Diuretic Use in Hemodialysis Patients With Residual Renal Function

NCT05915286 | Terminated Phase 4

• 1 other identifier: Pro00119451
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

End Stage Renal Disease on Dialysis

Outcome Measures

Primary Outcomes (10)

• Change in 24-hour urine output

  Change in urine output measured from 24-hour urine collection.

  Week 1

• Change in 24-hour urine output

  Change in urine output measured from 24-hour urine collection.

  Week 2

• Change in 24-hour urine output

  Change in urine output measured from 24-hour urine collection.

  Week 3

• Change in 24-hour urine output

  Change in urine output measured from 24-hour urine collection.

  Week 4

• Change in 24-hour urine output

  Change in urine output measured from 24-hour urine collection.

  Week 5

• Change in residual renal function

  Calculated based on weekly bloodwork (urea and creatinine levels) and 24-hour urine collection.

  Week 1

• Change in residual renal function

  Calculated based on weekly bloodwork (urea and creatinine levels) and 24-hour urine collection.

  Week 2

• Change in residual renal function

  Calculated based on weekly bloodwork (urea and creatinine levels) and 24-hour urine collection.

  Week 3

• Change in residual renal function

  Calculated based on weekly bloodwork (urea and creatinine levels) and 24-hour urine collection.

  Week 4

• Change in residual renal function

  Calculated based on weekly bloodwork (urea and creatinine levels) and 24-hour urine collection.

  Week 5

Secondary Outcomes (23)

• Interdialytic weight gain

  Week 1

• Interdialytic weight gain

  Week 2

• Interdialytic weight gain

  Week 3

• Interdialytic weight gain

  Week 4

• Interdialytic weight gain

  Week 5

Study Arms (1)

Diuretic Therapy

EXPERIMENTAL

Drug: Furosemide; Drug: Chlorthalidone

Interventions

Furosemide DRUG

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.

Diuretic Therapy

Chlorthalidone DRUG

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.

Diuretic Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Location

MeSH Terms

Interventions

Furosemide; Chlorthalidone

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds; Benzenesulfonamides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Benzophenones; Phthalimides; Imides; Ketones; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Branko Braam, MD/Ph.D.

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: June 22, 2023
• Study Start: May 29, 2023
• Primary Completion: February 21, 2025
• Study Completion: February 21, 2025
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)