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

Disorders Associated With Peritoneal Dialysis Clinical Trial

Official title:

Validity and Security of 2500ml Huaren Peritoneal Dialysate: A Prospective, Randomized, Controlled, Multi-Center Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02393261
• Other study ID #: Usix -2500PD-001
• Status: Recruiting
• Phase: N/A
• First received: March 9, 2015
• Last updated: March 18, 2015
• Start date: January 2015
• Est. completion date: June 2015

Study information

• Verified date: March 2015
• Source: Sun Yat-sen University
• Contact: Zongpei Jiang, M.D. & Ph.D.
• Phone: 8620-38379727
• Email: jx.home[@]medmail.com.cn
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationChina: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disorders Associated With Peritoneal Dialysis

Intervention

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
• 2000ml peritoneal dialysate
use 3-4 bags of normal 2000ml dialysate in the daytime and keep 1 bag of 2000ml dialysate in the night

Locations

Country	Name	City	State
China	Department of Nephrology, 6th Affiliated Hospital, Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adequacy of dialysis (kt/v)	kt/v	up to 8 weeks	Yes
Secondary	Residual kidney function (Residual kidney kt/v)	Residual kidney kt/v	up to 6 months	Yes
Secondary	Peritoneal function (Peritoneal equilibration test)	Peritoneal equilibration test	up to 6 months	Yes