Ended Therapeutic use (Phase IV) CKD 5, Peritoneal Dialysis

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

EU CTIS ID: 2023-509930-21-00

What this study is testing

The aim of the study is to determine if there is sufficient blood plasma and dialysate concentration of Cefepim after intraperitoneal application of Cefepim and to study the drugs pharmacodynamics and pharmacokinetics to assess the effectiveness after intraperitoneal application

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Males or females over the age of 18
  • APD regime has to be established for a minimum of 1 month
  • For short nighttime dwells patient need to use a glucose-based PDF (1,36% and/or 2.27%) and Icodextrin for the long daytime dwell
  • Preparedness and Compliance to the protocol
  • Signed informed consent

You likely can't join if

  • Any form of systemic infection
  • Any disease that might hinder proper study performance or puts the patient at risk
  • Severe hepatic impairment (Child-Pugh Class C)
  • Severe hepatic impairment (Child-Pugh Class C)
  • Pregnancy or woman of childbearing potential not minded to use appropriate contraception during the time of the study
  • Allergic or hypersensitive reactions against cephalosporins
See the full eligibility criteria
Who can join
  • Males or females over the age of 18
  • APD regime has to be established for a minimum of 1 month
  • For short nighttime dwells patient need to use a glucose-based PDF (1,36% and/or 2.27%) and Icodextrin for the long daytime dwell
  • Preparedness and Compliance to the protocol
  • Signed informed consent
What rules you out
  • Any form of systemic infection
  • Any disease that might hinder proper study performance or puts the patient at risk
  • Severe hepatic impairment (Child-Pugh Class C)
  • Severe hepatic impairment (Child-Pugh Class C)
  • Pregnancy or woman of childbearing potential not minded to use appropriate contraception during the time of the study
  • Allergic or hypersensitive reactions against cephalosporins
  • Hemoglobin below 9 g/dl
  • BMI below 19 or above 35

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.