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
-
-
-
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
14 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).
|
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.
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
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.