End Stage Renal Disease on DialysisPhase 4DIURESEDNCT05915286
Diuretic Use in Hemodialysis Patients With Residual Renal Function
A Phase 4 study testing Furosemide and Chlorthalidone in people with End Stage Renal Disease on Dialysis, run by University of Alberta at 1 site in Canada.
Trial summary
This pilot trial will evaluate the use of diuretic medications (furosemide and chlorthalidone) in participants on dialysis to see if these medications work to preserve existing kidney function, increase urine output, and reduce weight gain between dialysis treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease on Dialysis
- What is being tested?
- Furosemide and Chlorthalidone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteCanada
- Study dates
- 29 May 2023to 21 Feb 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (age 18 years or older), who are within their first 12 months of chronic (expected to need dialysis for at least 6 months), in-centre hemodialysis therapy, and
- Residual renal function defined as 24-hour urine volume >200cc, and
- Life expectancy of at least 6 months, and
- Participants must be able to understand the consent process and be able to sign a consent form or have a substitute decision maker who is able to understand and sign consent on their behalf. In the case of non-English speaking participants, a translator service will be used to provide study information and obtain consent.
Who cannot join
- Unable to complete baseline urine collection
- Documented allergy or adverse reaction to furosemide or chlorthalidone.
- Unable to take oral medications
- Patients expecting to change modality (peritoneal dialysis, home dialysis) or to receive a renal transplant in the next 6 weeks
- History of hypokalemia (<3.0 mmol/L), hypomagnesemia (<0.6mmol/L), or hypocalcaemia (<1.9mmol/L) in preceding 2 weeks.
- Already participating in another study and one of the studies could interfere with the other study
- Use of loop, or thiazide diuretic medications in the last week (if a patient is on chronic diuretics, they would need to be discontinued for 1 week before starting the trial)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diuretic Use in Hemodialysis Patients With Residual Renal Function: a Proof of Concept Study
This pilot trial will evaluate the use of diuretic medications (furosemide and chlorthalidone) in participants on dialysis to see if these medications work to preserve existing kidney function, increase urine output, and reduce weight gain between dialysis treatments. Diuretics, which are sometimes called water pills, help the body to get rid of salt (sodium) and water. There are currently no guidelines for the use of diuretic medications in dialysis patients, including the type to use, or how much to use.
Read the detailed description
Fluid overload, or extracellular fluid volume expansion, in patients on hemodialysis is an important predictor of mortality. It is associated with hypertension and left ventricular hypertrophy - both risk factors for cardiovascular disease. In the United States, 80% of patients receiving hemodialysis have hypertension and 40% of patients on hemodialysis die from cardiovascular disease. The pathophysiology of hypertension in these patients is multifactorial, however, combined excess fluid and sodium is a key contributor.
While ultrafiltration (removal of fluid through dialysis) is important in managing fluid overload, fluid removed by hemodialysis is a non-physiological process which imposes hemodynamic stress on the cardiovascular system in uremic patients. This system is already maladaptive as a result of decreased baroreceptor sensitivity and increased vascular stiffness, leading to higher risk of hemodynamic instability when fluid is removed from the intravascular compartment. In patients who are anuric, restriction of fluid and sodium intake and ultrafiltration are the only options for volume control. In patients who continue to produce urine, however, optimizing the amount of urine produced could improve fluid overload and decrease cardiovascular stress.
Previous studies have shown that patients on hemodialysis who have residual renal function have better volume and sodium control. Higher residual renal function and higher urine output lead to a lower interdialytic weight gain in patients receiving hemodialysis; each of these factors have been associated with lower mortality. One intervention that may increase or help maintain residual renal function and increase urine output and therefore reduce interdialytic weight gain is diuretic therapy, which promotes the excretion of sodium and water by the native kidneys. Questions remain regarding the dose-response of the drug furosemide, about the utility of adding the drug chlorthalidone, and their clinical affects.
The main objective of this study is to determine the effects of starting, and escalating doses of diuretic medications (furosemide +/- chlorthalidone) on 24-hour urine output (volume) over a five-week period in patients on hemodialysis who produce >200cc per day of urine.
Secondary objectives are:
- To evaluate the effect of diuretic medications on residual renal function
- To evaluate the effect of different doses of diuretics on interdialytic weight gain, ultrafiltration rates and intradialytic hypotension
- To examine the effect of diuretics on patient reported outcomes
- To evaluate adverse effects of different doses of diuretics
- To measure serum furosemide levels in this patient population
- Conditions
- End Stage Renal Disease on Dialysis
- Being tested
- Furosemide, Chlorthalidone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FurosemideDrug
Each participant will have a 2 week period of no diuretic use followed by 3 weeks of escalating doses: 1) initially furosemide twice daily, then (2) an increased dose of furosemide twice daily, and in the final week, (3) the addition of chlorthalidone once daily.
ChlorthalidoneDrug
Each participant will have a 2 week period of no diuretic use followed by 3 weeks of escalating doses: 1) initially furosemide twice daily, then (2) an increased dose of furosemide twice daily, and in the final week, (3) the addition of chlorthalidone once daily.
| Study group | Role | What they receive |
|---|---|---|
| Diuretic Therapy | Experimental | Not described Receives: Drug: Furosemide; Drug: Chlorthalidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 24-hour urine output
Change in urine output measured from 24-hour urine collection.
Measured: Week 1
Change in 24-hour urine output
Change in urine output measured from 24-hour urine collection.
Measured: Week 2
Change in 24-hour urine output
Change in urine output measured from 24-hour urine collection.
Measured: Week 3
Change in 24-hour urine output
Change in urine output measured from 24-hour urine collection.
Measured: Week 4
Change in 24-hour urine output
Change in urine output measured from 24-hour urine collection.
Measured: Week 5
Change in residual renal function
Calculated based on weekly bloodwork (urea and creatinine levels) and 24-hour urine collection.
Measured: Week 1
Change in residual renal function
Calculated based on weekly bloodwork (urea and creatinine levels) and 24-hour urine collection.
Measured: Week 2
Change in residual renal function
Calculated based on weekly bloodwork (urea and creatinine levels) and 24-hour urine collection.
Measured: Week 3
Change in residual renal function
Calculated based on weekly bloodwork (urea and creatinine levels) and 24-hour urine collection.
Measured: Week 4
Change in residual renal function
Calculated based on weekly bloodwork (urea and creatinine levels) and 24-hour urine collection.
Measured: Week 5
Secondary outcomes (23)
Interdialytic weight gain
Patient weight measured in kilograms
Measured: Week 1
Interdialytic weight gain
Patient weight measured in kilograms
Measured: Week 2
Interdialytic weight gain
Patient weight measured in kilograms
Measured: Week 3
Interdialytic weight gain
Patient weight measured in kilograms
Measured: Week 4
Interdialytic weight gain
Patient weight measured in kilograms
Measured: Week 5
Patient-reported outcomes - ESAS-r
Patient reported outcomes using the Edmonton Symptom Assessment System-revised (ESAS-r) questionnaire.
Measured: Week 1
Patient-reported outcomes - ESAS-r
Patient reported outcomes using the Edmonton Symptom Assessment System-revised (ESAS-r) questionnaire.
Measured: Week 2
Patient-reported outcomes - ESAS-r
Patient reported outcomes using the Edmonton Symptom Assessment System-revised (ESAS-r) questionnaire.
Measured: Week 3
Patient-reported outcomes - ESAS-r
Patient reported outcomes using the Edmonton Symptom Assessment System-revised (ESAS-r) questionnaire.
Measured: Week 4
Patient-reported outcomes - ESAS-r
Patient reported outcomes using the Edmonton Symptom Assessment System-revised (ESAS-r) questionnaire.
Measured: Week 5
Patient-reported outcomes - Muscle cramps
Patient reported outcomes using a muscle cramps question.
Measured: Week 1
Patient-reported outcomes - Muscle cramps
Patient reported outcomes using a muscle cramps question.
Measured: Week 2
Patient-reported outcomes - Muscle cramps
Patient reported outcomes using a muscle cramps question.
Measured: Week 3
Patient-reported outcomes - Muscle cramps
Patient reported outcomes using a muscle cramps question.
Measured: Week 4
Patient-reported outcomes - Muscle cramps
Patient reported outcomes using a muscle cramps question.
Measured: Week 5
Adverse effects
Adverse effects based on symptoms and weekly bloodwork.
Measured: Week 1
Adverse effects
Adverse effects based on symptoms and weekly bloodwork.
Measured: Week 2
Adverse effects
Adverse effects based on symptoms and weekly bloodwork.
Measured: Week 3
Adverse effects
Adverse effects based on symptoms and weekly bloodwork.
Measured: Week 4
Adverse effects
Adverse effects based on symptoms and weekly bloodwork.
Measured: Week 5
Urine furosemide levels
Urine furosemide levels from weekly urine samples
Measured: Week 3
Urine furosemide levels
Urine furosemide levels from weekly urine samples
Measured: Week 4
Urine furosemide levels
Urine furosemide levels from weekly urine samples
Measured: Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start29 May 2023
- Primary completion21 Feb 2025
- Study completion21 Feb 2025
Why it stopped: Personnel/staffing issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Disease on DialysisStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants enrolled in this proof-of-concept study will be treated with the intervention (diuretic medications) in escalating doses over the study period. Each participant will act as their own control with 2 weeks of no treatment followed by the intervention for 3 weeks.
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Branko Braam, MD/Ph.D., Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05915286
- Sponsor's protocol ID
- Pro00119451
- Acronym
- DIURESED
- Status last verified
- May 2026
- First submitted
- 13 Jun 2023
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diuretic Use in Hemodialysis Patients With Residual Renal Function: a Proof of Concept Study
- ClinicalTrials.gov ID
- NCT05915286
- Acronym / sponsor ID
- DIURESED / Pro00119451
- Conditions
- End Stage Renal Disease on Dialysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Personnel/staffing issues.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 29 May 2023 (actual)
- Primary completion
- 21 Feb 2025 (actual)
- Study completion
- 21 Feb 2025 (actual)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot trial will evaluate the use of diuretic medications (furosemide and chlorthalidone) in participants on dialysis to see if these medications work to preserve existing kidney function, increase urine output, and reduce weight gain between dialysis treatments. Diuretics, which are sometimes called water pills, help the body to get rid of salt (sodium) and water. There are currently no guidelines for the use of diuretic medications in dialysis patients, including the type to use, or how much to use.
Detailed description
Fluid overload, or extracellular fluid volume expansion, in patients on hemodialysis is an important predictor of mortality. It is associated with hypertension and left ventricular hypertrophy - both risk factors for cardiovascular disease. In the United States, 80% of patients receiving hemodialysis have hypertension and 40% of patients on hemodialysis die from cardiovascular disease. The pathophysiology of hypertension in these patients is multifactorial, however, combined excess fluid and sodium is a key contributor.
While ultrafiltration (removal of fluid through dialysis) is important in managing fluid overload, fluid removed by hemodialysis is a non-physiological process which imposes hemodynamic stress on the cardiovascular system in uremic patients. This system is already maladaptive as a result of decreased baroreceptor sensitivity and increased vascular stiffness, leading to higher risk of hemodynamic instability when fluid is removed from the intravascular compartment. In patients who are anuric, restriction of fluid and sodium intake and ultrafiltration are the only options for volume control. In patients who continue to produce urine, however, optimizing the amount of urine produced could improve fluid overload and decrease cardiovascular stress.
Previous studies have shown that patients on hemodialysis who have residual renal function have better volume and sodium control. Higher residual renal function and higher urine output lead to a lower interdialytic weight gain in patients receiving hemodialysis; each of these factors have been associated with lower mortality. One intervention that may increase or help maintain residual renal function and increase urine output and therefore reduce interdialytic weight gain is diuretic therapy, which promotes the excretion of sodium and water by the native kidneys. Questions remain regarding the dose-response of the drug furosemide, about the utility of adding the drug chlorthalidone, and their clinical affects.
The main objective of this study is to determine the effects of starting, and escalating doses of diuretic medications (furosemide +/- chlorthalidone) on 24-hour urine output (volume) over a five-week period in patients on hemodialysis who produce >200cc per day of urine.
Secondary objectives are:
- To evaluate the effect of diuretic medications on residual renal function
- To evaluate the effect of different doses of diuretics on interdialytic weight gain, ultrafiltration rates and intradialytic hypotension
- To examine the effect of diuretics on patient reported outcomes
- To evaluate adverse effects of different doses of diuretics
- To measure serum furosemide levels in this patient population
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants enrolled in this proof-of-concept study will be treated with the intervention (diuretic medications) in escalating doses over the study period. Each participant will act as their own control with 2 weeks of no treatment followed by the intervention for 3 weeks.
| Arm | Type | Receives |
|---|---|---|
| Diuretic Therapy | Experimental | Drug: Furosemide, Drug: Chlorthalidone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (age 18 years or older), who are within their first 12 months of chronic (expected to need dialysis for at least 6 months), in-centre hemodialysis therapy, and
- Residual renal function defined as 24-hour urine volume >200cc, and
- Life expectancy of at least 6 months, and
- Participants must be able to understand the consent process and be able to sign a consent form or have a substitute decision maker who is able to understand and sign consent on their behalf. In the case of non-English speaking participants, a translator service will be used to provide study information and obtain consent.
Key exclusion criteria (7 listed)
- Unable to complete baseline urine collection
- Documented allergy or adverse reaction to furosemide or chlorthalidone.
- Unable to take oral medications
- Patients expecting to change modality (peritoneal dialysis, home dialysis) or to receive a renal transplant in the next 6 weeks
- History of hypokalemia (<3.0 mmol/L), hypomagnesemia (<0.6mmol/L), or hypocalcaemia (<1.9mmol/L) in preceding 2 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FurosemideEach participant will have a 2 week period of no diuretic use followed by 3 weeks of escalating doses: 1) initially furosemide twice daily, then (2) an increased dose of furosemide twice daily, and in the final week, (3) the addition of chlorthalidone once daily. | Drug | Diuretic Therapy |
| ChlorthalidoneEach participant will have a 2 week period of no diuretic use followed by 3 weeks of escalating doses: 1) initially furosemide twice daily, then (2) an increased dose of furosemide twice daily, and in the final week, (3) the addition of chlorthalidone once daily. | Drug | Diuretic Therapy |
Primary outcome
Change in 24-hour urine output
Time frame: Week 1
Change in urine output measured from 24-hour urine collection.
Change in 24-hour urine output
Time frame: Week 2
Change in urine output measured from 24-hour urine collection.
Change in 24-hour urine output
Time frame: Week 3
Change in urine output measured from 24-hour urine collection.
Change in 24-hour urine output
Time frame: Week 4
Change in urine output measured from 24-hour urine collection.
Change in 24-hour urine output
Time frame: Week 5
Change in urine output measured from 24-hour urine collection.
Change in residual renal function
Time frame: Week 1
Calculated based on weekly bloodwork (urea and creatinine levels) and 24-hour urine collection.
Change in residual renal function
Time frame: Week 2
Calculated based on weekly bloodwork (urea and creatinine levels) and 24-hour urine collection.
Change in residual renal function
Time frame: Week 3
Calculated based on weekly bloodwork (urea and creatinine levels) and 24-hour urine collection.
Change in residual renal function
Time frame: Week 4
Calculated based on weekly bloodwork (urea and creatinine levels) and 24-hour urine collection.
Change in residual renal function
Time frame: Week 5
Calculated based on weekly bloodwork (urea and creatinine levels) and 24-hour urine collection.
23 secondary outcomes
Interdialytic weight gain
Time frame: Week 1
Interdialytic weight gain
Time frame: Week 2
Interdialytic weight gain
Time frame: Week 3
Interdialytic weight gain
Time frame: Week 4
Interdialytic weight gain
Time frame: Week 5
Patient-reported outcomes - ESAS-r
Time frame: Week 1
Patient-reported outcomes - ESAS-r
Time frame: Week 2
Patient-reported outcomes - ESAS-r
Time frame: Week 3
Patient-reported outcomes - ESAS-r
Time frame: Week 4
Patient-reported outcomes - ESAS-r
Time frame: Week 5
Patient-reported outcomes - Muscle cramps
Time frame: Week 1
Patient-reported outcomes - Muscle cramps
Time frame: Week 2
Patient-reported outcomes - Muscle cramps
Time frame: Week 3
Patient-reported outcomes - Muscle cramps
Time frame: Week 4
Patient-reported outcomes - Muscle cramps
Time frame: Week 5
Adverse effects
Time frame: Week 1
Adverse effects
Time frame: Week 2
Adverse effects
Time frame: Week 3
Adverse effects
Time frame: Week 4
Adverse effects
Time frame: Week 5
Urine furosemide levels
Time frame: Week 3
Urine furosemide levels
Time frame: Week 4
Urine furosemide levels
Time frame: Week 5
Results and safety
The study was stopped early (reason given: Personnel/staffing issues.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Branko Braam, MD/Ph.D. principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Furosemide and Chlorthalidone in people with End Stage Renal Disease on Dialysis, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Personnel/staffing issues.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 24-hour urine output (time frame: Week 1). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.