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

April 25, 2024 updated by: Fresenius Medical Care Deutschland GmbH

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Peritoneal dialysis (PD)

During the clinical phase, patients are treated continuously with the PD cycler sleep•safe harmony.

The total duration of the clinical phase is six weeks and is divided into 3 Phases à 2 weeks (Clinical phase I, II, and III) which only differ in the 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)
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Kt/V urea
Time Frame: every 2 weeks, during the 6 weeks treatment
Measurement of solute removal during peritoneal dialysis focuses on urea
every 2 weeks, during the 6 weeks treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean daily ultrafiltration (UF)
Time Frame: every day, during the 6 weeks treatment
Daily ultrafiltration reached by the patient during peritoneal dialysis
every day, during the 6 weeks treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fresenius Medical Care Deutschland GmbH

Collaborators

Alcedis GmbH

Investigators

  • Principal Investigator: Maite Rivera Gorrín, Dr., Hospital Universitario Ramon y Cajal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

April 25, 2024

First Submitted That Met QC Criteria

April 25, 2024

First Posted (Actual)

April 30, 2024

Study Record Updates

Last Update Posted (Actual)

April 30, 2024

Last Update Submitted That Met QC Criteria

April 25, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PD-SSH-01-INT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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