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Sodium-glucose cotransporter 2 (SGLT2) inhibitor

Empagliflozin for Kidney Disease (EMPA-PD Trial)

Phase 4
Recruiting
Led By Jeffrey Testani, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stable peritoneal dialysis prescription
Chronic loop diuretic usage (at Yale, essentially all patients that make urine are on chronic loop diuretics)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 to day 63
Awards & highlights

EMPA-PD Trial Summary

This trial studies if a drug can help reduce glucose absorption in people with end stage kidney disease who use dialysis.

Who is the study for?
This trial is for adults over 18 with end stage renal disease on peritoneal dialysis, who have been on a stable dialysis prescription for more than 3 months and produce at least 400 ml of urine daily. It's not suitable for those with type 1 diabetes, recent severe hypoglycemia, or infections related to their dialysis catheter.Check my eligibility
What is being tested?
The study tests if Empagliflozin can lower glucose absorption in patients undergoing peritoneal dialysis. Participants will either receive Empagliflozin or a placebo in a randomized manner, followed by an open label phase where all get the drug.See study design
What are the potential side effects?
Empagliflozin may cause low blood sugar levels (hypoglycemia), urinary tract infections, dehydration and genital yeast infections. Side effects vary from person to person.

EMPA-PD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My peritoneal dialysis treatment plan hasn't changed recently.
Select...
I am on long-term water pills for my condition.
Select...
I am currently on peritoneal dialysis with a working catheter.
Select...
I am older than 18 years.

EMPA-PD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 to day 63
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 to day 63 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Glucose absorption with empagliflozin vs. placebo
Secondary outcome measures
Change in PET test parameters
Change in peritoneal fluid inflammatory markers
Change in plasma glucose levels with empagliflozin vs. placebo- acute study
+3 more

Side effects data

From 2020 Phase 4 trial • 65 Patients • NCT03030222
12%
Exacerbation of Heart Failure
9%
Volume Depletion
9%
Hypokalemia
6%
Chest Pain
6%
Cough
3%
Hiccups
3%
Cellulitis - bilateral legs
3%
Myocardial Infarction
3%
Concussion
3%
Hematuria
3%
Contusion - scalp
3%
Esophagitis
3%
Groin Abcess
3%
Acute Kidney Injury
3%
Dysuria
3%
Pulmonary Nodule
3%
Quick Tempered
3%
Lower left extremity swelling
3%
Vaginal Yeast Infection
3%
Vertigo
3%
Wound Dehiscence
3%
Hypotension
3%
Osteoarthritis - left knee
3%
Abscess - bilateral - hips, buttocks and upper legs
3%
Squamous cell carcinoma
3%
Worsening Gout
3%
Sepsis
3%
Worsening Tricuspid Valve Regurgitation
3%
Congestion
3%
Increased craving for sweets
3%
Malaise
3%
Bronchitis
3%
Cellulitis
3%
Head Contusion
3%
Exertional Angina
3%
Gastritis
3%
Gastroenteritis
3%
Gout Flare
3%
Asymptomatic hypoglycemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Empagliflozin

EMPA-PD Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Empagliflozin or Placebo in AcuteExperimental Treatment1 Intervention
Acute phase: Participants will receive 25 mg empagliflozin once on Day 0 or Day 7. Participants receive empaglifozin or placebo on Day 0. On Day 7, they will be crossed over to the alternate treatment.
Group II: Empagliflozin in ChronicActive Control1 Intervention
Chronic phase: On day 8, all participants will receive 10 mg empagliflozin 10 mg x 8 weeks

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,843 Previous Clinical Trials
2,735,207 Total Patients Enrolled
Boehringer IngelheimIndustry Sponsor
2,498 Previous Clinical Trials
11,339,713 Total Patients Enrolled
Jeffrey Testani, MDPrincipal InvestigatorYale University
6 Previous Clinical Trials
609 Total Patients Enrolled

Media Library

Empagliflozin (Sodium-glucose cotransporter 2 (SGLT2) inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05671991 — Phase 4
Kidney Disease Research Study Groups: Empagliflozin or Placebo in Acute, Empagliflozin in Chronic
Kidney Disease Clinical Trial 2023: Empagliflozin Highlights & Side Effects. Trial Name: NCT05671991 — Phase 4
Empagliflozin (Sodium-glucose cotransporter 2 (SGLT2) inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05671991 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are participating in this experiment?

"Accurately, clinicaltrials.gov shows that this research trial is currently recruiting participants. It was first publicized on March 1st 2023 and has been refreshed as recently as May 1st of the same year. The team needs to find 30 people willing to participate at a single medical site."

Answered by AI

Has the FDA sanctioned Empagliflozin for chronic use?

"The team at Power has concluded that the safety of Empagliflozin in Chronic is a 3, as this medication is already approved and classified as a Phase 4 trial."

Answered by AI

Are there any available slots for volunteers to participate in this clinical experiment?

"Affirmative. The information hosted on clinicaltrials.gov specifies that this medical research, which was posted initially on March 1st 2023, is actively recruiting volunteers. It needs to obtain 30 patients from a single location for the experiment to proceed further."

Answered by AI
~13 spots leftby Dec 2024