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

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04749680
• Other study ID #: PD-Silencia-01-CL
• Status: Completed
• Phase: N/A
• Start date: May 31, 2021
• Est. completion date: October 12, 2021

Study information

• Verified date: August 2022
• Source: Fresenius Medical Care Deutschland GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 12, 2021
• Est. primary completion date: October 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic
• Renal Failure

Intervention

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).

Locations

Country	Name	City	State
Chile	Nephocare La Serena	La Serena
Chile	Nephocare Independencia	Santiago
Chile	Nephocare Providencia	Santiago
Chile	Nephocare San Bernardo	Santiago

Sponsors (3)

Lead Sponsor	Collaborator
Fresenius Medical Care Deutschland GmbH	James Motta, Clinical Research Associate (CRA), Winicker Norimed GmbH

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)