Clinical Performance of the Therapy Option FlexPoint of the PD Cycler Sleep•Safe Harmony (NCT06390592) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Performance of the Therapy Option FlexPoint of the PD Cycler Sleep•Safe Harmony
24 participantsStarted 2026-06
Plain-language summary
Analysis and comparison of treatments with and without the FlexPoint technology (flexible volume and dwell time management) of the PD cycler sleep•safe harmony
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* Patients using the sleep•safe harmony PD cycler (version 3.1)
* Fluid status regularly monitored with Body Composition Monitor (BCM)
* Proper functioning catheter
* Intraperitoneal Pressure (IPP) ≤ 18 cm H2O
* Ability to understand the nature and requirements of the study
Exclusion Criteria:
* 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
* Respiratory or abdominal wall disease deemed to contraindicate intraperitoneal fill volume (FV) manipulation
* Patients who suffer from peritonitis/exit site infection during the last 4 weeks
* Women of childbearing age without effective means of contraception, pregnancy (pregnancy test will be conducted at start and end of study) or lactation period
* Life expectancy \<3 months
* Participation in an interventional clinical study during the preceding 90 days
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total Kt/V urea
Timeframe: every 2 weeks, during the 6 weeks treatment