NCT01413074

Survival on Peritoneal Dialysis (PD) Versus Hemodialysis (HD) in China

A Prospective, Randomized, Multicenter, Open-Label, Interventional Study Comparing Survival in Subjects Receiving Peritoneal Dialysis vs Hemodialysis in China

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 416 (actual)
• Sponsor: Vantive Health LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• End Stage Renal Disease

Interventions

Type	Name	Description
OTHER	Peritoneal Dialysis treatment	PD treatment
OTHER	Hemodialysis treatment	HD treatment

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2011-08-10
• Last updated: 2026-02-17

Locations

7 sites across 1 country: China