Renal Failure Acute ChronicSilenciaPAEDNCT07004907
Efficacy and Tolerability of the APD Treatment in PAED Patients
A study testing Treatment with the pedriatic mode of the APD cycler in people with Renal Failure Acute Chronic, run by Fresenius Medical Care Deutschland GmbH.
Trial summary
The Silencia PD (peritoneal dialysis) cycler offers a pediatric (PAED) mode with advanced features such as Time and Volume Optimization (TAVO), supporting precise and individualized treatment. Read more about this study
- Who is it for?
- Ages 0 months and older
- Conditions the study is for
- Renal Failure Acute Chronic
- What is being tested?
- Treatment with the pedriatic mode of the APD cycler
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Nov 2026
- 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 0 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Informed consent signed and dated by legal representative and investigator/authorized physician
- The minors have received the information referred to in Article 63(2) MDR in a way adapted to their age and mental maturity and from investigators or members of the investigating team who are trained or experienced in working with children
- The explicit wish of a minor who is capable of forming an opinion and assessing the information referred to in Article 63(2) MDR to refuse participation in, or to withdraw from, the clinical investigation at any time, is respected by the investigator
- patients with renal failure treated or planned to be treated with APD
- Body weight ≤ 20 kg
- Ability to understand the nature and requirements of the study
Who cannot join
- Any conditions which could interfere with the patient's ability to comply with the study
- Patient or legal representative is not able to give informed consent according to European Medical Device Regulation and corresponding national regulations
- Participation in an interventional clinical study during the preceding 30 days
- Previous participation in the same study
- Life expectancy < 3 months
- Patients who suffer from peritonitis/exit site infection during the last 4 weeks
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: Efficacy and Tolerability of the APD Treatment of Toddlers and Newborns With the Silencia PD Cycler
The Silencia PD (peritoneal dialysis) cycler offers a pediatric (PAED) mode with advanced features such as Time and Volume Optimization (TAVO), supporting precise and individualized treatment. This study evaluates the efficacy and tolerability of Automated Peritoneal Dialysis (APD) using the Silencia PD cycler in patients weighing ≤ 20 kg and able to tolerate a minimum inflow volume of 100 mL. The primary objective is to determine whether patients achieve a total weekly Kt/Vurea ≥ 1.8.
- Conditions
- Renal Failure Acute Chronic
- Being tested
- Treatment with the pedriatic mode of the APD cycler
- Keywords
- Automated peritoneal dialysis, paedriatic patients, Kt/V, ultrafiltration, Chronic Kidney Disease
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with the pedriatic mode of the APD cyclerDevice
Patients weighing less than 20 kg will be treated for 4 weeks with APD using the PAED mode of the Silencia PD cycler
| Study group | Role | What they receive |
|---|---|---|
| SilenciaPAED | Experimental | Patients will receive treatment as prescribed by the physician using the Silencia PD cycler. Receives: Device: Treatment with the pedriatic mode of the APD cycler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total weekly Kt/V urea
The primary objective is to determine whether patients achieve a total weekly Kt/V urea ≥ 1.8.
Measured: The primary endpoint is total Kt/Vurea at week 2 and 4
Secondary outcomes (5)
Mean daily ultrafiltration (UF)
Measured: Mean UF will be measured at weeks 2 and 4
Residual renal function (RRF)
Renal urea clearance
Measured: RRF will be measured at weeks 2 and 4
Residual renal function (RRF)
Renal creatinine clearance
Measured: RRF will be measured at weeks 2 and 4
Residual renal function (RRF)
24h urine output
Measured: RRF will be measured at weeks 2 and 4
Residual renal function (RRF)
GFR (calculated during the analysis)
Measured: RRF will be measured at weeks 2 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study startJan 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Failure Acute ChronicStudies 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
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care Deutschland GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07004907
- Sponsor's protocol ID
- PD-Silencia-02-LA
- Acronym
- SilenciaPAED
- Status last verified
- Jun 2025
- First submitted
- 20 May 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability of the APD Treatment of Toddlers and Newborns With the Silencia PD Cycler
- ClinicalTrials.gov ID
- NCT07004907
- Acronym / sponsor ID
- SilenciaPAED / PD-Silencia-02-LA
- Conditions
- Renal Failure Acute Chronic
- Keywords
- Automated peritoneal dialysis, paedriatic patients, Kt/V, ultrafiltration, Chronic Kidney Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Fresenius Medical Care Deutschland GmbHIndustry (pharma, biotech, devices)
- Study start
- Jan 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 4 Jun 2025 (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 Silencia PD (peritoneal dialysis) cycler offers a pediatric (PAED) mode with advanced features such as Time and Volume Optimization (TAVO), supporting precise and individualized treatment. This study evaluates the efficacy and tolerability of Automated Peritoneal Dialysis (APD) using the Silencia PD cycler in patients weighing ≤ 20 kg and able to tolerate a minimum inflow volume of 100 mL. The primary objective is to determine whether patients achieve a total weekly Kt/Vurea ≥ 1.8.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SilenciaPAED | Experimental | Device: Treatment with the pedriatic mode of the APD cyclerPatients will receive treatment as prescribed by the physician using the Silencia PD cycler. |
Who may qualify
- Ages
- 0 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Informed consent signed and dated by legal representative and investigator/authorized physician
- The minors have received the information referred to in Article 63(2) MDR in a way adapted to their age and mental maturity and from investigators or members of the investigating team who are trained or experienced in working with children
- The explicit wish of a minor who is capable of forming an opinion and assessing the information referred to in Article 63(2) MDR to refuse participation in, or to withdraw from, the clinical investigation at any time, is respected by the investigator
- patients with renal failure treated or planned to be treated with APD
- Body weight ≤ 20 kg
Key exclusion criteria (6 listed)
- Any conditions which could interfere with the patient's ability to comply with the study
- Patient or legal representative is not able to give informed consent according to European Medical Device Regulation and corresponding national regulations
- Participation in an interventional clinical study during the preceding 30 days
- Previous participation in the same study
- 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 |
|---|---|---|
| Treatment with the pedriatic mode of the APD cyclerPatients weighing less than 20 kg will be treated for 4 weeks with APD using the PAED mode of the Silencia PD cycler | Device | SilenciaPAED |
Primary outcome
Total weekly Kt/V urea
Time frame: The primary endpoint is total Kt/Vurea at week 2 and 4
The primary objective is to determine whether patients achieve a total weekly Kt/V urea ≥ 1.8.
5 secondary outcomes
Mean daily ultrafiltration (UF)
Time frame: Mean UF will be measured at weeks 2 and 4
Residual renal function (RRF)
Time frame: RRF will be measured at weeks 2 and 4
Residual renal function (RRF)
Time frame: RRF will be measured at weeks 2 and 4
Residual renal function (RRF)
Time frame: RRF will be measured at weeks 2 and 4
Residual renal function (RRF)
Time frame: RRF will be measured at weeks 2 and 4
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 4 Jun 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.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment with the pedriatic mode of the APD cycler in people with Renal Failure Acute Chronic, 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 6 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 4 Jun 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?
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 Tatiana De los Ríos (+4961726092688876, tatiana.de-los-rios@freseniusmedicalcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total weekly Kt/V urea (time frame: The primary endpoint is total Kt/Vurea at week 2 and 4). 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 4 Jun 2025.