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Clinical Trials/NCT02388945
NCT02388945
Unknown
Not Applicable

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

Sun Yat-sen University1 site in 1 country600 target enrollmentJanuary 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Disorders Associated With Peritoneal Dialysis
Sponsor
Sun Yat-sen University
Enrollment
600
Locations
1
Primary Endpoint
Adequacy of dialysis
Last Updated
11 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
January 2015
End Date
June 2015
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Sun Yat-sen University
Responsible Party
Principal Investigator
Principal Investigator

Yanhong Deng

Sun Yat-sen University

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Adequacy of dialysis

Time Frame: up to 8 weeks

kt/v

Secondary Outcomes

  • Residual kidney function(up to 6 months)
  • Peritoneal function(up to 6 months)

Study Sites (1)

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