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New treatment option for Chronic Kidney Disease Requiring Hemodialysis
Official title DIALysis With EXpanded Solute Removal
ClinicalTrials.gov ID: NCT06660277
What this study is testing
- What it's testing
- The goal of this clinical trial is to evaluate the health effects of expanded hemodialysis in patients receiving hemodialysis. The main question it aims to answer is: 1) Does expanded hemodialysis reduce the risk of death from any cause?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 and older
You may be able to join if
- Inclusion requires that all the following are present:
- One of:
- Age 60 years or older; or
- Age 45 to 59 years with a history of diabetes mellitus (Type 1 or Type 2) regardless of current glycemic status; and
- Receiving any form of dialysis regularly for the previous 90 days; and
You likely can't join if
- Patients are ineligible if they meet any of the following criteria:
- Not appropriate for this study in the opinion of the treating nephrologist or dialysis nurse practitioner due to any of:
- Known or anticipated intolerance to the Nipro Elisio HX dialyzer; or
- Planned to receive HDF; or
- Planned to receive nocturnal HD; or
- Anticipated to discontinue in-centre HD in the next 3 months for any reason (examples: palliation, transplantation, home dialysis, recovery of kidney...
See the full eligibility criteria
- Inclusion requires that all the following are present:
- One of:
- Age 60 years or older; or
- Age 45 to 59 years with a history of diabetes mellitus (Type 1 or Type 2) regardless of current glycemic status; and
- Receiving any form of dialysis regularly for the previous 90 days; and
- Currently receiving HD in-centre (main or satellite unit) 3 or more times per week; and
- A valid provincial or territorial health insurance card number.
- Patients are ineligible if they meet any of the following criteria:
- Not appropriate for this study in the opinion of the treating nephrologist or dialysis nurse practitioner due to any of:
- Known or anticipated intolerance to the Nipro Elisio HX dialyzer; or
- Planned to receive HDF; or
- Planned to receive nocturnal HD; or
- Anticipated to discontinue in-centre HD in the next 3 months for any reason (examples: palliation, transplantation, home dialysis, recovery of kidney function, death, others); or
- Anticipated severe non-adherence to the frequency or duration of prescribed dialysis treatment; or
- An overriding clinical preference for expanded HD (i.e., dialysis with the Elisio HX or other comparable dialyzer, such as Baxter TheranovaTM); or
- Another medical, psychosocial, or logistical reason; or
- Enrolled in another clinical trial that explicitly prohibits concurrent participation in other clinical trials or that would substantially interfere with adherence to the DIALEX procedures (note that DIALEX otherwise...
- Previously enrolled in this trial; or
- Declined participation.
The study team makes the final eligibility decision.
Where it's taking place
- London, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.