NCT07004907

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (estimated)
• Sponsor: Fresenius Medical Care Deutschland GmbH · Industry
• Sex: All
• Age: 0 Months
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2025-06-04
• Last updated: 2025-06-04