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Home Hemodialysis for Kidney Failure
Study Summary
This trial compares the safety and effectiveness of Quanta SC+ when used at home versus in a hemodialysis facility.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- My heart's pumping ability is severely reduced.I am expected to receive an organ transplant during the study.Your blood has less than 28% red blood cells.My treatment costs are covered by insurance or another arrangement.I often miss my dialysis treatments.Your hemoglobin level is less than 9 g/dL when you join the study.My cancer is expected to worsen in the next 6-12 months.My blood pressure is stable and within 90 to 180 mmHg.You test positive for hepatitis B surface antigen.I or my caregiver understand the study and can follow its requirements, including home-based dialysis and returning to the treatment center as needed.I am receiving dialysis for sudden kidney failure.I or my caregiver can learn to use and troubleshoot a medical device.I have someone to help me with home hemodialysis.I am willing to undergo dialysis 3 times a week for 4 hours or as per the clinic's standard; or 4 times a week for 3.5 hours at home.I am not pregnant nor trying to become pregnant, and if capable, I use birth control.I have known issues with blood clotting.I cannot take care of myself without help.I am between 18 and 80 years old.I am currently suffering from a severe infection.I often have significant drops in blood pressure during dialysis that require intervention.I have a severe, life-threatening rheumatic disease.I have not had a major heart problem in the last 3 months.I have been on dialysis for at least 90 days and am stable enough for home dialysis.I have had severe allergic reactions to dialysis materials.I have severe swelling due to fluid buildup from liver cirrhosis.My heart disease is not stable.I cannot tolerate heparin.I do not have dementia and can understand medical procedures.I or my caregiver can perform hemodialysis at home.My doctor expects I have less than 12 months to live.
- Group 1: Hemodialysis Treatments
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
At how many locations can this research be accessed?
"This research is taking place at Northwest Kidney Centers in Seattle, Washington; Sundance Home Dialysis in Hurst, Texas; and Capital Nephrology Medical Group in Sacramento, Indiana. Additionally, there are nine other clinical sites conducting this trial."
Is the enrollment phase of this experiment still taking place?
"This research project is open for enrolment, with initial postings appearing on November 18th 2021 and the last update being October 18th 2022. This information can be found on clinicaltrials.gov."
Are participants of this trial restricted to those 18 years or older?
"Prerequisites for this clinical trial stipulate that all participants are between the ages of 18 and 80. There is a total of 6 trials aimed at minors and 172 specifically targeting seniors."
Am I eligible to join this medical experiment?
"This clinical trial is seeking 50 suitable patients with kidney failure between the ages of 18 and 80. In order to qualify, individuals must provide written consent, have a care partner available for training and present during home sessions, fulfill certain dialysis prescription criteria, possess adequate electrical connections along with cellular signal or wifi capacity in their homes as assessed by Quanta prior to visit C1, understand the nature of procedures required under this study's protocol, be able to use & troubleshoot machines when needed, demonstrate acceptable physical ability for hemodialysis at home according to treating physician's opinion, and possess working vascular access that allows blood flow rate of"
What is the participant count for this research endeavor?
"Quanta Dialysis Technologies Ltd is sponsoring a medical trial that necessitates 50 compliant patients. Northwest Kidney Centers in Seattle, Washington and Sundance Home Dialysis in Hurst, Texas are two of the many clinical sites where this research will be conducted."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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