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Diuretics for Chronic Kidney Failure (DIURESED Trial)
Phase 4
Waitlist Available
Led By Branko Braam, MD/Ph.D.
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 5
Awards & highlights
DIURESED Trial Summary
This trial is studying if diuretics (water pills) can help dialysis patients preserve kidney function, increase urine output, and reduce weight gain. No guidelines exist for their use.
Who is the study for?
This trial is for adults over 18 who started hemodialysis within the last year, still produce a fair amount of urine, and are expected to live at least another 6 months. They must understand and sign consent. It's not for those allergic to the study drugs, unable to take pills by mouth, changing dialysis type soon, or with recent severe electrolyte problems.Check my eligibility
What is being tested?
The trial tests if diuretics like Chlorthalidone and Furosemide can help maintain kidney function in dialysis patients. It aims to see if these 'water pills' increase urine output and reduce weight gain between treatments since there's no current standard on using them in this situation.See study design
What are the potential side effects?
Diuretics may cause dehydration, low blood pressure, dizziness upon standing up quickly (orthostatic hypotension), electrolyte imbalances like low potassium or magnesium levels which could affect heart rhythm or muscle function.
DIURESED Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 5
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 5
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in 24-hour urine output
Change in residual renal function
Secondary outcome measures
Adverse effects
Interdialytic weight gain
Patient-reported outcomes - ESAS-r
+2 moreDIURESED Trial Design
1Treatment groups
Experimental Treatment
Group I: Diuretic TherapyExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chlorthalidone
2013
Completed Phase 4
~41730
Furosemide
2015
Completed Phase 4
~4240
Find a Location
Who is running the clinical trial?
University of AlbertaLead Sponsor
897 Previous Clinical Trials
387,173 Total Patients Enrolled
Branko Braam, MD/Ph.D.Principal InvestigatorUniversity of Alberta
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a bad reaction or allergy to furosemide or chlorthalidone.If you have been taking certain water pills within the last week, you may not be able to participate in the trial. If you have been taking these pills for a while, you would need to stop taking them for a week before starting the trial.You are 18 years or older and have been on hemodialysis for less than a year.You still have good kidney function, as shown by producing more than 200cc of urine in a day.You cannot swallow pills or tablets.You are planning to switch to a different type of dialysis or have a kidney transplant within the next 6 weeks.You have had low levels of potassium, magnesium, or calcium in your blood in the past 2 weeks.You are expected to live for at least 6 more months.
Research Study Groups:
This trial has the following groups:- Group 1: Diuretic Therapy
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- 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.
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