A Controlled and Multi-Center Study of 2500ml Huaren Peri... | NCT02393261

Studies
A Controlled and Multi-Center Study of 2500ml Huaren Peritoneal Dialysate

NCT02393261

Sponsor

Sun Yat-sen University

Status

Unknown status

Last Update Posted

Mar 19, 2015Estimated

Enrollment

300Estimated

Phase

Not Applicable

Conditions

Disorders Associated With Peritoneal Dialysis

Interventions

2500ml Huaren peritoneal dialysate
2000ml peritoneal dialysate

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Jun 2015Estimated

Completion Date

Jun 2015Estimated

First Submitted Date

Mar 9, 2015

First Submission Date that Met QC Criteria

Mar 18, 2015

First Posted Date

Mar 19, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2015

Last Update Posted Date

Mar 19, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yanhong Deng, The Sixth Affiliated Hospital of Sun Yat-Sen University, Sun Yat-sen UniversityPrincipal Investigator

Lead Sponsor

Sun Yat-sen UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Peritoneal dialysis (PD) is one of important way of renal replacement treatment worldwide. In China, about 40,000 patients suffered from end stage renal disease treated with PD, and most of them used imported dialysate, of which the price carried a great burden. Now, cheaper domestic dialysate is accessed to the ESRD patients in china, but the efficacy and safety of which are not fully clear. And according to researches from Hongkong, 6000ml of dialysate every day is able to. Thus, we presume 3 bags of 2500ml Huaren dialysate will satisfy the everyday need of an normal Asian. This will be a prospective, randomized, controlled, multi-center study. Patients in treatment group will use 2-3 bags of 2500ml Huaren dialysate in the daytime and keep 1 bag of 2500ml Huaren dialysate in the night, while those in control group will use 3-4 bags of normal 2000ml dialysate in the daytime and keep 1 bag of 2000ml dialysate in the night for 12 weeks. After followed-up for 12 weeks, the adequacy of PD, residual kidney function , peritoneum function and QOL of patients will be evaluated.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A 2500mlGroup	Experimental	use 2-3 bags of 2500ml Huaren dialysate in the daytime and keep 1 bag of 2500ml Huaren dialysate in the night	Other: 2500ml Huaren peritoneal dialysate
B 2000mlGroup	Active Comparator	use 3-4 bags of normal 2000ml dialysate in the daytime and keep 1 bag of 2000ml dialysate in the night	Other: 2000ml peritoneal dialysate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
2500ml Huaren peritoneal dialysate	Other	use 2-3 bags of 2500ml Huaren dialysate in the daytime and keep 1 bag of 2500ml Huaren dialysate in the night	A 2500mlGroup

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adequacy of dialysis (kt/v)	kt/v	up to 8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Residual kidney function (Residual kidney kt/v)	Residual kidney kt/v	up to 6 months
Peritoneal function (Peritoneal equilibration test)	Peritoneal equilibration test

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

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

Exclusion criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zongpei Jiang, M.D. & Ph.D.	Contact	8620-38379727		jx.home@medmail.com.cn

Overall Officials

Name	Affiliation	Role
Zongpei Jiang, M.D. & Ph.D.	The Sixth Affiliated Hospital, Sun Yat-sen University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Nephrology, 6th Affiliated Hospital, Sun Yat-Sen University	Recruiting	Guangzhou	Guangdong	510655	China

Intervention Browse Module

MeSH Terms

ID	Term
D015314	Dialysis Solutions

Ancestor Terms

ID	Term
D019999	Pharmaceutical Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations
D045506	Therapeutic Uses

Browse Leaves

Not provided

Browse Branches

Not provided