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

March 2, 2020 updated by: Baxter Healthcare Corporation

A Randomized, Controlled, Open-label, Parallel Study in End Stage Renal Disease (ESRD) Patients on Hemodialysis to Determine Non-inferiority of the Theranova Dialyzer Compared to the FX80 Dialyzer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

156

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Baxter Investigational SIte
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Baxter Investigational SIte
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Baxter Investigational SIte
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310014
        • Baxter Investigational SIte

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged 18 years or older.
  • Patients able to give informed consent (IC) after an explanation of the proposed study.
  • Patients who have Kt/Vurea > 1.2 for the last 2 measurements, where the most recent Kt/Vurea measurement is taken within 4 weeks before or during study screening.
  • Patients with dialysis prescription (dialyzer, time, blood flow rate [QB], dialysis fluid flow rate [QD]) stable over 6 most recent treatments. The dialysis treatment duration time should be 3.5 - 4.5 hours per session, with QB of 220 - 300 mL/min and QD of 500 mL/min.
  • Patients who are on stable anticoagulation prescription and dose.
  • Patients with ESRD receiving chronic HD treatment with a history of thrice weekly HD, and at least 1 HDF session or HFHD, within 1 month prior to study.
  • Patients must be stable on in-center HD and/or HDF for >3 months prior to study enrollment.
  • Patients who have an adequate arteriovenous fistula (AVF) or graft, capable of providing a blood flow rate of at least 220 mL/min.

Exclusion Criteria:

  • Patients who have acute renal failure with the chance for recovery.
  • Patients who are pre-scheduled for a living kidney transplant within the next two months, who plan a change to PD within the next two months or who require single needle dialysis therapy.
  • Pregnant and lactating women.
  • Patients with positive serology tests for Hepatitis B surface antigen, positive Hepatitis C total antibody, HIV and syphilis.
  • Patients with known hemodynamic instability, anemia (Hgb < 90 g/L), and/or severe bleeding risks secondary to coagulation disorders.
  • Patients with active or ongoing infection per investigator's judgement.
  • Patients with a history of solid tumors requiring anti-cancer therapy in the past or next 6 months or a life expectancy less than 1 year or patients with a history of a hematology neoplasm.
  • Patients diagnosed with a NYHA Class IV congestive heart failure, or acute coronary syndrome and/or who have suffered a myocardial infarction within three months prior to the start of the study.
  • Patients with a history of severe mental disorders.
  • Patients who are currently participating or have previously participated in another interventional clinical trial in the past 4 weeks.
  • Patients who have had an allergic response to polyarylethersulfone (PAES) or polsulfone membranes or have a history of poor tolerance to dialyzers with synthetic membranes.
  • Patients with advanced liver, heart or pulmonary disease as judged by the Investigator.
  • Patients with any comorbidity possibly conflicting with the study purpose or procedures as judged by the Investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Theranova 400 Dialyzer
One treatment session in an in-center setting.
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.
Active Comparator: FX80 Dialyzer
One treatment session in an in-center setting.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Creatinine Clearance (K of Creatinine)
Time Frame: Up to 1 week
One mid-week dialysis session
Up to 1 week
Urea Clearance (K of Urea)
Time Frame: Up to 1 week
One mid-week dialysis session
Up to 1 week
Reduction Ratio (RR) of Beta-2 Microglobulin
Time Frame: Up to 1 week
One mid-week dialysis session
Up to 1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kappa and Lambda Free Light Chains (FLCs) Reduction Ratio
Time Frame: Up to 1 week
One mid-week dialysis session
Up to 1 week
Ultrafiltration Rate (QUF)
Time Frame: Up to 1 week
One mid-week dialysis session
Up to 1 week
Urea reduction ratio (URR)
Time Frame: Up to 1 week
One mid-week dialysis session
Up to 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baxter Healthcare Corporation

Investigators

  • Study Director: Baxter Clinical Trial, Baxter Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2018

Primary Completion (Actual)

June 14, 2019

Study Completion (Actual)

June 14, 2019

Study Registration Dates

First Submitted

May 16, 2018

First Submitted That Met QC Criteria

June 4, 2018

First Posted (Actual)

June 6, 2018

Study Record Updates

Last Update Posted (Actual)

March 4, 2020

Last Update Submitted That Met QC Criteria

March 2, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0080002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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