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| Sponsors and Collaborators: |
Hospital Clinic of Barcelona Societat Catalana de Nefrologia |
|---|---|
| Information provided by: | Hospital Clinic of Barcelona |
| ClinicalTrials.gov Identifier: | NCT00694031 |
Purpose
Patients on hemodialysis will be randomly assigned (1:1) to continue on conventional hemodialysis or on-line hemodiafiltration, both three times per week. A 3 year follow-up and a sample size of around 750 will be necessary to detect a 35% reduction in mortality.
| Condition | Intervention | Phase |
|---|---|---|
|
Hemodialysis |
Procedure: Hemodialysis Procedure: On-line hemodiafiltration |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Randomized Study to Evaluate Survival in Patients Undergoing Hemodialysis or On-Line Hemodiafiltration |
| Estimated Enrollment: | 800 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Active Comparator
Hemodialysis
|
Procedure: Hemodialysis
3 times per week
|
|
B: Experimental
On-line hemodiafiltration
|
Procedure: On-line hemodiafiltration
3 times per week
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Francesc Maduell, MD | 34-9-3227-5400 | fmaduell@clinic.ub.es |
| Spain | |
| Hospital Clinic de Barcelona | Recruiting |
| Barcelona, Spain, 08036 | |
| Contact: Francesc Maduell, MD 34-9-3227-5400 fmaduell@clinic.ub.es | |
| Spain, Barcelona | |
| CSU Bellvitge | Recruiting |
| Hospitalet de Llobregat, Barcelona, Spain, 08907 | |
| Principal Investigator: Albert Martinez-Castelao, MD | |
More Information
| Responsible Party: | Hospital Clínic ( Francesc Maduell ) |
| Study ID Numbers: | ESHOL |
| Study First Received: | June 5, 2008 |
| Last Updated: | June 9, 2008 |
| ClinicalTrials.gov Identifier: | NCT00694031 |
| Health Authority: | Spain: Spanish Agency of Medicines |
|
Mortality Convective therapies On-line Hemodiafiltration |
Dialysis Adequacy Age 18 or older Undergoing hemodialysis |
