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

NCT06390592 | Not Yet Recruiting

• 1 other identifier: PD-SSH-01-INT
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Renal Failure; Chronic Kidney Disease

Keywords

Renal replacement therapy; Peritoneal dialysis; Automated peritoneal dialysis; PD cycler

Outcome Measures

Primary Outcomes (1)

• Total Kt/V urea

  Measurement of solute removal during peritoneal dialysis focuses on urea

  every 2 weeks, during the 6 weeks treatment

Secondary Outcomes (1)

• Mean daily ultrafiltration (UF)

  every day, during the 6 weeks treatment

Study Arms (1)

Peritoneal dialysis (PD)

OTHER

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

Interventions

PD cycler DEVICE

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)

Peritoneal dialysis (PD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alcedis GmbH: collaborator
• Fresenius Medical Care Deutschland GmbH: lead

MeSH Terms

Conditions

Renal Insufficiency; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Elena Cuadrado Payán, Dr.

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manuela Stauss-Grabo, Dr.

CONTACT

+4961726085248; Manuela.Stauss-Grabo1@freseniusmedicalcare.com

Fiona Bellando

CONTACT

+49 6172 8868776; fiona.bellando@freseniusmedicalcare.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Interventional, prospective, multi-centric, controlled, randomized, crossover

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: April 30, 2024
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share