Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03608033
Registration number
NCT03608033
Ethics application status
Date submitted
21/06/2018
Date registered
31/07/2018
Titles & IDs
Public title
Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy
Query!
Scientific title
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)
Query!
Secondary ID [1]
0
0
OMS721-IGA-001
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
IgA Nephropathy
0
0
Query!
Condition category
Condition code
Renal and Urogenital
0
0
0
0
Query!
Kidney disease
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Autoimmune diseases
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Other - OMS721
Other interventions - Vehicle (D5W or saline)
Experimental: OMS721 - Administration of OMS721
Placebo comparator: Placebo - Administration of Vehicle (D5W or Saline Solution)
Treatment: Other: OMS721
Biological: OMS721
Other interventions: Vehicle (D5W or saline)
5% Dextrose in water or normal saline solution
Query!
Intervention code [1]
0
0
Treatment: Other
Query!
Intervention code [2]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Change from baseline in 24-hour UPE in IgA nephropathy (IgAN) patients assessed at 36 weeks from baseline
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
36 Weeks
Query!
Secondary outcome [1]
0
0
Renal function as determined by the rate of change in eGFR at up to 96 weeks from baseline.
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
96 Weeks
Query!
Secondary outcome [2]
0
0
Time-averaged change from baseline in the log-transformed 24-hour UPE between 36 weeks and 48 weeks
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
36 and 48 Weeks
Query!
Secondary outcome [3]
0
0
Time-averaged change from baseline in the log-transformed 24-hour UPE between 36 and 72 weeks
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
36 and 72 Weeks
Query!
Secondary outcome [4]
0
0
Safety and tolerability of narsoplimab for the treatment of IgAN
Query!
Assessment method [4]
0
0
As assessed by the incidence of adverse events through study completion (Week 112) in the patient group with baseline 24-hour UPE = 2 g and in the all-patients population
Query!
Timepoint [4]
0
0
Week 112
Query!
Secondary outcome [5]
0
0
Pharmacokinetics of narsoplimab intravenous infusion
Query!
Assessment method [5]
0
0
By evaluating the maximum concentration (Cmax) parameters at baseline and study days, T1, T4, T8, T10, T12 population (24-hour UPE \> 1 g/day)
Query!
Timepoint [5]
0
0
Week 12
Query!
Secondary outcome [6]
0
0
Assessment of pharmacokinetics of narsoplimab intravenous infusion
Query!
Assessment method [6]
0
0
By evaluating the area under the concentration-time curve from dosing time (AUC) at baseline and study days, T1, T4, T8, T10,T12
Query!
Timepoint [6]
0
0
Week 12
Query!
Secondary outcome [7]
0
0
Pharmacokinetics of narsoplimab intravenous infusion
Query!
Assessment method [7]
0
0
Pharmacokinetics of narsoplimab intravenous infusion by evaluating the maximum concentration Cmax parameters at baseline and study days, T1 Weeks 1, T4 Week 2-11, T8 Week 2-11, T10 Week 2-11, T12 Week 12 ±2 days measurement of anti-drug antibodies and neutralizing antibodies at baseline and study days T1, T4, T8, T10, T12
Query!
Timepoint [7]
0
0
Week 12
Query!
Secondary outcome [8]
0
0
Assessment of pharmacodynamics of narsoplimab intravenous infusion
Query!
Assessment method [8]
0
0
Assessment of pharmacokinetics of narsoplimab intravenous infusion by evaluating the area under the concentration-time curve from dosing time AUC at baseline and study days, T1 Weeks 1, T4 Week 2-11, T8 Week 2-11, T10 Week 2-11, T12 Week 12 ±2 days
Query!
Timepoint [8]
0
0
Week 12
Query!
Secondary outcome [9]
0
0
Assessment of pharmacodynamics of narsoplimab intravenous infusion with presence of positive anti-drug antibodies
Query!
Assessment method [9]
0
0
Assessment of percentage of participants with presence of positive anti-drug antibodies following intravenous infusion of narsoplimab at baseline and study days T1 Weeks 1, T4 Week 2-11, T8 Week 2-11, T10 Week 2-11, T12 Week 12 ±2 days.
Query!
Timepoint [9]
0
0
Week 12
Query!
Secondary outcome [10]
0
0
Assessment of percentage of participants with presence of neutralizing antibodies
Query!
Assessment method [10]
0
0
Assessment of percentage of participants with presence of neutralizing antibodies following intravenous infusion of narsoplimab at baseline and study days T1 Weeks 1, T4 Week 2-11, T8 Week 2-11, T10 Week 2-11, T12 Week 12 ±2 days.
Query!
Timepoint [10]
0
0
Week 12
Query!
Secondary outcome [11]
0
0
Change from baseline in log-transformed 24-hour uPCR through 36 weeks.
Query!
Assessment method [11]
0
0
Query!
Timepoint [11]
0
0
Week 36
Query!
Eligibility
Key inclusion criteria
* Age 18 years or older at the onset of Screening
* Biopsy confirmed diagnosis of IgAN within 8 years prior to Screening
* 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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Treatment with immunosuppressants (e.g., azathioprine or cyclophosphamide), or cytotoxic drugs, for IgA within 8 weeks prior to Screening. Treatment with immunosuppressants or cytotoxic drugs for IgAN is not allowed during the Run-In Period. Treatment with immunosuppressants are allowed if such treatment is for indications other than IgAN.
* Treatment with eculizumab within 8 weeks prior to Screening. Treatment with eculizumab is not allowed during the Run-In Period.
* Treatment with systemic corticosteroids within 8 weeks prior to Screening. Treatment with systemic corticosteroids is not allowed during the Run-In Period.
* 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 ACEIs, ARBs, or direct renin inhibitors at Screening and baseline
* 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
* History of renal transplantation
* Have a known hypersensitivity to any constituent of the investigational product
* Rapidly progressive glomerulonephritis
* Significant abnormalities in clinical laboratory values
* History of human immunodeficiency virus (HIV), evidence of immune suppression, active HCV infection (patients with positive anti-HCV antibody but a non-detected HCV RNA PCR can enroll), 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 and/or treatments within 30 days of the Screening Visit (SV)
* 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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Stopped early
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
16/02/2018
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
18/10/2023
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
356
Query!
Recruitment in Australia
Recruitment state(s)
ACT,, WodenSaint AlbansSA,VIC
Query!
Recruitment hospital [1]
0
0
Omeros Investigational Site - Garran
Query!
Recruitment hospital [2]
0
0
Omeros Investigational Site - Footscray
Query!
Recruitment hospital [3]
0
0
Omeros Investigational Site - Adelaide
Query!
Recruitment hospital [4]
0
0
Omeros Investigational Site - Clayton
Query!
Recruitment postcode(s) [1]
0
0
2606 - Garran
Query!
Recruitment postcode(s) [2]
0
0
3021 - Footscray
Query!
Recruitment postcode(s) [3]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [4]
0
0
3168 - Clayton
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Georgia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Illinois
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Iowa
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Massachusetts
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Minnesota
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Missouri
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
New York
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Ohio
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Pennsylvania
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
South Carolina
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Tennessee
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Texas
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Wisconsin
Query!
Country [19]
0
0
Argentina
Query!
State/province [19]
0
0
Misiones
Query!
Country [20]
0
0
Argentina
Query!
State/province [20]
0
0
Buenos Aires
Query!
Country [21]
0
0
Argentina
Query!
State/province [21]
0
0
Cordoba
Query!
Country [22]
0
0
Argentina
Query!
State/province [22]
0
0
Salta
Query!
Country [23]
0
0
Belgium
Query!
State/province [23]
0
0
Gent
Query!
Country [24]
0
0
Belgium
Query!
State/province [24]
0
0
Leuven
Query!
Country [25]
0
0
Belgium
Query!
State/province [25]
0
0
Liège
Query!
Country [26]
0
0
Bulgaria
Query!
State/province [26]
0
0
Plovdiv
Query!
Country [27]
0
0
Bulgaria
Query!
State/province [27]
0
0
Sofia
Query!
Country [28]
0
0
Canada
Query!
State/province [28]
0
0
British Columbia
Query!
Country [29]
0
0
Canada
Query!
State/province [29]
0
0
Ontario
Query!
Country [30]
0
0
Czechia
Query!
State/province [30]
0
0
Praha
Query!
Country [31]
0
0
Germany
Query!
State/province [31]
0
0
Baden-Wrttemberg
Query!
Country [32]
0
0
Germany
Query!
State/province [32]
0
0
Bayern
Query!
Country [33]
0
0
Germany
Query!
State/province [33]
0
0
Nordrhein-Westfalen
Query!
Country [34]
0
0
Germany
Query!
State/province [34]
0
0
Göttingen
Query!
Country [35]
0
0
Germany
Query!
State/province [35]
0
0
Villingen-Schwenningen
Query!
Country [36]
0
0
Greece
Query!
State/province [36]
0
0
Pilea-Chortiatis
Query!
Country [37]
0
0
Greece
Query!
State/province [37]
0
0
Athens
Query!
Country [38]
0
0
Greece
Query!
State/province [38]
0
0
Heraklion
Query!
Country [39]
0
0
Greece
Query!
State/province [39]
0
0
Iraklio
Query!
Country [40]
0
0
Greece
Query!
State/province [40]
0
0
Patra
Query!
Country [41]
0
0
Hungary
Query!
State/province [41]
0
0
Baja
Query!
Country [42]
0
0
Hungary
Query!
State/province [42]
0
0
Budapest
Query!
Country [43]
0
0
Hungary
Query!
State/province [43]
0
0
Gyor
Query!
Country [44]
0
0
Hungary
Query!
State/province [44]
0
0
Pecs
Query!
Country [45]
0
0
Hungary
Query!
State/province [45]
0
0
Szeged
Query!
Country [46]
0
0
India
Query!
State/province [46]
0
0
Ameerpet
Query!
Country [47]
0
0
India
Query!
State/province [47]
0
0
Gujarat
Query!
Country [48]
0
0
India
Query!
State/province [48]
0
0
Karnataka
Query!
Country [49]
0
0
India
Query!
State/province [49]
0
0
Kerala
Query!
Country [50]
0
0
India
Query!
State/province [50]
0
0
New India
Query!
Country [51]
0
0
India
Query!
State/province [51]
0
0
Rajasthan
Query!
Country [52]
0
0
India
Query!
State/province [52]
0
0
Telangana
Query!
Country [53]
0
0
India
Query!
State/province [53]
0
0
Chandigarh
Query!
Country [54]
0
0
Italy
Query!
State/province [54]
0
0
Bari
Query!
Country [55]
0
0
Italy
Query!
State/province [55]
0
0
Bergamo
Query!
Country [56]
0
0
Italy
Query!
State/province [56]
0
0
Eboli
Query!
Country [57]
0
0
Italy
Query!
State/province [57]
0
0
Messina
Query!
Country [58]
0
0
Italy
Query!
State/province [58]
0
0
Milano
Query!
Country [59]
0
0
Italy
Query!
State/province [59]
0
0
Modena
Query!
Country [60]
0
0
Italy
Query!
State/province [60]
0
0
Parma
Query!
Country [61]
0
0
Italy
Query!
State/province [61]
0
0
Piacenza
Query!
Country [62]
0
0
Korea, Republic of
Query!
State/province [62]
0
0
Geyonggi-do
Query!
Country [63]
0
0
Korea, Republic of
Query!
State/province [63]
0
0
Gyeonggi-do
Query!
Country [64]
0
0
Korea, Republic of
Query!
State/province [64]
0
0
Busan
Query!
Country [65]
0
0
Korea, Republic of
Query!
State/province [65]
0
0
Incheon
Query!
Country [66]
0
0
Korea, Republic of
Query!
State/province [66]
0
0
Seoul
Query!
Country [67]
0
0
Lithuania
Query!
State/province [67]
0
0
Kaunas
Query!
Country [68]
0
0
Lithuania
Query!
State/province [68]
0
0
Vilnius
Query!
Country [69]
0
0
Poland
Query!
State/province [69]
0
0
Todzi
Query!
Country [70]
0
0
Poland
Query!
State/province [70]
0
0
Krakow
Query!
Country [71]
0
0
Poland
Query!
State/province [71]
0
0
Olsztyn
Query!
Country [72]
0
0
Poland
Query!
State/province [72]
0
0
Warszawa
Query!
Country [73]
0
0
Singapore
Query!
State/province [73]
0
0
Singapore
Query!
Country [74]
0
0
Slovakia
Query!
State/province [74]
0
0
Banská Bystrica
Query!
Country [75]
0
0
Slovakia
Query!
State/province [75]
0
0
Kosice
Query!
Country [76]
0
0
Spain
Query!
State/province [76]
0
0
San Sebastian De Lost Reyes
Query!
Country [77]
0
0
Spain
Query!
State/province [77]
0
0
Almeria
Query!
Country [78]
0
0
Spain
Query!
State/province [78]
0
0
Barcelona
Query!
Country [79]
0
0
Spain
Query!
State/province [79]
0
0
Cordoba
Query!
Country [80]
0
0
Spain
Query!
State/province [80]
0
0
Lleida
Query!
Country [81]
0
0
Spain
Query!
State/province [81]
0
0
Madrid
Query!
Country [82]
0
0
Spain
Query!
State/province [82]
0
0
Valencia
Query!
Country [83]
0
0
Spain
Query!
State/province [83]
0
0
Zaragoza
Query!
Country [84]
0
0
Sweden
Query!
State/province [84]
0
0
Stockholm
Query!
Country [85]
0
0
Taiwan
Query!
State/province [85]
0
0
Changhua City
Query!
Country [86]
0
0
Taiwan
Query!
State/province [86]
0
0
Hualien City
Query!
Country [87]
0
0
Taiwan
Query!
State/province [87]
0
0
Kaohsiung City
Query!
Country [88]
0
0
Taiwan
Query!
State/province [88]
0
0
New Taipei City
Query!
Country [89]
0
0
Taiwan
Query!
State/province [89]
0
0
Taichung City
Query!
Country [90]
0
0
Taiwan
Query!
State/province [90]
0
0
Taoyuan City
Query!
Country [91]
0
0
Thailand
Query!
State/province [91]
0
0
Bangkok
Query!
Country [92]
0
0
Thailand
Query!
State/province [92]
0
0
Chiang Mai
Query!
Country [93]
0
0
Thailand
Query!
State/province [93]
0
0
Dusit
Query!
Country [94]
0
0
Thailand
Query!
State/province [94]
0
0
Khon Kaen
Query!
Country [95]
0
0
Thailand
Query!
State/province [95]
0
0
Songkla
Query!
Country [96]
0
0
Turkey
Query!
State/province [96]
0
0
Ankara
Query!
Country [97]
0
0
Turkey
Query!
State/province [97]
0
0
Bursa
Query!
Country [98]
0
0
Turkey
Query!
State/province [98]
0
0
Edirne
Query!
Country [99]
0
0
Turkey
Query!
State/province [99]
0
0
Istanbul
Query!
Country [100]
0
0
Turkey
Query!
State/province [100]
0
0
Kocaeli
Query!
Country [101]
0
0
Turkey
Query!
State/province [101]
0
0
Malatya
Query!
Country [102]
0
0
United Kingdom
Query!
State/province [102]
0
0
Evington
Query!
Country [103]
0
0
United Kingdom
Query!
State/province [103]
0
0
Cambridge
Query!
Country [104]
0
0
United Kingdom
Query!
State/province [104]
0
0
Cardiff
Query!
Country [105]
0
0
United Kingdom
Query!
State/province [105]
0
0
Dartford
Query!
Country [106]
0
0
United Kingdom
Query!
State/province [106]
0
0
London
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Omeros Corporation
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT03608033
Query!
Trial related presentations / publications
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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03608033