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

Primary Purpose

Renal Failure, End Stage Renal Disease

Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
PD cycler Silencia
Sponsored by
Fresenius Medical Care Deutschland GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Failure focused on measuring Peritoneal dialysis, Automated peritoneal dialysis (APD), PD cyler, Renal replacement therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Nephocare La Serena
  • Nephocare Independencia
  • Nephocare Providencia
  • Nephocare San Bernardo

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Peritoneal dialysis PD

Arm Description

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).

Outcomes

Primary Outcome Measures

Total Kt/V urea
Measurement of solute removal during peritoneal dialysis focuses on urea
Achieving Kt/Vurea ≥ 1.7
Measurement of solute removal during peritoneal dialysis focuses on urea
Mean daily ultrafiltration (UF)
Daily ultrafiltration reached by the Patient with APD

Secondary Outcome Measures

Full Information

First Posted
January 26, 2021
Last Updated
August 1, 2022
Sponsor
Fresenius Medical Care Deutschland GmbH
Collaborators
Winicker Norimed GmbH, James Motta, Clinical Research Associate (CRA)
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1. Study Identification

Unique Protocol Identification Number
NCT04749680
Brief Title
Comparison of Efficacy and Tolerability of APD Treatment With Different PD Cyclers
Official Title
Comparison of Efficacy and Tolerability of APD Treatment With Different PD Cyclers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 31, 2021 (Actual)
Primary Completion Date
October 12, 2021 (Actual)
Study Completion Date
October 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fresenius Medical Care Deutschland GmbH
Collaborators
Winicker Norimed GmbH, James Motta, Clinical Research Associate (CRA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure, End Stage Renal Disease
Keywords
Peritoneal dialysis, Automated peritoneal dialysis (APD), PD cyler, Renal replacement therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Prospective, controlled, multicentre, interventional
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peritoneal dialysis PD
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
PD cycler Silencia
Intervention Description
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 Outcome Measure Information:
Title
Total Kt/V urea
Description
Measurement of solute removal during peritoneal dialysis focuses on urea
Time Frame
at the beginning and end of clinical phase 1 and 2 (each clinical phase is 14 days)
Title
Achieving Kt/Vurea ≥ 1.7
Description
Measurement of solute removal during peritoneal dialysis focuses on urea
Time Frame
at the beginning and end of clinical phase 1 and 2 (each clinical phase is 14 days)
Title
Mean daily ultrafiltration (UF)
Description
Daily ultrafiltration reached by the Patient with APD
Time Frame
at the beginning and end of clinical phase 1 and 2 (each clinical phase is 14 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo Machuca, Dr
Organizational Affiliation
Fresenius Medical Care Chile S.A.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nephocare La Serena
City
La Serena
Country
Chile
Facility Name
Nephocare Independencia
City
Santiago
Country
Chile
Facility Name
Nephocare Providencia
City
Santiago
Country
Chile
Facility Name
Nephocare San Bernardo
City
Santiago
Country
Chile

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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