Blood Flow Effects on Silicon Substrates

NCT03241667 | Withdrawn FDA Device

• 1 other identifier: AK2017
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a non-randomized, open label, uncontrolled first in human safety study, testing the the material used in the artificial kidney device in subjects already on hemodialysis. Six subjects already on hemodialysis, who meet the study inclusion and exclusion criteria, and who dialyze at one of the UCSF associated hemodialysis units will be recruited. Each subject will be tested during one non hemodialysis day, at the UCSF Moffitt-Long Hospital Acute Hemodialysis Unit (AHU). The artificial kidney engineers have created a blood flow system that can be substituted for the dialysis filter in a standard hemodialysis machine. This is NOT a dialysis filter. It allows the subjects blood to come in contact with the material while the blood is being circulated as is regularly done during a hemodialysis session.

Conditions

ESRD

Outcome Measures

Primary Outcomes (2)

• material stability

  This is a first in human safety study, testing the safety of the material used in the artificial kidney device in subjects already on hemodialysis. Specific aims include: Aim 1: To prove that blood does not degrade the material (see study description for details of processes used) 1.a. by evaluating the effect on surface roughness via scanning electron microscopy of the hemocartridge plates 1\. b. by studying the effect on film thickness via scanning electron microscopy and immunohistochemistry for platelet adhesion.

  6 months

• effects of the hemocartridge materials on inflammatory and coagulation factors in blood

  Aim 2: To prove that this material is does not induce inflammatory or coagulation effects nor induce hemolysis. The investigators will do this by drawing blood before, during and after the procedure for inflammatory markers and coagulation factors. The investigators will also evaluate whether any evidence of mechanical dysfunction, such as hemolysis occurs during the treatment. See the detailed study description for the listing and timing of the tests. 1.c. evaluation of mechanical dysfunction

  6 months

Interventions

HemoCartridge DEVICE

Our goal is to apply MEMS (microelectromechanical systems) and nanotechnology to miniaturize the bioartificial kidney (BAK) into an implantable, self-monitoring, and self-regulating renal surrogate. The implantable BAK (iBAK) is a biocompatible cartridge containing stacks of hemofilter membranes (HemoCartridge) and renal tubule cell bioreactors (BioCartridge) combined to mimic nephron function. Here, we plan to test ONLY the material being used to construct the HemoCartridge, to be sure in humans when substituted for a standard hemodialysis filter, subjects don't develop any clinical problems or side effects during several hours of blood exposure to the material. The AK material will be engineered by the study team to allow the system to be substituted in place of a standard HD filter.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ESRD

You may qualify if:

• y/o
• ESRD on hemodialysis for at least 3 months
• HD access capable of sustaining at least 300 ml/min blood flow
• Hg \> 10.0 g
• Able to take aspirin 81 mg/day for a week prior to the study (for those subjects not already on aspirin)
• Able to read, speak and understand English
• Capable of providing signed informed consent
• HD pt at one of the UCSF outpatient HD units

You may not qualify if:

• Subjects with active liver, cardiovascular, neurologic or psychiatric diseases
• Subjects with other active medical problems (e.g., cancer undergoing treatment)
• h/o intradialytic or orthostatic hypotension
• h/o thrombosis or on treatment for thrombosis or use of anticoagulants, excluding antiplatelet agents
• h/o active infection or on antibiotics
• h/o active autoimmune diseases or other inflammatory states
• Ongoing alcohol or illegal drug use
• Pregnant
• H/o hemolysis or allergic reactions to any dialyzers
• Anyone who in the opinion of the study doctors is not qualified to be in the study.

Sponsors & Collaborators

• University of California, San Francisco: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood testing, hemocartridge system

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 Officials

• Shuvo Roy, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: August 7, 2017
• Study Start: July 15, 2019
• Primary Completion: February 15, 2020
• Study Completion: June 30, 2020
• Last Updated: February 28, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share