Clinical trial NCT04749680: 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
Overall status: COMPLETED
Phase: NA
Conditions: Renal Failure
End Stage Renal Disease
Keywords: Peritoneal dialysis
Automated peritoneal dialysis (APD)
PD cyler
Renal replacement therapy
Lead sponsor: Fresenius Medical Care Deutschland GmbH
Sponsor class: INDUSTRY
Collaborators: name: Winicker Norimed GmbH
name: James Motta, Clinical Research Associate (CRA)
First posted: 2021-02-11
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Prospective, controlled, multicentre, interventional
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Total Kt/V urea
timeFrame: at the beginning and end of clinical phase 1 and 2 (each clinical phase is 14 days)
measure: Achieving Kt/Vurea ≥ 1.7
timeFrame: at the beginning and end of clinical phase 1 and 2 (each clinical phase is 14 days)
measure: Mean daily ultrafiltration (UF)
timeFrame: at the beginning and end of clinical phase 1 and 2 (each clinical phase is 14 days)
Secondary outcomes:
Other outcomes:
Locations:
city: La Serena
country: Chile
facility: Nephocare La Serena
city: Santiago
country: Chile
facility: Nephocare Independencia
city: Santiago
country: Chile
facility: Nephocare Providencia
city: Santiago
country: Chile
facility: Nephocare San Bernardo
Study officials:
affiliation: Fresenius Medical Care Chile S.A.
name: Eduardo Machuca, Dr
role: PRINCIPAL_INVESTIGATOR
References: