Empagliflozin for Chronic Kidney Disease

Not yet recruiting at 105 trial locations

Overseen By Boehringer Ingelheim

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Boehringer Ingelheim

Must be taking: RAAS inhibitors

Disqualifiers: Type 1 diabetes, Chronic dialysis, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 15

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a medication called empagliflozin can help children and teens with chronic kidney disease (CKD). The study aims to evaluate the drug's effectiveness and how the body processes it. Participants will be randomly assigned to take either empagliflozin or a placebo (a sugar pill resembling the drug) for six months, followed by a year of taking empagliflozin. Children and teens aged 2 to 17 with CKD who are stable on their current kidney treatment might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

You will need to stay on a stable dose of your current medications, like RAAS inhibitors or immunosuppressive therapy, for at least 30 days before starting the trial and throughout the placebo-controlled part of the study. There should be no plans to change these doses during this time.

Is there any evidence suggesting that empagliflozin is likely to be safe for children and adolescents with chronic kidney disease?

Research has shown that empagliflozin is generally safe for people with chronic kidney disease (CKD). In earlier studies, it did not introduce new safety issues in patients with advanced CKD, and some benefits were observed, such as a lower risk of kidney failure.

Empagliflozin reduces the risk of worsening kidney disease and heart-related deaths compared to a placebo. Although there is a small initial drop in kidney function, this is followed by a slower decline over time, suggesting that the treatment might help maintain kidney function longer.

While typically used for adults with type 2 diabetes, its use in children with CKD is still under investigation. The current study is in a later phase, indicating some evidence already supports its safety. However, careful monitoring during the study remains crucial to ensure it is well-tolerated in younger patients. ^{1 2 3 4 5}

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

Empagliflozin is unique because it targets chronic kidney disease by blocking a specific protein called SGLT2, which is responsible for glucose reabsorption in the kidneys. This is different from standard treatments like ACE inhibitors or ARBs, which primarily focus on managing blood pressure and slowing kidney damage. Researchers are excited because empagliflozin not only helps control blood sugar levels but also offers potential protective benefits for the kidneys by reducing the pressure and stress on these organs. This dual action could lead to better outcomes for people with chronic kidney disease.

What evidence suggests that empagliflozin might be an effective treatment for chronic kidney disease?

Research has shown that empagliflozin, which participants in this trial may receive, can help slow chronic kidney disease (CKD). Studies have found it lowers the risk of kidney failure by 34% and reduces the chance of dying from heart problems. It also cuts the risk of negative kidney outcomes by 25%. Additionally, empagliflozin improves quality of life and lowers healthcare costs for people with CKD. These findings suggest that empagliflozin could be a promising treatment for managing CKD. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for children aged 2 to 17 with chronic kidney disease. Participants must be able to take tablets and commit to the study duration of over a year and a half, including visits and calls from site staff. Specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

I have kidney disease with specific lab test results.

I am between 2 and 17 years old.

My kidney disease treatment has been stable for the last 30 days and won't change during the trial.

Exclusion Criteria

My doctor says I have a bone condition that is not under control.

Severe, uncontrolled hypertension (based on investigator's judgement).

I have not had ketoacidosis in the last 8 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take empagliflozin or placebo as tablets once a day for 6 months

6 months

Approximately 7 visits (in-person), 2-3 calls (virtual)

Open-label Extension

Participants in both groups take empagliflozin as tablets once a day for 1 year

1 year

Approximately 8 visits (in-person), 2-3 calls (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Empagliflozin

Trial Overview The trial tests if empagliflozin helps kids with CKD compared to a placebo. It's randomized, meaning participants have double the chance of receiving empagliflozin than placebo. The treatment phase lasts 6 months, followed by all getting empagliflozin for another year.

How Is the Trial Designed?

Group I: Empagliflozin treatment arm Experimental Treatment 1 Intervention

Group II: Placebo arm Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+

Citations

1. nejm.org nejm.org/doi/full/10.1056/NEJMoa2204233

Empagliflozin in Patients with Chronic Kidney Disease Empagliflozin therapy led to a lower risk of progression of kidney disease or death from cardiovascular causes than placebo.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7616743/

Long-Term Effects of Empagliflozin in CKD Patients There was a 13% (0.87, 0.76-0.99) reduction in risk of the primary outcome during the post-trial period in the empagliflozin group. Compared ...

3. thelancet.com thelancet.com/journals/landia/article/PIIS2213-8587(25)00222-0/fulltext

an individual participant-level meta-analysis The risk of kidney failure was reduced by 34%. Benefits were evident irrespective of the predicted size of the acute dip in eGFR and ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2589537025002706

Empagliflozin: Quality of Life, Healthcare Use & Costs in CKD In summary, 2 years of allocation to empagliflozin in EMPA-KIDNEY increased quality-of-life-adjusted survival and reduced use and cost of other healthcare ...

5. nephjc.com nephjc.com/news/empa-long-term

Long Term Effects of Empagliflozin in Patients with CKD A large study across twenty US healthcare systems (62,197 patients) showed empagliflozin reduced kidney outcomes by 25% and cardiovascular ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9210861/

Safety of Empagliflozin in Patients With Type 2 Diabetes ... 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 ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2213858723003212

Effects of empagliflozin on progression of chronic kidney ... These analyses show that empagliflozin caused a modest initial drop in kidney function, followed by a substantial slowing of the rate of ...

8. journals.lww.com journals.lww.com/cjasn/fulltext/2020/10000/empagliflozin_and_cardiovascular_and_kidney.10.aspx

Empagliflozin and Cardiovascular and Kidney Outcomes ... Empagliflozin consistently slowed the long-term annual decline in eGFR across all patient subgroups regardless of KDIGO risk category, as assessed by mean eGFR ...