Not recruitingRare disease

Study on the Safety and Effects of OMS906 for Patients with C3 Glomerulopathy and Idiopathic Immune Complex-Mediated Glomerulonephritis

Fast replyInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying two kidney diseases: C3 Glomerulopathy (C3G) and Idiopathic Immune Complex-Mediated Glomerulonephritis (ICGN). These conditions affect the kidneys' ability to filter waste from the blood. The study will use a new investigational drug called OMS906, which is given as a solution for injection. The purpose of the study is to test the safety and effects of OMS906 in people with these diseases.

Participants in the study will receive OMS906 through an intravenous infusion, which means the drug is delivered directly into the bloodstream through a vein. The treatment will be given at regular intervals over a period of time. The study will monitor how well participants tolerate the drug and any side effects they may experience. Additionally, the study will observe changes in kidney function and protein levels in the urine, which are important indicators of kidney health.

The study aims to provide valuable information about the potential benefits and risks of using OMS906 for treating C3G and ICGN. By participating, individuals will contribute to research that could lead to new treatment options for these kidney diseases. The study will continue for a set duration, with regular assessments to track participants' health and response to the treatment.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status.
A biopsy confirming the diagnosis of C3 Glomerulopathy or Idiopathic Immune Complex-Mediated Glomerulonephritis must have been performed within the last 36 months.
Step 2
Vaccination verification
Verification of vaccination status for Neisseria meningitidis, Streptococcus pneumonia, and Haemophilus influenza is required. Vaccinations must be maintained throughout the study.
Step 3
Pregnancy test and birth control
Female participants of child-bearing potential must undergo a highly sensitive pregnancy test at screening and before each dose of the study drug.
Both male and female participants must use highly effective birth control during the trial and for 20 weeks after the last dose.
Step 4
Baseline measurements
Baseline measurements include a 24-hour urine protein-to-creatinine ratio (UPCR) and serum C3 concentration.
The estimated glomerular filtration rate (eGFR) is calculated using the CKD-EPI equation.
Step 5
Medication administration
The study drug, OMS906, is administered as a 5 mg/kg intravenous infusion every 4 weeks.
Participants must be on a stable dose of any other medications, such as ACE inhibitors, ARBs, SGLT-2 inhibitors, mycophenolate mofetil, mineralocorticoid receptor antagonists, or corticosteroids, for at least 90 days prior to starting the study drug.
Step 6
Ongoing assessments
Safety and tolerability are monitored through adverse events, vital signs, ECGs, and laboratory tests.
Proteinuria and kidney function are assessed at 12, 24, and 48 weeks.
Step 7
Study completion
The study is estimated to end by September 28, 2025.
Final assessments will be conducted to evaluate the overall safety and effectiveness of the study drug.

Who can join the trial?

13 criteria

Must be a male or female adult aged 18 years or older.
Must have up-to-date vaccinations for Neisseria meningitidis, Streptococcus pneumonia, and Haemophilus influenza (if available) and agree to keep vaccinations current during the study. If not vaccinated at screening, vaccinations can be done at least 2 weeks before the first study drug dose.
Female patients who can have children must have a negative pregnancy test at screening and before each dose of the study drug.
Females must use highly effective birth control to prevent pregnancy during the study and for 20 weeks (140 days) after the last dose of the study drug.
Males must use highly effective birth control with a female partner to prevent pregnancy during the study and for 20 weeks (140 days) after the last dose of the study drug.
Must be able to give informed consent and have completed the consent process.
Must have a diagnosis of C3G (C3 Glomerulopathy), including dense deposit disease, or ICGN (Idiopathic Immune Complex-Mediated Glomerulonephritis) confirmed by a biopsy within 36 months before screening.
Must have two 24-hour urine protein-to-creatinine ratio (UPCR) tests showing a result of 0.8 gm/gm or higher, with the tests done 14-28 days apart.
Must have a GFR (Glomerular Filtration Rate) estimated by the CKD-EPI equation of 45 mL/min/1.73m² or higher. GFR is a measure of kidney function.
Must have a serum C3 concentration lower than the normal range during screening. C3 is a protein in the blood related to the immune system.
Must be on a stable, maximally tolerated or allowed dose of an ACE inhibitor or ARB (types of blood pressure medications) for at least 90 days.
If taking a sodium-glucose co-transporter-2 (SGLT-2) inhibitor (a type of diabetes medication), must be on a stable dose for at least 90 days.
If taking mycophenolate mofetil (an immune system medication), a mineralocorticoid receptor antagonist (a type of medication affecting hormones), or a corticosteroid (a type of anti-inflammatory medication), must be on a stable dose for at least 90 days.

Who cannot join the trial?

8 criteria

Patients who have any other serious health condition that could affect their safety during the study.
Patients who are currently participating in another clinical trial.
Patients who have had a recent infection that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have a history of allergic reactions to similar medications.
Patients who have a history of drug or alcohol abuse.
Patients who have received certain treatments that could affect the study results.
Patients who are unable to follow the study procedures or attend study visits.

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Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
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Lodz, Poland

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Investigated drugs

OMS906 is an investigational medication being studied for its potential to treat patients with C3 Glomerulopathy (C3G) and Idiopathic Immune Complex-Mediated Glomerulonephritis (ICGN). This medication is administered through an intravenous (IV) infusion, meaning it is given directly into the bloodstream. The study aims to evaluate how safe and tolerable OMS906 is when given repeatedly every four weeks. Researchers are also looking at how the body processes the medication and its initial effectiveness in treating these kidney conditions.

Oms906

What is already known about the treatment

OMS906 – This medication is administered intravenously, with a repeat dose of 5 mg/kg given every four weeks. It is currently being studied in a Phase 2 clinical trial to evaluate its safety, tolerability, and preliminary efficacy in patients with C3 Glomerulopathy and Idiopathic Immune Complex-Mediated Glomerulonephritis. The main therapeutic indication for OMS906 is to treat these specific kidney conditions. At the molecular level, OMS906 works by targeting specific pathways involved in the immune response that contribute to kidney damage. It is classified pharmacologically as an immunomodulatory agent.

Investigated diseases

C3 Glomerulopathy
This is a rare kidney disease characterized by the abnormal accumulation of complement protein C3 in the glomeruli, which are tiny filtering units within the kidneys. The disease can lead to inflammation and damage to these structures, affecting their ability to filter waste from the blood. Over time, this can result in proteinuria, where excess protein is found in the urine, and a decline in kidney function. The progression of the disease varies among individuals, with some experiencing a slow decline in kidney function while others may have a more rapid progression.
Idiopathic Immune Complex-Mediated Glomerulonephritis
This condition involves inflammation of the glomeruli due to the deposition of immune complexes, which are clusters of antibodies and antigens. The exact cause of this immune response is unknown, hence the term "idiopathic." The inflammation can lead to damage in the glomeruli, resulting in symptoms such as blood in the urine, proteinuria, and reduced kidney function. The disease progression can vary, with some individuals experiencing stable symptoms while others may see a gradual worsening of kidney function.