Safety, Effectiveness and Manipulability Evaluation of a Domestic PD Machine

A Randomized, Multicenter, Crossover Study Comparing the Domestic FM Peritoneal Dialysis Machine With Baxter HOMECHOICE

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02525497

Enrollment

360

Registered

2015-08-17

Start date

2015-07-31

Completion date

2017-12-31

Last updated

2019-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Failure,Chronic

Keywords

Automated PD, Effectiveness, Safety, Manipulability

Brief summary

This study is a randomized, multi-center，crossover study of a domestic FM peritoneal dialysis machine and Baxter HOMECHOICE.It aims to verify safety, effectiveness and manipulability of a domestic peritoneal dialysis machine.

Detailed description

Our study is a randomized, multi-center，crossover study. It compares a domestic FM peritoneal dialysis machine with Baxter HOMECHOICE.It aims to verify safety, effectiveness and manipulability of a domestic peritoneal dialysis machine.

Interventions

DEVICEFM peritoneal dialysis machine

FM peritoneal dialysis machine APD 10L/10h

DEVICEHOMECHOICE peritoneal dialysis machine

HOMECHOICE peritoneal dialysis machine APD 10L/10h

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Age ≥18, male or female Dialysis duration:≥30 days Sign the written informed consent

Exclusion criteria

Hemodialysis Exit site infection or tunnel infection Peritonitis ≤30 days before screening Catheter mechanical failure Anti-HIV positive Allergic to components of dialysate Comorbidity:Active, residual malignant tumor, or systemic infection, liver cirrhosis, severe congestive heart failure,hypertension Poor compliance Pregnant or lactating, women of childbearing age do not agree to use effective contraceptive measures during the trial Has a history of alcoholism and drug abuse (defined as illegal drugs) Any circumstances when patients are believed unsuitable for this trial

Design outcomes

Primary

Measure	Time frame
Daily peritoneal Kt/V	1 day

Secondary

Measure	Time frame
The accuracy of filling	1 day

Other

Measure	Time frame
Serum potassium before and after dialysis	1 day
Serum calcium before and after dialysis	1 day
Serum phosphorus before and after dialysis	1 day
The accuracy of filling temperature	1 day
Serum creatinine before and after dialysis	1 day
Serum urea nitrogen before and after dialysis	1 day
Serum carbon dioxide binding force before and after dialysis	1 day
Serum sodium before and after dialysis	1 day

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026