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

August 1, 2022 updated by: Fresenius Medical Care Deutschland GmbH
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • La Serena, Chile
        • Nephocare La Serena
      • Santiago, Chile
        • Nephocare Independencia
      • Santiago, Chile
        • Nephocare Providencia
      • Santiago, Chile
        • Nephocare San Bernardo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Peritoneal dialysis PD
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
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at the beginning and end of clinical phase 1 and 2 (each clinical phase is 14 days)
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
at the beginning and end of clinical phase 1 and 2 (each clinical phase is 14 days)
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
at the beginning and end of clinical phase 1 and 2 (each clinical phase is 14 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fresenius Medical Care Deutschland GmbH

Collaborators

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

Investigators

  • Principal Investigator: Eduardo Machuca, Dr, Fresenius Medical Care Chile S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2021

Primary Completion (Actual)

October 12, 2021

Study Completion (Actual)

October 12, 2021

Study Registration Dates

First Submitted

January 26, 2021

First Submitted That Met QC Criteria

February 8, 2021

First Posted (Actual)

February 11, 2021

Study Record Updates

Last Update Posted (Actual)

August 2, 2022

Last Update Submitted That Met QC Criteria

August 1, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PD-Silencia-01-CL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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