50 Participants Needed

Empagliflozin for Polycystic Kidney Disease

MB
Overseen ByMichel B Chonchol, MD
Age: 18 - 65
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Colorado, Denver
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as loop diuretics and tolvaptan or other V2 receptor antagonists, before participating.

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

Research shows that empagliflozin, a drug used for chronic kidney disease, can slow down the progression of kidney disease and reduce the risk of heart-related deaths. This suggests it might also help with polycystic kidney disease, although specific studies for this condition are needed.12345

Is empagliflozin generally safe for humans?

Empagliflozin, also known as Jardiance, is generally well-tolerated in humans, but it can have side effects and contraindications. It has been studied for safety in people with type 2 diabetes and heart failure, showing it is safe for these conditions, though monitoring for side effects like fluid deficits is recommended.56789

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

Empagliflozin is unique because it is primarily used to treat type 2 diabetes by preventing glucose reabsorption in the kidneys, which also helps reduce blood pressure and body weight. Its potential use in polycystic kidney disease is novel, as it may help slow kidney disease progression, a benefit observed in chronic kidney disease patients.15101112

What is the purpose of this trial?

This trial tests empagliflozin, a drug that helps remove excess sugar through urine, in patients with ADPKD who suffer from kidney cysts and eventual kidney failure. The drug may help reduce kidney damage and improve heart health by blocking a protein that reabsorbs sugar. Empagliflozin has been shown to slow the progression of diabetic kidney disease.

Research Team

MB

Michel B Chonchol, MD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

This trial is for adults aged 18-50 with Autosomal Dominant Polycystic Kidney Disease (ADPKD) and moderately reduced kidney function, but not diabetes or heart failure. Participants should have stable kidney health without recent infections and must not be pregnant, using certain diuretics, or have contraindications to MRI scans.

Inclusion Criteria

I have been diagnosed with ADPKD according to specific criteria.
My kidney function has been stable for the last 3 months.
You have been categorized as having a specific risk level based on imaging tests done at the Mayo Clinic.
See 1 more

Exclusion Criteria

Your blood pressure while sitting is less than 100 mm Hg.
I am currently taking tolvaptan or a similar medication.
Pregnant or lactating
See 9 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive empagliflozin or placebo in a 12-month parallel-group, randomized, double-blind, placebo-controlled trial

12 months
Check-in visits every 2 weeks for the 1st month, monthly on month 2 and 3, then every 3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Empagliflozin
  • Placebo
Trial Overview The study tests the safety of Empagliflozin in ADPKD patients over a year. It's a double-blind trial where half the participants will receive Empagliflozin and the other half a placebo, neither group knowing which they're getting to ensure unbiased results.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ExperimentalExperimental Treatment1 Intervention
Empagliflozin
Group II: Placebo comparatorPlacebo Group1 Intervention
Placebo

Empagliflozin is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Jardiance for:
  • Type 2 diabetes mellitus
  • Heart failure with reduced ejection fraction
  • Chronic kidney disease
🇺🇸
Approved in United States as Jardiance for:
  • Type 2 diabetes mellitus
  • Heart failure with reduced ejection fraction
  • Chronic kidney disease
  • Cardiovascular risk reduction
🇨🇦
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

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials
1,842
Recruited
3,028,000+

University of Maryland

Collaborator

Trials
171
Recruited
325,000+

Findings from Research

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.
In CKD, once-daily empagliflozin reduced progression of kidney disease or CV death at 2 y.Kwong, YD., Hsu, CY.[2023]
In the EMPA-KIDNEY trial involving 6609 patients with chronic kidney disease, empagliflozin significantly reduced the risk of kidney disease progression or death from cardiovascular causes compared to placebo, with a hazard ratio of 0.72, indicating a 28% lower risk.
Patients taking empagliflozin also experienced fewer hospitalizations for any cause compared to those on placebo, suggesting a potential safety benefit, although there were no significant differences in heart failure hospitalizations or overall mortality between the two groups.
Empagliflozin in Patients with Chronic Kidney Disease.Herrington, WG., Staplin, N., Wanner, C., et al.[2023]
In the EMPA-KIDNEY trial involving 6609 participants, empagliflozin significantly slowed the progression of chronic kidney disease, reducing the chronic decline in kidney function by 50% after an initial dip in eGFR.
The benefits of empagliflozin were observed across various patient groups, indicating that albuminuria levels should not be the sole factor in deciding treatment with SGLT2 inhibitors, as even patients with low albuminuria experienced significant improvements.
Effects of empagliflozin on progression of chronic kidney disease: a prespecified secondary analysis from the empa-kidney trial.[2023]

References

In CKD, once-daily empagliflozin reduced progression of kidney disease or CV death at 2 y. [2023]
Empagliflozin in Patients with Chronic Kidney Disease. [2023]
Effects of empagliflozin on progression of chronic kidney disease: a prespecified secondary analysis from the empa-kidney trial. [2023]
Efficacy and Safety of Dapagliflozin by Baseline Glycemic Status: A Prespecified Analysis From the DAPA-CKD Trial. [2021]
Pharmacokinetics and bioequivalence of a generic empagliflozin tablet versus a brand-named product and the food effects in healthy Chinese subjects. [2021]
Diabetes Drug Now Approved for Heart Failure. [2023]
Pharmacokinetics, Safety, and Bioequivalence of Two Empagliflozin Formulations after Single Oral Administration under Fasting and Fed Conditions in Healthy Chinese Subjects: An Open-label Randomized Single-dose Two-sequence, Two-treatment, Two-period Crossover Study. [2021]
The dual role of empagliflozin: Cardio renal protection in T2DM patients. [2022]
Pooled Safety and Tolerability Analysis of Empagliflozin in Patients with Type 2 Diabetes Mellitus. [2022]
[EMPAGLIFLOZIN (JARDIANCE) :Nw SGLT2 COTRANSPORTER INHIBITOR FOR TREATING TYPE 2 DIABETES]. [2022]
11.Czech Republicpubmed.ncbi.nlm.nih.gov
[Empagliflozin - the new representative of SGLT2 transporter inhibitors for the treatment of patients with diabetes 2 type]. [2018]
12.United Statespubmed.ncbi.nlm.nih.gov
A Case of Severe Metabolic Acidosis due to Jardiance-Induced Euglycemic Diabetic Ketoacidosis. [2021]
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