Clinical trial NCT04211571: Theranova Versus High-flux Dialyzer on Preservation of Residual Renal Function
Official title: Randomized Controlled Trial of Theranova Versus High-flux Dialyzer on Preservation of REsidual RenAl Function in Incident HemoDialysis Patients (THREAD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Keywords: End-stage renal disease
Medium cut-off dialyzer
High-flux dialyzer
Residual renal function
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
Collaborators: name: Kyungpook National University Chilgok Hospital
name: Yeungnam University Hospital
name: Ewha Womans University
name: Baxter Healthcare Corporation
First posted: 2019-12-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of glomerular filtration rate
timeFrame: Between baseline and 12 months
Secondary outcomes:
measure: Change of glomerular filtration rate
timeFrame: 0, 3, 6, 9, 12 months
measure: Change of daily urine volume
timeFrame: 0, 3, 6, 9, 12 months
measure: Change and reduction ratio of inflammatory marker levels
timeFrame: 0, 12 months
measure: Change of hs-CRP
timeFrame: 0, 12 months
measure: Change of Beta 2-microglobulin
timeFrame: 0, 12 months
measure: Change of kidney injury markers
timeFrame: 0, 12 months
measure: Change of cystatin-C
timeFrame: 0, 12 months
measure: Change and reduction ratio of Kappa and lambda free light chains
timeFrame: 0, 12 months
measure: Hospitalization
timeFrame: Through 12-month study duration
measure: Mortality
timeFrame: Through 12-month study duration
measure: Patient-reported outcome
timeFrame: 0, 12 months
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook national university chilgok hospital
Study officials:
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.