An interventional study of PD cycler in Renal Failure and Chronic Kidney Disease, sponsored by Fresenius Medical Care Deutschland GmbH. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Fresenius Medical Care Deutschland GmbH (part of Fresenius Medical Care) · Not applicable, Interventional, and Treatment
Analysis and comparison of treatments with and without the FlexPoint technology (flexible volume and dwell time management) of the PD cycler sleep•safe harmony
The primary objective of this study are:
The secondary objectives of this study are:
1,409 studies on the registry are indexed under Renal Insufficiency; 143 are open to participants now.
This study's planned enrollment of 24 is below the median of 40 across 1,058 interventional studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →Fresenius Medical Care Deutschland GmbH is the lead sponsor of 36 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
During the clinical phase, patients are treated continuously with the PD cycler sleep•safe harmony. The total duration of the clinical phase is six weeks and is divided into 3 Phases à 2 weeks (Clinical phase I, II, and III) which only differ in the 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)
Device: PD cycler
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)
Total Kt/V urea
Measurement of solute removal during peritoneal dialysis focuses on urea
Time frame: every 2 weeks, during the 6 weeks treatment
Mean daily ultrafiltration (UF)
Daily ultrafiltration reached by the patient during peritoneal dialysis
Time frame: every day, during the 6 weeks treatment
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Aug 2027, 8 months later.
Of 31 industry-sponsored interventional studies with no phase under Renal Insufficiency, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 27. This study's planned 8 months is below that.
Counting every sponsor, half of 149 studies reached it within 22 months; a quarter within 8 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Fresenius Medical Care Deutschland GmbH →