Ongoing, recruitingTherapeutic use (Phase IV)Interventional

PHARMACOKINETICS OF CEFEPIME AFTER INTRAPERITONEAL ADMINISTRATION VIA CYCLER-THERAPY IN APD PATIENTS WITHOUT PERITONITIS

This study is for adults with severe kidney disease (also called CKD 5) who are currently using peritoneal dialysis. We are specifically looking at how a commonly used antibiotic called Cefepime behaves in the body when it's given directly into the tummy during dialysis treatment. This is not for people with an active infection, but to understand how the medicine spreads and is cleared from the body. We want to measure things like how much of the medicine gets into the body, how quickly it reaches its highest level, and how long it stays in the system. This information will help doctors know the best way to give Cefepime to patients on peritoneal dialysis to make sure it works effectively and safely.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Noe LGA Gesundheit Region Mitte GmbH

Enrolment target

Start

15 Apr 2024

CKD 5 Peritoneal Dialysis

What is this study about?

This study is for people who have very severe kidney disease (stage 5 Chronic Kidney Disease) and are being treated with peritoneal dialysis. Peritoneal dialysis is a way to clean your blood when your kidneys can no longer do their job. It involves a special fluid being put into your tummy through a tube and then drained out.

Doctors sometimes need to give antibiotics to people on peritoneal dialysis, either to treat infections that can happen in the tummy (peritonitis) or sometimes to prevent them. This particular study is looking at an antibiotic called Cefepime. We are interested in understanding exactly how Cefepime works in the body when it's given through the dialysis fluid – how much of it gets absorbed, how high the levels get, and how long it stays in different parts of the body, like the blood and the fluid in the tummy. This study is for people who do NOT currently have an infection called peritonitis.

The main goal is to gather important information about how the body handles Cefepime when it's given this way. This will help doctors decide the best doses and how often to give the medicine for people on peritoneal dialysis. Ultimately, this research aims to improve how we use Cefepime to keep patients on peritoneal dialysis healthy and safe, making sure they get the right amount of medicine to be effective.

Key takeaways

This study is for adults with severe kidney disease (CKD 5) on peritoneal dialysis.
It investigates how an antibiotic, Cefepime, works in the body when given this way.
The goal is to find the best way to use Cefepime for these patients.
You will receive a single dose of Cefepime and have blood and dialysis fluid samples taken.
You must NOT have an active peritonitis infection to participate.

Who may be eligible?

To be able to take part in this study, you must be an adult, aged 18 or older. There is no upper age limit. Both men and women can participate.

You must have severe kidney disease, which doctors call CKD Stage 5. This means your kidneys are not working well at all. You also need to be receiving treatment called peritoneal dialysis.

It's important that you are NOT currently suffering from an infection in your tummy called peritonitis. This study is about understanding how Cefepime works in the body, not about treating an active infection.

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 severe kidney disease (CKD Stage 5)?
Are you currently receiving peritoneal dialysis?
Are you NOT currently suffering from a tummy infection called peritonitis?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be given a single dose of the antibiotic Cefepime directly into your tummy through your peritoneal dialysis machine. This will happen during your usual dialysis treatment. Over a period of about 24 hours after receiving the medicine, doctors and nurses will take several small blood samples and samples of the fluid from your peritoneal dialysis. These samples will help them measure how much Cefepime is in your body and how it's being processed. There will be no extra clinic visits beyond what is needed for the sampling during your dialysis session. The total duration of your active involvement in the study will last about 24 hours.

Potential risks and benefits

Potential benefits of taking part include helping doctors understand how to use antibiotics more effectively for people on peritoneal dialysis, which could improve care for many patients in the future. There are potential risks associated with any medication, and Cefepime can have side effects, though it will be given under careful medical supervision. Risks also include discomfort from blood draws. You have the right to withdraw from the study at any time, for any reason, without it affecting your 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
Austria

Common questions

What is peritoneal dialysis?

Peritoneal dialysis is a treatment for severe kidney disease where a special fluid is put into your tummy to clean your blood.

What is Cefepime?

Cefepime is an antibiotic, a type of medicine used to treat or prevent bacterial infections.

Why is this study being done?

This study aims to understand how Cefepime works in the body when given during peritoneal dialysis, to help doctors use it more effectively.

Do I have to have an infection to join?

No, this study is for people who do NOT currently have an infection called peritonitis.

How long will my part in the study last?

Your active participation, including receiving the medicine and giving samples, will last about 24 hours.