Overview

This trial is active, not recruiting.

Condition kidney failure,chronic
Treatments fm peritoneal dialysis machine, homechoice peritoneal dialysis machine
Phase phase 4
Sponsor Chinese PLA General Hospital
Start date July 2015
End date October 2016
Trial size 300 participants
Trial identifier NCT02525497, MD-PD-2014

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
FM peritoneal dialysis machine APD 10L/10h;
fm peritoneal dialysis machine
FM peritoneal dialysis machine APD 10L/10h
(Active Comparator)
HOMECHOICE peritoneal dialysis machine APD 10L/10h;
homechoice peritoneal dialysis machine
HOMECHOICE peritoneal dialysis machine APD 10L/10h

Primary Outcomes

Measure
Daily peritoneal Kt/V
time frame: 1 day

Secondary Outcomes

Measure
The accuracy of filling
time frame: 1 day

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Randomized, Multicenter, Crossover Study Comparing the Domestic FM Peritoneal Dialysis Machine With Baxter HOMECHOICE
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Chinese PLA General Hospital.