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

Kidney Failure, Chronic Clinical Trial

— CARTOON  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03448887
• Other study ID #: Theranova-SNU-01
• Status: Completed
• Phase: N/A
• Start date: March 15, 2018
• Est. completion date: August 31, 2020

Study information

• Verified date: October 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 31, 2020
• Est. primary completion date: July 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Dialysis
• Renal Insufficiency

Intervention

Device:
• Theranova
Extended HD with theranova
• Online hemodiafiltration
Online hemodiafiltration

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Gyeonggi-do
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul St. Mary's Hospital	Seoul

Sponsors (5)

Lead Sponsor	Collaborator
Seoul National University Hospital	Baxter Healthcare Corporation, Samsung Medical Center, Seoul National University Bundang Hospital, Seoul St. Mary's Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cardiovascular surrogate marker	Brachial-ankle pulse wave velocity (m/s)	0, 6, 12 months
Secondary	Change in cardiac surrogate marker #1	CT coronary calcium scoring (score)	0, 6, 12 months
Secondary	Change in cardiac surrogate marker #2	Echocardiography: ejection fraction (%); E/e' ratio (cm/s per cm/s); LVMI (g/m2).	0, 6, 12 months
Secondary	Change in cardiovascular biomarkers #1	Plasma levels of BNP (pg/ml)	0, 6, 12 months
Secondary	Change in cardiovascular biomarkers #2	Plasma levels of NT-proBNP (pg/ml)	0, 6, 12 months
Secondary	Change in cardiovascular biomarkers #3	Plasma levels of hsCRP (mg/dl)	0, 6, 12 months
Secondary	Change in cardiovascular biomarkers #4	Plasma levels of troponin-I (ng/ml)	0, 6, 12 months
Secondary	Change in cardiovascular biomarkers #5	Plasma levels of troponin-T (ng/ml)	0, 6, 12 months
Secondary	Change in cardiovascular biomarkers #6	Plasma levels of IL-6 (pg/ml)	0, 6, 12 months
Secondary	Patient-reported outcomes #1	Dialysis symptom index (score)	0, 6, 12 months
Secondary	Patient-reported outcomes #2	Degree of fatigue after dialysis (scale from 0 to 10)	0, 6, 12 months
Secondary	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