Comparison of Efficacy and Tolerability of APD Treatment With Different PD Cyclers

Study Overview
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Brief Summary
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The study has been designed in order to investigate the performance and safety of the new Silencia PD cycler including the Silencia tubing system in comparison to the PD-Night and Homechoice PD cycler which are both well-established PD cyclers.

Official Title
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Comparison of Efficacy and Tolerability of APD Treatment With Different PD Cyclers

Conditions
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Renal Failure, End Stage Renal Disease

Intervention / Treatment
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* Device: PD cycler Silencia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent signed and dated by study patient and investigator/authorised physician CKD patients being treated with APD for at least 3 months Minimum age of 18 years Body weight ≥ 40 kg Fluid status regularly monitored with Body Composition Monitor (BCM) Patients planned to change to the Silencia PD cycler Proper functioning catheter Intraperitoneal Pressure (IPP) ≤ 18 cm H2O for the maximum of TAVO parameter permitted patient volume Ability to understand the nature and requirements of the study Exclusion Criteria: Patients who have any condition prohibiting the use of BCM, like patients with major amputations (e.g. lower leg) Patients receiving polyglucose containing PD solution 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 Women of childbearing age without effective means of contraception, pregnancy (pregnancy test will be conducted at start and end of study) or lactation period Life expectancy < 3 months Participation in an interventional clinical study during the preceding 30 days Previous participation in the same study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Interventional Model Description: Prospective, controlled, multicentre, interventional
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peritoneal dialysis PD<br>Treatment for 2 weeks either with the comparators PD-Night or Homechoice PD cycler depending on the previous treatment (clinical phase I). At the end of these 2 treatment weeks and a subsequent training phase which up to 3 weeks, treatment with the Silencia PD cycler for 2 further weeks (clinical phase II). | Device: PD cycler Silencia<br>* Treatment for 2 weeks either with PD-Night or Homechoice PD cycler (Comparators) depending on the previous Treatment ((clinical phase I). At the end of these 2 treatment weeks and a subsequent training phase which up to 3 weeks, treatment with the Silencia PD cycler for 2 further weeks (clinical phase II).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Kt/V urea | Measurement of solute removal during peritoneal dialysis focuses on urea | at the beginning and end of clinical phase 1 and 2 (each clinical phase is 14 days) | 
| Achieving Kt/Vurea ≥ 1.7 | Measurement of solute removal during peritoneal dialysis focuses on urea | at the beginning and end of clinical phase 1 and 2 (each clinical phase is 14 days) | 
| Mean daily ultrafiltration (UF) | Daily ultrafiltration reached by the Patient with APD | at the beginning and end of clinical phase 1 and 2 (each clinical phase is 14 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peritoneal dialysis, Automated peritoneal dialysis (APD), PD cyler, Renal replacement therapy