Recruiting

Observational Study

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT04759274

Conditions

Edema

Hypervolemia

Chronic Kidney Diseases

Nephrotic Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Diuretic Tuner

Study Details

Brief summary:

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 problems. The application will help in the day to day adjustments in diuretic medication dosing.

Participants in this study will have an application loaded on to their mobile phone by the study team and be taught how to use it over a 2 hour visit. Participants will need to check their blood pressure and weight daily and enter this information into the mobile phone application every day. Participants will need to follow daily instructions in their medication dosing provided by the application. There will be periodic blood testing. This will happen at 2 weeks, 90 days, and up to 4 other times if necessary. At the end of the study there is a 2 hour study visit during which participants will answer a survey. The total length of the study is 90 days.

Conditions

Edema

Hypervolemia

Chronic Kidney Diseases

Nephrotic Syndrome

Study ID

NCT04759274

Start date

Nov 20, 2023

Status verified date

Sep, 2025

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Weight < 100 lbs or > 300 lbs.
  • Autonomic insufficiency resulting in orthostatic hypotension at screening
  • Hypokalemia at enrollment (defined as serum potassium < 3.5 mmol/L)
  • Moderate to severe hyponatremia at enrollment (defined as serum sodium < 130 mmol/L)
  • Serum creatinine > 6 mg/dL or > 1.5 times baseline
  • Patients who are unable or unwilling to measure their home blood pressures and weights
  • Patients without a working phone number and smart phone device
  • Expectation that the patient will require dialysis initiation within < 3 months
  • Expected lifespan of < 6 months
  • The presence of a medical condition that would interfere with effectively using the Diuretic Tuner (dementia, illiteracy, or blindness)
  • Pregnant patients
  • Prisoners

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Diuretic Tuner users

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.

Interventions

Diuretic Tuner

Mobile device application for diuretic dose titration

Primary outcome measure

  • Mean time to the attainment of dry weight [ Time Frame: 90 days ]
  • 90 day weight variability [ Time Frame: 90 days ]

Central Contacts and Locations

Central contacts

Kamalanathan K Sambandam, M.D.

214-645-6190ksambandam@utsouthwestern.edu

Locations

University of Texas Southwestern

Recruiting

Dallas, Texas, United States, 75390

Contacts

Kamalanathan K Sambandam

469-441-7181ksambandam@utsouthwestern.edu

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Sep 16, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2025-09-16.