NCT03547336

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 212 (actual)
• Sponsor: Vantive Health LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
DEVICE	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.

Timeline

• Start date: 2018-06-29
• Primary completion: 2020-01-04
• Completion: 2020-01-04
• First posted: 2018-06-06
• Last updated: 2025-03-13

Locations

8 sites across 1 country: China