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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nephocare La Serena, La Serena, Chile

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PD cycler Silencia

Device

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).

Primary outcomes

Total Kt/V urea

Time frame: at the beginning and end of clinical phase 1 and 2 (each clinical phase is 14 days)

Measurement of solute removal during peritoneal dialysis focuses on urea
Achieving Kt/Vurea ≥ 1.7

Time frame: at the beginning and end of clinical phase 1 and 2 (each clinical phase is 14 days)

Measurement of solute removal during peritoneal dialysis focuses on urea
Mean daily ultrafiltration (UF)

Time frame: at the beginning and end of clinical phase 1 and 2 (each clinical phase is 14 days)

Daily ultrafiltration reached by the Patient with APD

Sponsors and collaborators

Lead sponsor

Fresenius Medical Care Deutschland GmbH

Industry

Collaborators

James Motta, Clinical Research Associate (CRA)
Winicker Norimed GmbH

Registry information

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2021
First posted: Feb 11, 2021
Registry last updated: Aug 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed