Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A clinical study to investigate the safety, tolerability and pharmacokinetic profile of single ascending concentrations of OPT101 in peritoneal dialysis patients.

This research study is for people with chronic kidney disease, which means their kidneys don't work as well as they should, and they are receiving a treatment called peritoneal dialysis. We are testing a new medicine, OPT101, for the very first time in people. The main goals are to make sure the medicine is safe, to see how people tolerate it (meaning if they have any side effects), and to understand how their bodies process the medicine at different dose levels. This early stage study helps us learn important information about new treatments before they can be tested in more people.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

OPTERION Health AG

Enrolment target

Start

09 Jan 2026

Chronic kidney disease

What is this study about?

This study is about a new medicine called OPT101. It's for people who have chronic kidney disease, which is a long-term condition where the kidneys don't work as well as they should. These people are also having a special type of kidney treatment called peritoneal dialysis.

The main purpose of this study is to carefully check if OPT101 is safe when given to people for the first time. We also want to understand how people react to the medicine – for example, if they have any side effects, and if their bodies handle different amounts of the medicine in different ways. This helps doctors learn a lot about a new drug before it can be used more widely.

Because this is the very first time OPT101 is being given to people, it’s called a 'Phase I' study. This early research is really important because it helps us understand if a new medicine has the potential to help people in the future and how best to develop it.

Key takeaways

This study is testing a new medicine (OPT101) for the first time in people.
It's for adults with long-term kidney disease who are on peritoneal dialysis.
The main goals are to check the medicine's safety and how the body handles it.
Participation involves receiving the medicine and regular health check-ups.
You might not directly benefit, but your involvement helps future patients.

Who may be eligible?

To join this study, you must be an adult aged 18 or older. Both men and women are welcome to take part.

Because this study is specifically for people with chronic kidney disease who are receiving peritoneal dialysis, you would need to be undergoing this specific treatment to be considered.

There might be other health conditions or medicines that would prevent someone from joining, but these will be discussed in detail by the study doctor to make sure it's safe for you.

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?
Do you have chronic kidney disease?
Are you currently undergoing peritoneal dialysis?
Are you willing to attend regular visits for check-ups?
Are you comfortable learning about and potentially taking a new, untested medicine?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medicine, OPT101. The amount of medicine you receive might change to see how different doses affect your body. You would have regular visits to the clinic where doctors and nurses would check your health carefully. This would involve things like blood tests, checking your blood pressure, and asking you about how you are feeling and any side effects you might be experiencing. The total duration of your participation, including follow-up visits, would be explained to you in detail by the study team.

Potential risks and benefits

Taking part in a study like this helps doctors learn more about chronic kidney disease and new potential treatments. You might not directly benefit from the medicine you receive, but the information gained could help others in the future. As with any medicine, there is always a chance of side effects, some of which might be unexpected. The study team will explain all known or potential risks to you. Remember, joining a study is always your choice, and you can leave at any time without having to give a reason.

Locations (1)

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

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Unverified
Latvia

Common questions

What is peritoneal dialysis?

Peritoneal dialysis is a type of treatment for kidney failure that uses the lining of your tummy (abdomen) to filter your blood inside your body.

What does 'Phase I study' mean?

It means this is one of the very first times the new medicine is being given to people. The main goal is to check its safety and how the body handles it.

Will I get better if I join this study?

While the study aims to gather important information, it's not guaranteed that you will personally feel better or that your condition will improve. The main goal is to learn about the new medicine's safety.

How long will the study last for me?

The study team will tell you the exact length of your participation, including how many visits you'll need to make and for how long.

Do I have to pay to be in the study?

No, you should not have to pay to participate in the study. All study-related care and medication are usually provided free of charge.