A Study to Demonstrate the Safety and Effectiveness of the NIKKISO DBB-EXA ES Hemodialysis Delivery System (HEMO)

A Prospective, Multi-Center, Randomized, Controlled Trial to Demonstrate the Safety and Effectiveness of the NIKKISO DBB-EXA ES Hemodialysis Delivery System in Adult Patients With Chronic Renal Failure

The study objective is to verify the safety and effectiveness of the DBB-EXA ES Hemodialysis Delivery System to consistently deliver dialysate of the appropriate quality for infusion.

Study Overview

• Status: Completed
• Conditions: Dialysis; Chronic Renal Failure
• Intervention / Treatment: Device: DBB-EXA ES Hemodialysis System

Detailed Description

The study objective is to verify the safety and effectiveness of the DBB-EXA ES Hemodialysis Delivery System to consistently deliver dialysate of the appropriate quality for infusion. The safety will be evaluated by comparing the adverse event rate in the DBB-EXA ES Hemodialysis group (investigational) vs. the standard dialysis group (control).

The study population will include eligible adult patients diagnosed with chronic renal failure requiring routine dialysis treatments for a minimum of 90 days and with a minimum of 3 weekly sessions. Treatment duration will be at the discretion of the investigator. The duration of study participation for each subject is approximately eight (8) weeks; four (4) weeks of routine dialysis and four (4) weeks of treatment dialysis. The expected total study duration across all subjects (from recruitment to last subject visits) is approximately five (5) to six (6) months, dependent upon subject recruitment/enrollment and meeting 360 evaluable treatments. A minimum of 30 eligible subjects will be enrolled into the study ensuring a minimum of 360 evaluable treatments in the treatment arm.

The sub-study, VARRM, was conducted following the subject's completion of the primary eight (8) week clinical study. The total participation time for the VARRM sub-study was approximately 1.5 weeks. Subjects that participated in the VARRM sub-study had their vascular recirculation rates collected during treatments. A minimum of 12 subjects were expected to participate in this sub-study, with a minimum of 21 and maximum of 36 dialysis accesses evaluated.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48215
      • Great Lakes Dialysis
    • Southfield, Michigan, United States, 48033
      • Great Lakes Dialysis - West

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female ≥18 years of age
2. Chronic renal failure diagnosis
3. Minimum of 90 days of stable hemodialysis treatment with a minimum of 3 treatment sessions per week. The duration of each treatment session is in the discretion of the investigator.
4. Reliable vascular access
5. Hemodialysis treatment a minimum of three (3) sessions per week
6. Subject agrees not to eat or drink during treatments
7. Understand and sign the informed consent form

Exclusion Criteria:

1. Unable to receive anticoagulation
2. Hypercoagulation diagnosis
3. Hyperviscosity diagnosis
4. Most recent hemoglobin less than 9
5. Active bacterial infection
6. Women of childbearing potential, pregnant and/or lactating females verified by urine or serum pregnancy test
7. Life expectancy less than 6 months
8. Cognitive impairment, dementia, or other condition that limits the ability to provide informed consent and to comply with study procedures, or any other reason that the Investigator believes to contraindicate study participation.
9. Current or known future need for a central venous catheter (CVC)
10. Involved in another clinical research trial within the prior 30 days
11. Diagnosed with systemic consistent hypotension as defined by being systolic <90 mm Hg or diastolic <60 mm Hg
12. Immunocompromised patients (e.g. active malignancy, current chemotherapy treatment, transplant recipients, any patient on immunosuppressive medication, or patients with current autoimmune disease).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Routine first; Group A subjects will be assigned to 4 weeks of routine dialysis (control group) followed by 4 weeks of treatment dialysis with the DBB-EXA ES Hemodialysis System (investigational group).	Device: DBB-EXA ES Hemodialysis System; The DBB-EXA ES Hemodialysis Delivery System is intended to support an optional online priming, rinseback and emergency bolus features. The appropriate priming of the hollow fiber dialyzer and blood tubing lines removes debris and air prior to device use, as well as ensuring proper rinseback.
Experimental: Investigational first; Group B subjects will be assigned to 4 weeks of treatment dialysis with the DBB-EXA ES Hemodialysis System (investigational group) followed by 4 weeks of routine dialysis (control group).	Device: DBB-EXA ES Hemodialysis System; The DBB-EXA ES Hemodialysis Delivery System is intended to support an optional online priming, rinseback and emergency bolus features. The appropriate priming of the hollow fiber dialyzer and blood tubing lines removes debris and air prior to device use, as well as ensuring proper rinseback.
Other: VARRM sub-study; Following completion of the initial 8-week treatment, subject's were eligible to participate in the sub-study, VARRM. The total participation time for the VARRM sub-study was approximately 1.5 weeks.	Device: DBB-EXA ES Hemodialysis System; The DBB-EXA ES Hemodialysis Delivery System is intended to support an optional online priming, rinseback and emergency bolus features. The appropriate priming of the hollow fiber dialyzer and blood tubing lines removes debris and air prior to device use, as well as ensuring proper rinseback.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Event Rate	The safety will be evaluated by comparing the adverse event rate in the DBB-EXA ES Hemodialysis group (investigational) vs. the standard dialysis group (control)	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Colony Forming Units and Endotoxin Levels	The effectiveness will be evaluated by comparing the total Colony Forming Units (CFUs) and endotoxin levels calculated within dialysis fluid in the DBB-EXA ES Hemodialysis group (investigational) vs. the standard dialysis group (control).	8 Weeks
Fluid Balance Evaluation	The impact that online priming, online rinse back and online emergency bolus, if performed, has on fluid balance will be evaluated by assessing the proportion of subjects that have a Post-Dialysis Target Weight variance of > 0.5kg in the DBB-EXA ES Hemodialysis group (investigational) vs. the standard dialysis group (control).	8 Weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sub-Study VARRM	The Vascular Access Recirculation Rate Measurement (VARRM) will be assessed by comparing the recirculation rate obtained from the DBB-EXA ES device to the non-invasive commercially approved Transonic® HD03 Hemodialysis Monitor (Transonic Systems, Inc.)	1.5 weeks

Collaborators and Investigators

• Sponsor: Nikkiso America, Inc.
• Collaborators: NAMSA

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2020
• Primary Completion (Actual): February 24, 2021
• Study Completion (Actual): May 1, 2021

Study Registration Dates

• First Submitted: November 30, 2020
• First Submitted That Met QC Criteria: November 30, 2020
• First Posted (Actual): December 7, 2020

Study Record Updates

• Last Update Posted (Actual): October 6, 2021
• Last Update Submitted That Met QC Criteria: September 28, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: DBB-EXA ES-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes