Survival on Peritoneal Dialysis (PD) Versus Hemodialysis (HD) in China
NCT01413074 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 416
Last updated 2026-02-17
Summary
Primary Objective: The primary objective is to prospectively assess and compare survival in subjects with End Stage Renal Disease (ESRD) randomized to Peritoneal Dialysis (PD) or Hemodialysis (HD) treatment.
Secondary Objectives: The secondary objectives are to prospectively assess and compare the following parameters in subjects receiving PD or HD treatment:
* Technique failure
* Cause of death
* Comorbidity status at baseline and changes throughout the study
* Change in residual renal function (RRF)
* Dialysis adequacy (i.e., Kt/Vurea)
* Change in blood pressure, hemoglobin, and S-phosphate
* Change in nutritional status
* Occurrence of bacterial and other infections
* Hospitalization, including number, duration, and underlying reason(s)
* Systemic inflammation as assessed by high-sensitivity C reactive protein (hs-CRP)
* Quality of life (QOL)
Safety Objectives: To compare the nature and frequency of adverse events (AEs) and serious adverse events (SAEs), including abnormal laboratory test findings with clinical significance, in subjects receiving PD or HD treatment.
Conditions
Interventions
- OTHER
-
Peritoneal Dialysis treatment
PD treatment
- OTHER
-
Hemodialysis treatment
HD treatment
Sponsors & Collaborators
-
Baxter Healthcare Corporation
collaborator INDUSTRY -
Vantive Health LLC
lead INDUSTRY
Principal Investigators
-
Quian Jia-Qi, Prof. · Shanghai Jiao Tong University School of Medicine
-
Yu Xue-qing, Prof. · First Affiliated Hospital, Sun Yat-Sen University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-06-30
- Primary Completion
- 2013-12-31
- Completion
- 2013-12-31
Countries
- China
Study Locations
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