NCT02525497

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 14, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 17, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

December 11, 2019

Status Verified

December 1, 2019

Enrollment Period

2.4 years

First QC Date

August 14, 2015

Last Update Submit

December 9, 2019

Conditions

Kidney Failure,Chronic

Keywords

Automated PDEffectivenessSafetyManipulability

Outcome Measures

Primary Outcomes (1)

  • Daily peritoneal Kt/V

    1 day

Secondary Outcomes (1)

  • The accuracy of filling

    1 day

Other Outcomes (8)

  • The accuracy of filling temperature

    1 day

  • Serum sodium before and after dialysis

    1 day

  • Serum potassium before and after dialysis

    1 day

  • +5 more other outcomes

Study Arms (2)

FM peritoneal dialysis machine

EXPERIMENTAL

FM peritoneal dialysis machine APD 10L/10h;

Device: FM peritoneal dialysis machine

HOMECHOICE peritoneal dialysis machine

ACTIVE COMPARATOR

HOMECHOICE peritoneal dialysis machine APD 10L/10h;

Device: HOMECHOICE peritoneal dialysis machine

Interventions

FM peritoneal dialysis machineDEVICE

FM peritoneal dialysis machine APD 10L/10h

FM peritoneal dialysis machine
HOMECHOICE peritoneal dialysis machineDEVICE

HOMECHOICE peritoneal dialysis machine APD 10L/10h

HOMECHOICE peritoneal dialysis machine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Related Publications (1)

  • Cao XY, He YN, Zhou JH, Sun SR, Miao LN, Chen W, Fang JA, Wang M, Wang NS, Lin HL, Liu J, Ni ZH, Liu WH, Na Y, Zhao JY, Guo ZY, Zheng HG, Shi W, Jiang GR, Cai GY, Chen XM. Safety, Effectiveness, and Manipulability of Peritoneal Dialysis Machines Made in China: A Randomized, Crossover, Multicenter Clinical Study. Chin Med J (Engl). 2018 Dec 5;131(23):2785-2791. doi: 10.4103/0366-6999.246079.

    PMID: 30511680DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • CHEN Xiangmei, yes

    Chinese PLA General Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

August 14, 2015

First Posted

August 17, 2015

Study Start

July 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

December 11, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)