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

Diality Inc.12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

End Stage Renal Disease End Stage Renal Disease on Dialysis End Stage Kidney Disease

Interventions

Moda-flx Hemodialysis SystemDEVICE

All participants will complete up to 4 dialysis treatments on the Moda-flx Hemodialysis System over a period of up to 2 weeks.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

North America Research Institute

Ontario, California, United States

Outcomes

Primary Outcomes

Single-Pool Standardized Dialysis Adequacy

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.

Time frame: 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

Changes in Blood Chemistry

Changes in overall blood chemistry laboratory levels from Visit 1 to Visit 4.

Time frame: 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 Complete Blood Count

Changes in overall complete blood count levels from Visit 1 to Visit 4.

Time frame: 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 Iron Studies

Changes in overall iron studies levels from Visit 1 to Visit 4.

Time frame: 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

Data from ClinicalTrials.gov

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