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

NCT06581393 | Completed FDA Device

• 1 other identifier: DIA-NSR-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  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

Study Arms (1)

Professional Care in an In-Center Hemodialysis Setting

EXPERIMENTAL

Hemodialysis using the Moda-flx Hemodialysis System

Device: Moda-flx Hemodialysis System

Interventions

Moda-flx Hemodialysis System DEVICE

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

Professional Care in an In-Center Hemodialysis Setting

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Diality Inc.: lead

Study Sites (1)

North America Research Institute

Ontario, California, 91762, United States

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: September 3, 2024
• Study Start: December 9, 2024
• Primary Completion: April 28, 2025
• Study Completion: April 28, 2025
• Last Updated: June 22, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)