Clinical Performance of the Therapy Option FlexPoint of the PD Cycler Sleep•Safe Harmony

Chronic Kidney Disease Clinical Trial

— FlexPoint  

Official title:

Clinical Performance of the Therapy Option FlexPoint (Flexible Volume and Dwell Time Management) of the PD Cycler Sleep•Safe Harmony

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06390592
• Other study ID #: PD-SSH-01-INT
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Fresenius Medical Care Deutschland GmbH
• Contact: Manuela Stauss-Grabo, Dr.
• Phone: +4961726085248
• Email: Manuela.Stauss-Grabo1[@]freseniusmedicalcare.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Analysis and comparison of treatments with and without the FlexPoint technology (flexible volume and dwell time management) of the PD cycler sleep•safe harmony

Description:

The primary objective of this study are:

• to investigate and compare the clinical performance of standard (default) FlexPoint settings to minimum FlexPoint settings and to the maximum value for permitted peritoneal residual volume of FlexPoint settings of the PD cycler sleep•safe harmony in the treatment of PD patients.

• to assess whether usage of the settings of the therapy option FlexPoint (flexible volume and dwell time management) of the PD cycler sleep•safe harmony that deviate from the system default and from former sleep•safe settings, influences the efficacy of APD treatments as well as the hydration status (by using BCM) of PD patients.

The secondary objectives of this study are:

• Patients´ Quality of Life (QoL)

• Number of alarms

• To investigate the effects on solute removal

• To investigate the tolerability of the FlexPoint therapy options

• Adverse events / SAE

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• 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

• Minimum age of 18 years

• CKD patients with indication for renal replacement therapy

• Patients being treated with APD for at least 3 months

• Patients using the sleep•safe harmony PD cycler (version 3.1)

• Fluid status regularly monitored with Body Composition Monitor (BCM)

• Proper functioning catheter

• Intraperitoneal Pressure (IPP) = 18 cm H2O

• Ability to understand the nature and requirements of the study

Exclusion Criteria:

• Any conditions which could interference with the patient's ability to comply with the study

• Previous participation in the same study

• 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

• Respiratory or abdominal wall disease deemed to contraindicate intraperitoneal fill volume (FV) manipulation

• 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 90 days

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Failure
• Renal Insufficiency, Chronic

Intervention

Device:
• PD cycler
Patients are treated continuously during Peritoneal dialysis with the PD cycler sleep•safe harmony with different FlexPoint settings. According to their randomization the patients are treated with Treatment A, B or C in a different order: standard (default) FlexPoint settings (Treatment A) minimum value FlexPoint settings (Treatment B) maximum value for permitted peritoneal residual volume (50%) of FlexPoint settings (Treatment C)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Fresenius Medical Care Deutschland GmbH	Alcedis GmbH

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Kt/V urea	Measurement of solute removal during peritoneal dialysis focuses on urea	every 2 weeks, during the 6 weeks treatment
Secondary	Mean daily ultrafiltration (UF)	Daily ultrafiltration reached by the patient during peritoneal dialysis	every day, during the 6 weeks treatment