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Study in End Stage Renal Disease (ESRD) Patients on Hemodialysis to Determine Non-inferiority of the Theranova Dialyzer Compared to the FX80 Dialyzer

NCT03547323 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2025-03-13

No results posted yet for this study

Summary

In China, the estimated prevalence of patients with ESRD receiving peritoneal dialysis (PD) or maintenance hemodialysis (HD) increased from 51.7 per million population (pmp) at the end of 2007 to 79.1 pmp at the end of 2008. There is a growing body of evidence that large uremic solutes play a significant role in clinical complications in dialysis patients. Since high-flux membranes show low permeability for large uremic solutes, extracorporeal blood purification treatments using these membranes have failed to significantly eliminate and reduce plasma levels of these molecules. To remove large sized uremic solutes by dialysis the membrane needs to have adequate permeability properties (pore size, porosity) for these solutes. The Theranova 400 contains a dialysis membrane that has a sharper sieving profile and a higher cutoff than that in conventional high-flux dialysis membranes. The primary objective of this study is to demonstrate non-inferiority of the Theranova Dialyzer compared to the FX80 with clinical endpoints.

Conditions

Interventions

DEVICE

Theranova 400 Dialyzer

An existing functioning vascular access (AVF, graft) must be in place and will be used for dialysis. Treatments will be administered by trained clinical staff. The use of temporary or tunneled dialysis catheters will not be allowed.

DEVICE

FX80 Dialyzer

An existing functioning vascular access (AVF, graft) must be in place and will be used for dialysis. Treatments will be administered by trained clinical staff. The use of temporary or tunneled dialysis catheters will not be allowed.

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    collaborator INDUSTRY

  • Vantive Health LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-14
Primary Completion
2019-06-14
Completion
2019-06-14

Countries

  • China

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 NCT03547323 on ClinicalTrials.gov