NCT04211571

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 26, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

April 23, 2020

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2023

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2023

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

3.4 years

First QC Date

December 21, 2019

Last Update Submit

November 19, 2023

Conditions

End Stage Renal Disease

Keywords

End-stage renal diseaseMedium cut-off dialyzerHigh-flux dialyzerResidual renal function

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Change of glomerular filtration rate

    0, 3, 6, 9, 12 months

  • Change of daily urine volume

    0, 3, 6, 9, 12 months

  • Change and reduction ratio of inflammatory marker levels

    0, 12 months

  • Change of hs-CRP

    0, 12 months

  • Change of Beta 2-microglobulin

    0, 12 months

  • +6 more secondary outcomes

Study Arms (2)

MCO group

EXPERIMENTAL

Hemodialysis using Theranova 400 dialyzer

Device: Theranova 400 dialyzer

High-flux group

ACTIVE COMPARATOR

Hemodialysis using high-flux dialyzer (Fx CorDiax 80; Fresenius Medical Care)

Device: High-flux dialyzer

Interventions

Theranova 400 dialyzerDEVICE

Hemodialysis using Theranova 400 dialyzer

MCO group
High-flux dialyzerDEVICE

Hemodialysis using high-flux dialyzer

Also known as: Fx CorDiax 80 dialyzer
High-flux group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyungpook national university chilgok hospital

Daegu, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 27587605BACKGROUND

  • Lim JH, Seo YJ, Jeon Y, Jeon YH, Jung HY, Choi JY, Park SH, Kim CD, Kang SH, Ryu JH, Kang DH, Cho JH, Kim YL. Expanded Hemodialysis with Theranova Dialyzer and Residual Kidney Function in Patients Starting Long-Term Hemodialysis: A Randomized Controlled Trial. J Am Soc Nephrol. 2025 Mar 4;36(8):1614-1625. doi: 10.1681/ASN.0000000655.

    PMID: 40036081DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph.D.

Study Record Dates

First Submitted

December 21, 2019

First Posted

December 26, 2019

Study Start

April 23, 2020

Primary Completion

September 17, 2023

Study Completion

September 24, 2023

Last Updated

November 21, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)