Introduction:
Steady concentration peritoneal dialysis (SCAPD) performed with the Carry Life UF system was used in a previous in-center clinical investigation comparing Carry Life UF treatments with a control 2.27% glucose CAPD treatment in eight subjects (CJASN 19: 224-32, 2024). The Carry Life UF treatment starts with a peritoneal fill of 1.36% glucose PD fluid, followed by a 5-hour treatment where 50% glucose is continuously added to the dialysate. The study showed higher ultrafiltration (UF) rates, greater sodium removal, and more efficient use of glucose (increased UF/gram of glucose absorbed) with the Carry Life UF treatments. The aim of this follow-up study is to compare safety and efficacy of the Carry Life UF system with the patient´s standard CAPD treatment in the home setting.
Methods:
A prospective, multicenter, randomized, crossover study with 25 adult subjects. End-stage kidney disease patients with a CAPD prescription of 2-4 exchanges per day, including at least one 2.27% glucose dwell, are eligible for the study. After inclusion, an in-clinic dose determination phase will be performed. A 2.27% glucose peritoneal equilibrium test will be performed to assess peritoneal transport characteristics, followed by two Carry Life UF treatments (11 and 15 g/h glucose dose). The in-clinic phase is followed by the home phase, where participants are randomized to start with the control arm or the Carry Life UF arm, each of four weeks. During the control arm, subjects will receive their standard CAPD treatment, including at least one 2.27% glucose dwell daily. During the Carry Life UF arm, one 2.27% glucose dwell will be replaced by a Carry Life UF treatment three days per week. The remaining four days of the week, one 2.27% glucose dwell per day will be replaced by a 1.36% glucose dwell to avoid excessive UF.
Results:
The primary endpoint is UF volume, comparing the control CAPD 2.27% glucose dwell with the Carry Life UF treatment, measured at two specific treatments during each arm of the home phase. An increase in UF volume with the Carry Life UF treatment vs. the control CAPD dwell of ≥ 250 ml is considered clinically relevant. Secondary endpoints include adverse events, peritoneal sodium removal, glucose UF efficiency and peak dialysate glucose concentration.
Conclusions:
This study sets out to evaluate a novel UF technology in PD in the home environment. This is particularly challenging due to the need to accurately measure UF at home as well as to support the patient in the use of a novel technology. To accurately measure UF volumes, the study design considers important parameters for adequate UF measurements in PD, e.g. bag overfill, flush volumes and bag weights. Great care has been taken to deliver reliable results in the home setting, including detailed weighing procedures. We have also provided research nursing support both for patient training and to support endpoint data collection, as device trials in the home environment typically cause a significant burden for patients. In this trial subjects are restricted to their homes during the 5-hour treatments and are requested to complete a daily PD diary. Due to the significant burden associated with many device trials it is important to offer study subjects a fair compensation reflecting the burden, to facilitate the recruitment process.
Trial registration number: NCT05874804 (ClinicalTrials.gov).
I have potential conflict of interest to disclose.
O. Carlsson and C. de Leon report employment with Triomed AB. J. Hegbrant reports employment with JBA Medical AB; consultancy for Triomed AB and myjoju Ltd; ownership interest in LundaTec AB, NorrDia AB, Redsense Medical AB, and Triomed AB; and advisory or leadership roles for Board of Directors of NorrDia AB. O. Heimbürger reports research funding from AstraZeneca, Baxter, and Triomed; honoraria from AstraZeneca, Baxter Healthcare, Fresenius Medical Care, and Vifor for presentations at company-organized courses; speakers bureau for AstraZeneca; and other interests or relationships as Secretary of Swedish Society of Renal Medicine (2021); and role on Editorial Boards of Blood Purification, Clinical Nephrology, Peritoneal Dialysis International, and Turkish Journal of Nephrology. M. Wilkie reports consultancy for Triomed, research funding from Baxter, honoraria from Baxter and Fresenius, speakers bureau for Baxter, and other interests or relationships with International Society for Peritoneal Dialysis.
I did not use generative AI and AI-assisted technologies in the writing process.