NCT07004907Not yet recruiting
Efficacy and Tolerability of the APD Treatment in PAED Patients
Efficacy and Tolerability of the APD Treatment of Toddlers and Newborns With the Silencia PD Cycler
Source: ClinicalTrials.gov · Last updated 4 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 13 (estimated)
- First submitted
- 20 May 2025
- Start date
- Jan 2026
- Primary completion date
- Nov 2026
- Lead sponsor
- Fresenius Medical Care Deutschland GmbH
- Diseases
- Chronic kidney disease
- NCT number
- NCT07004907
What you commit to
- Study type: Interventional
- Planned participants: 13
- From Jan 2026 to the primary completion date, Nov 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous participation in the same study
Other illness
- Any conditions which could interfere with the patient's ability to comply with the study
- Patients who suffer from peritonitis/exit site infection during the last 4 weeks
Other
- 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
- Life expectancy \< 3 months
Who the study is looking for
- 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
Age in the registry: 0 months to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.