NCT04749680

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 11, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

May 31, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2021

Completed
Last Updated

August 2, 2022

Status Verified

August 1, 2022

Enrollment Period

4 months

First QC Date

January 26, 2021

Last Update Submit

August 1, 2022

Conditions

Renal FailureEnd Stage Renal Disease

Keywords

Peritoneal dialysisAutomated peritoneal dialysis (APD)PD cylerRenal replacement therapy

Outcome Measures

Primary Outcomes (3)

  • Total Kt/V urea

    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

    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)

    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)

Study Arms (1)

Peritoneal dialysis PD

EXPERIMENTAL

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

Interventions

PD cycler SilenciaDEVICE

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).

Peritoneal dialysis PD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Nephocare La Serena

La Serena, Chile

Location

Nephocare Independencia

Santiago, Chile

Location

Nephocare Providencia

Santiago, Chile

Location

Nephocare San Bernardo

Santiago, Chile

Location

MeSH Terms

Conditions

Renal InsufficiencyKidney Failure, Chronic

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesRenal Insufficiency, ChronicChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Eduardo Machuca, Dr

    Fresenius Medical Care Chile S.A.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Prospective, controlled, multicentre, interventional
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2021

First Posted

February 11, 2021

Study Start

May 31, 2021

Primary Completion

October 12, 2021

Study Completion

October 12, 2021

Last Updated

August 2, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

CL(4)