Safety and Efficacy Study of OMS906 in Patients With C3G and ICGN (NCT06209736) | Clinical Trial Compass
RecruitingPhase 2
Safety and Efficacy Study of OMS906 in Patients With C3G and ICGN
Lithuania, New Zealand, Poland20 participantsStarted 2024-03-01
Plain-language summary
The purpose of this study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of OMS906 in patients with C3 Glomerulopathy (C3G) and Idiopathic Immune Complex-Mediated Glomerulonephritis (ICGN)
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female adults 18 years and older.
. Competent to provide informed consent and has completed informed consent procedures.
. Diagnosis of C3G, including dense deposit disease, or ICGN confirmed by biopsy within 36 months of screening.
. Two 24-hour UPCR ≥ 0.8 gm/gm with the 2 collections separated by 14 - 28 days.
. GFR estimated by the CKD-EPI equation ≥ 45 mL/min/1.73 m2.
. Serum C3 concentration less than the lower limit of laboratory normal during screening.
. Must be on stable maximally tolerated or allowed dose of ACE inhibitor or ARB for at least 90 days.
. If receiving a sodium-glucose co-transporter-2 (SGLT-2) inhibitor, must be on a stable dose for at least 90 days.
Exclusion criteria
. History of major organ transplant or hematopoietic stem cell/marrow transplant.
. Have known congenital deficiency of any of complement factors C1q, C1r, C1s, C2 or C4.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To assess OMS906 5mg/kg IV administration at 4-week intervals in patients with C3G and ICGN.
. Have rapidly progressing glomerulonephritis defined as a 50% or greater decline in the eGFR within 3 months with renal biopsy findings of glomerular crescent formation seen in at least 50% of glomeruli.
. Have renal biopsy findings showing interstitial fibrosis/tubular atrophy of more than 50%.
. Immunodeficiency or treatment with immunosuppressive agents (except mycophenolate mofetil or corticosteroids at the prednisone equivalent of ≤ 7.5 mg/day in patients with C3G only) within 90 days of screening.
. Treatment with rituximab within 6 months of screening.
. Resting blood pressure \> 140/90 mmHg during screening.
. History of any active malignancy within 5 years of screening except non-melanoma skin cancers.