Cardiovascular Risk Comparison Between Expanded Hemodialysis Using Theranova and On-line Hemodiafiltration

Not Applicable

Completed

• Conditions: Kidney Failure, Chronic; Renal Dialysis
• Interventions: Device: Theranova; Device: Online hemodiafiltration

• Registration Number: NCT03448887
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study First Submitted: 2018-02-16
• Study First Submitted QC: 2018-02-27
• Study First Posted: 2018-02-28
• Study Start: 2018-03-15
• Primary Completion: 2020-07-15
• Study Completion: 2020-08-31
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-05
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	Theranova	Extended HD with MCO dialyzer
Control group	Online hemodiafiltration	Online hemodiafiltration

Primary Outcome Measures

Name	Time	Method
Change in cardiovascular surrogate marker	0, 6, 12 months	Brachial-ankle pulse wave velocity (m/s)

Secondary Outcome Measures

Name	Time	Method
Change in cardiac surrogate marker #2	0, 6, 12 months	Echocardiography: ejection fraction (%); E/e' ratio (cm/s per cm/s); LVMI (g/m2).
Change in cardiovascular biomarkers #1	0, 6, 12 months	Plasma levels of BNP (pg/ml)
Change in cardiovascular biomarkers #2	0, 6, 12 months	Plasma levels of NT-proBNP (pg/ml)
Change in cardiovascular biomarkers #3	0, 6, 12 months	Plasma levels of hsCRP (mg/dl)
Change in cardiovascular biomarkers #4	0, 6, 12 months	Plasma levels of troponin-I (ng/ml)
Change in cardiovascular biomarkers #5	0, 6, 12 months	Plasma levels of troponin-T (ng/ml)
Change in cardiovascular biomarkers #6	0, 6, 12 months	Plasma levels of IL-6 (pg/ml)
Change in cardiac surrogate marker #1	0, 6, 12 months	CT coronary calcium scoring (score)
Patient-reported outcomes #1	0, 6, 12 months	Dialysis symptom index (score)
Patient-reported outcomes #2	0, 6, 12 months	Degree of fatigue after dialysis (scale from 0 to 10)
Patient-reported outcomes #3	0, 6, 12 months	Post-dialysis recovery time (within minutes, when arriving home, at bed time, next morning, by next dialysis)

Trial Locations

Locations (4)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Gyeonggi-do, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of