Efficacy and Tolerability of the APD Treatment in PAED Patients

Not Applicable

Not yet recruiting

• Conditions: Renal Failure Acute Chronic

• Registration Number: NCT07004907
• Lead Sponsor: Fresenius Medical Care Deutschland GmbH

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-20
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-02
• Last Update Submitted: 2025-06-02
• Study First Posted: 2025-06-04
• Last Update Posted: 2025-06-04
• Study Start: 2026-01
• Primary Completion: 2026-11
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Total weekly Kt/V urea	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.

Secondary Outcome Measures

Name	Time	Method
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	GFR (calculated during the analysis)