NCT03448887

Brief 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.

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 Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

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

February 16, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 28, 2018

Completed
15 days until next milestone

Study Start

First participant enrolled

March 15, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

2.3 years

First QC Date

February 16, 2018

Last Update Submit

October 5, 2020

Conditions

Kidney Failure, ChronicRenal Dialysis

Keywords

End-stage renal diseaseMedium cut-off dialyzerHemodiafiltrationCardiovascularPulse wave velocity

Outcome Measures

Primary Outcomes (1)

  • Change in cardiovascular surrogate marker

    Brachial-ankle pulse wave velocity (m/s)

    0, 6, 12 months

Secondary Outcomes (11)

  • Change in cardiac surrogate marker #1

    0, 6, 12 months

  • Change in cardiac surrogate marker #2

    0, 6, 12 months

  • Change in cardiovascular biomarkers #1

    0, 6, 12 months

  • Change in cardiovascular biomarkers #2

    0, 6, 12 months

  • Change in cardiovascular biomarkers #3

    0, 6, 12 months

  • +6 more secondary outcomes

Study Arms (2)

Study group

EXPERIMENTAL

Extended HD with MCO dialyzer

Device: Theranova

Control group

ACTIVE COMPARATOR

Online hemodiafiltration

Device: Online hemodiafiltration

Interventions

TheranovaDEVICE

Extended HD with theranova

Study group
Online hemodiafiltrationDEVICE

Online hemodiafiltration

Control group

Eligibility Criteria

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

You may qualify if:

  • years old and older
  • Hemodialysis more than 3 months because of end-stage renal disease
  • Consent to the study protocol

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Seoul National University Bundang Hospital

Gyeonggi-do, 13620, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Seoul St. Mary's Hospital

Seoul, 06591, South Korea

Location

Related 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.

    PMID: 27587605RESULT

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 Officials

  • Kwon Wook Joo, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Exploratory, Multicenter, Randomized
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 16, 2018

First Posted

February 28, 2018

Study Start

March 15, 2018

Primary Completion

July 15, 2020

Study Completion

August 31, 2020

Last Updated

October 8, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(4)