A Phase 4 interventional study of Modality: Peritoneal Dialysis in End Stage Renal Disease, sponsored by Baxter Healthcare Corporation. Completed at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-09-29.
Sponsored by Baxter Healthcare Corporation · Phase 4, Interventional, and Treatment
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.
refer to brief summary
2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.
This study's planned enrollment of 50 is close to the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Baxter Healthcare Corporation is the lead sponsor of 78 studies on the registry; 1 is open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients justified as not eligible for either PD or HD due to:
Peritoneal Dialysis
Procedure: Modality: Peritoneal Dialysis
Hemodialysis
Procedure: Modality: Peritoneal Dialysis
Peritoneal Dialysis: CAPD; Hemodialysis: 3 times/week
To assess willingness of ESRD patients to be randomized to either PD or HD; thereby determining if an adequate number of eligible patients can be recruited for a future large-scale study.
Time frame: August 2008
This study is completed, as verified in Sep 2008. You cannot join it, but the record below documents what was studied.
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Baxter Healthcare Corporation