What side effects are associated with this type of intervention?

Hemodialysis, a common treatment for kidney failure that filters blood through a dialyzer to remove waste products and excess fluid, is associated with several side effects. Patients often experience fatigue, low blood pressure, muscle cramps, and headaches. There are also risks of complications such as infections at the access site, anemia, and cardiovascular issues. These side effects and complications highlight the importance of careful monitoring and management during hemodialysis treatment.

What prior FDA approvals exist?

The FDA has approved numerous hemodialysis machines and dialyzers for the treatment of kidney failure, ensuring they meet rigorous safety and efficacy standards. These devices are designed to filter blood through a dialyzer to remove waste products and excess fluid, similar to the HemoCare™ Hemodialysis System being studied. Additionally, the FDA has approved medications to manage complications associated with kidney failure, including phosphate binders, erythropoiesis-stimulating agents, and drugs to control blood pressure and diabetes, which are common in patients undergoing dialysis.

What other types of research exist?

Promising novel alternatives to the HemoCare™ Hemodialysis System for kidney failure patients in 2024 include medium cut-off membrane dialyzers, which enhance the clearance of middle molecular weight uremic toxins without significant albumin loss. These dialyzers represent a significant advancement in dialysis technology, potentially offering better outcomes for patients. Additionally, ongoing research into wearable and portable dialysis devices, as well as advancements in bioartificial kidneys, may provide further innovative treatment options in the near future.

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Device

HemoCare Hemodialysis for Kidney Failure

N/A

Waitlist Available

Research Sponsored by Deka Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have a trained study care partner able to support subject for all at-home study treatments.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to ensure the safety of the HemoCare™ Hemodialysis System, which helps patients with severe kidney failure by cleaning their blood, similar to a healthy kidney. This is crucial for patients who rely on hemodialysis to stay healthy.

Who is the study for?

This trial is for individuals with chronic kidney failure who have used the HemoCare™ Hemodialysis System and can follow study requirements. They need a supportive care partner, stable vascular access, and must understand English. Pregnant or planning to become pregnant soon, significant other medical conditions or psychiatric disorders that could affect participation are reasons for exclusion.

What is being tested?

The safety of the HemoCare™ Hemodialysis System is being tested in patients who require ongoing treatment for kidney failure. This open-label study allows participants continued use while pre-market evaluations are conducted.

What are the potential side effects?

While specific side effects aren't listed here, hemodialysis systems like HemoCare™ may cause low blood pressure, muscle cramps, itching, sleep problems, anemia or infection at the dialysis site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have someone to help me with my treatment at home.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety Measures

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: The HemoCare™ Hemodialysis SystemExperimental Treatment1 Intervention

The HemoCare™ Hemodialysis System is intended for hemodialysis treatment, including short daily and nocturnal hemodialysis, of renal failure patients. The HemoCare™ Hemodialysis System is intended for use in chronic dialysis facilities, self-care dialysis facilities, or the home setting. All treatments must be prescribed by a physician and administered by a trained operator. Treatments must be performed under the supervision or assistance of a medical professional or a care partner who has been trained and deemed competent in the use of the device by the prescribing physician.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

HemoCare™ Hemodialysis System

2019

N/A

~70

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Hemodialysis, a common treatment for kidney failure, involves filtering the patient's blood through a dialyzer to remove waste products, excess fluids, and toxins. This artificial kidney process helps maintain electrolyte and fluid balance, which is crucial for patients whose kidneys can no longer perform these functions. Understanding this mechanism is vital for kidney failure patients as it underscores the importance of hemodialysis in managing their condition and preventing complications like fluid overload and toxin accumulation.

Design and challenges of the Randomized Evaluation of Normal versus Augmented Level Replacement Therapy (RENAL) Trial: high-dose versus standard-dose hemofiltration in acute renal failure.The membrane perspective of uraemic toxins: which ones should, or can, be removed?High-volume haemofiltration for sepsis in adults.