Empagliflozin for Kidney Disease

(EMPA-PD Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Jeffrey Testani, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Yale University

Must not be taking: SGLT2 inhibitors

Disqualifiers: Type 1 diabetes, Anemia, others

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing if empagliflozin can help patients with severe kidney disease on dialysis by reducing their sugar absorption. The medication works by helping the kidneys remove sugar from the blood. Empagliflozin has been shown to improve kidney outcomes and slow the progression of diabetic kidney disease in previous trials.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but you cannot have used an SGLT2 inhibitor in the last 30 days.

What data supports the effectiveness of the drug empagliflozin for kidney disease?

Empagliflozin has been shown to reduce the progression of chronic kidney disease and lower the risk of cardiovascular issues in patients with type 2 diabetes and established cardiovascular disease. In the EMPA-REG Outcome trial, it significantly reduced the risk of cardiovascular death and worsening kidney problems. ^{1 2 3 4 5}

Is empagliflozin safe for people with kidney disease?

Empagliflozin (Jardiance) is generally considered safe for people with kidney disease, but it can have side effects like fluid deficits. It has been studied in patients with type 2 diabetes and chronic kidney disease, showing it is well-tolerated, though some side effects and contraindications exist. ^{5 6 7 8 9}

How does the drug empagliflozin differ from other treatments for kidney disease?

Empagliflozin is unique because it is a sodium-glucose co-transporter-2 (SGLT2) inhibitor that not only helps manage blood sugar levels in type 2 diabetes but also offers kidney and heart protection, reducing the progression of chronic kidney disease and cardiovascular risks. ^{2 4 5 7 10}

Research Team

Jeffrey Testani, MD

Principal Investigator

Yale University

Eligibility Criteria

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.

Inclusion Criteria

You have been diagnosed with Parkinson's disease for more than 3 months.

My peritoneal dialysis treatment plan hasn't changed recently.

I am on long-term water pills for my condition.

Exclusion Criteria

I have had peritonitis or an infection in my dialysis catheter recently.

I have taken an SGLT2 inhibitor in the last 30 days.

Your hemoglobin level is less than 8 grams per deciliter.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Acute Treatment

Participants receive 25 mg empagliflozin or placebo once, with crossover to the alternate treatment after one week

1 week

2 visits (in-person)

Chronic Treatment

All participants receive 10 mg empagliflozin daily for 8 weeks

8 weeks

3 study visits and up to 4 safety visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Empagliflozin (Sodium-glucose cotransporter 2 (SGLT2) inhibitor)

Trial Overview 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.

Participant Groups

Group I: Empagliflozin or Placebo in Acute Experimental Treatment 1 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 Chronic Active Control 1 Intervention

Chronic phase: On day 8, all participants will receive 10 mg empagliflozin 10 mg x 8 weeks

Empagliflozin is already approved in Canada, Japan for the following indications:

Approved in Canada as Jardiance for:

• Type 2 diabetes mellitus
• Heart failure with reduced ejection fraction
• Chronic kidney disease

Approved in Japan as Jardiance for:

• Type 2 diabetes mellitus
• Heart failure with reduced ejection fraction

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Yale University New Haven, CT

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1963

Patients Recruited

3,046,000+

Boehringer Ingelheim

Industry Sponsor

Trials

2566

Patients Recruited

16,150,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Empagliflozin in Patients with Chronic Kidney Disease. Herrington, WG., Staplin, N., Wanner, C., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of empagliflozin on progression of chronic kidney disease: a prespecified secondary analysis from the empa-kidney trial. [2023]

In the EMPA-REG Outcome trial involving 6952 patients with type 2 diabetes and established cardiovascular disease, empagliflozin significantly reduced the risk of cardiovascular death by 38%, hospitalization for heart failure by 35%, and worsening kidney disease by 39% compared to placebo.

The efficacy of empagliflozin was consistent across different Kidney Disease Improving Global Outcomes (KDIGO) risk categories, indicating that its benefits on cardiovascular and kidney outcomes were not influenced by the patients' baseline chronic kidney disease status, although it was associated with a higher rate of genital infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Empagliflozin and Cardiovascular and Kidney Outcomes across KDIGO Risk Categories: Post Hoc Analysis of a Randomized, Double-Blind, Placebo-Controlled, Multinational Trial. Levin, A., Perkovic, V., Wheeler, DC., et al.[2023]

The EMPA-KIDNEY study evaluated the effects of empagliflozin in patients with chronic kidney disease, demonstrating significant benefits in slowing the progression of kidney disease.

This study involved a large cohort of patients, providing robust evidence for the efficacy of empagliflozin as a treatment option for chronic kidney disease, highlighting its potential to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In CKD, once-daily empagliflozin reduced progression of kidney disease or CV death at 2 y. Kwong, YD., Hsu, CY.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The dual role of empagliflozin: Cardio renal protection in T2DM patients. Shafiq, A., Mahboob, E., Samad, MA., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes Drug Now Approved for Heart Failure. Aschenbrenner, DS.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design, recruitment, and baseline characteristics of the EMPA-KIDNEY trial. [2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Safety Analysis of Empagliflozin in Type 2 Diabetes Mellitus Patients with Chronic Kidney Disease versus Normal Kidney Function: A Nationwide Cohort Study in Korea. Jang, HY., Kim, IW., Oh, JM.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Tuttle, KR., Levin, A., Nangaku, M., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[EMPAGLIFLOZIN (JARDIANCE) :Nw SGLT2 COTRANSPORTER INHIBITOR FOR TREATING TYPE 2 DIABETES]. Scheen, AJ.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Empagliflozin in Patients with Chronic Kidney Disease. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Effects of empagliflozin on progression of chronic kidney disease: a prespecified secondary analysis from the empa-kidney trial. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Empagliflozin and Cardiovascular and Kidney Outcomes across KDIGO Risk Categories: Post Hoc Analysis of a Randomized, Double-Blind, Placebo-Controlled, Multinational Trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

In CKD, once-daily empagliflozin reduced progression of kidney disease or CV death at 2 y. [2023]

5. England pubmed.ncbi.nlm.nih.gov

The dual role of empagliflozin: Cardio renal protection in T2DM patients. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Diabetes Drug Now Approved for Heart Failure. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Design, recruitment, and baseline characteristics of the EMPA-KIDNEY trial. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Comparative Safety Analysis of Empagliflozin in Type 2 Diabetes Mellitus Patients with Chronic Kidney Disease versus Normal Kidney Function: A Nationwide Cohort Study in Korea. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. [2022]

10. Belgium pubmed.ncbi.nlm.nih.gov

[EMPAGLIFLOZIN (JARDIANCE) :Nw SGLT2 COTRANSPORTER INHIBITOR FOR TREATING TYPE 2 DIABETES]. [2022]