Mobile app to manage swelling in kidney patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of a mobile application designed to assist patients with kidney issues in managing body swelling through diuretic medication adjustments. Participants will receive the app and training on its use, requiring them to log daily blood pressure and weight. The app will provide personalized guidance based on their health data and will track medication compliance. The study will last for 90 days, with periodic blood tests and a final survey to assess outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Texas Southwestern
  Dallas, Texas, United States Recruiting

Study contacts

• Study coordinator: Kamalanathan K Sambandam, M.D.
• Email: ksambandam@utsouthwestern.edu
• Phone: 214-645-6190

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.