End Stage Renal DiseaseNCT05874804
Carry Life@ UF System Clinical Study
A study testing Carry Life UF and 2.27% glucose peritoneal dialysis dwell in people with End Stage Renal Disease, run by Triomed AB at 11 sites in 3 countries.
Trial summary
The Carry Life UF system performs peritoneal ultrafiltration by adding glucose to the low glucose strength (1.36%) peritoneal dialysis fluid which has been instilled into the peritoneal cavity prior to the connection of the device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Carry Life UF and 2.27% glucose peritoneal dialysis dwell
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 11 sitesin 3 countries
- Study dates
- 19 Sep 2023to 4 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Subjects with ESKD treated with PD for at least three (3) months.
- 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.
- Subjects must be able to tolerate a 2 L PD fill volume for the PET.
- Subjects using the Baxter PD system with a MiniCap transfer set.
- 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.
- Obtained written consent to participate in the study.
Who cannot join
- A PD prescription including a regular 3.86% glucose day dwell.
- An episode of peritonitis within the last three (3) months.
- Serum potassium > 6 mmol/l within the last three (3) months.
- Serum urea > 35 mmol/l within the last three (3) months.
- Clinical signs of dehydration.
- Systolic blood pressure < 100 mmHg within the last month.
Show all 13Show fewer
- Known diagnosis of clinically significant aortic stenosis.
- Clinical condition of unstable diabetes.
- Subjects with a life expectancy of < six (6) months.
- Evidence of any other diseases or medical conditions that may interfere with the planned treatment or affect participant compliance.
- Participation in clinical trials, interfering with the present study, within the previous month.
- Anticipated living donor kidney transplantation within six (6) months of screening.
- Pregnant, breastfeeding, or women of childbearing potential who are not using an effective method of contraception (hormonal contraceptives or barrier contraceptive methods).
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
United Kingdom6 sites
Heartlands Hospital
Birmingham
Queen Elisabeth's Hospital
Birmingham
King's College Hospital
London
London Royal Hospital, Barth Health NHS Trust
London
Royal Free London NHS Foundation Trust
London
Nottingham University Hospitals NHS Trust
Nottingham
Sweden3 sites
Sahlgrenska Universitetssjukhuset
Gothenburg
Skånes University Hospital
Lund
Karolinska Universitetssjukhuset, Njurmedicin Rosenlund
Stockholm
About this study
Official title: A Clinical Study With the Carry Life® UF System in Continuous Ambulatory Peritoneal Dialysis (CAPD) Patients
The Carry Life UF system performs peritoneal ultrafiltration by adding glucose to the low glucose strength (1.36%) peritoneal dialysis fluid which has been instilled into the peritoneal cavity prior to the connection of the device. By maintaining a stable glucose concentration in the intraperitoneal fluid during the 5-hour treatment, the ultrafiltration can be increased compared to a standard CAPD dwell.
Read the detailed description
A study of the peritoneal ultrafiltration achieved with Carry Life® UF system compared to standard peritoneal dialysis (PD) therapy, in CAPD patients.
The study consists of the following five (5) phases:
- Inclusion phase.
- In-clinic treatment phase for dose determination and safety evaluation.
- Randomization phase.
- Transition to home treatment phase.
- 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
- End Stage Renal Disease
- Being tested
- Carry Life UF, 2.27% glucose peritoneal dialysis dwell
- Keywords
- Steady concentration peritoneal dialysis, SCPD
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carry Life UFDevice
A 5-hour treatment with the Carry Life UF used with a 1.36% glucose PD fill.
2.27% glucose peritoneal dialysis dwellDrug
A 5-hour CAPD dwell with a 2.27% glucose PD fluid.
| Study group | Role | What they receive |
|---|---|---|
| Control CAPD treatment | Active comparator | The subjects will receive their standard CAPD treatment. Receives: Drug: 2.27% glucose peritoneal dialysis dwell |
| Carry Life UF | Experimental | 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. Receives: Device: Carry Life UF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrafiltration volume
The UF volume is the difference between the drained fluid volume and the administered fluid volume. The average of two treatments per arm during the home phase of the study.
Measured: 8 weeks
Secondary outcomes (4)
Adverse event rates
Rates of adverse events (AEs) and serious adverse events (SAEs) during the home phase of the study.
Measured: 8 weeks
Peritoneal sodium removal
Sodium removed with the drained fluid volume minus the sodium administered with the PD fluid. The average of two treatments per arm during the home phase of the study.
Measured: 8 weeks
Glucose UF efficiency
ml UF/gram glucose absorbed.Glucose absorbed is the glucose added with the solutions minus the glucose removed by the peritoneal drains. The average of two treatments per arm during the home phase of the study
Measured: 8 weeks
Peak dialysate glucose concentration
The peak glucose concentration recorded during the two Carry Life UF treatments in the clinic phase of the study.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start19 Sep 2023
- Primary completion24 Oct 2025
- Study completion4 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Triomed AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Responsible party
- Sponsor
- Investigators
- Olof Heimbürger, MD, PhD, Principal investigator, Karolinska InstitutetStanley Fan, MD, PhD, Principal investigator, Barts & The London NHS TrustGiuseppe Castellano, MD, PhD, Principal investigator, Policlinic of Milan, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05874804
- Sponsor's protocol ID
- Tmed-010
- Other IDs
- CIV-23-03-042555
- Status last verified
- Oct 2025
- First submitted
- 18 Apr 2023
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wilkie M, Heimburger O, de Leon C, Carlsson O, Davenport A, Fan SL, Allen J, Castellano G, Daenen K, Dick J, Kamesh L, Cornacchia F, Hegbrant J. Ultrafiltration and Sodium Removal in Steady Concentration Peritoneal Dialysis: A Prospective, Multicenter, Randomized, Crossover Study. J Am Soc Nephrol. 2026 Jun 4. doi: 10.1681/ASN.0000001152. Online ahead of print.
PubMed 42240452Wilkie 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.
PubMed 40181271
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study With the Carry Life® UF System in Continuous Ambulatory Peritoneal Dialysis (CAPD) Patients
- ClinicalTrials.gov ID
- NCT05874804
- Acronym / sponsor ID
- Tmed-010
- Conditions
- End Stage Renal Disease
- Keywords
- Steady concentration peritoneal dialysis, SCPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Triomed ABIndustry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- 24 Oct 2025 (actual)
- Study completion
- 4 Nov 2025 (actual)
- First posted
- 25 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Carry Life UF system performs peritoneal ultrafiltration by adding glucose to the low glucose strength (1.36%) peritoneal dialysis fluid which has been instilled into the peritoneal cavity prior to the connection of the device. By maintaining a stable glucose concentration in the intraperitoneal fluid during the 5-hour treatment, the ultrafiltration can be increased compared to a standard CAPD dwell.
Detailed description
A study of the peritoneal ultrafiltration achieved with Carry Life® UF system compared to standard peritoneal dialysis (PD) therapy, in CAPD patients.
The study consists of the following five (5) phases:
- Inclusion phase.
- In-clinic treatment phase for dose determination and safety evaluation.
- Randomization phase.
- Transition to home treatment phase.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control CAPD treatment | Active comparator | Drug: 2.27% glucose peritoneal dialysis dwellThe subjects will receive their standard CAPD treatment. |
| Carry Life UF | Experimental | Device: Carry Life UFThree 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years.
- Subjects with ESKD treated with PD for at least three (3) months.
- 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.
- Subjects must be able to tolerate a 2 L PD fill volume for the PET.
- Subjects using the Baxter PD system with a MiniCap transfer set.
Key exclusion criteria (13 listed)
- A PD prescription including a regular 3.86% glucose day dwell.
- An episode of peritonitis within the last three (3) months.
- Serum potassium > 6 mmol/l within the last three (3) months.
- Serum urea > 35 mmol/l within the last three (3) months.
- Clinical signs of dehydration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carry Life UFA 5-hour treatment with the Carry Life UF used with a 1.36% glucose PD fill. | Device | Carry Life UF |
| 2.27% glucose peritoneal dialysis dwellA 5-hour CAPD dwell with a 2.27% glucose PD fluid. | Drug | Control CAPD treatment |
Primary outcome
Ultrafiltration volume
Time frame: 8 weeks
The UF volume is the difference between the drained fluid volume and the administered fluid volume. The average of two treatments per arm during the home phase of the study.
4 secondary outcomes
Adverse event rates
Time frame: 8 weeks
Peritoneal sodium removal
Time frame: 8 weeks
Glucose UF efficiency
Time frame: 8 weeks
Peak dialysate glucose concentration
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Derived from this study: PubMed 42240452Wilkie M, Heimburger O, de Leon C, Carlsson O, Davenport A, Fan SL, Allen J, Castellano G, Daenen K, Dick J, Kamesh L, Cornacchia F, Hegbrant J. Ultrafiltration and Sodium Removal in Steady Concentration Peritoneal Dialysis: A Prospective, Multicenter, Randomized, Crossover Study. J Am Soc Nephrol. 2026 Jun 4. doi: 10.1681/ASN.0000001152. Online ahead of print.
- Derived from this study: PubMed 40181271Wilkie 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olof Heimbürger, MD, PhD principal investigator
Karolinska Institutet
Stanley Fan, MD, PhD principal investigator
Barts & The London NHS Trust
Giuseppe Castellano, MD, PhD principal investigator
Policlinic of Milan, Italy
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carry Life UF and 2.27% glucose peritoneal dialysis dwell in people with End Stage Renal Disease, run by Triomed AB at 11 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United Kingdom, Sweden, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrafiltration volume (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05874804, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.