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

NCT03547336 | Completed

• 1 other identifier: 7408001
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (3)

• Reduction ratio of lambda free light chains (λ FLC)

  At the first mid-week treatment day

  Up to 1 week

• Reduction ratio of β2 microglobulin

  At the first mid-week treatment day

  Up to 1 week

• Pre-dialysis serum albumin

  Study Completion (Week 12)

Secondary Outcomes (9)

• Kt/V urea

  Week 1, Week 5, Week 9, Week 13

• Urea reduction ratio (URR)

  Week 1, Week 5, Week 9, Week 13

• Pre-dialysis serum levels of λ FLC

  Week 1, Week 5, Week 9, Week 13

• Pre-dialysis serum levels of β2 microglobulin

  Week 1, Week 5, Week 9, Week 13

• Reduction ratio of α1 microglobulin (α1M)

  Up to 1 week

Study Arms (2)

Theranova 400 Dialyzer

EXPERIMENTAL

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.

Device: Theranova 400 Dialyzer

FX800

ACTIVE COMPARATOR

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.

Device: FX800 Dialyzer

Interventions

Theranova 400 Dialyzer DEVICE

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.

Theranova 400 Dialyzer

FX800 Dialyzer DEVICE

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.

FX800

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vantive Health LLC: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (8)

Investigational Site

Hefei, Anhui, 230601, China

Location

Investigational Site

Guangzhou, Guangdong, 510515, China

Location

Investigational Site

Zhengzhou, Henan, 450052, China

Location

Investigational Site

Wuhan, Hubei, 430060, China

Location

Investigational Site

Shanghai, Shanghai Municipality, 200011, China

Location

Investigational Site

Chengdu, Sichuan, 610041, China

Location

Investigational Site

Hangzhou, Zhejiang, 310014, China

Location

Investigational Site

Beijing, 100034, China

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: June 6, 2018
• Study Start: June 29, 2018
• Primary Completion: January 4, 2020
• Study Completion: January 4, 2020
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

CN (8)