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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

Primary Purpose

End Stage Renal Disease

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Theranova 400 Dialyzer
FX80 Dialyzer
Sponsored by
Baxter Healthcare Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Baxter Investigational Site
  • Baxter Investigational Site
  • Baxter Investigational Site
  • Baxter Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Theranova 400 Dialyzer

FX80 Dialyzer

Arm Description

One treatment session in an in-center setting.

One treatment session in an in-center setting.

Outcomes

Primary Outcome Measures

Creatinine Clearance (K of Creatinine)
One mid-week dialysis session
Urea Clearance (K of Urea)
One mid-week dialysis session
Reduction Ratio (RR) of Beta-2 Microglobulin
One mid-week dialysis session

Secondary Outcome Measures

Kappa and Lambda Free Light Chains (FLCs) Reduction Ratio
One mid-week dialysis session
Ultrafiltration Rate (QUF)
One mid-week dialysis session
Urea reduction ratio (URR)
One mid-week dialysis session

Full Information

First Posted
May 16, 2018
Last Updated
March 2, 2020
Sponsor
Baxter Healthcare Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03547323
Brief Title
Study in End Stage Renal Disease (ESRD) Patients on Hemodialysis to Determine Non-inferiority of the Theranova Dialyzer Compared to the FX80 Dialyzer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 14, 2018 (Actual)
Primary Completion Date
June 14, 2019 (Actual)
Study Completion Date
June 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baxter Healthcare Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Theranova 400 Dialyzer
Arm Type
Experimental
Arm Description
One treatment session in an in-center setting.
Arm Title
FX80 Dialyzer
Arm Type
Active Comparator
Arm Description
One treatment session in an in-center setting.
Intervention Type
Device
Intervention Name(s)
Theranova 400 Dialyzer
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
FX80 Dialyzer
Intervention Description
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.
Primary Outcome Measure Information:
Title
Creatinine Clearance (K of Creatinine)
Description
One mid-week dialysis session
Time Frame
Up to 1 week
Title
Urea Clearance (K of Urea)
Description
One mid-week dialysis session
Time Frame
Up to 1 week
Title
Reduction Ratio (RR) of Beta-2 Microglobulin
Description
One mid-week dialysis session
Time Frame
Up to 1 week
Secondary Outcome Measure Information:
Title
Kappa and Lambda Free Light Chains (FLCs) Reduction Ratio
Description
One mid-week dialysis session
Time Frame
Up to 1 week
Title
Ultrafiltration Rate (QUF)
Description
One mid-week dialysis session
Time Frame
Up to 1 week
Title
Urea reduction ratio (URR)
Description
One mid-week dialysis session
Time Frame
Up to 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baxter Clinical Trial
Organizational Affiliation
Baxter Healthcare
Official's Role
Study Director
Facility Information:
Facility Name
Baxter Investigational Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Baxter Investigational Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Name
Baxter Investigational Site
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Baxter Investigational Site
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310014
Country
China

12. IPD Sharing Statement

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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

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