Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study to test how kidney problems influence the blood concentrations of efgartigimod

This research study is looking at a new medicine called efgartigimod. The main aim is to understand how well the body processes this medicine in people who have different levels of kidney health. Researchers want to see if kidney problems change how much of the medicine stays in the blood. This information is important for doctors to know the right dosage to give if this medicine is approved for use. The study will involve adults aged 18 and over, and both men and women can take part. It's an early-stage study to gather important information about how the drug works in the body.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Argenx

Enrolment target

Start

20 Jun 2023

renal impairment

What is this study about?

This study is about a medicine called efgartigimod. When we take a medicine, our bodies process it, and different organs like the kidneys can play a big part in this. The researchers want to find out precisely how people's kidneys affect the amount of efgartigimod that stays in their blood after they've taken it. This is really important information because it helps doctors understand how to give the medicine safely and effectively in the future, especially to people who might have kidney conditions.

Imagine you're trying to figure out how much sugar to put in a cup of tea. If you always use the same amount, but some people have bigger mugs than others, the sweetness will be different. Similarly, if kidneys process medicine differently, the amount in the body could be too high or too low, affecting how well it works or if it causes side effects.

This is an early-stage study, sometimes called a 'Phase I' study. This means it's one of the first times this medicine is being given to people in a research setting, specifically to understand how the body handles it. The results will help in planning future studies and developing clear guidelines for doctors on how to use efgartigimod if it becomes a common treatment.

Key takeaways

This study investigates how kidney health affects a new medicine called efgartigimod.
It aims to understand how much of the medicine stays in the blood for different kidney functions.
Results will help doctors prescribe the right doses in the future.
It's an early-stage study focusing on drug behaviour in the body.
Adults aged 18 and over, both men and women, are invited to participate.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old. Both men and women are welcome to take part.

The most important part of deciding if you can join is your kidney health. The researchers are looking for people with various levels of kidney function, including those with healthy kidneys and those with different stages of kidney problems. This helps them compare how the medicine works across these different groups.

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?
Are you comfortable having regular blood tests?
Are you willing to take a new study medicine?
Do you have a kidney condition, or do you have healthy kidneys?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given the study medicine, efgartigimod. You will also have regular visits to the study clinic where the research team will take blood samples to measure the amount of the medicine in your blood. This helps them understand how your body is handling the drug.

The research team will also carefully check your health at these visits, including your kidney function, to make sure you are doing well. They will explain exactly what is involved, how many visits you'll need, and how long the study will last after they check if you're suitable to join.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is contributing to important medical knowledge that could help future patients. However, you will not directly benefit from this study, as it's primarily designed to gather information about the medicine's behaviour in the body. Potential risks could include side effects from the study medicine or discomfort from blood tests. The research team will discuss all known and potential risks with you in detail. Remember, joining is entirely voluntary, and you have the right to withdraw from the study at any time without giving a reason, and it will not affect your usual medical care.

Locations (1)

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

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Unverified
Germany

Common questions

What is efgartigimod?

It's a new medicine currently being tested in research studies, not yet widely available for patients.

Why is it important to study kidneys in this research?

Our kidneys play a big role in removing medicines from our body, so understanding how they affect efgartigimod helps doctors give the right dose.

Will I get any treatment for my kidney condition in this study?

No, this study is about understanding how the medicine works in the body, not about treating your kidney condition directly.

How long will I be in the study?

The study team will tell you the exact duration, but most early-stage studies have a specific number of visits over a set period.

Do I have to pay to join the study?

No, you don't have to pay to take part. All study-related care and medicines are provided at no cost to you.