RecruitingPHASE2INTERVENTIONAL

Safety and Efficacy Study of OMS906 in Patients With C3G and ICGN

This research study is about a new drug called OMS906, designed for adults who have rare kidney conditions known as C3 Glomerulopathy (C3G) or Idiopathic Immune Complex-Mediated Glomerulonephritis (ICGN). These conditions affect how your kidneys filter waste. The main goal is to check if OMS906 is safe and how well people tolerate it. Researchers will also look at how the drug moves through the body, how it affects the body, and if it shows any signs of improving the conditions. This is an early-stage study involving about 20 patients to gather important information before larger studies can be done.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Omeros Corporation

Enrolment target

Start

01 Mar 2024

Estimated completion

01 Apr 2026

C3 Glomerulopathy Idiopathic Immune Complex-Mediated Glomerulonephritis

What is this study about?

This study is looking into a new medication called OMS906, which might help people with two rare kidney diseases: C3 Glomerulopathy (C3G) and Idiopathic Immune Complex-Mediated Glomerulonephritis (ICGN). These conditions cause damage to the tiny filters in your kidneys, which can lead to kidney problems. Both C3G and ICGN are believed to involve a part of the body's defence system called the 'complement system' not working properly.

The main purpose of this study is to find out how safe the new drug OMS906 is and if people can take it without too many problems. It's important to understand this before the drug can be tested more widely. Researchers will also be checking to see if OMS906 has any noticeable effects on the conditions, such as reducing the amount of protein in your urine, which is a sign of kidney damage.

This is a small, early-stage study, meaning it's one of the first times this drug is being tested in people with these specific conditions. It doesn't compare OMS906 to other treatments; instead, it focuses on understanding this new drug better. The information gathered will be crucial for deciding if further, larger studies are needed.

Key takeaways

This study tests a new drug (OMS906) for rare kidney diseases C3G and ICGN.
It's a small, early-stage study focused on safety and initial effectiveness.
The drug is given as an intravenous drip every four weeks.
You need a recent kidney biopsy confirming your diagnosis.
Specific kidney function and protein levels in urine are required.
Vaccinations and birth control requirements apply for participation.

Who may be eligible?

To join this study, you must be an adult aged 18 or older. You need to have been diagnosed with either C3 Glomerulopathy (including a type called dense deposit disease) or Idiopathic Immune Complex-Mediated Glomerulonephritis within the last three years, and this diagnosis must have been confirmed by a kidney biopsy. Your kidneys also need to be working within a certain range, and you must have a specific level of protein in your urine.

Another important requirement is that your blood levels of a protein called C3 must be lower than what's considered normal. If you're already taking specific kidney medications like ACE inhibitors, ARBs, SGLT-2 inhibitors, mycophenolate mofetil, or certain steroids, you need to have been on a stable dose for at least three months. You also need to be up-to-date with certain vaccinations (for meningitis, pneumonia, and flu) to protect you during the study.

There are also reasons why you might not be able to join. For example, if you've had a major organ transplant or a stem cell transplant, or if you have a known problem with certain parts of your body's immune system (specifically C1q or C1r complement factors), you wouldn't be able to take part. Women who could become pregnant and men with female partners must use effective birth control during and for several months after the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with C3G or ICGN by biopsy in the last 3 years?
Are your kidney function and urine protein levels within specific ranges?
Are you able to get required vaccinations?
If you could get pregnant or have a female partner, are you willing to use effective birth control?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the study drug, OMS906, as a drip into your vein (intravenous infusion). This infusion will be given every four weeks. In total, the study aims to include around 20 patients. During the study, the research team will regularly check your safety through various tests and observations. They will also collect blood samples to understand how the drug moves through your body and what effects it has. The total duration of your participation in the study, including follow-up, will be explained in detail by the study team.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. A potential benefit could be that OMS906 helps your kidney condition, though this is not guaranteed as it's an early-stage study. You might also receive closer medical monitoring than usual. Potential risks include side effects from the drug, which are currently unknown and will be carefully monitored. There's also the time commitment involved in attending appointments. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Omeros Investigational Site
Verified postcode
Kaunas, Lithuania· Recruiting
Omeros Investigational Site
Verified postcode
Vilnius, Lithuania· Recruiting
Omeros Investigational Site
Verified postcode
Auckland, New Zealand· Recruiting
Omeros Investigational Site
Verified postcode
Lodz, Poland· Recruiting
Omeros Investigational Site
Verified postcode
Leicester, United Kingdom· Recruiting
Omeros Investigational Site
Verified postcode
Newcastle upon Tyne, United Kingdom· Recruiting

Common questions

What are C3G and ICGN?

These are rare kidney diseases where parts of your body's defence system mistakenly damage your kidneys, making it harder for them to filter waste.

What is OMS906?

OMS906 is a new drug being tested to see if it can help treat C3G and ICGN by affecting the body's immune system.

How will I receive the drug?

You will receive OMS906 through a drip into your arm (an intravenous infusion) once every four weeks.

How long will the study last?

The information provided does not specify the exact total duration, but the study involves regular infusions and monitoring over time. The study team will explain the full timeline to you.

Will I get paid to participate?

The information provided does not state if participants will be compensated. You should ask the study team about any potential reimbursement for travel or other expenses.

How to find out more

Omeros Clinical Trial Information

ctinfo@omeros.com 206-676-5000 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.