Status:
COMPLETED
Comparison of Post-dilution On-line Hemodiafiltration and Hemodialysis
Lead Sponsor:
Ercan OK
Collaborating Sponsors:
Fresenius Medical Care North America
Conditions:
End-Stage Renal Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study aims to compare high-efficiency post-dilution on-line hemodiafiltration and high-flux hemodialysis regarding mortality, hospitalization rate, several clinical and laboratory parameters, and...
Detailed Description
The proposed controlled, randomized study aims to compare high-efficiency post-dilution on-line hemodiafiltration and high-flux hemodialysis regarding mortality, hospitalization rate, several clinical...
Eligibility Criteria
Inclusion
- older than 18 years
- on maintenance bicarbonate HD scheduled thrice weekly 12 hours/week,achieved mean single pool Kt/V above 1.2
- willingness to participate in the study with a written informed consent
Exclusion
- To be scheduled for living donor renal transplantation
- To have serious life-limiting co-morbid situations, namely active malignancy, active infection, end-stage cardiac, pulmonary, or hepatic disease
- Pregnancy or lactating
- Current requirement for HD more than three times per week due to medical comorbidity
- GFR greater than 10 ml/min/1.73 m2 as measured by the average of urea and creatinine clearances obtained from a urine collection of at least 24 hours
- Use of temporary catheter
- Insufficient vascular access (blood flow rate lower than 250 ml/min)
- Mental incompetence
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
782 Patients enrolled
Trial Details
Trial ID
NCT00411177
Start Date
January 1 2007
End Date
March 1 2010
Last Update
September 9 2013
Active Locations (2)
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1
Ege University School of Medicine
Bornova, İzmir, Turkey (Türkiye), 35100
2
FMC Clinics Turkey
Adana, Turkey (Türkiye), 01000