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

Cardiovascular Risk Comparison Between Expanded Hemodialysis Using Theranova and On-line Hemodiafiltration - Exploratory, Multicenter, Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Kidney Failure, Chronic; Renal Dialysis
• Intervention / Treatment: Device: Theranova; Device: Online hemodiafiltration

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do, Korea, Republic of, 13620
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 06591
    • Seoul st. mary's hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group; Extended HD with MCO dialyzer	Device: Theranova; Extended HD with theranova
Active Comparator: Control group; Online hemodiafiltration	Device: Online hemodiafiltration; Online hemodiafiltration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cardiovascular surrogate marker	Brachial-ankle pulse wave velocity (m/s)	0, 6, 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Samsung Medical Center; Seoul St. Mary's Hospital; Baxter Healthcare Corporation; Seoul National University Bundang Hospital
• Investigators: Principal Investigator: Kwon Wook Joo, MD, PhD, Seoul National University Hospital

Publications and helpful links

General Publications

• 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. Erratum In: Nephrol Dial Transplant. 2021 Jul 23;36(8):1555-1556.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2018
• Primary Completion (Actual): July 15, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: February 16, 2018
• First Submitted That Met QC Criteria: February 27, 2018
• First Posted (Actual): February 28, 2018

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 5, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: End-stage renal disease; Cardiovascular; Medium cut-off dialyzer; Pulse wave velocity; Hemodiafiltration
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: Theranova-SNU-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes