Study in End Stage Renal Disease (ESRD) Patients on Hemodialysis Comparing the Theranova Dialyzer to Hemodiafiltration

End Stage Renal Disease Clinical Trial

Official title:

A Randomized, Controlled, Open-label, Parallel Study in End Stage Renal Disease (ESRD) Patients on Hemodialysis Comparing the Theranova Dialyzer to Hemodiafiltration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03547336
• Other study ID #: 7408001
• Status: Completed
• Phase: N/A
• Start date: June 29, 2018
• Est. completion date: January 4, 2020

Study information

• Verified date: March 2020
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: January 4, 2020
• Est. primary completion date: January 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Device:
• Theranova 400 Dialyzer
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.
• FX800 Dialyzer
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.

Locations

Country	Name	City	State
China	Baxter Investigational Site	Beijing
China	Baxter Investigational Site	Chengdu	Sichuan
China	Baxter Investigational Site	Guangzhou	Guangdong
China	Baxter Investigational Site	Hangzhou	Zhejiang
China	Baxter Investigational Site	Hefei	Anhui
China	Baxter Investigational Site	Shanghai	Shanghai
China	Baxter Investigational Site	Wuhan	Hubei
China	Baxter Investigational Site	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction ratio of lambda free light chains (? FLC)	At the first mid-week treatment day	Up to 1 week
Primary	Reduction ratio of ß2 microglobulin	At the first mid-week treatment day	Up to 1 week
Primary	Pre-dialysis serum albumin		Study Completion (Week 12)
Secondary	Kt/V urea	Mid-Week Treatment Day	Week 1, Week 5, Week 9, Week 13
Secondary	Urea reduction ratio (URR)	Mid-Week Treatment Day	Week 1, Week 5, Week 9, Week 13
Secondary	Pre-dialysis serum levels of ? FLC	Mid-Week Treatment Day	Week 1, Week 5, Week 9, Week 13
Secondary	Pre-dialysis serum levels of ß2 microglobulin	Mid-Week Treatment Day	Week 1, Week 5, Week 9, Week 13
Secondary	Reduction ratio of a1 microglobulin (a1M)	At the first mid-week treatment day	Up to 1 week
Secondary	Reduction ratio of Chitinase-3-like protein (YKL-40)	At the first mid-week treatment day	Up to 1 week
Secondary	Reduction ratio of complement factor D (CFD)	At the first mid-week treatment day	Up to 1 week
Secondary	Reduction ratio of myoglobin	At the first mid-week treatment day	Up to 1 week
Secondary	Reduction ratio of kappa free light chains (? FLC)	At the first mid-week treatment day	Up to 1 week