Chronic Renal FailureNCT03724682
A Performance Analysis of the Peritoneal Ultrafiltration (PUF) Achieved With the Carry Life® UF
A study testing Carry Life UF device in people with Chronic Renal Failure, run by Triomed AB at 3 sites in Sweden.
Trial summary
The Carry Life UF device performs peritoneal ultrafiltration by adding a concentrated glucose to peritoneal dialysis fluid which has been instilled into the abdomen prior to the connection of the device. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Renal Failure
- What is being tested?
- Carry Life UF device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 3 sitesSweden
- Study dates
- 1 Mar 2019to 26 Jun 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Male or female
- On stable PD including Icodextrin, treated at the clinic for at least 3 months
- No clinical signs of dehydration.
- Obtained written consent to participate in the study
Who cannot join
- Significant illness or active infection (evaluated by clinical examination) in the past 4 weeks
- Episodes of peritonitis during the past 2 months
- Active malignant disease
- Diabetes type 1
- Abdominal hernias
- HIV and/or hepatitis positive within the last 3 months
Show all 9Show fewer
- Known pregnancy or breastfeeding and pregnancy test for women of child bearing age.
- Conditions deemed by investigator as inappropriate for participation
- Participation in clinical trials, interfering with the present study, one month prior to inclusion
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Skånes Universitetssjukhus, Lund
Lund
Skånes Universitetssjukhus, Malmö
Malmö, Skåne County, 205 02
Karolinska Universitetssjukhuset
Stockholm
About this study
The Carry Life UF device performs peritoneal ultrafiltration by adding a concentrated glucose to peritoneal dialysis fluid which has been instilled into the abdomen prior to the connection of the device. Maintaining the glucose concentration in the intraperitoneal fluid results in an increased fluid removal (ultrafiltration).
The clinical investigation will evaluate the ultrafiltration achieved with the Carry Life UF device compared to standard peritoneal dialysis (PD) therapy
Read the detailed description
A study of the peritoneal ultrafiltration achieved with Carry Life® UF compared to standard PD therapy, performed in 12 stable PD patients. The study consists of one baseline study session with Icodextrin overnight and one four-hour, 2.27% glucose exchange and three Carry Life® UF treatments with different glucose doses. All treatments are preceded by an Icodextrin dwell overnight.
Visit 1: The patient will be screened for study eligibility and a signed informed consent obtained before any of the study activities commence. Once included in the study the patient will be asked to document their ultrafiltration volumes for the week prior to the baseline study session (PD bags to be weighed before and after).
Visit 2: Baseline study session with standard PD therapy. The evening before visit 2 the patient will use Icodextrin 2000 ml overnight which is drained at the clinic before the start of the second PD exchange.
- A four-hour dwell with 2.27%, 2000 ml PD fluid will be performed at the clinic.
- During the study sessions the fluid intake and output will be measured.
- A 24 h urine collection for urea and creatinine clearance started the day before the baseline study session will be completed at the baseline study session.
Visit 3, 4 and 5: Carry Life® UF study sessions The evening before the visits the patient will use Icodextrin 2000 ml overnight which is drained at the clinic the next day before the start of the Carry Life® UF study session.
- The Carry Life UF study session starts with filling the peritoneal cavity with 1500 ml of a standard glucose-based PD solution of 1.36%.
- The Carry Life® UF is then connected to the PD catheter and the 5-hour treatment starts. The glucose dose for visit 3 is 11 g/h, visit 4, 14 g/h and visit 5, 20 g/h.
- During the treatment, IP fluid will be drained hourly and as required.
- During the study sessions the fluid intake and output will be measured.
- During and after each study session the patient's tolerability of the treatment will be evaluated by monitoring vital signs (blood pressure and heart rate hourly).
- Evaluation of the patient's experience of the Carry Life® UF treatment is documented in the CRF, regarding the sensation of the flow in and out of the abdomen and a short questionnaire between visit 4 and 5, regarding the usability and experience of the device.
Follow-up: Follow-up will be performed after the completion of the Carry Life® UF study sessions. The follow-up can either be performed at the clinic or by telephone which is at the discretion of the investigator and the patient.
- Conditions
- Chronic Renal Failure
- Being tested
- Carry Life UF device
- 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 UF deviceDevice
Treatment with the Carry Life UF device compared to standard PD therapy
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Single arm in which everyone enrolled in a trial receives treatment with Carry Life UF device, Receives: Device: Carry Life UF device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrafiltration volume
The ultrafiltration volumes achieved during the study sessions
Measured: During a five hour study session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start1 Mar 2019
- Primary completion26 Jun 2019
- Study completion26 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Renal FailureStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Baseline study session with standard PD therapy. Three study sessions with the Carry Life UF device at three different glucose dosages, starting with the lowest dose of 11g/h, increasing to 14g/h and finally 20g/h.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Triomed AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ann-Cathrine Johansson, Principal investigator, Renal Unit, Skånes Universitetssjukhus, Malmö
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03724682
- Sponsor's protocol ID
- Tmed-007 (Malmö)
- Status last verified
- Oct 2018
- First submitted
- 26 Oct 2018
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The results of the investigation will be submitted for publication, and publications and presentations will be based upon the clinical investigation report.
Publications
Heimburger O, Hegbrant J, Martus G, Wilkie M, De Leon C, Carlsson O, Johansson AC. Effects of Steady Glucose Concentration Peritoneal Dialysis on Ultrafiltration Volume and Sodium Removal: A Pilot Crossover Trial. Clin J Am Soc Nephrol. 2024 Feb 1;19(2):224-232. doi: 10.2215/CJN.0000000000000342. Epub 2023 Oct 30.
PubMed 37902732
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Performance Analysis of the Peritoneal Ultrafiltration (PUF) Achieved With the Carry Life® UF
- ClinicalTrials.gov ID
- NCT03724682
- Acronym / sponsor ID
- Tmed-007 (Malmö)
- Conditions
- Chronic Renal Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Triomed ABIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 26 Jun 2019 (actual)
- Study completion
- 26 Jun 2019 (actual)
- First posted
- 30 Oct 2018 (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 device performs peritoneal ultrafiltration by adding a concentrated glucose to peritoneal dialysis fluid which has been instilled into the abdomen prior to the connection of the device. Maintaining the glucose concentration in the intraperitoneal fluid results in an increased fluid removal (ultrafiltration).
The clinical investigation will evaluate the ultrafiltration achieved with the Carry Life UF device compared to standard peritoneal dialysis (PD) therapy
Detailed description
A study of the peritoneal ultrafiltration achieved with Carry Life® UF compared to standard PD therapy, performed in 12 stable PD patients. The study consists of one baseline study session with Icodextrin overnight and one four-hour, 2.27% glucose exchange and three Carry Life® UF treatments with different glucose doses. All treatments are preceded by an Icodextrin dwell overnight.
Visit 1: The patient will be screened for study eligibility and a signed informed consent obtained before any of the study activities commence. Once included in the study the patient will be asked to document their ultrafiltration volumes for the week prior to the baseline study session (PD bags to be weighed before and after).
Visit 2: Baseline study session with standard PD therapy. The evening before visit 2 the patient will use Icodextrin 2000 ml overnight which is drained at the clinic before the start of the second PD exchange.
- A four-hour dwell with 2.27%, 2000 ml PD fluid will be performed at the clinic.
- During the study sessions the fluid intake and output will be measured.
- A 24 h urine collection for urea and creatinine clearance started the day before the baseline study session will be completed at the baseline study session.
Visit 3, 4 and 5: Carry Life® UF study sessions The evening before the visits the patient will use Icodextrin 2000 ml overnight which is drained at the clinic the next day before the start of the Carry Life® UF study session.
- The Carry Life UF study session starts with filling the peritoneal cavity with 1500 ml of a standard glucose-based PD solution of 1.36%.
- The Carry Life® UF is then connected to the PD catheter and the 5-hour treatment starts. The glucose dose for visit 3 is 11 g/h, visit 4, 14 g/h and visit 5, 20 g/h.
- During the treatment, IP fluid will be drained hourly and as required.
- During the study sessions the fluid intake and output will be measured.
- During and after each study session the patient's tolerability of the treatment will be evaluated by monitoring vital signs (blood pressure and heart rate hourly).
- Evaluation of the patient's experience of the Carry Life® UF treatment is documented in the CRF, regarding the sensation of the flow in and out of the abdomen and a short questionnaire between visit 4 and 5, regarding the usability and experience of the device.
Follow-up: Follow-up will be performed after the completion of the Carry Life® UF study sessions. The follow-up can either be performed at the clinic or by telephone which is at the discretion of the investigator and the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Baseline study session with standard PD therapy. Three study sessions with the Carry Life UF device at three different glucose dosages, starting with the lowest dose of 11g/h, increasing to 14g/h and finally 20g/h.
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Device: Carry Life UF deviceSingle arm in which everyone enrolled in a trial receives treatment with Carry Life UF device, |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Male or female
- On stable PD including Icodextrin, treated at the clinic for at least 3 months
- No clinical signs of dehydration.
- Obtained written consent to participate in the study
Key exclusion criteria (9 listed)
- Significant illness or active infection (evaluated by clinical examination) in the past 4 weeks
- Episodes of peritonitis during the past 2 months
- Active malignant disease
- Diabetes type 1
- Abdominal hernias
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 UF deviceTreatment with the Carry Life UF device compared to standard PD therapy | Device | Single arm |
Primary outcome
Ultrafiltration volume
Time frame: During a five hour study session
The ultrafiltration volumes achieved during the study sessions
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 28 Aug 2019.
- Derived from this study: PubMed 37902732Heimburger O, Hegbrant J, Martus G, Wilkie M, De Leon C, Carlsson O, Johansson AC. Effects of Steady Glucose Concentration Peritoneal Dialysis on Ultrafiltration Volume and Sodium Removal: A Pilot Crossover Trial. Clin J Am Soc Nephrol. 2024 Feb 1;19(2):224-232. doi: 10.2215/CJN.0000000000000342. Epub 2023 Oct 30.
- Individual participant dataSharing planned: No. The results of the investigation will be submitted for publication, and publications and presentations will be based upon the clinical investigation report.
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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.
Ann-Cathrine Johansson principal investigator
Renal Unit, Skånes Universitetssjukhus, Malmö
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carry Life UF device in people with Chronic Renal Failure, run by Triomed AB at 3 sites in Sweden.
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 5 inclusion and 9 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 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. 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: During a five hour study session). 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 NCT03724682, which also lists 1 linked publication.
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 28 Aug 2019.