Empagliflozin for Chronic Kidney Disease

(SGLT2I-IN-KIDS Trial)

Recruiting in Palo Alto (17 mi)

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Must not be taking: SGLT2i, Immunosuppressives

Disqualifiers: Heart disease, Diabetes, Pregnancy, others

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

The goal of this study is to learn if a clinical trial of sodium-glucose co-transporter 2 inhibitors (SGLT2i) is possible in youth with chronic kidney disease (CKD). The investigators also plan to explore whether treatment with SGLT2i (Empagliflozin) helps improve risk factors for worsening kidney and heart disease. The main questions are: 1. Is enrolling 40 youth with CKD into a clinical trial of empagliflozin feasible (ie achievable)? 2. Does taking empagliflozin for 3 months result in positive changes in blood, urine, and heart function tests? Participants will be randomly selected (like flipping a coin) to either receive empagliflozin or not start treatment with empagliflozin and remain on their usual care. Study Procedures Include * For participants randomly selected for treatment, take empagliflozin once daily for 3 months * Phone calls with researchers every 2 weeks for check-ins * For participants taking empagliflozin, clinic visits 4 and 8 weeks after starting for check-ups and tests * All study participants will have clinic visits at the beginning and end (3 months) where researchers will collect information about their health and perform tests

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using an SGLT2 inhibitor or need to adjust your blood pressure medications in the next 3 months.

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

Empagliflozin has been shown to reduce the progression of kidney disease and the risk of cardiovascular death in patients with chronic kidney disease over a two-year period. Additionally, it has been effective in lowering the risk of hospitalization in people with heart failure, indicating its potential benefits for heart and kidney health. ^{1 2 3 4 5}

Is empagliflozin safe for humans?

Empagliflozin, also known as Jardiance, is generally considered safe for humans, but it can have side effects. It is used for conditions like diabetes and heart failure, and patients should be monitored for issues like fluid deficits. ^{1 2 6 7 8}

How is the drug empagliflozin unique for treating chronic kidney disease?

Empagliflozin is unique because it is a sodium-glucose co-transporter-2 (SGLT2) inhibitor, which not only helps manage blood sugar levels but also slows the progression of chronic kidney disease and reduces the risk of heart-related issues. This dual benefit makes it different from many other treatments that focus solely on kidney function or heart health. ^{1 2 3 4 9}

Research Team

Eligibility Criteria

This trial is for young people with chronic kidney disease (CKD). To join, they must be eligible to start treatment and willing to take a daily pill or stick with their usual care. They'll also need to check in by phone every two weeks and visit the clinic at specific times.

Inclusion Criteria

My kidney function is moderately to severely reduced.

Exclusion Criteria

Pregnancy

Lack of clearance by primary nephrologist for participation

I am able to follow study instructions and procedures.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive empagliflozin once daily for 3 months

12 weeks

Clinic visits at 4 and 8 weeks, phone calls every 2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Empagliflozin (Sodium-Glucose coTransporter 2 Inhibitor)

Trial Overview The study tests if it's possible to run a larger trial on Empagliflozin (a diabetes drug) in kids with CKD, and if taking it for 3 months improves blood, urine, and heart function. Participants are randomly chosen to either get the drug or continue regular care.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

Empagliflozin 10mg daily for 3 months (n=20)

Group II: Standard of Care Active Control 1 Intervention

Participants will not take empagliflozin (n=20)

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

Who Is Running the Clinical Trial?

Ann & Robert H Lurie Children's Hospital of Chicago

Lead Sponsor

Trials

275

Recruited

5,182,000+

Dr. Michael D. Kelleher

Ann & Robert H Lurie Children's Hospital of Chicago

Chief Medical Officer since 2012

MD from University of Chicago

Dr. Thomas Shanley

Ann & Robert H Lurie Children's Hospital of Chicago

Chief Executive Officer since 2019

MD from University of Chicago Pritzker School of Medicine

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Dr. Griffin P. Rodgers

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Chief Executive Officer since 2007

MD, M.A.C.P.

Dr. Griffin P. Rodgers

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Chief Medical Officer since 2007

MD, M.A.C.P.

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

In the EMPEROR-Reduced study involving over 3700 participants with chronic heart failure and reduced ejection fraction, empagliflozin significantly reduced the risk of hospitalization for heart failure complications (13.2% vs. 18.3% for placebo) over an average of 16 months.

Empagliflozin also showed a lower incidence of serious kidney problems (1.6% vs. 3.1% for placebo), indicating its potential safety and efficacy in managing heart failure, although it was associated with a higher rate of genital tract infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug treatment with empagliflozin lowered risk for hospitalization in people with heart failure with reduced ejection fraction: plain language summary of the EMPEROR-Reduced study. Zannad, F., Macari, S.[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.

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]

Empagliflozin (Jardiance®) is an effective treatment for type 2 diabetes (T2D) that works by inhibiting the sodium glucose cotransporter-2 (SGLT2), and it also offers cardioprotective and renoprotective benefits, making it particularly suitable for patients with cardiovascular disease (CVD) and chronic kidney disease (CKD).

While empagliflozin is generally well-tolerated and easy to administer, it does have some side effects and contraindications that need to be considered, highlighting the importance of evaluating its benefits against potential risks in clinical practice.

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]

Empagliflozin, when administered to 15,081 patients with type 2 diabetes and moderate to severe chronic kidney disease (CKD), showed no new safety concerns, with similar rates of serious adverse events compared to placebo.

The treatment was associated with significantly lower risks of hyperkalemia and edema, suggesting potential benefits for patients with advanced CKD.

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]

Dapagliflozin has been shown to be effective in improving outcomes for patients with chronic kidney disease, as highlighted in the commentary on a study involving diverse patient populations.

The commentary emphasizes the importance of dapagliflozin's mechanism of action, which includes reducing the risk of kidney disease progression and cardiovascular events, making it a valuable treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dapagliflozin in people with chronic kidney disease. Sylvester, RD., Khong, TK.[2023]

References

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

Empagliflozin in Patients with Chronic Kidney Disease. [2023]

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

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

3. England pubmed.ncbi.nlm.nih.gov

Drug treatment with empagliflozin lowered risk for hospitalization in people with heart failure with reduced ejection fraction: plain language summary of the EMPEROR-Reduced study. [2023]

4. 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]

5. Belgium pubmed.ncbi.nlm.nih.gov

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

6. England pubmed.ncbi.nlm.nih.gov

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

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

Diabetes Drug Now Approved for Heart Failure. [2023]

8. 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]

9. England pubmed.ncbi.nlm.nih.gov

Dapagliflozin in people with chronic kidney disease. [2023]