Comparison of the Impact of Dialysis Treatment Type on Patient Survival

End Stage Renal Disease Clinical Trial

Official title: A Prospective, Randomized, Multicenter, Open Label, Interventional Pilot Study To Compare Mortality, Morbidity and QOL in Hemodialysis Versus Peritoneal Dialysis Subjects

Status Completed

Clinical Trial Summary

As the influence of type of dialysis on survival of end stage renal disease (ESRD) patients remains unanswered, the present study is designed (randomized, prospective, multicenter, interventional) to assess clinical outcomes, and compare mortality, morbidity, Quality of Life (QOL) and cost effectiveness between maintenance In-center Hemodialysis (ICHD) and Continuous Ambulatory Peritoneal dialysis (CAPD). These data will ultimately bring clarity on whether or not any difference in patient survival exists between the two modalities.

In order to test the feasibility of patients' willingness to be randomized to two different modality groups and retained in the randomized group, a pilot study is planned before the conduct of a main study.

This pilot study comprises of a 6 months study, plus a 6 months observation if there is possibility to switch the patients into the main study.

All ESRD patients requiring dialysis treatment within 8 weeks after a pre-study visit will be recorded in each site. Patients who provide written inform consent for collecting relevant information will be screened using certain inclusion/exclusion criteria. Eligible patients will undergo a standardized education regarding ESRD and treatment options. Thereafter the patient will be required to provide a second inform consent allowing for randomization and entrance into the study. Eligible patient will be randomized to either PD or HD treatment.

The patients will be followed for a period of 6 months, during which patients will be treated with PD or HD as prescribed at each site, while meeting the dialysis adequacy and other indicators. For the first 3 months monthly visits are required, after which an every 3 months visit is planned.

In this pilot study, the main objective is to assess the willingness of ESRD patients to be randomized to either PD or HD treatment; thereby determining if an adequate number of eligible patients can be recruited for a future large-scale study.

Clinical Trial Description

refer to brief summary ;

Study Design

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

• NCT number: NCT00510549
• Study type: Interventional
• Source: Baxter Healthcare Corporation
• Status: Completed
• Phase: Phase 4
• Start date: July 2007
• Completion date: August 2008