Renal FailurepPDNCT06443021
Influence of Variable Inflow Volume, Dwell Duration and Glucose Concentration on Ultrafiltration Volume in APD Patients
A study testing PD cycler in people with Renal Failure and Chronic Kidney Diseases, run by Fresenius Medical Care Deutschland GmbH.
Trial summary
The purpose of the current investigation is to provide proof of concept for a future approach to improve UF prediction accuracy. While building on the ideas of the past, the concept is augmented by leveraging additional diagnostic technologies and digital data analytics methodologies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure, Chronic Kidney Diseases
- 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2025to Dec 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
- Informed consent signed and dated by study patient and investigator/ authorized physician
- Patients between 18-65 of age
- Chronic kidney disease (CKD) patients being treated with nocturnal APD for at least 3 months
- Ability to understand the nature and requirements of the study
- Total Kt/V ≥ 1.7 (counting from recruitment of the patient the measurement should not be older than 3 months)
- APD patients using sleep•safe PD-cycler or sleep•safe harmony PD-cycler with an IPP ≤ 18 cm H2O for the fill volume of 120%
Who cannot join
- Any condition which could interfere with the patient's ability to comply with the study
- Patients who have any condition prohibiting the use of BCM, like patients with major amputations (e.g. lower leg)
- Patients who have been subject to peritonitis/ exit site infection during the last 4 weeks
- 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
- Patients suffering from uncontrolled/ not well adjustable diabetes
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- Recent history of drain related problems, catheter malfunction, or frequent alarms during treatment
- Patients with uncontrolled hypertension and/ or previous history of vascular instability during PD
- Patients treated with intermittent APD
- Participation in an interventional clinical study during the preceding 30 days
- Previous participation in the same study
- APD patients having dwell exchanges throughout the day ("day dwell")
About this study
Official title: Investigation of the Influence of Variable Fill Volume, Dwell Duration and Dialysis Fluid Glucose Composition on Measured Ultrafiltration Volume (UFV) in Automated Peritoneal Dialysis (APD) Patients
The purpose of the current investigation is to provide proof of concept for a future approach to improve UF prediction accuracy. While building on the ideas of the past, the concept is augmented by leveraging additional diagnostic technologies and digital data analytics methodologies.
Read the detailed description
The primary objective of this study is:
- UFV determined per defined dwells with variable dwell duration, dialysis fluid glucose composition and inflow volumes
The secondary objectives of this study are:
- Mean daily UFV
- Defined laboratory parameter like urea, creatinine, glucose, sodium determined in blood and dialysate during the extended PET (in dialysate additionally determination: phosphate, albumin removal)
- Treatment parameter: performed treatment duration and volume
- Fluid status measured by Body Composition Monitor (BCM)
- Manual IPP determination during the extended PET: At the first half of the dwell (during the first hour) for every 20 min and during the second half after 2h, 3h and 4h dwell time
- Residual renal function (RRF): renal urea and creatinine clearance, 24h urine output, Glomerular filtration rate (GFR)
- Extended PET
- 24 h batch collection (including e.g. total peritoneal clearance)
- Analysis of daily dietetic fluid intake, weight and further parameters documented by the patient in a patient diary
- Conditions
- Renal Failure, Chronic Kidney Diseases
- 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
After a training phase and a run-in period of up to 6 weeks, depending on the PD cycler used prior to the study, the interventional phase will be initiated.
- Study phase A, variation of dwell duration: Duration of short cycles (cycle 1 and 2) 30 min, 60 min, 90 min, 120 min (and 150 min depending on the patient´s constitution and at the discretion of the treating physician)
- Study phase B, variation of dialysis fluid glucose composition: 1st cycle: 1.5% glucose concentration, 2nd cycle: 2.3% glucose concentration, 3rd cycle: 1.5% glucose concentration, 4th cycle: 2.3% glucose concentration; all following cycles to be applied as prescribed by the treating physician.
- Study phase C, variation of fill volume: 60% fill volume, 80% fill volume, 100% fill volume and 120% fill volume. (Volume of 120% will only be applied in case the patient tolerates these volumes according to the IPP.
| 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 for the individual patient comprises a maximum of 17 weeks starting from V0 Receives: Device: PD cycler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrafiltration volume (UFV)
UFV determined per defined dwells with variable dwell duration, dialysis fluid glucose composition and inflow volumes.
Measured: every day during the 11 weeks treatment
Secondary outcomes (7)
Fluid status
Fluid status measured by Body Composition Monitor (BCM)
Measured: At study start, and then after 3 weeks, 4 weeks and 5 weeks.
24 h batch collection
RRF (24 h urine output)
Measured: At study start, and then after 3 weeks, 4 weeks and 5 weeks.
24 h batch collection
RRF (GFR)
Measured: At study start, and then after 3 weeks, 4 weeks and 5 weeks.
24 h batch collection
RRF (renal creatinine clearance)
Measured: At study start, and then after 3 weeks, 4 weeks and 5 weeks.
24 h batch collection
RRF (renal urea clearance)
Measured: At study start, and then after 3 weeks, 4 weeks and 5 weeks.
24 h batch collection
Peritoneal urea clearance
Measured: At study start, and then after 3 weeks, 4 weeks and 5 weeks.
24 h batch collection
Peritoneal creatinine clearance
Measured: At study start, and then after 3 weeks, 4 weeks and 5 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study startOct 2025 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: Internal decision
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
- Prospective, multi-centric, interventional
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care Deutschland GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Winicker Norimed GmbH
- Responsible party
- Sponsor
- Investigators
- Isabel Garcia Méndez, Dr., Principal investigator, Hospital Son Espases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06443021
- Sponsor's protocol ID
- PD-pPD-01-ESP
- Acronym
- pPD
- Status last verified
- Sep 2025
- First submitted
- 17 May 2024
- Last updated
- 22 Sep 2025
- 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 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Influence of Variable Fill Volume, Dwell Duration and Dialysis Fluid Glucose Composition on Measured Ultrafiltration Volume (UFV) in Automated Peritoneal Dialysis (APD) Patients
- ClinicalTrials.gov ID
- NCT06443021
- Acronym / sponsor ID
- pPD / PD-pPD-01-ESP
- Conditions
- Renal Failure, Chronic Kidney Diseases
- Keywords
- Renal replacement therapy, Peritoneal dialysis, Automated peritoneal dialysis, PD cycler
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Internal decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fresenius Medical Care Deutschland GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Winicker Norimed GmbH
- Study start
- Oct 2025 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 5 Jun 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.
The purpose of the current investigation is to provide proof of concept for a future approach to improve UF prediction accuracy. While building on the ideas of the past, the concept is augmented by leveraging additional diagnostic technologies and digital data analytics methodologies.
Detailed description
The primary objective of this study is:
- UFV determined per defined dwells with variable dwell duration, dialysis fluid glucose composition and inflow volumes
The secondary objectives of this study are:
- Mean daily UFV
- Defined laboratory parameter like urea, creatinine, glucose, sodium determined in blood and dialysate during the extended PET (in dialysate additionally determination: phosphate, albumin removal)
- Treatment parameter: performed treatment duration and volume
- Fluid status measured by Body Composition Monitor (BCM)
- Manual IPP determination during the extended PET: At the first half of the dwell (during the first hour) for every 20 min and during the second half after 2h, 3h and 4h dwell time
- Residual renal function (RRF): renal urea and creatinine clearance, 24h urine output, Glomerular filtration rate (GFR)
- Extended PET
- 24 h batch collection (including e.g. total peritoneal clearance)
- Analysis of daily dietetic fluid intake, weight and further parameters documented by the patient in a patient diary
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, multi-centric, interventional
| 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 for the individual patient comprises a maximum of 17 weeks starting from V0 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Informed consent signed and dated by study patient and investigator/ authorized physician
- Patients between 18-65 of age
- Chronic kidney disease (CKD) patients being treated with nocturnal APD for at least 3 months
- Ability to understand the nature and requirements of the study
- Total Kt/V ≥ 1.7 (counting from recruitment of the patient the measurement should not be older than 3 months)
Key exclusion criteria (12 listed)
- Any condition which could interfere with the patient's ability to comply with the study
- Patients who have any condition prohibiting the use of BCM, like patients with major amputations (e.g. lower leg)
- Patients who have been subject to peritonitis/ exit site infection during the last 4 weeks
- 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
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 cyclerAfter a training phase and a run-in period of up to 6 weeks, depending on the PD cycler used prior to the study, the interventional phase will be initiated. * Study phase A, variation of dwell duration: Duration of short cycles (cycle 1 and 2) 30 min, 60 min, 90 min, 120 min (and 150 min depending on the patient´s constitution and at the discretion of the treating physician) * Study phase B, variation of dialysis fluid glucose composition: 1st cycle: 1.5% glucose concentration, 2nd cycle: 2.3% glucose concentration, 3rd cycle: 1.5% glucose concentration, 4th cycle: 2.3% glucose concentration; all following cycles to be applied as prescribed by the treating physician. * Study phase C, variation of fill volume: 60% fill volume, 80% fill volume, 100% fill volume and 120% fill volume. (Volume of 120% will only be applied in case the patient tolerates these volumes according to the IPP. | Device | Peritoneal dialysis (PD) |
Primary outcome
Ultrafiltration volume (UFV)
Time frame: every day during the 11 weeks treatment
UFV determined per defined dwells with variable dwell duration, dialysis fluid glucose composition and inflow volumes.
7 secondary outcomes
Fluid status
Time frame: At study start, and then after 3 weeks, 4 weeks and 5 weeks.
24 h batch collection
Time frame: At study start, and then after 3 weeks, 4 weeks and 5 weeks.
24 h batch collection
Time frame: At study start, and then after 3 weeks, 4 weeks and 5 weeks.
24 h batch collection
Time frame: At study start, and then after 3 weeks, 4 weeks and 5 weeks.
24 h batch collection
Time frame: At study start, and then after 3 weeks, 4 weeks and 5 weeks.
24 h batch collection
Time frame: At study start, and then after 3 weeks, 4 weeks and 5 weeks.
24 h batch collection
Time frame: At study start, and then after 3 weeks, 4 weeks and 5 weeks.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- 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.
Isabel Garcia Méndez, Dr. principal investigator
Hospital Son Espases
Questions about this trial
What is this clinical trial studying?
A study testing PD cycler in people with Renal Failure and Chronic Kidney Diseases, 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 6 inclusion and 12 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: withdrawn, as of the sponsor's last update on 22 Sep 2025. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 (UFV) (time frame: every day during the 11 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 22 Sep 2025.