Dialysis study pulled before starting: no patients enrolled
NCT ID NCT06443021
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study was designed to see how changing the amount of fluid, the time it stays in the belly, and the sugar level in the dialysis fluid affects how much fluid is removed during automated peritoneal dialysis. It was meant for adults with chronic kidney disease on dialysis for at least 3 months. However, the study was withdrawn before any patients were enrolled, so no results are available.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Expected to start
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Oct 2025
An estimate. Start dates often move.
- Expected to finish
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Dec 2025
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Informed consent signed and dated by study patient and investigator/ authorized physician * Patients between 18-65 of age * Chronic kidney disease (CKD) patients being treated with nocturnal APD for at least 3 months * Ability to understand the nature and requirements of the study * Total Kt/V ≥ 1.7 (counting from recruitment of the patient the measurement should not be older than 3 months) * APD patients using sleep•safe PD-cycler or sleep•safe harmony PD-cycler with an IPP ≤ 18 cm H2O for the fill volume of 120% Exclusion Criteria: * Any condition which could interfere with the patient's ability to comply with the study * Patients who have any condition prohibiting the use of BCM, like patients with major amputations (e.g. lower leg) * Patients who have been subject to 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 * Patients suffering from uncontrolled/ not well adjustable diabetes * Recent history of drain related problems, catheter malfunction, or frequent alarms during treatment * Patients with uncontrolled hypertension and/ or previous history of vascular instability during PD * Patients treated with intermittent APD * Participation in an interventional clinical study during the preceding 30 days * Previous participation in the same study * APD patients having dwell exchanges throughout the day ("day dwell")
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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