Efficacy and Tolerability of the APD Treatment in PAED Patients

NCT ID: NCT07004907

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2026-11-30

Brief 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. 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SilenciaPAED

Patients will receive treatment as prescribed by the physician using the Silencia PD cycler.

Group Type: EXPERIMENTAL

Treatment with the pedriatic mode of the APD cycler

Intervention Type: DEVICE

Patients weighing less than 20 kg will be treated for 4 weeks with APD using the PAED mode of the Silencia PD cycler

Interventions

Treatment with the pedriatic mode of the APD cycler

Patients weighing less than 20 kg will be treated for 4 weeks with APD using the PAED mode of the Silencia PD cycler

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 0 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fresenius Medical Care Deutschland GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Tatiana De los Ríos

Role: CONTACT

tatiana.de-los-rios@freseniusmedicalcare.com

+4961726092688876

Other Identifiers

PD-Silencia-02-LA

Identifier Type: -

Identifier Source: org_study_id