|
|
|
|
|
|
Sponsored by: |
Baxter Healthcare Corporation |
Information provided by: | Baxter Healthcare Corporation |
ClinicalTrials.gov Identifier: | NCT00510549 |
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.
Condition | Intervention | Phase |
End Stage Renal Disease |
Procedure: Modality: Peritoneal Dialysis |
Phase IV |
MedlinePlus related topics: | Dialysis Kidney Failure |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Prospective, Randomized, Multicenter, Open Label, Interventional Pilot Study To Compare Mortality, Morbidity and QOL in Hemodialysis Versus Peritoneal Dialysis Subjects |
Estimated Enrollment: | 50 |
Study Start Date: | July 2007 |
Study Completion Date: | August 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1, PD: Active Comparator
Peritoneal Dialysis
|
Procedure: Modality: Peritoneal Dialysis
Peritoneal Dialysis: CAPD; Hemodialysis: 3 times/week
|
2, HD: Active Comparator
Hemodialysis
|
Procedure: Modality: Peritoneal Dialysis
Peritoneal Dialysis: CAPD; Hemodialysis: 3 times/week
|
refer to brief summary
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients justified as not eligible for either PD or HD due to:
China | |||||
Renji Hospital, Shanghai | |||||
Shanghai, China | |||||
Bejing No.3 Hospital | |||||
Beijing, China |
Baxter Healthcare Corporation |
Principal Investigator: | Jia-Qi QIAN, Prof | Center for one Baxter -Tel: 8004229837 |
Principal Investigator: | Tao Wang, Prof | Center for one Baxter -Tel: 8004229837 |
Responsible Party: | Company ( Baxter Healthcare Corporation ) |
Study ID Numbers: | SurvivalHD/PDFinal 28/03/2007 |
First Received: | July 16, 2007 |
Last Updated: | September 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00510549 |
Health Authority: | China: State Food and Drug Administration |
|
|