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

End Stage Renal Disease Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

• NCT number: NCT01413074
• Study type: Interventional
• Source: Baxter Healthcare Corporation
• Status: Terminated
• Phase: Phase 4
• Start date: June 2011
• Completion date: December 2013