Diabetes Is The Leading Cause of Kidney Disease: Could A New Pill Help?

Once again, diaTribe is bringing you a double trial watch – two clinical studies assessing the safety and efficacy of the drug Finerenone in adults with type 2 diabetes and diabetic kidney disease (“nephropathy”). Finerenone is a new medication working in a similar way to long established medicines affecting salt balance in the kidney. It is being developed to help blood pressure control, heart failure, and diabetic kidney disease.

Why is this new/important?

About 30% of people with type 1 diabetes and 10-40% of those with type 2 diabetes eventually will suffer from kidney disease, which makes diabetes the leading cause of chronic kidney disease. Currently, there are no universally successful treatments for the treatment or reversal of diabetic kidney disease, so the discovery of new drugs has tremendous potential to improve outcomes. Research suggests that Finerenone may help reduce markers of kidney malfunction called “proteinuria” (the presence of abnormal quantities of protein in the urine).

These two phase 3 studies are collecting additional data on the safety and efficacy of Finerenone for improving kidney disease. The main differences between the two studies are trial length and location. You can find information on both trials below.

39-MONTH TRIAL

Clinical Trial Identifier: NCT02540993

Trial Name: Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease (FIDELIO-DKD)

What it’s testing: This trial will assess the efficacy and safety of Finerenone in adults with type 2 diabetes and diabetic kidney disease. Trial participants will be randomized to take either a once-daily Finerenone pill or a placebo in addition to standard daily therapy.

What the trial is measuring: This study is primarily focused on the decrease in kidney failure and cardiovascular issues, as well as other outcomes such as the change in abnormal quantities of protein in urine. More details here.

Trial Length: 39 months

Trial Location: The trial is currently recruiting in the following US states: AL, CA, FL, GA, MI, MO, NY, TN, TX, and VA. For a full list of current and future locations (including several European locations, Canada, and Australia), see here.

Do you qualify?

• 18+ years old

• Type 2 diabetes

• Diagnosis of diabetic kidney disease (DKD)

• Pretreated with either ACE-inhibitors or angiotensin II receptor blockers

Exclusion criteria include:

• A1c over 12%

• Kidney disease without diabetes

• High blood pressure

• Chronic heart failure

For a full list of inclusion and exclusion criteria see here.

Where to get more information: For more information, please go to the trial’s webpage and view the contact information specific to each enrolling location.

36-MONTH TRIAL

Clinical Trial Identifier: NCT02545049

Trial Name: Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease (FIGARO-DKD)

What it’s testing: This trial will assess the efficacy and safety of Finerenone in adults with type 2 diabetes and diabetic kidney disease. Trial participants will be randomized to take either a once-daily Finerenone pill or placebo in addition to standard daily therapy.

What the trial is measuring: This study is primarily focused on the decrease in cardiovascular issues and kidney failure, as well as other outcomes such as the change in abnormal quantities of protein in urine. More details here.

Trial Length: 36 months

Trial Location: The trial is currently recruiting in the following US states: AL, AZ, CA, CT, FL, GA, HI, KS, MI, MO, NM, NY, OH, PA, TN, TX, and VA. For a full list of current and future locations (including several European locations, Canada, and Australia), see here.

Do you qualify?

• 18+ years old

• Type 2 diabetes

• Diagnosis of diabetic kidney disease (DKD)

• Pretreated with either ACE-inhibitors or angiotensin II receptor blockers

Exclusion criteria include:

• A1c greater than 12%

• Kidney disease without diabetes

• High blood pressure

• Chronic heart failure

For a full list of inclusion and exclusion criteria see here.

Where to get more information: For more information, please go to the trial’s webpage and view the contact information specific to each enrolling location.