A Study of Domestic Automated Peritoneal Dialysis Machine

March 9, 2015 updated by: Yanhong Deng, Sun Yat-sen University

Validity and Security of Domestic Automated Peritoneal Dialysis Machine: A Prospective, Randomized, Controlled, Multi-Center Clinical Trial

This prospective, randomized, controlled, multi-center clinical trial will evaluate the validity and security of domestic APD machine compared with the patients followed CAPD.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 almost of them followed continuous ambulatory peritoneal dialysis (CAPD) because of the expensive price of import automated PD (APD) machines although the higher clearance of solute, lower rate of PD related peritonitis and higher quality of life (QOL) in patients treated with APD compared those with CAPD. Now, cheaper domestic APD machines ( PDGO, Fuzhou, China) are accessed to the ESRD patients in china, but the efficacy and safety of which are not fully clear. This will be a prospective, randomized, controlled, multi-center study. Patients in treatment group will receive APD while those in control group will receive CAPD for 8 weeks. After followed-up for 8 weeks, the adequacy of PD, residual kidney function , peritoneum function and QOL of patients will be evaluated.

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A APDGroup
PDGO APD machines used in the PD patients for 8 weeks
Other: APD
PDGO APD machines used in the PD patients for 8 weeks
Active Comparator: B CAPDGroup
CAPD used in the PD Patients for 8 weeks
Other: CAPD
CAPD used in the PD Patients for 8 weeks

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

February 15, 2015

First Submitted That Met QC Criteria

March 9, 2015

First Posted (Estimate)

March 17, 2015

Study Record Updates

Last Update Posted (Estimate)

March 17, 2015

Last Update Submitted That Met QC Criteria

March 9, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • Usix-APD-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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