Clinical trial NCT03448887: Cardiovascular Risk Comparison Between Expanded Hemodialysis Using Theranova and On-line Hemodiafiltration
Official title: Cardiovascular Risk Comparison Between Expanded Hemodialysis Using Theranova and On-line Hemodiafiltration - Exploratory, Multicenter, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Failure, Chronic
Renal Dialysis
Keywords: End-stage renal disease
Medium cut-off dialyzer
Hemodiafiltration
Cardiovascular
Pulse wave velocity
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Samsung Medical Center
name: Seoul St. Mary's Hospital
name: Seoul National University Bundang Hospital
name: Baxter Healthcare Corporation
First posted: 2018-02-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Exploratory, Multicenter, Randomized
Primary purpose: TREATMENT

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 hemodiafiltration (HDF). The present study addresses to compare clinical outcomes including cardiovascular endpoint between HD with theranova dialyzer and HDF.

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 on importance of middle molecule removal, on-line hemodiafiltration (HDF) is getting more attention from healthcare professionals. However, HDF has not been widely used in Korea due to its technical burden and limited public funding issue.

Novel medium cut-off (MCO) dialyzer, Theranova, is available in Korea, which showed superior performance on middle molecule removal to conventional HD and HDF from the previous study. This new dialyzer can be a good alternative option replacing conventional HD or even HDF with its benefits. However, current data available on the MCP dialyzer has certain limitations such as small sample size, no Asian subject included, limited types of biomarkers, and no clinical outcomes (particularly cardiovascular diseases) included.

With this respect, performance comparison of MCO dialyzer with HDF in terms of clinical outcomes, including cardiovascular endpoint would fill the exiting data gap, which is absolutely important to make a clinical decision on dialysis modality.

Eligibility criteria: Inclusion Criteria:

* 18 years old and older
* Hemodialysis more than 3 months because of end-stage renal disease
* Consent to the study protocol

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in cardiovascular surrogate marker
timeFrame: 0, 6, 12 months
Secondary outcomes:
measure: Change in cardiac surrogate marker #1
timeFrame: 0, 6, 12 months
measure: Change in cardiac surrogate marker #2
timeFrame: 0, 6, 12 months
measure: Change in cardiovascular biomarkers #1
timeFrame: 0, 6, 12 months
measure: Change in cardiovascular biomarkers #2
timeFrame: 0, 6, 12 months
measure: Change in cardiovascular biomarkers #3
timeFrame: 0, 6, 12 months
measure: Change in cardiovascular biomarkers #4
timeFrame: 0, 6, 12 months
measure: Change in cardiovascular biomarkers #5
timeFrame: 0, 6, 12 months
measure: Change in cardiovascular biomarkers #6
timeFrame: 0, 6, 12 months
measure: Patient-reported outcomes #1
timeFrame: 0, 6, 12 months
measure: Patient-reported outcomes #2
timeFrame: 0, 6, 12 months
measure: Patient-reported outcomes #3
timeFrame: 0, 6, 12 months
Other outcomes:
Locations:
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Kwon Wook Joo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kirsch AH, Lyko R, Nilsson LG, Beck W, Amdahl M, Lechner P, Schneider A, Wanner C, Rosenkranz AR, Krieter DH. Performance of hemodialysis with novel medium cut-off dialyzers. Nephrol Dial Transplant. 2017 Jan 1;32(1):165-172. doi: 10.1093/ndt/gfw310.