Status:
COMPLETED
Cardiovascular Risk Comparison Between Expanded Hemodialysis Using Theranova and On-line Hemodiafiltration
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Samsung Medical Center
Seoul St. Mary's Hospital
Conditions:
Kidney Failure, Chronic
Renal Dialysis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Theranova is a novel medium cut-off (MCO) dialyzer. Previous studies identified that theranova dialyzer had superior performance on middle molecule removal to conventional hemodialysis (HD) and hemodi...
Detailed Description
While conventional hemodialysis (HD) modality effectively removes small-sized molecules, performance with middle-sized and protein-bound molecules is not well established. With increasing perception o...
Eligibility Criteria
Inclusion
- 18 years old and older
- Hemodialysis more than 3 months because of end-stage renal disease
- Consent to the study protocol
Exclusion
- Already receiving online hemodiafiltration before study enrollment
- Dialysis schedule other than three times per week (e.g., once per week)
- Receiving concurrent peritoneal dialysis
- Having a plan to receive kidney transplantation within 1 year
- Having multiple myeloma or monoclonal gammopathy
- Having advanced or active malignancy
- Having a plan to be pregnant or being pregnant / breast-feeding or not having a plan to use contraception
- Participating in other clinical trials
Key Trial Info
Start Date :
March 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2020
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03448887
Start Date
March 15 2018
End Date
August 31 2020
Last Update
October 8 2020
Active Locations (4)
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1
Seoul National University Bundang Hospital
Gyeonggi-do, South Korea, 13620
2
Seoul National University Hospital
Seoul, South Korea, 03080
3
Samsung Medical Center
Seoul, South Korea, 06351
4
Seoul St. Mary's Hospital
Seoul, South Korea, 06591