A Study of Domestic Automated Peritoneal Dialysis Machine
Validity and Security of Domestic Automated Peritoneal Dialysis Machine: A Prospective, Randomized, Controlled, Multi-Center Clinical Trial
1 other identifier
interventional
600
1 country
1
Brief Summary
This prospective, randomized, controlled, multi-center clinical trial will evaluate the validity and security of domestic APD machine compared with the patients followed CAPD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 15, 2015
CompletedFirst Posted
Study publicly available on registry
March 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedMarch 17, 2015
March 1, 2015
5 months
February 15, 2015
March 9, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Adequacy of dialysis
kt/v
up to 8 weeks
Secondary Outcomes (2)
Residual kidney function
up to 6 months
Peritoneal function
up to 6 months
Study Arms (2)
A APDGroup
EXPERIMENTALPDGO APD machines used in the PD patients for 8 weeks
B CAPDGroup
ACTIVE COMPARATORCAPD used in the PD Patients for 8 weeks
Interventions
Eligibility Criteria
You may qualify if:
- The duration of PD is more than 1 month.
- The age is range from 18 to 80 years old.
- The patient can be treated with regular PD in home.
- The volume of peritoneal dialysate is from 8L to 10 L in 1 day.
- The patient can be visited regularly.
- The patient must be freely given informed consent
You may not qualify if:
- Peritonitis was happened within 1 month
- The KT/V\<1.7
- Infections in the exit or tunnel
- With tumors.
- With low transport of peritoneum.
- With mental and behavior disorders.
- With acute renal failure
- Hemodialysis meanwhile
- With heart failure( NYHA III-IV ) or cardio- cerebrovascular events
- Attending other clinical trails
- Refused to give informed consent Exit criteria
- （1）Stop PD for more than 10 days （2）The patient demand to quit from the RCT （3）With serious adverse events.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Nephrology, 6th Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510655, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zongpei Jiang, M.D. & Ph.D.
The Sixth Affiliated Hospital, Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Sun Yat-sen University
Study Record Dates
First Submitted
February 15, 2015
First Posted
March 17, 2015
Study Start
January 1, 2015
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
March 17, 2015
Record last verified: 2015-03