A clinical study of efficacy and safety of the Carry Life UF system in continuous ambulatory peritoneal dialysis patients: protocol for a prospective, multicenter, randomized, crossover study
Carry Life UF is a novel peritoneal dialysis (PD) technology for improved fluid management using steady concentration PD (SCPD). The Carry Life UF treatment starts with a manual peritoneal fill of 1.36% glucose PD fluid, followed by a 5-hour treatment where small amounts of glucose are continuously...
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| Published in | BMC nephrology Vol. 26; no. 1; pp. 174 - 12 |
|---|---|
| Main Authors | , , , , |
| Format | Journal Article |
| Language | English |
| Published |
England
BioMed Central Ltd
03.04.2025
BioMed Central BMC |
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| Online Access | Get full text |
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| Abstract | Carry Life UF is a novel peritoneal dialysis (PD) technology for improved fluid management using steady concentration PD (SCPD). The Carry Life UF treatment starts with a manual peritoneal fill of 1.36% glucose PD fluid, followed by a 5-hour treatment where small amounts of glucose are continuously added to maintain a stable intraperitoneal glucose concentration. A recent in-center clinical study using the Carry Life UF system demonstrated higher ultrafiltration (UF) rates, more efficient use of glucose (increased UF volume/gram of glucose absorbed), and greater sodium removal with the Carry Life UF treatments compared with a 2.27% glucose continuous ambulatory PD (CAPD) dwell. The aim of this study is to compare efficacy and safety of the Carry Life UF system with a standard CAPD prescription in the home setting.
A prospective, multicenter, randomized, crossover study of 19 adult subjects at up to 12 sites in Italy, Sweden and the UK will complete the investigation. End-stage kidney disease patients with a CAPD prescription of 2-4 exchanges per day, including at least one 2.27% glucose dwell, will be included. After a Carry Life UF glucose dose determination phase performed in-clinic, subjects will be randomized to start the home treatment part of the study with either the control arm (2.27% glucose CAPD dwell) or the Carry Life UF arm (11 or 15 g/h glucose dose), each for four weeks. The primary endpoint is UF volume comparing the control CAPD 2.27% glucose dwell with the Carry Life UF treatment. Secondary endpoints include adverse event rates, peritoneal sodium removal, glucose UF efficiency, and peak dialysate glucose concentration.
This study will evaluate a novel PD technology in the home environment. Challenging aspects include the need to accurately measure UF volumes at home and to support subjects in using a novel technology. The study design considers important parameters for precise UF volume measurements and provides detailed weighing instructions to the study team to ensure consistency between study centers. Research nursing support will be provided for training of subjects and to support endpoint data collection in the subjects' home. Due to the significant burden associated with the study, subjects will be offered a fair compensation, in accordance with local regulations.
ClinicalTrials.gov Identifier: NCT05874804 Registration date: 18th of April 2023. |
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| AbstractList | Abstract Background Carry Life UF is a novel peritoneal dialysis (PD) technology for improved fluid management using steady concentration PD (SCPD). The Carry Life UF treatment starts with a manual peritoneal fill of 1.36% glucose PD fluid, followed by a 5-hour treatment where small amounts of glucose are continuously added to maintain a stable intraperitoneal glucose concentration. A recent in-center clinical study using the Carry Life UF system demonstrated higher ultrafiltration (UF) rates, more efficient use of glucose (increased UF volume/gram of glucose absorbed), and greater sodium removal with the Carry Life UF treatments compared with a 2.27% glucose continuous ambulatory PD (CAPD) dwell. The aim of this study is to compare efficacy and safety of the Carry Life UF system with a standard CAPD prescription in the home setting. Methods A prospective, multicenter, randomized, crossover study of 19 adult subjects at up to 12 sites in Italy, Sweden and the UK will complete the investigation. End-stage kidney disease patients with a CAPD prescription of 2–4 exchanges per day, including at least one 2.27% glucose dwell, will be included. After a Carry Life UF glucose dose determination phase performed in-clinic, subjects will be randomized to start the home treatment part of the study with either the control arm (2.27% glucose CAPD dwell) or the Carry Life UF arm (11 or 15 g/h glucose dose), each for four weeks. The primary endpoint is UF volume comparing the control CAPD 2.27% glucose dwell with the Carry Life UF treatment. Secondary endpoints include adverse event rates, peritoneal sodium removal, glucose UF efficiency, and peak dialysate glucose concentration. Discussion This study will evaluate a novel PD technology in the home environment. Challenging aspects include the need to accurately measure UF volumes at home and to support subjects in using a novel technology. The study design considers important parameters for precise UF volume measurements and provides detailed weighing instructions to the study team to ensure consistency between study centers. Research nursing support will be provided for training of subjects and to support endpoint data collection in the subjects’ home. Due to the significant burden associated with the study, subjects will be offered a fair compensation, in accordance with local regulations. Trial registration ClinicalTrials.gov Identifier: NCT05874804 Registration date: 18th of April 2023. Carry Life UF is a novel peritoneal dialysis (PD) technology for improved fluid management using steady concentration PD (SCPD). The Carry Life UF treatment starts with a manual peritoneal fill of 1.36% glucose PD fluid, followed by a 5-hour treatment where small amounts of glucose are continuously added to maintain a stable intraperitoneal glucose concentration. A recent in-center clinical study using the Carry Life UF system demonstrated higher ultrafiltration (UF) rates, more efficient use of glucose (increased UF volume/gram of glucose absorbed), and greater sodium removal with the Carry Life UF treatments compared with a 2.27% glucose continuous ambulatory PD (CAPD) dwell. The aim of this study is to compare efficacy and safety of the Carry Life UF system with a standard CAPD prescription in the home setting. A prospective, multicenter, randomized, crossover study of 19 adult subjects at up to 12 sites in Italy, Sweden and the UK will complete the investigation. End-stage kidney disease patients with a CAPD prescription of 2-4 exchanges per day, including at least one 2.27% glucose dwell, will be included. After a Carry Life UF glucose dose determination phase performed in-clinic, subjects will be randomized to start the home treatment part of the study with either the control arm (2.27% glucose CAPD dwell) or the Carry Life UF arm (11 or 15 g/h glucose dose), each for four weeks. The primary endpoint is UF volume comparing the control CAPD 2.27% glucose dwell with the Carry Life UF treatment. Secondary endpoints include adverse event rates, peritoneal sodium removal, glucose UF efficiency, and peak dialysate glucose concentration. This study will evaluate a novel PD technology in the home environment. Challenging aspects include the need to accurately measure UF volumes at home and to support subjects in using a novel technology. The study design considers important parameters for precise UF volume measurements and provides detailed weighing instructions to the study team to ensure consistency between study centers. Research nursing support will be provided for training of subjects and to support endpoint data collection in the subjects' home. Due to the significant burden associated with the study, subjects will be offered a fair compensation, in accordance with local regulations. ClinicalTrials.gov Identifier: NCT05874804 Registration date: 18th of April 2023. Carry Life UF is a novel peritoneal dialysis (PD) technology for improved fluid management using steady concentration PD (SCPD). The Carry Life UF treatment starts with a manual peritoneal fill of 1.36% glucose PD fluid, followed by a 5-hour treatment where small amounts of glucose are continuously added to maintain a stable intraperitoneal glucose concentration. A recent in-center clinical study using the Carry Life UF system demonstrated higher ultrafiltration (UF) rates, more efficient use of glucose (increased UF volume/gram of glucose absorbed), and greater sodium removal with the Carry Life UF treatments compared with a 2.27% glucose continuous ambulatory PD (CAPD) dwell. The aim of this study is to compare efficacy and safety of the Carry Life UF system with a standard CAPD prescription in the home setting.BACKGROUNDCarry Life UF is a novel peritoneal dialysis (PD) technology for improved fluid management using steady concentration PD (SCPD). The Carry Life UF treatment starts with a manual peritoneal fill of 1.36% glucose PD fluid, followed by a 5-hour treatment where small amounts of glucose are continuously added to maintain a stable intraperitoneal glucose concentration. A recent in-center clinical study using the Carry Life UF system demonstrated higher ultrafiltration (UF) rates, more efficient use of glucose (increased UF volume/gram of glucose absorbed), and greater sodium removal with the Carry Life UF treatments compared with a 2.27% glucose continuous ambulatory PD (CAPD) dwell. The aim of this study is to compare efficacy and safety of the Carry Life UF system with a standard CAPD prescription in the home setting.A prospective, multicenter, randomized, crossover study of 19 adult subjects at up to 12 sites in Italy, Sweden and the UK will complete the investigation. End-stage kidney disease patients with a CAPD prescription of 2-4 exchanges per day, including at least one 2.27% glucose dwell, will be included. After a Carry Life UF glucose dose determination phase performed in-clinic, subjects will be randomized to start the home treatment part of the study with either the control arm (2.27% glucose CAPD dwell) or the Carry Life UF arm (11 or 15 g/h glucose dose), each for four weeks. The primary endpoint is UF volume comparing the control CAPD 2.27% glucose dwell with the Carry Life UF treatment. Secondary endpoints include adverse event rates, peritoneal sodium removal, glucose UF efficiency, and peak dialysate glucose concentration.METHODSA prospective, multicenter, randomized, crossover study of 19 adult subjects at up to 12 sites in Italy, Sweden and the UK will complete the investigation. End-stage kidney disease patients with a CAPD prescription of 2-4 exchanges per day, including at least one 2.27% glucose dwell, will be included. After a Carry Life UF glucose dose determination phase performed in-clinic, subjects will be randomized to start the home treatment part of the study with either the control arm (2.27% glucose CAPD dwell) or the Carry Life UF arm (11 or 15 g/h glucose dose), each for four weeks. The primary endpoint is UF volume comparing the control CAPD 2.27% glucose dwell with the Carry Life UF treatment. Secondary endpoints include adverse event rates, peritoneal sodium removal, glucose UF efficiency, and peak dialysate glucose concentration.This study will evaluate a novel PD technology in the home environment. Challenging aspects include the need to accurately measure UF volumes at home and to support subjects in using a novel technology. The study design considers important parameters for precise UF volume measurements and provides detailed weighing instructions to the study team to ensure consistency between study centers. Research nursing support will be provided for training of subjects and to support endpoint data collection in the subjects' home. Due to the significant burden associated with the study, subjects will be offered a fair compensation, in accordance with local regulations.DISCUSSIONThis study will evaluate a novel PD technology in the home environment. Challenging aspects include the need to accurately measure UF volumes at home and to support subjects in using a novel technology. The study design considers important parameters for precise UF volume measurements and provides detailed weighing instructions to the study team to ensure consistency between study centers. Research nursing support will be provided for training of subjects and to support endpoint data collection in the subjects' home. Due to the significant burden associated with the study, subjects will be offered a fair compensation, in accordance with local regulations.ClinicalTrials.gov Identifier: NCT05874804 Registration date: 18th of April 2023.TRIAL REGISTRATIONClinicalTrials.gov Identifier: NCT05874804 Registration date: 18th of April 2023. Background Carry Life UF is a novel peritoneal dialysis (PD) technology for improved fluid management using steady concentration PD (SCPD). The Carry Life UF treatment starts with a manual peritoneal fill of 1.36% glucose PD fluid, followed by a 5-hour treatment where small amounts of glucose are continuously added to maintain a stable intraperitoneal glucose concentration. A recent in-center clinical study using the Carry Life UF system demonstrated higher ultrafiltration (UF) rates, more efficient use of glucose (increased UF volume/gram of glucose absorbed), and greater sodium removal with the Carry Life UF treatments compared with a 2.27% glucose continuous ambulatory PD (CAPD) dwell. The aim of this study is to compare efficacy and safety of the Carry Life UF system with a standard CAPD prescription in the home setting. Methods A prospective, multicenter, randomized, crossover study of 19 adult subjects at up to 12 sites in Italy, Sweden and the UK will complete the investigation. End-stage kidney disease patients with a CAPD prescription of 2-4 exchanges per day, including at least one 2.27% glucose dwell, will be included. After a Carry Life UF glucose dose determination phase performed in-clinic, subjects will be randomized to start the home treatment part of the study with either the control arm (2.27% glucose CAPD dwell) or the Carry Life UF arm (11 or 15 g/h glucose dose), each for four weeks. The primary endpoint is UF volume comparing the control CAPD 2.27% glucose dwell with the Carry Life UF treatment. Secondary endpoints include adverse event rates, peritoneal sodium removal, glucose UF efficiency, and peak dialysate glucose concentration. Discussion This study will evaluate a novel PD technology in the home environment. Challenging aspects include the need to accurately measure UF volumes at home and to support subjects in using a novel technology. The study design considers important parameters for precise UF volume measurements and provides detailed weighing instructions to the study team to ensure consistency between study centers. Research nursing support will be provided for training of subjects and to support endpoint data collection in the subjects' home. Due to the significant burden associated with the study, subjects will be offered a fair compensation, in accordance with local regulations. Trial registration ClinicalTrials.gov Identifier: NCT05874804 Registration date: 18th of April 2023. Keywords: Peritoneal dialysis, Steady concentration peritoneal dialysis, Ultrafiltration, Sodium removal, Glucose, Carry life UF system BackgroundCarry Life UF is a novel peritoneal dialysis (PD) technology for improved fluid management using steady concentration PD (SCPD). The Carry Life UF treatment starts with a manual peritoneal fill of 1.36% glucose PD fluid, followed by a 5-hour treatment where small amounts of glucose are continuously added to maintain a stable intraperitoneal glucose concentration. A recent in-center clinical study using the Carry Life UF system demonstrated higher ultrafiltration (UF) rates, more efficient use of glucose (increased UF volume/gram of glucose absorbed), and greater sodium removal with the Carry Life UF treatments compared with a 2.27% glucose continuous ambulatory PD (CAPD) dwell. The aim of this study is to compare efficacy and safety of the Carry Life UF system with a standard CAPD prescription in the home setting.MethodsA prospective, multicenter, randomized, crossover study of 19 adult subjects at up to 12 sites in Italy, Sweden and the UK will complete the investigation. End-stage kidney disease patients with a CAPD prescription of 2–4 exchanges per day, including at least one 2.27% glucose dwell, will be included. After a Carry Life UF glucose dose determination phase performed in-clinic, subjects will be randomized to start the home treatment part of the study with either the control arm (2.27% glucose CAPD dwell) or the Carry Life UF arm (11 or 15 g/h glucose dose), each for four weeks. The primary endpoint is UF volume comparing the control CAPD 2.27% glucose dwell with the Carry Life UF treatment. Secondary endpoints include adverse event rates, peritoneal sodium removal, glucose UF efficiency, and peak dialysate glucose concentration.DiscussionThis study will evaluate a novel PD technology in the home environment. Challenging aspects include the need to accurately measure UF volumes at home and to support subjects in using a novel technology. The study design considers important parameters for precise UF volume measurements and provides detailed weighing instructions to the study team to ensure consistency between study centers. Research nursing support will be provided for training of subjects and to support endpoint data collection in the subjects’ home. Due to the significant burden associated with the study, subjects will be offered a fair compensation, in accordance with local regulations.Trial registrationClinicalTrials.gov Identifier: NCT05874804 Registration date: 18th of April 2023. Background: Carry Life UF is a novel peritoneal dialysis (PD) technology for improved fluid management using steady concentration PD (SCPD). The Carry Life UF treatment starts with a manual peritoneal fill of 1.36% glucose PD fluid, followed by a 5-hour treatment where small amounts of glucose are continuously added to maintain a stable intraperitoneal glucose concentration. A recent in-center clinical study using the Carry Life UF system demonstrated higher ultrafiltration (UF) rates, more efficient use of glucose (increased UF volume/gram of glucose absorbed), and greater sodium removal with the Carry Life UF treatments compared with a 2.27% glucose continuous ambulatory PD (CAPD) dwell. The aim of this study is to compare efficacy and safety of the Carry Life UF system with a standard CAPD prescription in the home setting. Methods: A prospective, multicenter, randomized, crossover study of 19 adult subjects at up to 12 sites in Italy, Sweden and the UK will complete the investigation. End-stage kidney disease patients with a CAPD prescription of 2–4 exchanges per day, including at least one 2.27% glucose dwell, will be included. After a Carry Life UF glucose dose determination phase performed in-clinic, subjects will be randomized to start the home treatment part of the study with either the control arm (2.27% glucose CAPD dwell) or the Carry Life UF arm (11 or 15 g/h glucose dose), each for four weeks. The primary endpoint is UF volume comparing the control CAPD 2.27% glucose dwell with the Carry Life UF treatment. Secondary endpoints include adverse event rates, peritoneal sodium removal, glucose UF efficiency, and peak dialysate glucose concentration. Discussion: This study will evaluate a novel PD technology in the home environment. Challenging aspects include the need to accurately measure UF volumes at home and to support subjects in using a novel technology. The study design considers important parameters for precise UF volume measurements and provides detailed weighing instructions to the study team toensure consistency between study centers. Research nursing support will be provided for training of subjects and to support endpoint data collection in the subjects’ home. Due to the significant burden associated with the study, subjects will be offered a fair compensation, in accordance with local regulations. Trial registration: ClinicalTrials.gov Identifier: NCT05874804 Registration date: 18th of April 2023. Carry Life UF is a novel peritoneal dialysis (PD) technology for improved fluid management using steady concentration PD (SCPD). The Carry Life UF treatment starts with a manual peritoneal fill of 1.36% glucose PD fluid, followed by a 5-hour treatment where small amounts of glucose are continuously added to maintain a stable intraperitoneal glucose concentration. A recent in-center clinical study using the Carry Life UF system demonstrated higher ultrafiltration (UF) rates, more efficient use of glucose (increased UF volume/gram of glucose absorbed), and greater sodium removal with the Carry Life UF treatments compared with a 2.27% glucose continuous ambulatory PD (CAPD) dwell. The aim of this study is to compare efficacy and safety of the Carry Life UF system with a standard CAPD prescription in the home setting. A prospective, multicenter, randomized, crossover study of 19 adult subjects at up to 12 sites in Italy, Sweden and the UK will complete the investigation. End-stage kidney disease patients with a CAPD prescription of 2-4 exchanges per day, including at least one 2.27% glucose dwell, will be included. After a Carry Life UF glucose dose determination phase performed in-clinic, subjects will be randomized to start the home treatment part of the study with either the control arm (2.27% glucose CAPD dwell) or the Carry Life UF arm (11 or 15 g/h glucose dose), each for four weeks. The primary endpoint is UF volume comparing the control CAPD 2.27% glucose dwell with the Carry Life UF treatment. Secondary endpoints include adverse event rates, peritoneal sodium removal, glucose UF efficiency, and peak dialysate glucose concentration. This study will evaluate a novel PD technology in the home environment. Challenging aspects include the need to accurately measure UF volumes at home and to support subjects in using a novel technology. The study design considers important parameters for precise UF volume measurements and provides detailed weighing instructions to the study team to ensure consistency between study centers. Research nursing support will be provided for training of subjects and to support endpoint data collection in the subjects' home. Due to the significant burden associated with the study, subjects will be offered a fair compensation, in accordance with local regulations. |
| ArticleNumber | 174 |
| Audience | Academic |
| Author | de Leon, Charlotte Hegbrant, Jörgen Heimbürger, Olof Wilkie, Martin Carlsson, Ola |
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| CorporateAuthor | Department of Clinical Sciences, Lund Nephrology Njurmedicin Faculty of Medicine Institutionen för kliniska vetenskaper, Lund Sektion II Section II Lunds universitet Medicinska fakulteten Lund University |
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| PublicationTitle | BMC nephrology |
| PublicationTitleAlternate | BMC Nephrol |
| PublicationYear | 2025 |
| Publisher | BioMed Central Ltd BioMed Central BMC |
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| References | G Esiason (4095_CR11) 2024; 23 W Van Biesen (4095_CR6) 2011; 6 EA Brown (4095_CR1) 2020; 40 F Vrtovsnik (4095_CR9) 2021; 14 V La Milia (4095_CR13) 2017; 37 BC Kwan (4095_CR4) 2014; 34 K Ates (4095_CR7) 2001; 60 I Teitelbaum (4095_CR2) 2021; 77 C Ronco (4095_CR5) 2015; 30 Y Shu (4095_CR8) 2018; 46 O Heimburger (4095_CR10) 2023; 19 SJ Davies (4095_CR12) 2006; 26 Q Guo (4095_CR3) 2013; 8 |
| References_xml | – volume: 26 start-page: 449 issue: 4 year: 2006 ident: 4095_CR12 publication-title: Perit Dial Int doi: 10.1177/089686080602600408 – volume: 37 start-page: 633 issue: 6 year: 2017 ident: 4095_CR13 publication-title: Perit Dial Int doi: 10.3747/pdi.2017.00004 – volume: 40 start-page: 244 issue: 3 year: 2020 ident: 4095_CR1 publication-title: Perit Dial Int doi: 10.1177/0896860819895364 – volume: 23 start-page: 881 issue: 12 year: 2024 ident: 4095_CR11 publication-title: Nat Rev Drug Discov doi: 10.1038/d41573-024-00107-2 – volume: 60 start-page: 767 issue: 2 year: 2001 ident: 4095_CR7 publication-title: Kidney Int doi: 10.1046/j.1523-1755.2001.060002767.x – volume: 30 start-page: 849 issue: 5 year: 2015 ident: 4095_CR5 publication-title: Nephrol Dial Transpl doi: 10.1093/ndt/gfv013 – volume: 8 start-page: e53294 issue: 1 year: 2013 ident: 4095_CR3 publication-title: PLoS ONE doi: 10.1371/journal.pone.0053294 – volume: 14 start-page: 570 issue: 2 year: 2021 ident: 4095_CR9 publication-title: Clin Kidney J doi: 10.1093/ckj/sfz175 – volume: 19 start-page: 224 issue: 2 year: 2023 ident: 4095_CR10 publication-title: Clin J Am Soc Nephrol doi: 10.2215/CJN.0000000000000342 – volume: 6 start-page: e17148 issue: 2 year: 2011 ident: 4095_CR6 publication-title: PLoS ONE doi: 10.1371/journal.pone.0017148 – volume: 46 start-page: 350 issue: 4 year: 2018 ident: 4095_CR8 publication-title: Blood Purif doi: 10.1159/000492148 – volume: 77 start-page: 157 issue: 2 year: 2021 ident: 4095_CR2 publication-title: Am J Kidney Dis doi: 10.1053/j.ajkd.2020.09.010 – volume: 34 start-page: 409 issue: 4 year: 2014 ident: 4095_CR4 publication-title: Perit Dial Int doi: 10.3747/pdi.2013.00066 |
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| Snippet | Carry Life UF is a novel peritoneal dialysis (PD) technology for improved fluid management using steady concentration PD (SCPD). The Carry Life UF treatment... Background Carry Life UF is a novel peritoneal dialysis (PD) technology for improved fluid management using steady concentration PD (SCPD). The Carry Life UF... BackgroundCarry Life UF is a novel peritoneal dialysis (PD) technology for improved fluid management using steady concentration PD (SCPD). The Carry Life UF... Background: Carry Life UF is a novel peritoneal dialysis (PD) technology for improved fluid management using steady concentration PD (SCPD). The Carry Life UF... Abstract Background Carry Life UF is a novel peritoneal dialysis (PD) technology for improved fluid management using steady concentration PD (SCPD). The Carry... |
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| SubjectTerms | Adult Analysis Blood pressure Care and treatment Caregivers Carry life UF system Chronic kidney failure Clinical Medicine Clinical trials Comparative analysis Consent Continuous ambulatory peritoneal dialysis Creatinine Cross-Over Studies Dextrose Diagnosis Dialysate Dialysis Solutions - administration & dosage End-stage renal disease Endocrinology and Diabetes Endokrinologi och diabetes Female Glucose Glucose - administration & dosage Glucose tolerance tests Hemodialysis Humans Kidney diseases Kidney Failure, Chronic - therapy Klinisk medicin Male Medical and Health Sciences Medicin och hälsovetenskap Multicenter Studies as Topic Patient outcomes Patients Peritoneal dialysis Peritoneal Dialysis, Continuous Ambulatory - adverse effects Peritoneal Dialysis, Continuous Ambulatory - instrumentation Peritoneal Dialysis, Continuous Ambulatory - methods Peritoneum Prospective Studies Risk factors Sodium removal Steady concentration peritoneal dialysis Technology application Treatment Outcome Ultrafiltration Ultrafiltration - instrumentation Ultrafiltration - methods Urine |
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| Title | A clinical study of efficacy and safety of the Carry Life UF system in continuous ambulatory peritoneal dialysis patients: protocol for a prospective, multicenter, randomized, crossover study |
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