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Sodium-glucose cotransporter 2 (SGLT2) inhibitor
Empagliflozin for Dialysis Patients with Kidney Failure
Phase 1
Recruiting
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Dialysis treatment history of ≥3 months
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-weeks
Awards & highlights
Study Summary
This trial studies if a diabetes med, empagliflozin, is safe & tolerated in dialysis patients. If successful, it could help reduce their risk of heart failure & death. #medicine
Who is the study for?
This trial is for adults with severe chronic kidney disease (ESKD) who have been on dialysis for at least 3 months, regardless of whether they have diabetes. It's not open to those with active cancer treatment, unhealed skin ulcers on the lower body, allergies to empagliflozin, pregnancy, type 1 diabetes, current IV antibiotic therapy for infections, a history of Fournier's gangrene or recent severe hypoglycemia.Check my eligibility
What is being tested?
The study tests if empagliflozin is safe and can be tolerated by patients dependent on dialysis due to ESKD. Empagliflozin has helped prevent heart failure in diabetic and non-diabetic patients but hasn't been studied in those with advanced kidney disease undergoing dialysis.See study design
What are the potential side effects?
Potential side effects may include risks associated with lowering blood sugar such as hypoglycemia (especially if diabetic), urinary tract infections due to increased glucose in urine, dehydration from increased urination which could affect blood pressure and kidney function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been on dialysis for 3 months or more.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The proportion of participants in each intervention group who remain in follow-up and adhere to the full randomized dose of empagliflozin at the end of the 12-week intervention period.
Secondary outcome measures
Dialytic clearance of empagliflozin
Long-term accumulation of empagliflozin
Proportions of participants in each group who have ≥ 80% pill count compliance.
+2 moreSide effects data
From 2021 Phase 3 trial • 5988 Patients • NCT0305795115%
Cardiac failure
7%
Hypertension
7%
Urinary tract infection
7%
Hypotension
6%
Hyperkalaemia
6%
Fall
6%
Renal impairment
5%
Atrial fibrillation
5%
Diabetes mellitus
4%
Anaemia
4%
Hyperuricaemia
3%
Acute kidney injury
3%
Pneumonia
2%
Acute myocardial infarction
2%
COVID-19
2%
Cardiac failure congestive
2%
Death
1%
Myocardial infarction
1%
Cardiac failure chronic
1%
Angina pectoris
1%
Angina unstable
1%
Ventricular tachycardia
1%
COVID-19 pneumonia
1%
Cellulitis
1%
Sepsis
1%
Chronic kidney disease
1%
Coronary artery disease
1%
Chronic obstructive pulmonary disease
1%
Basal cell carcinoma
1%
Cerebrovascular accident
1%
Ischaemic stroke
1%
Syncope
1%
Transient ischaemic attack
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
10 mg Empagliflozin
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Empagliflozin 25mgExperimental Treatment1 Intervention
Empagliflozin 25 mg oral: Those randomized to 25 mg daily dose will be treated with 10 mg QD for the first 2 weeks before escalating the dose to 25 mg QD in week 3, based on tolerability. At the end of the dose-escalation phase (weeks 3-4), participants will continue the randomized assignment for additional 8 weeks (weeks 5-12, treatment phase), for a total of 12 weeks.
Group II: Empagliflozin 10mgExperimental Treatment1 Intervention
Empagliflozin10mg oral: Those randomized to 10 mg daily dose will be treated with 10 mg QD throughout the dose escalation and the treatment phase for a total of 12 weeks.
Group III: PlaceboPlacebo Group1 Intervention
Encapsulated placebo with an identical appearance to empagliflozin: Those randomized to placebo will be treated with an oral placebo QD throughout the dose escalation and the treatment phase for a total of 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Empagliflozin
2017
Completed Phase 4
~181750
Find a Location
Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,314,517 Total Patients Enrolled
9 Trials studying Kidney Failure
10,645 Patients Enrolled for Kidney Failure
University of UtahLead Sponsor
1,100 Previous Clinical Trials
1,778,826 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had very low blood sugar that needed help from someone else in the past year.I have been on dialysis for 3 months or more.I am an adult, with or without diabetes.I am currently receiving treatment for cancer.You are allergic to empagliflozin.I have an open sore on my leg that hasn't healed.I am currently receiving IV antibiotics for an infection.I have Type 1 diabetes.I have had Fournier's gangrene before.I have had diabetic ketoacidosis.
Research Study Groups:
This trial has the following groups:- Group 1: Empagliflozin 25mg
- Group 2: Empagliflozin 10mg
- Group 3: Placebo
Awards:
This trial has 0 awards, including: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.
Has the U.S. Food and Drug Administration sanctioned Empagliflozin 10mg for medical use?
"Given that this is just a Phase 1 trial, the safety of Empagliflozin 10mg was estimated to be only a score of 1 due to minimal data demonstrating its efficacy and security."
Answered by AI
Have enrolment opportunities for this research still available to participants?
"Affirmative. Details available on clinicaltrials.gov signify that this investigation is actively recruiting suitable participants, with the initial posting being made on March 21st 2023 and a most recent update occurring May 2nd 2023. The study requires 75 subjects to be enrolled at one medical site."
Answered by AI
What is the participant quota for this research experiment?
"Affirmative. According to clinicaltrials.gov, this research initiative is still recruiting participants after launching on March 21st 2023 and having its latest update on May 2nd 2023. The trial's quotas are currently set at 75 patients that will be recruited from a single location."
Answered by AI
Who else is applying?
What site did they apply to?
University of Utah
What portion of applicants met pre-screening criteria?
Met criteria
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