Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
28 participants
INTERVENTIONAL
2023-09-19
2025-11-04
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The study consists of the following five (5) phases:
1. Inclusion phase.
2. In-clinic treatment phase for dose determination and safety evaluation.
3. Randomization phase.
4. Transition to home treatment phase.
5. Home treatment phase for efficacy and safety evaluation.
The in-clinic phase consists of one 2.27% Peritoneal equilibrium test (PET) and two Carry Life® UF treatments; one with a 11 g/h glucose dose and one with a 15 g/h glucose dose. The Carry Life® UF treatments will be used for a safety evaluation and based on the UF volumes achieved with the Carry Life® UF treatments, the Carry Life® UF glucose dose for the home treatment phase will be determined. A 24-h urine sample will be collected before the first visit for determination of residual renal function.
After completion of the in-clinic treatment phase, subjects will be randomized to start the home treatment phase either with the control treatment arm or with the Carry Life® UF treatment arm. Subjects in the control arm will continue their standard CAPD treatment as prescribed. In the Carry Life® UF arm, for three days of the week one 2.27% glucose CAPD dwell per day will be replaced by a Carry Life® UF treatment. For the remaining four days of the week, one 2.27% glucose CAPD dwell will be replaced with a 1.36% glucose CAPD dwell.
Immediately before the subject starts using the Carry Life® UF device at home, there will be a transition to the home treatment phase during which the subjects will undergo training on the device and an assessment of their device competency will be performed.
During the home treatment phase of the study, the subject will record body weight, blood pressure and heart rate daily in a patient diary. The PD fill and drain volumes for each dwell during the study will be recorded, as well as any clinical symptoms or device malfunctions.
At the start of the second and third week of each study arm of the home treatment phase a nurse will contact the subject to check on clinical status, AEs, and Carry Life® UF device malfunctions.
Based on the clinical assessments throughout the study, the responsible physician will adjust the subject's PD prescription in order to maintain an adequate fluid balance according to clinical judgement and standard clinical practice. In the control arm, the glucose concentration of the PD dwells may be adjusted as required.
Efficacy evaluation days: The efficacy evaluation days will be performed during week 2 and week 4 of each study arm during the home treatment phase.
During the efficacy evaluation days the dialysate drained from the comparator 2.27% glucose dwell (control) and from the Carry Life® UF treatment will be collected by a research assistant for endpoint evaluation. The 2.27% glucose control dwell will be 5 hours i.e., the same duration as the Carry Life® UF treatment.
The day after the completion of each arm (control and Carry Life® UF), the subject will visit the clinic for data collection. A 24-hour urine sample will be collected before each end-of-arm visit for determination of residual renal function.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control CAPD treatment
The subjects will receive their standard CAPD treatment.
2.27% glucose peritoneal dialysis dwell
A 5-hour CAPD dwell with a 2.27% glucose PD fluid.
Carry Life UF
Three days per week, the subject will replace a 2.27% glucose dwell with the Carry Life® UF treatment. The remaining four days of the week, one 2.27% glucose dwell will be replaced by a 1.36% glucose dwell.
Carry Life UF
A 5-hour treatment with the Carry Life UF used with a 1.36% glucose PD fill.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Carry Life UF
A 5-hour treatment with the Carry Life UF used with a 1.36% glucose PD fill.
2.27% glucose peritoneal dialysis dwell
A 5-hour CAPD dwell with a 2.27% glucose PD fluid.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Subjects with ESKD treated with PD for at least three (3) months.
3. A PD prescription of 2-4 CAPD dwells/day unchanged for a minimum of two (2) weeks, with at least one 1.5-2L, 2.27% glucose day dwell daily.
4. Subjects must be able to tolerate a 2 L PD fill volume for the PET.
5. Subjects using the Baxter PD system with a MiniCap transfer set.
6. In the opinion of the Investigator, the subject has the capacity to learn how to use the Carry Life® UF system or has a caregiver who can do so.
7. Obtained written consent to participate in the study.
Exclusion Criteria
2. An episode of peritonitis within the last three (3) months.
3. Serum potassium \> 6 mmol/l within the last three (3) months.
4. Serum urea \> 35 mmol/l within the last three (3) months.
5. Clinical signs of dehydration.
6. Systolic blood pressure \< 100 mmHg within the last month.
7. Known diagnosis of clinically significant aortic stenosis.
8. Clinical condition of unstable diabetes.
9. Subjects with a life expectancy of \< six (6) months.
10. Evidence of any other diseases or medical conditions that may interfere with the planned treatment or affect participant compliance.
11. Participation in clinical trials, interfering with the present study, within the previous month.
12. Anticipated living donor kidney transplantation within six (6) months of screening.
13. Pregnant, breastfeeding, or women of childbearing potential who are not using an effective method of contraception (hormonal contraceptives or barrier contraceptive methods).
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Iqvia Pty Ltd
INDUSTRY
Triomed AB
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Olof Heimbürger, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Stanley Fan, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Barts & The London NHS Trust
Giuseppe Castellano, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Policlinic of Milan, Italy
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
ASST-Cremona
Cremona, , Italy
Polyclinic Milan
Milan, , Italy
Sahlgrenska Universitetssjukhuset
Gothenburg, , Sweden
Skånes University Hospital
Lund, , Sweden
Karolinska Universitetssjukhuset, Njurmedicin Rosenlund
Stockholm, , Sweden
Heartlands Hospital
Birmingham, , United Kingdom
Queen Elisabeth's Hospital
Birmingham, , United Kingdom
King's College Hospital
London, , United Kingdom
London Royal Hospital, Barth Health NHS Trust
London, , United Kingdom
Royal Free London NHS Foundation Trust
London, , United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Wilkie M, de Leon C, Carlsson O, Hegbrant J, Heimburger O. 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. BMC Nephrol. 2025 Apr 3;26(1):174. doi: 10.1186/s12882-025-04095-2.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Tmed-010
Identifier Type: -
Identifier Source: org_study_id
CIV-23-03-042555
Identifier Type: OTHER
Identifier Source: secondary_id