A Controlled and Multi-Center Study of 2500ml Huaren Peritoneal Dialysate
Validity and Security of 2500ml Huaren Peritoneal Dialysate: A Prospective, Randomized, Controlled, Multi-Center Clinical Trial
1 other identifier
interventional
300
1 country
1
Brief Summary
This prospective, randomized, controlled, multi-center clinical trial will evaluate the validity and security of 2500ml Huaren Peritoneal Dialysate compared with normal 2000ml peritoneal dialysate.
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
March 9, 2015
CompletedFirst Posted
Study publicly available on registry
March 19, 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 19, 2015
March 1, 2015
5 months
March 9, 2015
March 18, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Adequacy of dialysis (kt/v)
kt/v
up to 8 weeks
Secondary Outcomes (2)
Residual kidney function (Residual kidney kt/v)
up to 6 months
Peritoneal function (Peritoneal equilibration test)
up to 6 months
Study Arms (2)
A 2500mlGroup
EXPERIMENTALuse 2-3 bags of 2500ml Huaren dialysate in the daytime and keep 1 bag of 2500ml Huaren dialysate in the night
B 2000mlGroup
ACTIVE COMPARATORuse 3-4 bags of normal 2000ml dialysate in the daytime and keep 1 bag of 2000ml dialysate in the night
Interventions
use 2-3 bags of 2500ml Huaren dialysate in the daytime and keep 1 bag of 2500ml Huaren dialysate in the night
use 3-4 bags of normal 2000ml dialysate in the daytime and keep 1 bag of 2000ml dialysate in the night
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
- The Sixth Affiliated Hospital of Sun Yat-Sen University
Study Record Dates
First Submitted
March 9, 2015
First Posted
March 19, 2015
Study Start
January 1, 2015
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
March 19, 2015
Record last verified: 2015-03