Clinical Performance of the Therapy Option FlexPoint of the PD Cycler Sleep•Safe Harmony
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFresenius Medical Care Deutschland GmbH
About this trial
Analysis and comparison of treatments with and without the FlexPoint technology (flexible volume and dwell time management) of the PD cycler sleep•safe harmony
Eligibility criteria
Qualifiers
Informed consent signed and dated by study patient and investigator/ authorised physician
Minimum age of 18 years
CKD patients with indication for renal replacement therapy
Patients being treated with APD for at least 3 months
Disqualifiers
Any conditions which could interference with the patient's ability to comply with the study
Previous participation in the same study
Patients who have any condition prohibiting the use of BCM, like patients with major amputations (e.g. lower leg)
Patients receiving polyglucose containing PD solution
Trial design
Treatments tested in this trial
- PD cycler
Treatment groups
24 Participants
are divided into 1 treatment groupLocations
This trial has no locations
Sponsors and collaborators
Fresenius Medical Care Deutschland GmbH
Lead sponsor
Alcedis GmbH
Collaborator
Source ClinicalTrials.gov