← Back to Search

Diuretic Tuner App for Chronic Kidney Disease

N/A

Recruiting

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The presence of nephrotic range proteinuria (> 3 g/d proteinuria by 24hr urine protein, 24hr urine albumin, spot urine protein/creatinine ratio, or spot urine albumin/creatinine ratio) or stage 4 or 5 chronic kidney disease (estimated glomerular filtration rate < 30 mL/min/1.73 m2 by Modification of Diet in Renal Disease equation) PLUS Clinical signs of hypervolemia present (lower extremity edema, ascites, or pleural effusions) with an estimated dry weight (defined as edema-free weight without orthostatic hypotension) 5 lbs less than enrollment body weight

Be older than 18 years old

Must not have

Weight < 100 lbs or > 300 lbs

Autonomic insufficiency resulting in orthostatic hypotension at screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a mobile phone application can help people with kidney problems control their body swelling.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the trial itself may not cause direct side effects, adjusting diuretics can lead to changes in electrolyte levels, dehydration, dizziness from low blood pressure (especially when standing up), and potential kidney function changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My weight is either below 100 lbs or above 300 lbs.

Select...

I experience significant dizziness or fainting when standing up.

Select...

My kidney function is reduced, with high creatinine levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

90 day weight variability

Mean time to the attainment of dry weight

Secondary study objectives

Composite rate of hospitalization, hypokalemia, or acute renal insufficiency

Diuretic Tuner usability assessed by user survey

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diuretic Tuner usersExperimental Treatment1 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.

0 / 4Eligibility criteria met