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

Completed · Not applicable

Conditions studied: Dialysis, Chronic Renal Failure

In brief

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.

Key facts

Study ID

NCT04655989

Run by

Nikkiso America, Inc.

People needed

31

Starts

2020-11-30

Expected to finish

2021-05-01

Last updated by the study team

2021-10-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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).

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.