| CTRI Number |
CTRI/2022/01/039428 [Registered on: 14/01/2022] Trial Registered Prospectively |
| Last Modified On: |
07/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Other |
|
Public Title of Study
|
Phase 3 Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy |
|
Scientific Title of Study
|
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) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT03608033 |
ClinicalTrials.gov |
| OMS721-IGA-001 Amendment 03 dated 01-June-2020 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Mughda Tapdiya |
| Designation |
Sr. Medical Director, Medical Management |
| Affiliation |
Syneos Health |
| Address |
Syneos Health
Presidency Tower B, 46/4, 3rd Floor, M.G. Road,
Sector-14, Gurgaon-122001, Haryana
India
Gurgaon
HARYANA
122001
India |
| Phone |
|
| Fax |
|
| Email |
mugdha.tapdiya@syneoshealth.com |
|
Details of Contact Person
Public Query
|
| Name |
Bir Sengupta |
| Designation |
Site Start-Up & Regulatory Specialist II, Country SSU |
| Affiliation |
Syneos Health |
| Address |
Syneos Health
Presidency Tower B, 46/4, 3rd Floor, M.G. Road,
Sector-14, Gurgaon-122001, Haryana
India
Gurgaon
HARYANA
122001
India |
| Phone |
|
| Fax |
|
| Email |
bir.sengupta@syneoshealth.com |
|
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Source of Monetary or Material Support
|
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Primary Sponsor
|
| Name |
Omeros Corporation |
| Address |
201 Elliott Ave West, Seattle, WA 98119, USA |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
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Details of Secondary Sponsor
|
| Name |
Address |
| Kendle India Pvt Ltd Syneos Health |
Building 14, Tower B, 14th Floor, DLF Cybercity,
(SEZ), DL Phase III, Haryana (India) – 122001. |
|
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Countries of Recruitment
|
Australia
Belgium
Bulgaria
Canada
Czech Republic
Germany
Greece
Hungary
India
Italy
Lithuania
Poland
Singapore
Slovakia
Spain
Sweden
Taiwan
Thailand
Turkey
United Kingdom
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bhimavarapu Sudhakar |
Aster Prime Hospitals |
Opp. Passport Seva Kendra, Ameerpet
Hyderabad Telangana 500 036
Hyderabad
TELANGANA |
9246542123
drbsudhakar@yahoo.com |
| Dr Melemadathl Sreelatha |
Government Medical College Medical College, Kozhikode |
Medical College Road,Kozhikode,Kerala 673008,India
Kozhikode
KERALA |
04952350216
drsreelathacmc@gmail.com |
| Dr Ritesh Vernekar |
K.L.E.S. Dr. Prabhakar Kore Hospital & Medical Research Centre |
Nehru Nagar,Belagavi Karnataka 590010
Belgaum
KARNATAKA |
08312470400
riteshvernekar@gmail.com |
| Dr Mayoor Vasant Prabhu |
Kasturba Medical College Hospital |
Department of Nephrology
Attavar Mangalore Karnataka 575001 India
Dakshina Kannada
KARNATAKA |
9740360720
drprabhunephro@gmail.com |
| Dr Dinesh Khullar |
Max Super Speciality Hospital MSSH - Saket |
1 press enclave road Saket
New Delhi, Delhi 110017
New Delhi
DELHI |
9810124066
drdineshkhullar@gmail.com |
| Dr Sishir Gang |
Muljibhai Patel Urological Hospital |
Dr.Virendra Desai Road,Nadiad,Gujarat 387001
Kheda
GUJARAT |
02682520323
sishirgang@hotmail.com |
| Dr D Sree Bhushan Raju |
Nizams Institute of Medical Sciences |
Punjagutta Hyderabad Telangana 500082
Hyderabad
TELANGANA |
9848492951
Sreebhushan@hotmail.com |
| Dr Raja Ramachandran |
Post Graduate Institute of Medical Education and Research |
Department of Nephrology, Ground Floor C-Block, Nehru Hospital, PGIMER
Chandigarh
CHANDIGARH |
9216958874
drraja1980@gmail.com |
| Dr Dhananjai Agarwal |
SMS Hospital |
JLN Marg, Jaipur 302004
Jaipur
RAJASTHAN |
9414459790
dhananjaynephro@gmail.com |
| Dr Jyothsna Guttikonda |
Star Hospitals |
8-2-596/5, Road no-10, Banjara Hills, Hyderabad-500 034
Hyderabad
TELANGANA |
9963884644
jyothsnag@yahoo.com |
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Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Ethics Committee-Prime Hospitals |
Approved |
| Institute Ethics Committee, Post Graduate Institute of Medical Education and Research |
Approved |
| Institutional Ethics Committee Government Medical College |
Approved |
| Institutional Ethics Committee Star Hospitals |
Approved |
| Institutional Ethics Committee, KLE University’s KLE PK Hospital |
Approved |
| Institutional Ethics Committee, S.M.S. Medical College and Attached Hospital |
Approved |
| Manipal Academy of Higher Education (MAHE) Ethics Committee |
Approved |
| Max Healthcare Ethic Committee |
Approved |
| Muljibhai Patel Society for Research in Nephro-Urology Ethics Committee |
Approved |
| Nizam’s Institute of Ethics Committee |
Approved |
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Regulatory Clearance Status from DCGI
Modification(s)
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N08||Glomerular disorders in diseases classified elsewhere, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Biological: OMS721 |
185 mg/mL, 2-mL vial containing 2 mL of solution.
intravenously (IV) once weekly, for up to 1 year
Vehicle Control to Match OMS721
50 mL 5% dextrose in water (D5W) or normal saline solution.
intravenously (IV) once weekly, for up to 1 year
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
1. Age 18 years or older at the onset of Screening
2. Biopsy confirmed diagnosis of IgAN within 8 years prior to Screening
3. Proteinuria of > 1 g/day within 6 months prior to Screening or uPCR > 0.75 by spot urine at Screening
4. Mean of two proteinuria measurements > 1 g/day at baseline
5. Estimated glomerular filtration rate of ≥ 30 mL/min/1.73 m2 at Screening and baseline
|
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| ExclusionCriteria |
| Details |
1. 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.
2. Treatment with eculizumab within 8 weeks prior to Screening. Treatment with eculizumab is not allowed during the Run-In Period.
3. Treatment with systemic corticosteroids within 8 weeks prior to Screening. Treatment with systemic corticosteroids is not allowed during the Run-In Period.
4. 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
5. 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
6. 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
7. History of renal transplantation
8. Have a known hypersensitivity to any constituent of the investigational product
9. Rapidly progressive glomerulonephritis
10. Significant abnormalities in clinical laboratory values
11. 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).
12. 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
13. Have received any other investigational drug or device or experimental procedures within 30 days of the Screening Visit (SV
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Change from baseline in 24-hour urine protein excretion (UPE) in g/day at 36 weeks from beginning of treatment [ Time Frame: 36 Weeks ] |
1. Change from baseline in 24-hour urine protein excretion (UPE) in g/day at 36 weeks from beginning of treatment [ Time Frame: 36 Weeks ] |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Number of patients with treatment related Adverse Events as assessed by CTCAE v 4.0 [ Time Frame: 168 Weeks ]
|
168 Weeks |
| 2. Change from baseline in renal function as determined by the rate of change in estimated glomerular filtration rate (eGFR) up to 144 weeks from beginning of treatment [ Time Frame: 144 Weeks ] |
144 weeks |
| 3. Change from baseline in 24-hour urine protein excretion (UPE) in g/day at 36 weeks from beginning of treatment in the subset of patients with baseline high proteinuria (defined as 24-hour UPE ≥ 2 g/day) [ Time Frame: 36 Weeks ] |
36 weeks |
| 4. Time-averaged change in urine protein/creatinine ratio (uPCR) through 36 weeks. [ Time Frame: 36 Weeks ] |
36 Weeks |
|
|
Target Sample Size
|
Total Sample Size="450"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
11/02/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/04/2018 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="11"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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 > 1
g at baseline. The study will be conducted at approximately 140 study sites in
North America, Europe, Australia, and Asia. Approximately 450 patients are to
be enrolled in two groups of 225 patients per arm. During the study, all
patients will continue optimized renin-angiotensin system (RAS) blockade. The
study consists of five periods: Screening, Run-In, Initial Treatment (Weeks
1-12), Response Evaluation (Weeks 13-36), and Follow-Up (Weeks 37 to Week
144/end-of-study). The duration of study for each patient is expected to be
approximately 160 weeks, comprising a 1-year study with a 2-year follow-up. The
primary endpoint of this study is the change from baseline in log-transformed
24-hour UPE in g/day at 36 weeks from baseline. The key secondary endpoints of
this study are: ∙ Proteinuria responder defined as having a 24-hour UPE of at
least 50% reduction from baseline as assessed at Week 36 (patients with ≥ 2
g/day UPE at baseline only) ∙ The rate of change in eGFR up to 144 weeks from
baseline.
|