Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05874804 |
| Other study ID # |
Tmed-010 |
| Secondary ID |
CIV-23-03-042555 |
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 19, 2023 |
| Est. completion date |
August 2024 |
Study information
| Verified date |
November 2023 |
| Source |
Triomed AB |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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:
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.
