Carry Life@ UF System Clinical Study

NCT05874804 | Completed

• 2 other identifiers: Tmed-010CIV-23-03-042555
• Study Type: interventional
• Target: 28
• Locations: 3 countries
• Sites: 11

Brief 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. 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.

Conditions

End Stage Renal Disease

Keywords

Steady concentration peritoneal dialysis; SCPD

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Secondary Outcomes (4)

• Adverse event rates

  8 weeks

• Peritoneal sodium removal

  8 weeks

• Glucose UF efficiency

  8 weeks

• Peak dialysate glucose concentration

  2 weeks

Other Outcomes (2)

• Peritoneal urea and creatinine removal

  8 weeks

• Weekly peritoneal ultrafiltration volume

  8 weeks

Study Arms (2)

Control CAPD treatment

ACTIVE COMPARATOR

The subjects will receive their standard CAPD treatment.

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.

Device: Carry Life UF

Interventions

Carry Life UF DEVICE

A 5-hour treatment with the Carry Life UF used with a 1.36% glucose PD fill.

Carry Life UF

2.27% glucose peritoneal dialysis dwell DRUG

A 5-hour CAPD dwell with a 2.27% glucose PD fluid.

Control CAPD treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Triomed AB: lead
• Iqvia Pty Ltd: collaborator

Study Sites (11)

ASST-Cremona

Cremona, Italy

Location

Polyclinic Milan

Milan, Italy

Location

Sahlgrenska Universitetssjukhuset

Gothenburg, Sweden

Location

Skånes University Hospital

Lund, Sweden

Location

Karolinska Universitetssjukhuset, Njurmedicin Rosenlund

Stockholm, Sweden

Location

Heartlands Hospital

Birmingham, United Kingdom

Location

Queen Elisabeth's Hospital

Birmingham, United Kingdom

Location

King's College Hospital

London, United Kingdom

Location

London Royal Hospital, Barth Health NHS Trust

London, United Kingdom

Location

Royal Free London NHS Foundation Trust

London, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 40181271 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Olof Heimbürger, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Stanley Fan, MD, PhD

  Barts & The London NHS Trust

  PRINCIPAL INVESTIGATOR

• Giuseppe Castellano, MD, PhD

  Policlinic of Milan, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: May 25, 2023
• Study Start: September 19, 2023
• Primary Completion: October 24, 2025
• Study Completion: November 4, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3); GB (6); IT (2)