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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a drug called empagliflozin (Jardiance) to determine its safety and tolerability for individuals with Autosomal Dominant Polycystic Kidney Disease (ADPKD). Researchers aim to compare the effects of empagliflozin with a placebo (a pill with no active drug) over 12 months. The trial seeks participants with ADPKD who have maintained a certain level of kidney function and stable kidney health over the past three months. Eligible participants should not have diabetes or certain heart conditions and should not be using specific medications like loop diuretics. For those with ADPKD who meet these criteria, this trial might be a suitable option. As a Phase 2 trial, this research measures how well empagliflozin works in an initial, smaller group, offering a chance to contribute to important findings.

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.

Is there any evidence suggesting that empagliflozin is likely to be safe for humans?

Research shows that empagliflozin is generally safe for people with certain kidney and heart conditions. Studies have found that it can reduce the risk of worsening kidney disease and may help prevent heart issues. In patients with type 2 diabetes and advanced chronic kidney disease (CKD), empagliflozin did not cause any unexpected safety problems, meaning people did not experience surprising adverse reactions to the treatment.

In trials for autosomal dominant polycystic kidney disease (ADPKD), researchers are carefully monitoring empagliflozin for safety. They observe how people respond to the drug and check for any side effects. Overall, evidence so far suggests that empagliflozin is well-tolerated by patients, meaning most people can take this medication without serious issues.12345

Why do researchers think this study treatment might be promising for polycystic kidney disease?

Empagliflozin is unique because it targets polycystic kidney disease (PKD) by inhibiting a protein called SGLT2, which plays a role in glucose reabsorption in the kidneys. Unlike the standard treatments for PKD, which often focus on managing symptoms like hypertension and pain, empagliflozin directly affects kidney function by promoting glucose excretion in urine. This mechanism not only helps in potentially slowing cyst growth and preserving kidney function but also offers the added benefit of improving blood sugar control, which is not addressed by current PKD treatments. Researchers are excited about empagliflozin because it represents a novel approach that could offer more comprehensive benefits to PKD patients.

What evidence suggests that empagliflozin might be an effective treatment for ADPKD?

Research has shown that empagliflozin, which participants in this trial may receive, may help with kidney problems. Studies have found that it can slow kidney disease and reduce the risk of death related to it. For individuals with long-term kidney disease, empagliflozin performed better than a placebo, improving their quality of life and lowering healthcare costs. Although more research is needed for polycystic kidney disease, these findings suggest potential benefits. Participants in this trial will receive either empagliflozin or a placebo to evaluate its effectiveness specifically for polycystic kidney disease.12467

Who Is on the Research Team?

MB

Michel B Chonchol, MD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ExperimentalExperimental Treatment1 Intervention
Group II: Placebo comparatorPlacebo Group1 Intervention

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

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Approved in European Union as Jardiance for:
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Approved in United States as Jardiance for:
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Approved in Canada as Jardiance for:
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Approved in Japan as Jardiance for:

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+

Published Research Related to This Trial

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]
The study found that a generic empagliflozin tablet is bioequivalent to the brand-named Jardiance® in terms of key pharmacokinetic parameters, indicating that both formulations can be expected to have similar efficacy and safety profiles in healthy individuals.
Consumption of high-fat food did not affect the pharmacokinetics of empagliflozin, suggesting that it can be taken with or without food without impacting its effectiveness.
Pharmacokinetics and bioequivalence of a generic empagliflozin tablet versus a brand-named product and the food effects in healthy Chinese subjects.Li, X., Liu, L., Deng, Y., et al.[2021]
Empagliflozin (10 mg and 25 mg) is well tolerated in patients with type 2 diabetes mellitus (T2DM), showing similar rates of adverse events compared to placebo across a pooled analysis of 20 clinical trials involving over 14,000 participants.
While empagliflozin did not significantly increase the risk of hypoglycemia or urinary tract infections compared to placebo, it was associated with a higher incidence of genital infections, highlighting the need for monitoring in patients receiving this treatment.
Pooled Safety and Tolerability Analysis of Empagliflozin in Patients with Type 2 Diabetes Mellitus.Kinduryte Schorling, O., Clark, D., Zwiener, I., et al.[2022]

Citations

Empagliflozin in patients with autosomal dominant ...The EMPA-PKD trial is assessing the safety of empagliflozin in patients with rapid progressive ADPKD with and without concomitant tolvaptan use.
NCT06391450 | Study of Empagliflozin in Patients with ...The primary endpoint is progression of cystic kidney growth by monitoring MRI-based changes in total kidney volume and the secondary endpoint is exploring ...
Empagliflozin in Patients with Chronic Kidney DiseaseEmpagliflozin therapy led to a lower risk of progression of kidney disease or death from cardiovascular causes than placebo.
Effects of empagliflozin on quality of life and healthcare use ...We report that allocation to empagliflozin in EMPA-KIDNEY increased quality-of-life-adjusted survival and reduced the use and cost of other healthcare over 2 ...
SGLT2 inhibition for patients with ADPKD - Oxford AcademicThis review summarizes the current knowledge on SGLT2i in this specific patient population and outlines running and upcoming clinical trial programs.
Safety of Empagliflozin in Patients With Type 2 Diabetes and ...Use of empagliflozin in patients with type 2 diabetes and advanced CKD raised no new safety concerns and may have beneficial effects on the development of ...
secondary analyses of the EMPA-KIDNEY trialThe EMPA-KIDNEY trial showed that empagliflozin reduced the risk of the primary composite outcome of kidney disease progression or cardiovascular death in ...
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