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

NCT04655989 | Completed DMC FDA Device

• 1 other identifier: DBB-EXA ES-001
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Dialysis; Chronic Renal Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Total Colony Forming Units and Endotoxin Levels

  8 Weeks

• Fluid Balance Evaluation

  8 Weeks

Other Outcomes (1)

• Sub-Study VARRM

  1.5 weeks

Study Arms (3)

Routine first

EXPERIMENTAL

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

Investigational first

EXPERIMENTAL

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

VARRM sub-study

OTHER

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

Interventions

DBB-EXA ES Hemodialysis System DEVICE

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.

Investigational first; Routine first; VARRM sub-study

Eligibility Criteria

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

You may qualify if:

• Male or female ≥18 years of age
• Chronic renal failure diagnosis
• 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.
• Reliable vascular access
• Hemodialysis treatment a minimum of three (3) sessions per week
• Subject agrees not to eat or drink during treatments
• Understand and sign the informed consent form

You may not qualify if:

• Unable to receive anticoagulation
• Hypercoagulation diagnosis
• Hyperviscosity diagnosis
• Most recent hemoglobin less than 9
• Active bacterial infection
• Women of childbearing potential, pregnant and/or lactating females verified by urine or serum pregnancy test
• Life expectancy less than 6 months
• 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.
• Current or known future need for a central venous catheter (CVC)
• Involved in another clinical research trial within the prior 30 days
• Diagnosed with systemic consistent hypotension as defined by being systolic \<90 mm Hg or diastolic \<60 mm Hg
• Immunocompromised patients (e.g. active malignancy, current chemotherapy treatment, transplant recipients, any patient on immunosuppressive medication, or patients with current autoimmune disease).

Sponsors & Collaborators

• Nikkiso America, Inc.: lead
• NAMSA: collaborator

Study Sites (2)

Great Lakes Dialysis

Detroit, Michigan, 48215, United States

Location

Great Lakes Dialysis - West

Southfield, Michigan, 48033, 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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant -Office of Chief Medical Officer

Model Details: 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). 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). After completion of the initial 8-week treatment period, subjects were eligible for the Vascular Access Recirculation Rate Measurement (VARRM) sub-study.

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 7, 2020
• Study Start: November 30, 2020
• Primary Completion: February 24, 2021
• Study Completion: May 1, 2021
• Last Updated: October 6, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)