Renal FailureFlexPointNCT06390592
Clinical Performance of the Therapy Option FlexPoint of the PD Cycler Sleep•Safe Harmony
A study testing PD cycler in people with Renal Failure and Chronic Kidney Disease, run by Fresenius Medical Care Deutschland GmbH.
Trial summary
Analysis and comparison of treatments with and without the FlexPoint technology (flexible volume and dwell time management) of the PD cycler sleep•safe harmony Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure, Chronic Kidney Disease
- What is being tested?
- PD cycler
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Informed consent signed and dated by study patient and investigator/ authorised physician
- Minimum age of 18 years
- CKD patients with indication for renal replacement therapy
- Patients being treated with APD for at least 3 months
- Patients using the sleep•safe harmony PD cycler (version 3.1)
- Fluid status regularly monitored with Body Composition Monitor (BCM)
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- Proper functioning catheter
- Intraperitoneal Pressure (IPP) ≤ 18 cm H2O
- Ability to understand the nature and requirements of the study
Who cannot join
- Any conditions which could interference with the patient's ability to comply with the study
- Previous participation in the same study
- Patients who have any condition prohibiting the use of BCM, like patients with major amputations (e.g. lower leg)
- Patients receiving polyglucose containing PD solution
- Respiratory or abdominal wall disease deemed to contraindicate intraperitoneal fill volume (FV) manipulation
- Patients who suffer from peritonitis/exit site infection during the last 4 weeks
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- Women of childbearing age without effective means of contraception, pregnancy (pregnancy test will be conducted at start and end of study) or lactation period
- Life expectancy <3 months
- Participation in an interventional clinical study during the preceding 90 days
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Performance of the Therapy Option FlexPoint (Flexible Volume and Dwell Time Management) of the PD Cycler Sleep•Safe Harmony
Analysis and comparison of treatments with and without the FlexPoint technology (flexible volume and dwell time management) of the PD cycler sleep•safe harmony
Read the detailed description
The primary objective of this study are:
- to investigate and compare the clinical performance of standard (default) FlexPoint settings to minimum FlexPoint settings and to the maximum value for permitted peritoneal residual volume of FlexPoint settings of the PD cycler sleep•safe harmony in the treatment of PD patients.
- to assess whether usage of the settings of the therapy option FlexPoint (flexible volume and dwell time management) of the PD cycler sleep•safe harmony that deviate from the system default and from former sleep•safe settings, influences the efficacy of APD treatments as well as the hydration status (by using BCM) of PD patients.
The secondary objectives of this study are:
- Patients´ Quality of Life (QoL)
- Number of alarms
- To investigate the effects on solute removal
- To investigate the tolerability of the FlexPoint therapy options
- Adverse events / SAE
- Conditions
- Renal Failure, Chronic Kidney Disease
- Being tested
- PD cycler
- Keywords
- Renal replacement therapy, Peritoneal dialysis, Automated peritoneal dialysis, PD cycler
- Medical subject headings
- Renal Insufficiency, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD cyclerDevice
Patients are treated continuously during Peritoneal dialysis with the PD cycler sleep•safe harmony with different FlexPoint settings.
According to their randomization the patients are treated with Treatment A, B or C in a different order:
- standard (default) FlexPoint settings (Treatment A)
- minimum value FlexPoint settings (Treatment B)
- maximum value for permitted peritoneal residual volume (50%) of FlexPoint settings (Treatment C)
| Study group | Role | What they receive |
|---|---|---|
| Peritoneal dialysis (PD) | Other | During the clinical phase, patients are treated continuously with the PD cycler sleep•safe harmony.
The total duration of the clinical phase is six weeks and is divided into 3 Phases à 2 weeks (Clinical phase I, II, and III) which only differ in the FlexPoint settings.
According to their randomization the patients are treated with Treatment A, B or C in a different order:
* standard (default) FlexPoint settings (Treatment A)
* minimum value FlexPoint settings (Treatment B)
* maximum value for permitted peritoneal residual volume (50%) of FlexPoint settings (Treatment C) Receives: Device: PD cycler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Kt/V urea
Measurement of solute removal during peritoneal dialysis focuses on urea
Measured: every 2 weeks, during the 6 weeks treatment
Secondary outcomes (1)
Mean daily ultrafiltration (UF)
Daily ultrafiltration reached by the patient during peritoneal dialysis
Measured: every day, during the 6 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study startDec 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Sequential
- Model description
- Interventional, prospective, multi-centric, controlled, randomized, crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care Deutschland GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alcedis GmbH
- Responsible party
- Sponsor
- Investigators
- Elena Cuadrado Payán, Dr., Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06390592
- Sponsor's protocol ID
- PD-SSH-01-INT
- Acronym
- FlexPoint
- Status last verified
- Sep 2026
- First submitted
- 25 Apr 2024
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of the Therapy Option FlexPoint (Flexible Volume and Dwell Time Management) of the PD Cycler Sleep•Safe Harmony
- ClinicalTrials.gov ID
- NCT06390592
- Acronym / sponsor ID
- FlexPoint / PD-SSH-01-INT
- Conditions
- Renal Failure, Chronic Kidney Disease
- Keywords
- Renal replacement therapy, Peritoneal dialysis, Automated peritoneal dialysis, PD cycler
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Fresenius Medical Care Deutschland GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Alcedis GmbH
- Study start
- Dec 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 30 Apr 2024 (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.
Analysis and comparison of treatments with and without the FlexPoint technology (flexible volume and dwell time management) of the PD cycler sleep•safe harmony
Detailed description
The primary objective of this study are:
- to investigate and compare the clinical performance of standard (default) FlexPoint settings to minimum FlexPoint settings and to the maximum value for permitted peritoneal residual volume of FlexPoint settings of the PD cycler sleep•safe harmony in the treatment of PD patients.
- to assess whether usage of the settings of the therapy option FlexPoint (flexible volume and dwell time management) of the PD cycler sleep•safe harmony that deviate from the system default and from former sleep•safe settings, influences the efficacy of APD treatments as well as the hydration status (by using BCM) of PD patients.
The secondary objectives of this study are:
- Patients´ Quality of Life (QoL)
- Number of alarms
- To investigate the effects on solute removal
- To investigate the tolerability of the FlexPoint therapy options
- Adverse events / SAE
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interventional, prospective, multi-centric, controlled, randomized, crossover
| Arm | Type | Receives |
|---|---|---|
| Peritoneal dialysis (PD) | Other | Device: PD cyclerDuring the clinical phase, patients are treated continuously with the PD cycler sleep•safe harmony. The total duration of the clinical phase is six weeks and is divided into 3 Phases à 2 weeks (Clinical phase I, II, and III) which only differ in the FlexPoint settings. According to their randomization the patients are treated with Treatment A, B or C in a different order: * standard (default) FlexPoint settings (Treatment A) * minimum value FlexPoint settings (Treatment B) * maximum value for permitted peritoneal residual volume (50%) of FlexPoint settings (Treatment C) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Informed consent signed and dated by study patient and investigator/ authorised physician
- Minimum age of 18 years
- CKD patients with indication for renal replacement therapy
- Patients being treated with APD for at least 3 months
- Patients using the sleep•safe harmony PD cycler (version 3.1)
Key exclusion criteria (9 listed)
- Any conditions which could interference with the patient's ability to comply with the study
- Previous participation in the same study
- Patients who have any condition prohibiting the use of BCM, like patients with major amputations (e.g. lower leg)
- Patients receiving polyglucose containing PD solution
- Respiratory or abdominal wall disease deemed to contraindicate intraperitoneal fill volume (FV) manipulation
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 |
|---|---|---|
| PD cyclerPatients are treated continuously during Peritoneal dialysis with the PD cycler sleep•safe harmony with different FlexPoint settings. According to their randomization the patients are treated with Treatment A, B or C in a different order: * standard (default) FlexPoint settings (Treatment A) * minimum value FlexPoint settings (Treatment B) * maximum value for permitted peritoneal residual volume (50%) of FlexPoint settings (Treatment C) | Device | Peritoneal dialysis (PD) |
Primary outcome
Total Kt/V urea
Time frame: every 2 weeks, during the 6 weeks treatment
Measurement of solute removal during peritoneal dialysis focuses on urea
1 secondary outcome
Mean daily ultrafiltration (UF)
Time frame: every day, during the 6 weeks treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- 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.
Elena Cuadrado Payán, Dr. principal investigator
Hospital Clinic of Barcelona
Questions about this trial
What is this clinical trial studying?
A study testing PD cycler in people with Renal Failure and Chronic Kidney Disease, run by Fresenius Medical Care Deutschland GmbH.
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 9 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: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manuela Stauss-Grabo, Dr. (+4961726085248, Manuela.Stauss-Grabo1@freseniusmedicalcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Kt/V urea (time frame: every 2 weeks, during the 6 weeks treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Sep 2026.