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Dialysis study pulled before starting: no patients enrolled

NCT ID NCT06443021

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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 However, the study was withdrawn before any patients were enrolled, so no results are available.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

Oct 2025

An estimate. Start dates often move.

Expected to finish

Dec 2025

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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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