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Sodium-glucose cotransporter 2 (SGLT2) inhibitor
Empagliflozin for Kidney Failure (SEED Trial)
Phase 2
Recruiting
Led By David Charytan, MS, MSc
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 12
Awards & highlights
SEED Trial Summary
This trial will study a new medicine's safety, effectiveness, and tolerability for end-stage kidney disease patients on dialysis.
Who is the study for?
Adults over 18 who recently started hemodialysis for end-stage kidney disease can join this trial. They must be able to consent and, if female and able to have children, show a negative pregnancy test. People with plans for a kidney transplant soon, severe heart failure, recent major cardiovascular events or surgery, certain diabetes types or complications, active serious infections or cancer treatments are excluded.Check my eligibility
What is being tested?
The study is testing the safety and potential benefits of Empagliflozin (a diabetes medication) in patients on hemodialysis due to chronic kidney failure. Participants will either receive Empagliflozin or a placebo without knowing which one they're getting for 12 weeks to compare outcomes.See study design
What are the potential side effects?
Empagliflozin may cause low blood pressure, urinary tract infections, dehydration leading to dizziness or fainting spells especially when standing up quickly from sitting/lying down positions; rare but serious side effects include diabetic ketoacidosis even in non-diabetics.
SEED Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in 24-Hour Urine Volume from Baseline to 12 Weeks
Change in Extracellular Volume from Baseline to 12 Weeks
Change in Intracellular Volume from Baseline to 12 Weeks
+1 moreSecondary outcome measures
Change in 24-Hour Ambulatory Blood Pressure from Baseline to 12 Weeks
Change in 24-Hour Urine Albumin Excretion from Baseline to 12 Weeks
Change in Heart Rate Variability from Baseline to 12 Weeks
+8 moreOther outcome measures
Percentage of Participants Lost to Follow-Up
Recruitment Rate
Withdrawal Rate
Side effects data
From 2019 Phase 2 trial • 80 Patients • NCT0320086038%
Renal/Urinary
33%
Musculoskeletal
23%
Cardiovascular
23%
Metabolic
15%
Other
15%
Gastrointestinal
8%
Worsening Heart Failure
8%
Respiratory
3%
Angioedema
3%
Acute Kidney Injury
3%
S. Aureus Bacteremia
3%
Worsening Renal Function
3%
Syncope
100%
80%
60%
40%
20%
0%
Study treatment Arm
Empagliflozin
Placebo
SEED Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: EmpagliflozinExperimental Treatment1 Intervention
Participants with end-stage kidney disease (ESRD) initiating hemodialysis will receive Empagliflozin 10 mg daily for 12 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Participants with ESRD initiating hemodialysis will receive Empagliflozin-matching placebo daily for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Empagliflozin 10 MG
2016
Completed Phase 4
~900
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,369 Previous Clinical Trials
840,538 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,314,532 Total Patients Enrolled
10 Trials studying Kidney Failure
10,720 Patients Enrolled for Kidney Failure
Boehringer IngelheimIndustry Sponsor
2,507 Previous Clinical Trials
11,340,847 Total Patients Enrolled
1 Trials studying Kidney Failure
3,352 Patients Enrolled for Kidney Failure
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently receiving treatment for cancer, except for certain skin cancers and early-stage cervical cancer.I have had more than 2 urinary tract infections in a year.I am 18 or older and started hemodialysis within the last 6 months.I am unable to understand and give consent for medical procedures.I have not had major surgery in the last 12 weeks.I have had diabetic ketoacidosis in the past.I have had a limb amputated without injury in the last year or had severe lower limb skin or bone conditions in the past 6 months.I haven't had a heart attack, unstable chest pain, heart surgery, or stroke in the last 3 months.I am on a thrice-weekly hemodialysis schedule.I have the most severe form of heart failure.I have a rare inherited disorder affecting how my body absorbs sugar.I am taking both ACE inhibitors and ARB medications.I have been taking an SGLT2 inhibitor medication for the last 6 weeks.I haven't used any experimental drugs or devices in the last 12 weeks.I have Type 1 Diabetes.I am allergic to SGLT2 inhibitors or their ingredients.I am of childbearing age and have a negative pregnancy test.I do not have severe liver disease or significantly high liver enzyme levels.I am willing and able to give my consent for treatment.I am scheduled for a kidney transplant within the next 3 months.I produce less than a cup of urine daily.
Research Study Groups:
This trial has the following groups:- Group 1: Empagliflozin
- Group 2: 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.
What potential perils should patients be aware of when taking Empagliflozin?
"Based on the evidence, Empagliflozin is rated a 2 in terms of safety. This rating was assigned after assessing the Phase 2 trial data that supports its security though it doesn't back up its efficacy."
Answered by AI
Are there still openings for participants in this clinical research?
"According to clinicaltrials.gov, this particular medical trial is no longer recruiting patients; however, it was initially posted on June 1st 2023 and has been recently updated on March 15th 2023. In addition, there are 189 other ongoing studies presently accepting applicants."
Answered by AI
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