Efficacy and Tolerability of the APD Treatment in PAED Patients

NCT07004907 | Not Yet Recruiting DMC

• 1 other identifier: PD-Silencia-02-LA
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

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

Keywords

Automated peritoneal dialysis; paedriatic patients; Kt/V; ultrafiltration; Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Total weekly Kt/V urea

  The primary objective is to determine whether patients achieve a total weekly Kt/V urea ≥ 1.8.

  The primary endpoint is total Kt/Vurea at week 2 and 4

Secondary Outcomes (5)

• Mean daily ultrafiltration (UF)

  Mean UF will be measured at weeks 2 and 4

• Residual renal function (RRF)

  RRF will be measured at weeks 2 and 4

• Residual renal function (RRF)

  RRF will be measured at weeks 2 and 4

• Residual renal function (RRF)

  RRF will be measured at weeks 2 and 4

• Residual renal function (RRF)

  RRF will be measured at weeks 2 and 4

Study Arms (1)

SilenciaPAED

EXPERIMENTAL

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

Device: Treatment with the pedriatic mode of the APD cycler

Interventions

Treatment with the pedriatic mode of the APD cycler DEVICE

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

SilenciaPAED

Eligibility Criteria

• Age: 0 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fresenius Medical Care Deutschland GmbH: lead

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Tatiana De los Ríos

CONTACT

+4961726092688876; tatiana.de-los-rios@freseniusmedicalcare.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: June 4, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share