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SGLT2 Inhibitor
Empagliflozin for Chronic Kidney Disease
Phase 3
Waitlist Available
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
CKD-EPI eGFR ≥20 to <45 mL/min/1.73m² or CKD-EPI eGFR ≥45 to <90 mL/min/1.73m² with urinary albumin:creatinine ratio ≥200 mg/g (or protein:creatinine ratio ≥300 mg/g)
Evidence of chronic kidney disease at risk of kidney disease progression defined by at least 3 months before and at the time of Screening Visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up follow-up period: from the day of randomisation to the day of the final follow-up visit, up to 1140 days.
Awards & highlights
Study Summary
This trial is investigating whether empagliflozin can help prevent kidney disease progression or cardiovascular death in patients with pre-existing chronic kidney disease, compared to placebo.
Who is the study for?
Adults with chronic kidney disease who don't need or can't take empagliflozin (or similar drugs) and are not on dialysis, without recent drug trials, poor medication adherence, pregnancy, certain cardiovascular diseases with better kidney function, polycystic kidney disease, recent bariatric surgery or ketoacidosis. Must be able to tolerate ACE inhibitors or ARBs unless contraindicated.Check my eligibility
What is being tested?
The trial is testing whether empagliflozin slows down the progression of chronic kidney disease or prevents death from heart problems compared to a placebo. Participants will also receive standard care and some will be observed after the trial for long-term outcomes.See study design
What are the potential side effects?
Empagliflozin may cause urinary infections, dehydration leading to low blood pressure, potential increase in cholesterol levels, and rare cases of diabetic ketoacidosis even in those without diabetes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is reduced but not severely, and I may have protein in my urine.
Select...
I have had chronic kidney disease for at least 3 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ follow-up period: from the day of randomisation to the day of the final follow-up visit, up to 1140 days.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~follow-up period: from the day of randomisation to the day of the final follow-up visit, up to 1140 days.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Interventional Part: Time to First Occurrence of Kidney Disease Progression or Cardiovascular Death ('as Adjudicated')
Secondary outcome measures
Interventional Part: Time to Cardiovascular Death ('as Adjudicated')
Interventional Part: Time to First Occurrence Cardiovascular Death ('as Adjudicated') or End Stage Kidney Disease (ESKD)
Interventional Part: Time to First Occurrence of Kidney Disease Progression
+3 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
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Empagliflozin 10 mgExperimental Treatment1 Intervention
Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily 10 milligram (mg) film-coated tablets of empagliflozin.
Group II: PlaceboPlacebo Group1 Intervention
Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily film-coated tablets of placebo to match empagliflozin.
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?
Boehringer IngelheimLead Sponsor
2,509 Previous Clinical Trials
11,334,406 Total Patients Enrolled
Medical Research Council Population Health Research Unit, CTSU, University of Oxford (academic lead)UNKNOWN
Eli Lilly and CompanyIndustry Sponsor
2,622 Previous Clinical Trials
3,210,166 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I haven't had IV immunosuppression in the last 3 months and am not on high doses of steroids.I am taking or can take RAS-inhibitors unless they are not suitable for me.My doctor thinks I don't need nor should avoid empagliflozin or similar drugs.I am not pregnant, breastfeeding, or if capable of becoming pregnant, I am using effective birth control.I have polycystic kidney disease.I have type 2 diabetes and a history of heart disease, with normal kidney function.I have not had ketoacidosis in the last 5 years.I am taking both ACE inhibitors and ARB medications.I am on dialysis, have a working kidney transplant, or will receive one from a living donor.I have had or am scheduled for weight loss surgery.I am allergic to empagliflozin or similar diabetes medications.I do not have severe health issues that could stop me from completing the study.My kidney function is reduced but not severely, and I may have protein in my urine.I have had chronic kidney disease for at least 3 months.I have type 1 diabetes.Your ALT or AST levels are more than three times the upper limit of normal.My blood pressure is either below 90 or above 180 mmHg.I am currently taking medication for diabetes that includes SGLT-2 inhibitors.
Chronic Kidney Disease Patient Testimony for trial: Trial Name: NCT03594110 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this trial have a large presence in our city?
"Currently, there are 68 sites running this study. A few examples include LMC Clinical Research Inc. (Bayview) in Toronto, Montreal Clinical Research Institute (IRCM) in Montreal, and Clinical Research Solutions Inc. in Waterloo."
Answered by AI
Does Empagliflozin have any dangerous side effects?
"Empagliflozin's safety is estimated to be a 3. This is because it is a Phase 3 trial, which suggests that there is some data affirming its efficacy and multiple rounds of data affirming its safety."
Answered by AI
Are there any precedent clinical trials for Empagliflozin?
"Empagliflozin was first researched in 2018 at the Fundação de Apoio ao Ensino, Pesquisa e Assistencia do Hospital das Clinicas da Faculdade de Medicina de Ribeir�o Preto.231 studies have been completed, with 50 more currently ongoing. Many of the live trials are based in Toronto, Quebec."
Answered by AI
What is the unique aspect of this research?
"Empagliflozin is being trialled in 237 cities, across 43 countries, with 50 active studies currently underway. The first study was sponsored by Boehringer Ingelheim in 2018. This initial Phase 3 clinical trial involved 175 patients. In the years since, there have been a total of 231 studies."
Answered by AI
What are some common medical reasons why a doctor might prescribe Empagliflozin?
"Empagliflozin is generally used to mitigate the effects of cardiovascular diseases. However, it has also been shown to be effective in treating heart failure, type 2 diabetes mellitus, and cardiovascular mortality."
Answered by AI
Can new patients still sign up for this clinical trial?
"This study is no longer recruiting individuals. The research was first posted on 1/31/2019, with the latest update being on 11/2/2022. However, if you are seeking other opportunities, there are 511 clinical trials for patients with chronic kidney diseases and 50 studies involving Empagliflozin that are actively looking for participants."
Answered by AI
Who else is applying?
What state do they live in?
Arizona
North Carolina
What site did they apply to?
University of California Los Angeles
Northwestern University
Seacoast Kidney and Hypertension Specialists
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I’m hoping to not have my stage 4 elevate to stage 5 and dialysis. I await a trail that accepts me. I do not have much protein in my spot urine.
PatientReceived 1 prior treatment
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