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Comparison of Efficacy and Tolerability of APD Treatment With Different PD Cyclers | Clinical Trials | Clareo Health

COMPLETEDNA

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

NCT04749680•Fresenius Medical Care Deutschland GmbH

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (4)

Nephocare La Serena

La Serena, Chile

Nephocare Independencia

Santiago, Chile

Nephocare Providencia

Santiago, Chile

Nephocare San Bernardo

Santiago, Chile

Key Dates

Start Date

May 31, 2021

Primary Completion Date

October 12, 2021

Completion Date

October 12, 2021

Last Updated

August 2, 2022

Enrollment

ACTUAL participants

Conditions

Renal FailureEnd Stage Renal Disease

Interventions

PD cycler Silencia

DEVICE

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 2, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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