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Dapagliflozin for Chronic Kidney Disease
Phase 1 & 2
Recruiting
Led By Rupal Mehta, MD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Evidence of subclinical heart failure with preserved ejection fraction at their pre-exercise echocardiogram (defined as meeting any of the American Society of Echocardiography (ASE) criteria for diastolic dysfunction [septal e'<7 cm/wc, average E/e' ratio>14, left atrial volume index >34 mL/m2, and peak TR velocity >2.8 m/sec] or absolute left ventricular longitudinal strain < 18%)
>18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial looks at how a drug affects heart, lung & metabolic health in CKD patients.
Who is the study for?
This trial is for adults over 18 with chronic kidney disease who are on stable heart medication, have signs of a specific type of heart failure but no symptoms, and an eGFR between 25-60. It's not for those with liver disease, recent heart procedures, extreme blood pressure levels, pregnancy, certain systemic diseases like amyloidosis or sarcoidosis, diabetes, severe lung disease requiring oxygen therapy or significant chest pain.Check my eligibility
What is being tested?
The study tests the effects of Dapagliflozin (Farxiga), a drug that affects sugar transport in kidneys when added to standard care. It focuses on how this drug influences heart and lung function as well as metabolites in patients with chronic kidney disease.See study design
What are the potential side effects?
While the information provided does not specify side effects for Dapagliflozin in this context directly, common ones may include dehydration leading to low blood pressure; genital yeast infections; urinary tract infections; increased urination; and potential risk of diabetic ketoacidosis.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart test shows early signs of heart failure but it can still pump well.
Select...
I am older than 18 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Circulating plasma metabolite concentrations
Left ventricular longitudinal strain (LVLS)
Peak VO2 (oxygen consumption)
Secondary outcome measures
Left Atrial Reservoir Strain (LARS)
Right ventricular free wall strain
Side effects data
From 2018 Phase 4 trial • 30 Patients • NCT0300647120%
Cervicovaginal infection
13%
Urinary tract infections
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dapagliflozin
Placebo
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention groupExperimental Treatment1 Intervention
Thirty individuals will be randomized to dapagliflozin 10mg to be taken daily for six months.
Group II: Standard of Care groupActive Control1 Intervention
Thirty individuals will be randomized to standard of care treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dapagliflozin 10 MG [Farxiga]
2021
Completed Phase 2
~20
Find a Location
Who is running the clinical trial?
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,790 Total Patients Enrolled
35 Trials studying Heart Failure
7,826 Patients Enrolled for Heart Failure
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,840 Previous Clinical Trials
47,852,064 Total Patients Enrolled
206 Trials studying Heart Failure
677,388 Patients Enrolled for Heart Failure
Northwestern UniversityLead Sponsor
1,589 Previous Clinical Trials
917,027 Total Patients Enrolled
20 Trials studying Heart Failure
4,243 Patients Enrolled for Heart Failure
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart test shows early signs of heart failure but it can still pump well.I am on a stable dose of medication for my blood pressure or heart condition.I currently have active cancer.My heart pumps less blood than normal.I do not have any chronic conditions that would prevent me from completing heart tests.I have heart issues that haven't been treated with surgery.I have a serious heart valve problem.I am currently taking medication for diabetes that includes SGLT2 inhibitors.You are allergic to a medication called SGLT2i.I am older than 18 years.I am on immunosuppressive therapy.I have a liver condition.I have not had heart artery surgery in the last 6 months.Your blood pressure is too low (less than 100) or too high (more than 180).I have a condition like amyloidosis or sarcoidosis that can lead to heart failure.I have had frequent UTIs or one in the last 3 months.I experience symptoms of heart failure.Your kidney function, measured by eGFR, is between 25 and 60 ml per minute per 1.73 square meters of body surface.I have diabetes or have had it in the past.Your liver enzymes, ALT and AST, are more than three times the normal levels.I need home oxygen for my lung condition.I experience chest pain.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention group
- Group 2: Standard of Care group
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 recruitment still underway for this research project?
"The clinicaltrials.gov records indicate that this trial is no longer recruiting patients; the study was first posted on March 1st 2023 and last updated February 8th 2023. While there are not any opportunities available with this particular research project, 1185 other trials have open enrollment right now."
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