ClinicalTrials.Veeva

Menu

Safety, Effectiveness and Manipulability Evaluation of a Domestic PD Machine

C

Chinese PLA General Hospital (301 Hospital)

Status

Completed

Conditions

Kidney Failure,Chronic

Treatments

Device: FM peritoneal dialysis machine
Device: HOMECHOICE peritoneal dialysis machine

Study type

Interventional

Funder types

Other

Identifiers

NCT02525497
MD-PD-2014

Details and patient eligibility

About

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.

Full 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.

Enrollment

360 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

360 participants in 2 patient groups

FM peritoneal dialysis machine
Experimental group
Description:
FM peritoneal dialysis machine APD 10L/10h;
Treatment:
Device: FM peritoneal dialysis machine
HOMECHOICE peritoneal dialysis machine
Active Comparator group
Description:
HOMECHOICE peritoneal dialysis machine APD 10L/10h;
Treatment:
Device: HOMECHOICE peritoneal dialysis machine

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems