NCT03257410

Theranova 400 Dialyzer In End Stage Renal Disease (ESRD) Patients

A Multi-Center, Prospective, Randomized, Controlled, Open-label, Parallel Study to Evaluate the Safety and Efficacy of the Theranova 400 Dialyzer In End Stage Renal Disease (ESRD) Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: Vantive Health LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study evaluates the efficacy and safety of the Theranova 400 dialyzer compared with Elisio-17 H dialyzer in end stage renal disease patients receiving hemodialysis treatment. Efficacy will be determined by the removal of middle molecules (with different molecular size) from the blood compartment. Safety will be evaluated by maintaining pre-dialysis serum albumin levels and other safety events including laboratory tests and adverse events. Patients will undergo 3 dialysis sessions per week, for 24 weeks.

Conditions

• End Stage Renal Disease

Interventions

Type	Name	Description
DEVICE	Theranova 400 dialyzer	Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
DEVICE	Elisio-17H dialyzer	Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.

Timeline

• Start date: 2017-09-29
• Primary completion: 2018-10-27
• Completion: 2018-10-27
• First posted: 2017-08-22
• Last updated: 2025-07-14
• Results posted: 2020-12-19

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated device study