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

Investigation of the Influence of Variable Fill Volume, Dwell Duration and Dialysis Fluid Glucose Composition on Measured Ultrafiltration Volume (UFV) in Automated Peritoneal Dialysis (APD) Patients

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.

Study Overview

• Status: Withdrawn
• Conditions: Chronic Kidney Diseases; Renal Failure
• Intervention / Treatment: Device: PD cycler

Detailed Description

The primary objective of this study is:

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

The secondary objectives of this study are:

• Mean daily UFV
• Defined laboratory parameter like urea, creatinine, glucose, sodium determined in blood and dialysate during the extended PET (in dialysate additionally determination: phosphate, albumin removal)
• Treatment parameter: performed treatment duration and volume
• Fluid status measured by Body Composition Monitor (BCM)
• Manual IPP determination during the extended PET: At the first half of the dwell (during the first hour) for every 20 min and during the second half after 2h, 3h and 4h dwell time
• Residual renal function (RRF): renal urea and creatinine clearance, 24h urine output, Glomerular filtration rate (GFR)
• Extended PET
• 24 h batch collection (including e.g. total peritoneal clearance)
• Analysis of daily dietetic fluid intake, weight and further parameters documented by the patient in a patient diary

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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")

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Peritoneal dialysis (PD); 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fluid status	Fluid status measured by Body Composition Monitor (BCM)	At study start, and then after 3 weeks, 4 weeks and 5 weeks.
24 h batch collection	RRF (24 h urine output)	At study start, and then after 3 weeks, 4 weeks and 5 weeks.
24 h batch collection	RRF (GFR)	At study start, and then after 3 weeks, 4 weeks and 5 weeks.
24 h batch collection	RRF (renal creatinine clearance)	At study start, and then after 3 weeks, 4 weeks and 5 weeks.
24 h batch collection	RRF (renal urea clearance)	At study start, and then after 3 weeks, 4 weeks and 5 weeks.
24 h batch collection	Peritoneal urea clearance	At study start, and then after 3 weeks, 4 weeks and 5 weeks.
24 h batch collection	Peritoneal creatinine clearance	At study start, and then after 3 weeks, 4 weeks and 5 weeks.

Collaborators and Investigators

• Sponsor: Fresenius Medical Care Deutschland GmbH
• Collaborators: Winicker Norimed GmbH
• Investigators: Principal Investigator: Isabel Garcia Méndez, Dr., Hospital Son Espases

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2025
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: May 17, 2024
• First Submitted That Met QC Criteria: June 3, 2024
• First Posted (Actual): June 5, 2024

Study Record Updates

• Last Update Posted (Actual): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 16, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Renal replacement therapy; Peritoneal dialysis; Automated peritoneal dialysis; PD cycler
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Renal Insufficiency, Chronic
• Other Study ID Numbers: PD-pPD-01-ESP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No