First Evaluation of the Moda-Flx Hemodialysis System™ in Real World Clinical Settings

Not Applicable

Not yet recruiting

• Conditions: End Stage Renal Disease; End Stage Renal Disease on Dialysis; End Stage Kidney Disease
• Interventions: Device: Moda-flx Hemodialysis System

• Registration Number: NCT06581393
• Lead Sponsor: Diality Inc.

Brief Summary

This is a non-significant risk study utilizing a device cleared for use by the FDA under its 510(k) clearance. Consented patients will complete their usual dialysis treatment under professional care in an ICHD (In-Center Hemodialysis) setting.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-26
• Study First Submitted QC: 2024-08-29
• Last Update Submitted: 2024-08-29
• Study Start: 2024-09
• Study First Posted: 2024-09-03
• Last Update Posted: 2024-09-03
• Primary Completion: 2024-10
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Have a diagnosis of end stage kidney disease (ESKD) adequately treated by maintenance dialysis (defined as achieving a spKt/V ≥ 1.2 OR stdKt/V ≥ 2.1) and be deemed stable by their treating nephrologist prior to consent.
• Must sign the informed consent and a Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant authorization statement.
• Understand the nature of the procedures and the requirements of the Study.

Exclusion Criteria

• Have a significant cognitive impairment that would preclude informed consent or the capacity for completing dialysis as prescribed by their treating nephrologist.
• In the opinion of the treating nephrologist, any other reason in which study participation would result in undue risk, including but not limited to protocol required prescription parameters.
• Are contraindicated for or not indicated to use the Moda-flx Hemodialysis System™ according to the Instructions For Use (IFU).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Professional Care in an In-Center Hemodialysis Setting	Moda-flx Hemodialysis System	Hemodialysis using the Moda-flx Hemodialysis System

Primary Outcome Measures

Name	Time	Method
Single-Pool Standardized Dialysis Adequacy	Samples will be collected before and after each dialysis treatment at Visit 1, Visit 2, Visit 3 and at Visit 4 over a two week period	Single-pool standardized dialysis adequacy (spKt/V) will be measured using the second-generation formula of Daugirdas. This formula normalizes urea clearance among heterogeneous hemodialysis schedules, where K=dialyzer clearance or urea, t=treatment time, and V=subject's volume of urea distribution. spKt/V values of ≥ 1.2 are regarded as being adequate.
Changes in Blood Chemistry	Samples will be collected at Visit 1 prior to initiating the first dialysis treatment, Visit 2, Visit 3 and at the conclusion of Visit 4 over a two week period	Changes in overall blood chemistry laboratory levels from Visit 1 to Visit 4.
Changes in Complete Blood Count	Samples will be collected at Visit 1 prior to initiating the first dialysis treatment, Visit 2, Visit 3 and at the conclusion of Visit 4 over a two week period	Changes in overall complete blood count levels from Visit 1 to Visit 4.
Changes in Iron Studies	Samples will be collected at Visit 1 prior to initiating the first dialysis treatment, Visit 2, Visit 3 and at the conclusion of Visit 4 over a two week period	Changes in overall iron studies levels from Visit 1 to Visit 4.

Trial Locations

Locations (1)

North America Research Institute; 🇺🇸 Ontario, California, United States