-hour UPE in g/Day Between 36 Weeks and 48 Weeks in All Patients
Time Frame: 36 weeks and 48 weeks
Time-averaged Change from Baseline in the Log-transformed 24-hour UPE Between 36 Weeks and 48 Weeks in the All-patients Population
36 weeks and 48 weeks
Change in 24-hour UPE in g/Day Between 36 Weeks and 72 Weeks in All Patients
Time Frame: 36 weeks and 72 weeks
Time-averaged Change from Baseline in the Log-transformed 24-hour UPE between 36 Weeks and 72 Weeks in the All-patients Population
36 weeks and 72 weeks
Safety and Tolerability of Narsoplimab for the Treatment of IgAN as Assessed by AEs, Vital Signs, Clinical Laboratory Tests, and ECGs
Time Frame: Week 112
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.
Week 112

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Omeros Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 5, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 12, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 12, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 21, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OMS721-IGA-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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