At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- OMS906 study drug (drug)
- How long the study runs
- Study runs about 25 months (dates as stated)
- About the drug or intervention
- OMS906 study drug — drug: OMS906 study drug dose 5mg/kg IV administration at 4-week internals
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at how safe and effective a medicine called OMS906 is for adults with two rare kidney conditions: C3 glomerulopathy (C3G, including dense deposit disease) and idiopathic immune complex-mediated glomerulonephritis (ICGN). Both conditions affect the kidneys' filtering units. The study is run by Omeros Corporation.
Who can take part
- Adults aged 18 or over, male or female
- Diagnosis of C3G (including dense deposit disease) or ICGN confirmed by a kidney biopsy within the last 36 months
- Two urine tests (24-hour collections) at least 14 to 28 days apart showing raised protein levels
- Kidney function (GFR) of at least 45 mL/min/1.73 m2
- Low levels of a blood protein called C3 during screening
- Already taking a stable dose of an ACE inhibitor or ARB blood pressure medicine for at least 90 days (and other medicines, if used, at a stable dose for at least 90 days)
- Up to date with certain vaccinations (against meningococcal disease, pneumococcal disease and Haemophilus influenzae, where available) and willing to keep these up to date during the study
- Women who can become pregnant must have a negative pregnancy test and use highly effective birth control during the study and for 20 weeks (140 days) after the last dose; men must also use highly effective birth control with a female partner during the study and for 20 weeks after the last dose
Who may not be able to
- People who have had a major organ transplant or a stem cell or bone marrow transplant
- People born without certain complement proteins (C1q, C1r, C1s, C2 or C4)
- People with rapidly worsening kidney disease (a 50% or bigger drop in kidney function within 3 months, with certain biopsy findings)
- Biopsy results showing more than 50% scarring of the kidney
- Weakened immune system or certain immunosuppressive medicines within 90 days (some exceptions apply for people with C3G)
- Treatment with rituximab within the last 6 months
- Blood pressure above 140/90 mmHg at screening
- Cancer within the last 5 years (except non-melanoma skin cancer)
- A history of monoclonal gammopathy of unknown significance or any autoimmune disorder
- Certain abnormal liver blood tests
- Past severe allergic reactions to monoclonal antibodies or to ingredients in OMS906
- A significant infection (including COVID-19) in the 2 weeks before screening
- Use of any other complement inhibitor within the last 6 months
- HIV, hepatitis B, or untreated hepatitis C infection
- Women who are pregnant, planning to become pregnant, or breastfeeding
- Recent or planned surgery needing a general anaesthetic (within 2 weeks before screening or during treatment)
- Any other significant medical, neurological or psychiatric condition that the study doctor thinks would make taking part unsuitable
- Taking another investigational medicine or device within the last 30 days, or taking part in another clinical trial of a treatment (observational or registry studies are allowed)
- Unable or unwilling to follow the study requirements
What taking part involves
- • Taking the study medicine OMS906 (how it is given and how often is not stated — ask the trial team)
- • Two 24-hour urine collections before joining
- • Vaccinations kept up to date throughout the study
- • Highly effective birth control during the study and for 20 weeks after the last dose
Time commitment: Number of visits, study duration and how long treatment lasts are not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years to 99 Years
- Who
- All
- Number of participants
- 20
- Started
- 2024-03-01
- Last checked
- 2025-07
Plain English Summary
What is this study?
- • Testing a new treatment for c3 glomerulopathy
- • Phase2 - 20 participants
- • 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 take part?
- • Ages 18 Years to 99 Years
- • Diagnosed with c3 glomerulopathy
Where?
- • Leicester - Omeros Investigational Site
- • Newcastle upon Tyne - Omeros Investigational Site
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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)
More detail
This is a multicenter, open-label, uncontrolled, non-comparative, fixed-dose study. The primary objective is to assess safety and tolerability of OMS906 in patients with C3G or idiopathic ICGN, both complement-mediated disorders. Patients will receive 5 mg/kg administered as intravenous (IV) infusions at 4-week intervals. The study will enroll up to approximately 20 patients with C3G or ICGN. Safety will be evaluated in all patients and by disease cohort. Preliminary efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) will be evaluated by disease cohort.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 99 Years
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ a negative highly sensitive pregnancy test at screening and
What the study is looking for
- ✓Male or female adults 18 years and older.
- ✓Competent to provide agreement to take part and has completed agreement to take part 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.
Who cannot take part
- ✗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.
- ✗Have kidney biopsy findings showing interstitial fibrosis/tubular atrophy of more than 50%.
- ✗Treatment with rituximab within 6 months of screening.
- ✗Resting blood pressure \> 140/90 mmHg during screening.
See the full criteria
Where Is This Study? (2 UK sites)
Omeros Investigational Site
Leicester, United Kingdom
Omeros Investigational Site
Newcastle upon Tyne, United Kingdom
How to Get in Touch
Omeros Clinical Trial Information
Sponsor contactCONTACT
