A PROSPECTIVE, MULTICENTER, RANDOMIZED, CROSSOVER STUDY OF THE CARRY LIFE UF SYSTEM IN CAPD PATIENTS IN THE HOME SETTING

 

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A PROSPECTIVE, MULTICENTER, RANDOMIZED, CROSSOVER STUDY OF THE CARRY LIFE UF SYSTEM IN CAPD PATIENTS IN THE HOME SETTING

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Olof
Heimbürger
Olof Heimbürger olof.heimburger@ki.se Karolinska University Hospital Medical Unit Renal Medicine Stockholm Sweden *
Martin Wilkie wilkieme@gmail.com Sheffield Teaching Hospitals Sheffield Kidney Institute Sheffield United Kingdom -
Charlotte de Leon charlotte.deleon@triomed.se Triomed AB Clinical Science Lund Sweden -
Ola Carlsson ola.carlsson@triomed.se Triomed AB Clinical Science Lund Sweden -
Andrew Davenport andrewdavenport@nhs.net University College London Department of Renal Medicine London United Kingdom -
Stanley Fan f.stanley@nhs.net Queen Mary University of London William Harvey Research Institute Lundon United Kingdom -
Jennifer Allen jennifer.allen36@nhs.net Nottingham University Hospitals NHS Trust Nottingham Renal and Transplant Unit Nottingham United Kingdom -
Guiseppe Castellano giuseppe.castellano@policlinico.mi.it Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Division of Nephrology, Dialysis and Kidney Transplantation Milan Italy -
Jörgen Hegbrant jbahegbrant@gmail.com Lund University Division of Nephrology, Department of Clinical Sciences Lund Lund Sweden -
 
 
 
 
 
 

Carry Life UF (CLUF) is a novel peritoneal dialysis (PD) technology for improved fluid management using steady concentration PD (SCPD). During the 5h CLUF treatment small amounts of glucose are continuously added to a 1.36% glucose PD dwell which maintains a stable intraperitoneal glucose concentration, enabling effective ultrafiltration (UF) throughout the dwell.

A previous in-center study with the CLUF system showed increased UF, more efficient use of glucose (increased UF/g glucose absorbed) and greater sodium removal with the CLUF treatments vs. a 2.27% glucose continuous ambulatory PD (CAPD) dwell (CJASN 2024; 19: 224-32). The aim of this study was to compare efficacy and safety of the CLUF system with a standard CAPD prescription in the home setting.

A prospective, multicenter, randomized, crossover study in which CAPD patients with a prescription of 2-4 exchanges per day, including at least one 2.27% glucose dwell daily, were eligible for the study.

In an in-clinic glucose dose determination phase, 3 investigations were performed at least 2 days apart: a 4h 2.27% CAPD glucose dwell and two 5h CLUF treatments (11 g/h and 15 g/h glucose dose). The in-clinic phase was followed by the home treatment phase, where patients were randomized to start with the control arm or the CLUF arm, each lasting 4 weeks.

During the control arm, patients received their standard CAPD treatment, including at least one daily 2.27% glucose dwell. During the CLUF arm, one 2.27% glucose dwell was replaced by a CLUF treatment (11 g/h or 15 g/h glucose dose) 3 days per week, and by a 1.36% glucose dwell the remaining 4 days of the week (Fig).

The protocol was carefully designed to consider important parameters for precise UF volume measurements in the home setting and provided detailed weighing and sampling instructions. Nursing support was provided to ensure accurate endpoint data collection in the patients’ home (BMC Nephrology 2025; 26: 174). 

The primary endpoint was the difference in UF volume between a 5h CLUF treatment and a 5h control 2.27% glucose dwell at 2 specific treatments week 2 and week 4 of each arm. An increase in UF volume with the CLUF treatment vs. the control CAPD dwell of ≥ 250 mL was considered clinically relevant. Secondary endpoints were adverse events, peritoneal sodium removal, glucose UF efficiency and peak dialysate glucose concentration.

In accordance with the study protocol, 19 adult CAPD patients (6 females, median age [range] 55 [26-82] years), enrolled from 8 study centers (UK 5, Sweden 2, Italy 1), completed the study.

Study results with respect to the primary and secondary endpoints will be presented at the congress.

We anticipate that this study will demonstrate the effectiveness and safety of SCPD using the CLUF system in the home setting with UF exceeding the primary endpoint of an increase of ≥ 250 mL vs. the control treatment. The use of this device will enable a step change in the way PD will be prescribed with a reduction in the requirement for hypertonic glucose exchanges while delivering effective UF. There will be ecological benefits as fewer exchanges will be required to deliver the required UF.

Trial registration number: NCT05874804 (ClinicalTrials.gov).

Kewords