Influence of Variable Inflow Volume, Dwell Duration and Glucose Concentration on Ultrafiltration Volume in APD Patients

NCT06443021 | Withdrawn

• 1 other identifier: PD-pPD-01-ESP
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the current investigation is to provide proof of concept for a future approach to improve UF prediction accuracy. While building on the ideas of the past, the concept is augmented by leveraging additional diagnostic technologies and digital data analytics methodologies.

Conditions

Renal Failure; Chronic Kidney Diseases

Keywords

Renal replacement therapy; Peritoneal dialysis; Automated peritoneal dialysis; PD cycler

Outcome Measures

Primary Outcomes (1)

• Ultrafiltration volume (UFV)

  UFV determined per defined dwells with variable dwell duration, dialysis fluid glucose composition and inflow volumes.

  every day during the 11 weeks treatment

Secondary Outcomes (7)

• Fluid status

  At study start, and then after 3 weeks, 4 weeks and 5 weeks.

• 24 h batch collection

  At study start, and then after 3 weeks, 4 weeks and 5 weeks.

• 24 h batch collection

  At study start, and then after 3 weeks, 4 weeks and 5 weeks.

• 24 h batch collection

  At study start, and then after 3 weeks, 4 weeks and 5 weeks.

• 24 h batch collection

  At study start, and then after 3 weeks, 4 weeks and 5 weeks.

Study Arms (1)

Peritoneal dialysis (PD)

OTHER

During the clinical phase, patients are treated continuously with the PD cycler sleep•safe harmony. The total duration of the clinical for the individual patient comprises a maximum of 17 weeks starting from V0

Device: PD cycler

Interventions

PD cycler DEVICE

After a training phase and a run-in period of up to 6 weeks, depending on the PD cycler used prior to the study, the interventional phase will be initiated. * Study phase A, variation of dwell duration: Duration of short cycles (cycle 1 and 2) 30 min, 60 min, 90 min, 120 min (and 150 min depending on the patient´s constitution and at the discretion of the treating physician) * Study phase B, variation of dialysis fluid glucose composition: 1st cycle: 1.5% glucose concentration, 2nd cycle: 2.3% glucose concentration, 3rd cycle: 1.5% glucose concentration, 4th cycle: 2.3% glucose concentration; all following cycles to be applied as prescribed by the treating physician. * Study phase C, variation of fill volume: 60% fill volume, 80% fill volume, 100% fill volume and 120% fill volume. (Volume of 120% will only be applied in case the patient tolerates these volumes according to the IPP.

Peritoneal dialysis (PD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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")

Sponsors & Collaborators

• Fresenius Medical Care Deutschland GmbH: lead
• Winicker Norimed GmbH: collaborator

MeSH Terms

Conditions

Renal Insufficiency; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Isabel Garcia Méndez, Dr.

  Hospital Son Espases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multi-centric, interventional

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: June 5, 2024
• Study Start: October 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share