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

NCT04211571 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-11-21

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Theranova 400 dialyzer

Hemodialysis using Theranova 400 dialyzer

DEVICE

High-flux dialyzer

Hemodialysis using high-flux dialyzer

Sponsors & Collaborators

  • Kyungpook National University Chilgok Hospital

    collaborator OTHER

  • Yeungnam University Hospital

    collaborator OTHER

  • Ewha Womans University

    collaborator OTHER

  • Baxter Healthcare Corporation

    collaborator INDUSTRY

  • Kyungpook National University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-23
Primary Completion
2023-09-17
Completion
2023-09-24

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04211571 on ClinicalTrials.gov