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

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.

Study Overview

• Status: Unknown
• Conditions: Disorders Associated With Peritoneal Dialysis
• Intervention / Treatment: Other: 2500ml Huaren peritoneal dialysate; Other: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510655
      • Recruiting
      • Department of Nephrology, 6th Affiliated Hospital, Sun Yat-Sen University
      • Principal Investigator: Zongpei Jiang, M.D. & Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

1. The duration of PD is more than 1 month.
2. The age is range from 18 to 80 years old.
3. The patient can be treated with regular PD in home.
4. The volume of peritoneal dialysate is from 8L to 10 L in 1 day.
5. The patient can be visited regularly.
6. The patient must be freely given informed consent

Exclusion criteria:

1. Peritonitis was happened within 1 month
2. The KT/V<1.7
3. Infections in the exit or tunnel
4. With tumors.
5. With low transport of peritoneum.
6. With mental and behavior disorders.
7. With acute renal failure
8. Hemodialysis meanwhile
9. With heart failure( NYHA III-IV ) or cardio- cerebrovascular events
10. Attending other clinical trails
11. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A 2500mlGroup; 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; use 2-3 bags of 2500ml Huaren dialysate in the daytime and keep 1 bag of 2500ml Huaren dialysate in the night
Active Comparator: B 2000mlGroup; 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; use 3-4 bags of normal 2000ml dialysate in the daytime and keep 1 bag of 2000ml dialysate in the night

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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	up to 6 months

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): June 1, 2015
• Study Completion (Anticipated): June 1, 2015

Study Registration Dates

• First Submitted: March 9, 2015
• First Submitted That Met QC Criteria: March 18, 2015
• First Posted (Estimate): March 19, 2015

Study Record Updates

• Last Update Posted (Estimate): March 19, 2015
• Last Update Submitted That Met QC Criteria: March 18, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Solutions; Dialysis Solutions
• Other Study ID Numbers: Usix -2500PD-001