Safety, Effectiveness and Manipulability Evaluation of a Domestic PD Machine

Kidney Failure,Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02525497
• Other study ID #: MD-PD-2014
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: December 2017

Study information

• Verified date: December 2019
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Kidney Failure,Chronic
• Renal Insufficiency

Intervention

Device:
• FM peritoneal dialysis machine
FM peritoneal dialysis machine APD 10L/10h
• HOMECHOICE peritoneal dialysis machine
HOMECHOICE peritoneal dialysis machine APD 10L/10h

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The accuracy of filling temperature		1 day
Other	Serum sodium before and after dialysis		1 day
Other	Serum potassium before and after dialysis		1 day
Other	Serum calcium before and after dialysis		1 day
Other	Serum phosphorus before and after dialysis		1 day
Other	Serum carbon dioxide binding force before and after dialysis		1 day
Other	Serum creatinine before and after dialysis		1 day
Other	Serum urea nitrogen before and after dialysis		1 day
Primary	Daily peritoneal Kt/V		1 day
Secondary	The accuracy of filling		1 day