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Study on Cefepime for Patients with Chronic Kidney Disease on Peritoneal Dialysis Without Peritonitis

Verified siteRegistered drugNo 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 the effects of the antibiotic cefepime in patients with Chronic Kidney Disease (CKD) stage 5 who are undergoing a type of dialysis called Peritoneal Dialysis. The study aims to understand how cefepime behaves in the body when it is administered directly into the abdominal cavity through a process known as cycler-therapy. This method is used in patients who do not have an infection called peritonitis, which is an inflammation of the lining of the abdominal cavity.

The purpose of the study is to determine if there is enough concentration of cefepime in the blood and the dialysis fluid to be effective. The study will also look at how the drug moves through the body and how it is processed, which is known as its pharmacokinetics and pharmacodynamics. Participants will receive cefepime through an injection or infusion, and the study will monitor how the drug is absorbed, distributed, and eliminated over a period of time.

Throughout the study, participants will be observed to see how their bodies respond to the treatment. The study will measure various factors, such as the highest concentration of the drug in the blood and how long it takes to reach this level. This information will help researchers understand the effectiveness of cefepime when used in this specific way for patients with CKD stage 5 on Peritoneal Dialysis.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after signing an informed consent form, confirming understanding and agreement to the study's terms.
Eligibility requires being over 18 years old, having been on an automated peritoneal dialysis (APD) regime for at least one month, and using specific dialysis solutions.
Step 2
Medication administration
The medication used in the study is cefepime, administered as a solution for injection or infusion.
Cefepime is given through the abdomen (intraperitoneal use) using a cycler-therapy method, which is part of the APD process.
Step 3
Monitoring and data collection
The study aims to measure the concentration of cefepime in blood plasma and dialysis fluid to understand how the drug moves and works in the body.
Key measurements include the area under the concentration-time curve (AUC), maximum concentration (Cmax), half-life, and time to reach maximum concentration.
Step 4
Evaluation of results
The study evaluates the effectiveness of cefepime by comparing drug concentration ratios and the time the drug remains above the minimum level needed to inhibit bacteria.
The study is expected to conclude by January 31, 2026.

Who can join the trial?

5 criteria

Participants must be males or females over the age of 18.
Participants must have an APD regime (a type of dialysis treatment) established for at least 1 month.
For short nighttime treatments, participants need to use a glucose-based PDF (a special fluid used in dialysis) with concentrations of 1.36% and/or 2.27%, and Icodextrin for the long daytime treatment.
Participants must show preparedness and compliance to follow the study's rules and procedures.
Participants must provide a signed informed consent, which means they agree to join the study after understanding all the details.

Who cannot join the trial?

4 criteria

Patients who are not undergoing peritoneal dialysis. Peritoneal dialysis is a treatment for kidney failure that uses the lining of your abdomen to filter waste from your blood.
Patients who do not have CKD 5. CKD 5, or Chronic Kidney Disease stage 5, is the most severe stage of kidney disease where the kidneys have lost nearly all their ability to function.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, which means groups of people who might be at higher risk of harm or exploitation.

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Verified sites

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Verified
Noe LGA Gesundheit Region Mitte GmbH
St. Poelten, Austria

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Investigated drugs

Cefepime is an antibiotic used in this study to understand how it behaves in the body when administered directly into the peritoneal cavity of patients undergoing automated peritoneal dialysis (APD) without peritonitis. The study aims to determine if the concentration of Cefepime in the blood plasma and dialysate is sufficient to be effective. Researchers are examining how the drug is absorbed, distributed, metabolized, and excreted to assess its effectiveness in this specific method of administration.

Cefepime

What is already known about the treatment

Cefepime – Cefepime is administered intraperitoneally, specifically through cycler-therapy in patients undergoing automated peritoneal dialysis (APD) without peritonitis. It is currently being studied to understand its pharmacokinetics and pharmacodynamics when delivered this way, focusing on its concentration in blood plasma and dialysate. The main therapeutic indication for Cefepime in this context is for patients with chronic kidney disease stage 5 (CKD 5) undergoing peritoneal dialysis. At the molecular level, Cefepime works by inhibiting bacterial cell wall synthesis, effectively killing bacteria. It is classified as a fourth-generation cephalosporin antibiotic.

Investigated diseases

Chronic Kidney Disease Stage 5
This is the most advanced stage of chronic kidney disease, where the kidneys have lost nearly all their ability to function effectively. At this stage, the kidneys are functioning at less than 15% of their normal capacity. Waste products and excess fluid build up in the body, leading to symptoms such as fatigue, swelling, and difficulty concentrating. Patients often require dialysis or a kidney transplant to manage the condition. The progression to this stage is typically gradual, occurring over several years. It is crucial to monitor and manage symptoms to maintain quality of life.
Peritoneal Dialysis
This is a treatment for kidney failure that uses the lining of the abdomen, called the peritoneum, to filter waste from the blood. A cleansing fluid is introduced into the abdominal cavity through a catheter, where it absorbs waste products and excess fluids. After a set period, the fluid is drained, taking the waste with it. This process can be done at home, allowing for more flexibility compared to other dialysis methods. It is typically performed daily and can be done while sleeping or during the day. The procedure helps to maintain the balance of fluids and electrolytes in the body.