Diuretic Tuner App for Chronic Kidney Disease

Overseen By Kamalanathan K Sambandam, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Must be taking: Diuretics

Disqualifiers: Dialysis, Dementia, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 90 days

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile app called the Diuretic Tuner, designed to help people with kidney problems manage body swelling by adjusting their diuretic medication. The app guides users in changing their diuretic dosage based on daily entries of weight and blood pressure. It suits those with serious kidney issues who experience body swelling and have a smartphone. Participants will use the app daily and attend a few study visits over 90 days. As an unphased trial, this study allows participants to contribute to innovative research that could enhance kidney care management.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you will need to follow daily instructions for diuretic medication dosing provided by the mobile app.

What prior data suggests that this mobile phone application is safe for patients with kidney problems?

Research has shown that diuretics, the medications managed by the Diuretic Tuner app, are generally safe and help control fluid levels in people with kidney issues. Studies have found that diuretics can improve heart health and lower blood pressure by reducing fluid in the body.

The Diuretic Tuner app is a new tool designed to help patients manage their diuretic medications more effectively. Although specific data on the app's safety is not yet available, it introduces no new chemical risks since it is not a new drug. Participants using the app will continue to have regular blood tests to ensure their safety.

In summary, the Diuretic Tuner app aims to help people use diuretics safely and effectively. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Diuretic Tuner app because it offers a personalized approach to managing chronic kidney disease, unlike traditional diuretic treatments that often involve a one-size-fits-all prescription. This app stands out by using a patient’s specific health data—like dry weight, diuretic dose, daily weights, and blood pressures—to provide tailored guidance on diuretic use. Additionally, it helps patients track their progress and adherence with a built-in diary for weights, blood pressures, fluid intake, and medication compliance. By empowering patients with this level of personalized data, the app could lead to more effective and safer diuretic management.

What evidence suggests that the Diuretic Tuner app is effective for controlling body swelling in patients with kidney problems?

Research has shown that diuretics aid people with chronic kidney disease (CKD) by lowering blood pressure and reducing swelling. Diuretics decrease the amount of fluid in the body, improving heart health and making physical activity easier. This trial tests the Diuretic Tuner app, which aims to enhance these benefits by helping users adjust their diuretic doses based on daily weight and blood pressure measurements. By doing so, the app personalizes diuretic treatment, making it more effective for managing symptoms like swelling. Early evidence suggests that this customized approach might help patients control their symptoms more successfully. ^{2 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for adults with severe kidney disease or nephrotic syndrome who have swelling due to fluid overload. They must be able to use a smartphone app, weigh between 100-300 lbs, and not be at immediate risk of needing dialysis or have life-threatening low potassium or sodium levels.

Inclusion Criteria

I have severe kidney issues with swelling in my body and weigh less without the swelling.

Exclusion Criteria

Your blood test shows low levels of potassium.

You are expected to live for less than 6 months.

The presence of a medical condition that would interfere with effectively using the Diuretic Tuner (dementia, illiteracy, or blindness)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Diuretic Tuner mobile application to adjust diuretic dosing based on daily weight and blood pressure inputs

90 days

1 initial visit (in-person), periodic blood testing at 2 weeks, 90 days, and up to 4 other times

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a survey on tool usability

4 weeks

1 visit (in-person) for survey completion

What Are the Treatments Tested in This Trial?

Interventions

• Diuretic Tuner

Trial Overview The study tests a mobile app called Diuretic Tuner that guides daily diuretic dosing based on the patient's blood pressure and weight inputs. The goal is to manage body swelling in patients over a 90-day period with regular monitoring and final feedback via survey.

How Is the Trial Designed?

Group I: Diuretic Tuner users Experimental Treatment 1 Intervention

The Diuretic Tuner is a mobile device application that integrates a patient's estimated dry weight and starting diuretic dose (both defined by a healthcare provider) with daily weights and blood pressures to provide individualized guidance to the patient in day-to-day adjustments to his or her diuretic regimen. In addition, the application generates a diary of daily weights, blood pressures, fluid intake, and medication compliance.

Diuretic Tuner is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Diuretics for:

• High Blood Pressure
• Edema
• Heart Failure
• Chronic Kidney Disease
• Liver Disease

Approved in United States as Diuretics for:

• High Blood Pressure
• Edema
• Heart Failure
• Chronic Kidney Disease
• Liver Disease

Approved in Canada as Diuretics for:

• High Blood Pressure
• Edema
• Heart Failure
• Chronic Kidney Disease
• Liver Disease

Approved in Japan as Diuretics for:

• High Blood Pressure
• Edema
• Heart Failure
• Chronic Kidney Disease
• Liver Disease

Approved in China as Diuretics for:

• High Blood Pressure
• Edema
• Heart Failure
• Chronic Kidney Disease
• Liver Disease

Approved in Switzerland as Diuretics for:

• High Blood Pressure
• Edema
• Heart Failure
• Chronic Kidney Disease
• Liver Disease

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Published Research Related to This Trial

Thiazide diuretics are established as first-line treatments for hypertension and can be used alone or in combination with other medications, but their use in patients with advanced chronic kidney disease (CKD) is often avoided due to safety and efficacy concerns.

An updated review by Minutolo et al. examines the pharmacological properties and clinical trial data of thiazide diuretics in CKD patients, suggesting that these medications may still be effective and safe despite the reluctance to prescribe them in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thiazides in chronic kidney disease: "back to the future". de la Espriella, R., Cobo, M., Núñez, J.[2023]

Potassium-sparing diuretics are particularly useful for cirrhotic patients with ascites, as they provide diuretic effects without the risk of potassium loss, which can be dangerous with stronger diuretics.

These drugs can enhance the effects of other diuretics and can be safely combined with medications like ACE inhibitors, making them versatile in treating conditions such as hypertension and specific syndromes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Potassium-sparing diuretics (spironolactone, triamterene, amylorid)]. Haris, A., Radó, J.[2013]

In a study of 33 patients with severe congestive cardiac failure, a fixed 3-day course of a combination of thiazide and loop diuretics was found to be as effective as longer treatment durations in managing the condition.

Both thiazide diuretics, bendrofluazide and metolazone, were equally effective in promoting weight loss due to fluid removal, but bendrofluazide resulted in fewer electrolyte disturbances, suggesting it may be a safer option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination diuretic treatment in severe heart failure: a randomised controlled trial. Channer, KS., McLean, KA., Lawson-Matthew, P., et al.[2019]

Diuretics, including thiazide, loop, and potassium-sparing types, are among the most commonly used medications, highlighting their importance in clinical practice.

While there is substantial information on the pharmacokinetics of diuretics, the metabolism of some remains unclear, and their pharmacodynamic interactions with other drugs can often be anticipated based on their known effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical pharmacology of diuretics. Rahn, KH.[2019]

Loop diuretics are effective in increasing sodium excretion and urine output, even in patients with significantly impaired kidney function, particularly in cases of chronic renal failure and conditions like nephrotic syndrome or chronic heart failure.

While loop diuretics can help manage fluid overload in patients on dialysis, their effectiveness is limited, and high doses can lead to serious side effects such as neurological issues and muscle pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The place of loop diuretics in the treatment of acute and chronic renal failure. Russo, D., Memoli, B., Andreucci, VE.[2010]

In a study of 3,773 patients prescribed thiazide diuretics, 20.6% experienced low sodium or potassium levels, indicating a significant risk of hyponatraemia and hypokalaemia associated with these medications.

Hyponatraemia was particularly prevalent in older patients, with those over 70 years having nearly four times the odds of developing this condition, highlighting the need for careful monitoring and potentially lower dosing in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thiazide diuretic prescription and electrolyte abnormalities in primary care. Clayton, JA., Rodgers, S., Blakey, J., et al.[2022]

In a study of 12,722 older adults, chlorthalidone was associated with a higher risk of significant kidney function decline (≥30% eGFR decline) and cardiovascular events compared to hydrochlorothiazide, indicating potential safety concerns with chlorthalidone use.

Chlorthalidone also increased the risk of hypokalemia (low potassium levels), particularly in patients with better kidney function, while no significant differences were found between the two medications regarding dialysis, all-cause mortality, or other electrolyte imbalances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Clinical Outcomes and Safety Associated With Chlorthalidone vs Hydrochlorothiazide in Older Adults With Varying Levels of Kidney Function. Edwards, C., Hundemer, GL., Petrcich, W., et al.[2023]

In a study involving seven patients with severe renal failure and hypertension, hydrochlorothiazide was found to significantly increase the excretion of sodium and chloride compared to furosemide, suggesting it may be more effective in this population.

Both furosemide and hydrochlorothiazide equally reduced mean arterial blood pressure, but combining the two diuretics did not enhance the effectiveness of hydrochlorothiazide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of furosemide vs hydrochlorothiazide in patients with chronic renal failure and hypertension. Dussol, B., Moussi-Frances, J., Morange, S., et al.[2013]

Diuretics have transformed the treatment of various conditions, turning once fatal diseases into manageable ones, particularly in cases of salt and water overload and edema.

Different types of diuretics are used for specific conditions: thiazide diuretics for hypertension, loop diuretics for edema and heart failure, and potassium-sparing diuretics for preventing low potassium levels, highlighting their versatility and importance in modern medicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Edema and principles of diuretic use. Morrison, RT.[2019]

Chlorthalidone has been shown to effectively reduce blood pressure in patients with advanced chronic kidney disease (CKD), suggesting that thiazide diuretics can still be beneficial even at lower glomerular filtration rates (GFR).

While diuretics can have adverse effects, recent studies indicate that they do not negatively impact kidney or cardiovascular outcomes in CKD patients, and careful monitoring of electrolytes and GFR is essential for safe use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Revisiting diuretic choice in chronic kidney disease. Ali, S., Navaneethan, SD., Virani, SS., et al.[2023]

In a study of 32 patients with chronic kidney disease (CKD) stage 4-5, the combination of bumetanide and chlorthalidone significantly reduced total body water and extracellular water compared to bumetanide with placebo, indicating improved management of volume overload.

The combination treatment also led to a greater reduction in both systolic and diastolic blood pressure over 30 days, demonstrating its efficacy in treating hypertension in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of the combination of bumetanide plus chlorthalidone on hypertension and volume overload in patients with chronic kidney disease stage 4-5 KDIGO without renal replacement therapy: a double-blind randomized HEBE-CKD trial. Solis-Jimenez, F., Perez-Navarro, LM., Cabrera-Barron, R., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-nephrosis-7-2021-9994f

Diuretic Tuner App for Chronic Kidney Disease This purpose of this study is to determine the effectiveness of a mobile phone application in helping to control body swelling in patients with kidney ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6485696/

Diuretics for people with chronic kidney disease - PMC The principal use of diuretics in CKD is to reduce blood pressure and treat swelling (oedema) (Sica 2011a).

3. sciencedirect.com sciencedirect.com/science/article/pii/S0753332222014470

Review Diuretic resistance in patients with kidney disease The main causes and coping strategies of diuretic resistance in patients with kidney diseases were described in detail in this report.

4. mdpi.com mdpi.com/2392-7674/12/1/26

Diuretic Therapy: Mechanisms, Clinical Applications, and ... By reducing the blood volume and peripheral vascular resistance, diuretics improve cardiac function, lower blood pressure, and enhance exercise tolerance.

5. jacc.org jacc.org/doi/10.1016/j.jacc.2010.06.034

Combination of Loop Diuretics With Thiazide-Type ... Combination of loop + thiazide-type diuretics can be effective in patients with advanced chronic kidney disease. •. Synergistic effects of ...

6. play.google.com play.google.com/store/apps/details?id=com.utswmed.DiureticTuner&hl=en_AU

Diuretic Tuner – Apps on Google Play Diuretic Tuner is a mobile app to designed to improve ambulatory volume control in patients with chronic kidney disease. The app instructs ...