Finerenone for Diabetic Kidney Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how two medications, Empagliflozin and Finerenone, can treat kidney problems in people with type 2 diabetes. It aims to understand how these drugs, either alone or together, affect kidney health by examining specific proteins that indicate kidney damage. The study seeks African American veterans with type 2 diabetes who have kidney issues and protein in their urine. Participants should not currently smoke or have certain other health conditions. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, allowing researchers to understand how it benefits more patients.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if you are on a statin, you need to be on a stable dose for a month before joining.
What is the safety track record for these treatments?
Earlier studies have shown that finerenone is safe for people with chronic kidney disease (CKD) and type 2 diabetes. It lowers the risk of kidney problems without causing major side effects. Research indicates that it does not negatively affect potassium levels or kidney function test results.
Similarly, studies show that empagliflozin reduces the risk of worsening kidney disease and is generally safe for people with type 2 diabetes and CKD. No new safety concerns have been reported with its use.
When used together, early research provides important information about the safety of finerenone and empagliflozin. The combination was well-tolerated and significantly reduced kidney-related issues.
Overall, both treatments, whether used alone or together, have been shown to be safe in previous studies. However, individual experiences may vary, so consulting a healthcare provider before joining any trial is important.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about these treatments for diabetic kidney disease because they offer a fresh approach compared to standard options like ACE inhibitors or ARBs. Finerenone is a non-steroidal mineralocorticoid receptor antagonist, which helps reduce inflammation and fibrosis in kidneys more effectively. Empagliflozin, a type of SGLT2 inhibitor, works by lowering blood sugar and helping protect the kidneys. The combination of finerenone and empagliflozin could provide enhanced kidney protection by tackling the disease from multiple angles, potentially offering better outcomes for patients.
What evidence suggests that this trial's treatments could be effective for diabetic kidney disease?
Research shows that Finerenone, which participants in this trial may receive, helps reduce kidney problems in people with chronic kidney disease (CKD) and type 2 diabetes. It lowers the risk of CKD worsening and decreases the amount of a protein called albumin in urine by 31% compared to a placebo. Finerenone also improves kidney function and reduces the risk of heart issues and death.
Empagliflozin, another treatment option in this trial, has been proven to slow the progression of kidney disease and improve kidney health. It also reduces protein levels in urine and protects the kidneys from damage.
Participants in this trial may also receive a combination of Finerenone and Empagliflozin, which can be even more effective. This combination significantly lowers the urine albumin-to-creatinine ratio, providing better kidney protection than either treatment alone.56789Who Is on the Research Team?
Sabyasachi Sen, MD, PhD
Principal Investigator
Washington DC VA Medical Center
Are You a Good Fit for This Trial?
This trial is for African American veterans aged 20-90 with type 2 diabetes, chronic kidney disease stages 2 and 3, and signs of kidney damage in their urine. They must have a certain level of kidney function (eGFR ≥25-89 mL/min/1.73 m2), controlled blood pressure (≤140/90), and be able to consent to the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Finerenone, Empagliflozin, or a combination therapy to study podocyte specific injury markers in African American Veterans with DKD
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Empagliflozin
- Finerenone
Trial Overview
The trial tests Finerenone and Empagliflozin, alone or combined, on markers of kidney injury in urine from participants. It aims to see if these drugs affect proteins linked to podocyte injury, standard biomarkers like ACR and eGFR, inflammation indicators, arterial stiffness measures, and APOL1 gene expression levels.
How Is the Trial Designed?
3
Treatment groups
Active Control
Finerenone 10mg orally daily for 4 months
Empagliflozin 10mg orally daily for 4 months
Take 10mg Empagliflozin daily, followed by Fineronone 10mg daily after 4 weeks or 1 month of taking empagliflozin. The combination will continue for 3 months or 12 weeks
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington D.C. Veterans Affairs Medical Center
Lead Sponsor
Bayer
Industry Sponsor
Bill Anderson
Bayer
Chief Executive Officer since 2023
BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT
Michael Devoy
Bayer
Chief Medical Officer since 2014
MD, PhD
Citations
Empagliflozin and Progression of Kidney Disease in Type ...
Empagliflozin was associated with slower progression of kidney disease and lower rates of clinically relevant renal events than was placebo when added to ...
Effects of Empagliflozin on Progression of Chronic Kidney ...
Empagliflozin slowed the rate of progression of CKD among all types of participant in the EMPA-KIDNEY trial, including those with little albuminuria.
Empagliflozin attenuates renal damage in diabetic ...
The results also showed that empagliflozin (Empa) treatment improved proteinuria and ameliorated renal pathological damage. We observed that Empa has an impact ...
Cost-Effectiveness of Empagliflozin in Patients With ...
A utility reduction for composite kidney outcome was based on published analysis of EQ-5D data for nephropathy among respondents with T2D to the ...
5.
diabetesjournals.org
diabetesjournals.org/care/article/45/6/1445/145036/Safety-of-Empagliflozin-in-Patients-With-Type-2Safety 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 ...
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.
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 ...
Nephrotic-range proteinuria in type 2 diabetes: Effects of ...
Our data suggests that empagliflozin might slow kidney function loss and delay the estimated onset of projected ESKD in patients with type 2 ...
Empagliflozin and Clinical Outcomes in Patients With Type ...
Conclusions: Empagliflozin improved clinical outcomes and reduced mortality in vulnerable patients with type 2 diabetes mellitus, established ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.