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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
Date last updated
15/03/2024

Titles & IDs
Public title
Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy
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)
Secondary ID [1] 0 0
OMS721-IGA-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
IgA Nephropathy 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in 24-hour UPE in IgA nephropathy (IgAN) patients assessed at 36 weeks from baseline
Timepoint [1] 0 0
36 Weeks
Secondary outcome [1] 0 0
Renal function as determined by the rate of change in eGFR at up to 96 weeks from baseline.
Timepoint [1] 0 0
96 Weeks
Secondary outcome [2] 0 0
Time-averaged change from baseline in the log-transformed 24-hour UPE between 36 weeks and 48 weeks
Timepoint [2] 0 0
36 and 48 Weeks
Secondary outcome [3] 0 0
Time-averaged change from baseline in the log-transformed 24-hour UPE between 36 and 72 weeks
Timepoint [3] 0 0
36 and 72 Weeks
Secondary outcome [4] 0 0
Safety and tolerability of narsoplimab for the treatment of IgAN
Timepoint [4] 0 0
Week 112
Secondary outcome [5] 0 0
Pharmacokinetics of narsoplimab intravenous infusion
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Assessment of pharmacokinetics of narsoplimab intravenous infusion
Timepoint [6] 0 0
Week 12
Secondary outcome [7] 0 0
Pharmacokinetics of narsoplimab intravenous infusion
Timepoint [7] 0 0
Week 12
Secondary outcome [8] 0 0
Assessment of pharmacodynamics of narsoplimab intravenous infusion
Timepoint [8] 0 0
Week 12
Secondary outcome [9] 0 0
Assessment of pharmacodynamics of narsoplimab intravenous infusion with presence of positive anti-drug antibodies
Timepoint [9] 0 0
Week 12
Secondary outcome [10] 0 0
Assessment of percentage of participants with presence of neutralizing antibodies
Timepoint [10] 0 0
Week 12
Secondary outcome [11] 0 0
Change from baseline in log-transformed 24-hour uPCR through 36 weeks.
Timepoint [11] 0 0
Week 36

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/02/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/10/2023
Sample size
Target
Accrual to date
Final
356
Recruitment in Australia
Recruitment state(s)
ACT,, WodenSaint AlbansSA,VIC
Recruitment hospital [1] 0 0
Omeros Investigational Site - Garran
Recruitment hospital [2] 0 0
Omeros Investigational Site - Footscray
Recruitment hospital [3] 0 0
Omeros Investigational Site - Adelaide
Recruitment hospital [4] 0 0
Omeros Investigational Site - Clayton
Recruitment postcode(s) [1] 0 0
2606 - Garran
Recruitment postcode(s) [2] 0 0
3021 - Footscray
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Omeros Corporation
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT03608033
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.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
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Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03608033