- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03547336
Study in End Stage Renal Disease (ESRD) Patients on Hemodialysis Comparing the Theranova Dialyzer to Hemodiafiltration
March 2, 2020 updated by: Baxter Healthcare Corporation
A Randomized, Controlled, Open-label, Parallel Study in End Stage Renal Disease (ESRD) Patients on Hemodialysis Comparing the Theranova Dialyzer to Hemodiafiltration
In China, the estimated prevalence of patients with ESRD receiving PD or maintenance HD increased from 51.7 per million population (pmp) at the end of 2007 to 79.1 pmp at the end of 2008.
Theranova 400 is designed to deliver the performance of hemodiafiltration (HDF) using standard hemodialysis (HD) equipment and treatment mode, including HD machines, disposables, blood and dialysate flows, length of treatment and frequency of treatment.
Theranova 400 utilizes a Medium Cut-Off (MCO) membrane with extended permeability for middle solutes to closely modulate the removal function of the kidney without the complexity of HDF.
The primary objective of the study is to demonstrate non-inferiority of the Theranova Dialyzer in hemodialysis (HD) mode compared to hemodiafiltration (HDF), using FX 800 in HDF mode.
Comparison of the study arms over time will be used to support the safety of Theranova 400 by demonstrating stable serum albumin levels, as well as support the dialyzer's efficacy to significantly remove serum middle molecules.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
212
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
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Beijing, China, 100034
- Baxter Investigational SIte
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Anhui
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Hefei, Anhui, China, 230601
- Baxter Investigational SIte
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Guangdong
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Guangzhou, Guangdong, China, 510515
- Baxter Investigational SIte
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Henan
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Zhengzhou, Henan, China, 450052
- Baxter Investigational SIte
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Hubei
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Wuhan, Hubei, China, 430060
- Baxter Investigational SIte
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Shanghai
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Shanghai, Shanghai, China, 200011
- Baxter Investigational SIte
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Sichuan
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Chengdu, Sichuan, China, 610041
- Baxter Investigational SIte
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Zhejiang
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Hangzhou, Zhejiang, China, 310014
- Baxter Investigational SIte
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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
18 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 who are able to give IC after an explanation of the proposed study.
- Patients who have Kt/Vurea > 1.2 for the last 2 measurements, with the most recent Kt/Vurea measurement taken within 4 weeks before or during study screening.
- Patients with a dialysis prescription (dialyzer, time, dialysis fluid flow rate (QD), blood flow rate (QB)) stable over 6 recent treatments. The dialysis treatment time should be 3.5 to 4.5 hours per session with minimum QB of at least 250 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 within 1 month prior to study.
- Patients who have been stable on in-center HD for >3 months prior to study enrollment
- Patients who have an adequate arteriovenous (AV) fistula or graft, or dual-lumen tunneled catheter capable of providing a blood flow rate of at least 250 mL/min.
- Patients with a minimum total convective volume (including ultrafiltration (UF)) of 16 L post-dilution for the most recent HDF treatment.
- Patients who receive in-center treatment hemodialysis at a site that routinely implements high flux dialysis and HDF.
Exclusion Criteria:
- Patients who have acute renal failure with the chance for recovery.
- Patients who are pre-scheduled for a living donor kidney transplant within the next six months, who plan a change to PD within the next six months, or who require single-needle dialysis therapy.
- Pregnant and lactating women.
- Patients with positive serology tests for Hepatitis B surface antigen, Hepatitis C total antibody), HIV and Syphilis.
- Patients with known hemodynamic instability, anemia (Hgb < 90 g/L), and/or patients with Hgb >130g/L for coagulation risk.
- Patients who are severely malnourished or with significant disease that interferes with liver synthetic function, e.g. with serum albumin <35 g/L.
- Patients with active or ongoing infection as per investigator's judgement.
- Patients with history of solid tumors requiring anti-cancer therapy in the past or next 6 months, or life expectancy less than 1 year, or patients or with history of 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 in, or have previously participated in other interventional clinical trials during the past 4 weeks.
- Patients who have had an allergic response to polyarylethersulfone (PAES) or polysulfone (PS) membrane or have 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 |
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Experimental: Theranova 400 Dialyzer
In-center hemodialysis (in HD mode), 3 times a week for 12 week duration.
The patient will undergo regular HD treatment on the first treatment of the first week of study, after which, the patient will switch to the randomized dialyzer, from the second treatment to the end of study treatment.
Blood sampling will be obtained at the hospital by trained personnel according to local routines.
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Dialysis performed in HD mode.
Treatment duration for each individual subject will vary based on clinical requirements determined by the Investigator, based on the subject's need, residual renal function, access function, tolerance to HD/HDF and other relevant factors.
The participating subjects' HD/HDF prescriptions should be kept stable throughout the study.
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Active Comparator: FX800
In-center hemodialysis (in HDF mode), 3 times a week for 12 week duration.
The patient will undergo regular HD treatment on the first treatment of the first week of study, after which, the patient will switch to the randomized dialyzer, from the second treatment to the end of study treatment.
Blood sampling will be obtained at the hospital by trained personnel according to local routines.
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Dialysis performed in HDF mode.
Treatment duration for each individual subject will vary based on clinical requirements determined by the Investigator, based on the subject's need, residual renal function, access function, tolerance to HD/HDF and other relevant factors.
The participating subjects' HD/HDF prescriptions should be kept stable throughout the study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Reduction ratio of lambda free light chains (λ FLC)
Time Frame: Up to 1 week
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At the first mid-week treatment day
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Up to 1 week
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Reduction ratio of β2 microglobulin
Time Frame: Up to 1 week
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At the first mid-week treatment day
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Up to 1 week
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Pre-dialysis serum albumin
Time Frame: Study Completion (Week 12)
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Study Completion (Week 12)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Kt/V urea
Time Frame: Week 1, Week 5, Week 9, Week 13
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Mid-Week Treatment Day
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Week 1, Week 5, Week 9, Week 13
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Urea reduction ratio (URR)
Time Frame: Week 1, Week 5, Week 9, Week 13
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Mid-Week Treatment Day
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Week 1, Week 5, Week 9, Week 13
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Pre-dialysis serum levels of λ FLC
Time Frame: Week 1, Week 5, Week 9, Week 13
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Mid-Week Treatment Day
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Week 1, Week 5, Week 9, Week 13
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Pre-dialysis serum levels of β2 microglobulin
Time Frame: Week 1, Week 5, Week 9, Week 13
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Mid-Week Treatment Day
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Week 1, Week 5, Week 9, Week 13
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Reduction ratio of α1 microglobulin (α1M)
Time Frame: Up to 1 week
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At the first mid-week treatment day
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Up to 1 week
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Reduction ratio of Chitinase-3-like protein (YKL-40)
Time Frame: Up to 1 week
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At the first mid-week treatment day
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Up to 1 week
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Reduction ratio of complement factor D (CFD)
Time Frame: Up to 1 week
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At the first mid-week treatment day
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Up to 1 week
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Reduction ratio of myoglobin
Time Frame: Up to 1 week
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At the first mid-week treatment day
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Up to 1 week
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Reduction ratio of kappa free light chains (κ FLC)
Time Frame: Up to 1 week
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At the first mid-week treatment day
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Up to 1 week
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
June 29, 2018
Primary Completion (Actual)
January 4, 2020
Study Completion (Actual)
January 4, 2020
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
- 7408001
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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