Health TrialsbyHealthPanel

Clinical Performance of the Therapy Option FlexPoint of the PD Cycler Sleep•Safe Harmony

ConditionsRenal FailureChronic Kidney Disease
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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • PD cycler

    Device

    Patients are treated continuously during Peritoneal dialysis with the PD cycler sleep•safe harmony with different FlexPoint settings. According to their randomization the patients are treated with Treatment A, B or C in a different order: * standard (default) FlexPoint settings (Treatment A) * minimum value FlexPoint settings (Treatment B) * maximum value for permitted peritoneal residual volume (50%) of FlexPoint settings (Treatment C)

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: Peritoneal dialysis (PD)Other 1 intervention

Trial outcomes

Primary outcomes

1

Total Kt/V urea

Measurement of solute removal during peritoneal dialysis focuses on urea

Time frame
every 2 weeks, during the 6 weeks treatment

Secondary outcomes

1

Mean daily ultrafiltration (UF)

Daily ultrafiltration reached by the patient during peritoneal dialysis

Time frame
every day, during the 6 weeks treatment

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fresenius Medical Care Deutschland GmbH

Lead sponsor

Alcedis GmbH

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: