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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have severe kidney issues with swelling in my body and weigh less without the swelling.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
90 day weight variability
Mean time to the attainment of dry weight
Secondary outcome measures
Composite rate of hospitalization, hypokalemia, or acute renal insufficiency
Diuretic Tuner usability assessed by user survey
Side effects data
From 2019 Phase 2 trial • 130 Patients • NCT031361988%
NSTEMI type 2
6%
Acute Kidney Injury
3%
Respiratory failure
2%
Mural thrombus
2%
Nonsustained ventricular tachycardia
2%
Bradycardia
2%
Hypotension
2%
NSTEMI
2%
Iron deficiency anemia
2%
MGUS, new diagnosis
2%
Hyperkalemia
2%
Urinary retention
2%
Proteinuria
2%
Pulmonary embolism
2%
Mitral Regurgitation, severe
2%
Mitral valve disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
Usual Care
LUS-guided Strategy-of-care
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.
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Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,047 Previous Clinical Trials
1,053,769 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood test shows low levels of potassium.You are expected to live for less than 6 months.My weight is either below 100 lbs or above 300 lbs.I experience significant dizziness or fainting when standing up.Your blood sodium levels are very low when you join the study.My kidney function is reduced, with high creatinine levels.You can't or don't want to check your blood pressure and weight at home.I have severe kidney issues with swelling in my body and weigh less without the swelling.You are expected to start dialysis within the next 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Diuretic Tuner users
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment in this research effort open at present?
"The information on clinicaltrials.gov discloses that this investigation is no longer actively searching for candidates as the last edit was made on July 24th 2022. Notwithstanding, there are 618 other studies recruiting participants at present."
Answered by AI
Who else is applying?
What site did they apply to?
University of Texas Southwestern
What portion of applicants met pre-screening criteria?
Met criteria
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