Theranova Versus High-flux Dialyzer on Preservation of Residual Renal Function

End Stage Renal Disease Clinical Trial

— THREAD  

Official title:

Randomized Controlled Trial of Theranova Versus High-flux Dialyzer on Preservation of REsidual RenAl Function in Incident HemoDialysis Patients (THREAD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04211571
• Other study ID #: KNU-Theranova-01
• Status: Completed
• Phase: N/A
• Start date: April 23, 2020
• Est. completion date: September 24, 2023

Study information

• Verified date: November 2023
• Source: Kyungpook National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Theranova is a novel medium cut-off dialyzer and has better performance for removal of middle molecules compared to conventional hemodialysis. The study investigates the effect of Theranova dialzyer on preserving residual renal function in the incident hemodialysis pateitns compared to high-flux dialzyer. The primary endpoint is change of glomerular filtration rate, calculated using creatinine and urea clearance. The secondary endpoints are serial changes of glomerular filtration rate and daily urine volume, changes of serum middle molecule concentrations, hospitalization, mortality, and patient reported outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 24, 2023
• Est. primary completion date: September 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Incident end-stage renal disease ESRD patient receiving hemodialysis for less than 1 month

• 18 years old and older

• Creatinine clearance of more than 2 ml/min

• Agreement to participate in the clinical study

• Vascular access by arteriovenous fistula/graft

Exclusion Criteria:

• Plan for kidney transplantation within 6 months

• Severe volume overloading state

• Dialysis through permanent catheter

• Any hematologic malignancy or monoclonal gammopathy

• Any malignancy

• Active infectious disease

• HIV infection

• Patient enrolled to another study within 3 month from starting the present study

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Device:
• Theranova 400 dialyzer
Hemodialysis using Theranova 400 dialyzer
• High-flux dialyzer
Hemodialysis using high-flux dialyzer

Locations

Country	Name	City	State
Korea, Republic of	Kyungpook national university chilgok hospital	Daegu

Sponsors (5)

Lead Sponsor	Collaborator
Kyungpook National University Hospital	Baxter Healthcare Corporation, Ewha Womans University, Kyungpook National University Chilgok Hospital, Yeungnam University 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. Erratum In: Nephrol Dial Transplant. 2021 Jul 23;36(8):1555-1556. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of glomerular filtration rate	Glomerular filtration rate is calculated as the mean of creatinine and urea clearance adjusted for body surface area. The outcome refers to the mean difference of glomerular filtration rate between baseline and after 12 months.	Between baseline and 12 months
Secondary	Change of glomerular filtration rate	Calculated as the mean of creatinine and urea clearance adjusted for body surface area	0, 3, 6, 9, 12 months
Secondary	Change of daily urine volume	Total urine output for 24 hours	0, 3, 6, 9, 12 months
Secondary	Change and reduction ratio of inflammatory marker levels	TNF-alpha, GDF-15, etc.	0, 12 months
Secondary	Change of hs-CRP	hs-CRP	0, 12 months
Secondary	Change of Beta 2-microglobulin	Beta 2-microglobulin	0, 12 months
Secondary	Change of kidney injury markers	NGAL, KIM-1, TIMP-2, IGFBP-7, etc	0, 12 months
Secondary	Change of cystatin-C	Cystatin-C	0, 12 months
Secondary	Change and reduction ratio of Kappa and lambda free light chains	Kappa and lambda free light chains	0, 12 months
Secondary	Hospitalization	Frequency, cause, etc.	Through 12-month study duration
Secondary	Mortality	Deaths number and causes of death	Through 12-month study duration
Secondary	Patient-reported outcome	Using Kidney Disease Quality of Life Questionnaire-36™ (KDQOL-36™; score ranges from 0 to 100 - higher scores represent better quality of life)	0, 12 months