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

Fresenius Medical Care (FMC)

Status: Completed

Conditions: Renal Failure; End Stage Renal Disease

Treatments: Device: PD cycler Silencia

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04749680

PD-Silencia-01-CL

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Peritoneal dialysis PD

Experimental group

Description:

Treatment for 2 weeks either with the comparators PD-Night or Homechoice PD cycler 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).

Treatment:

Device: PD cycler Silencia