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Finerenone for Chronic Kidney Disease in Type 1 Diabetes (FINE-ONE Trial)
FINE-ONE Trial Summary
This trial is for people with type 1 diabetes and chronic kidney disease. Researchers want to learn if a drug called finerenone works better than a placebo to reduce kidney disease from getting worse.
FINE-ONE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowFINE-ONE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.FINE-ONE Trial Design
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Who is running the clinical trial?
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- I have Type 2 diabetes.My blood pressure is either above 160/100 mmHg or below 90 mmHg systolic.Your potassium levels are within a certain range when tested at the local clinic.I have not used SGLT-2/-1 inhibitors or GLP1 agonists in the last 8 weeks.I was diagnosed with diabetes after 35 and have specific diabetes-related antibodies or had a severe diabetes complication.I have been on a steady dose of ACEI or ARB medication for at least 4 weeks.I have chronic kidney disease with specific kidney function and protein levels.I am at least 18 years old or the legal age in my country.I have Type 1 diabetes and started insulin within a year of diagnosis.Your HbA1c level at the start of the trial should be less than 10%. If the first test is not clear, you can have it checked again.I have heart failure with a need for specific heart medication.
- Group 1: Placebo arm
- Group 2: Finerenone arm
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any facilities in North America conducting this research project?
"Currently, this clinical trial is enrolling patients at University of Colorado School of Medicine - Barbara Davis Center for Childhood Diabetes (BDC) in Aurora, Colorado; Elixia Fort Lauderdale, LLC (Renal Electrolyte and Hypertension Consultants) in Orlando, Florida; Hanson Diabetes Center in Port Charlotte, Georgia; as well as 42 other sites."
Is the recruitment process still open for this clinical trial?
"According to the data provided on clinicaltrials.gov, this trial is not accepting new participants. It was initially listed on September 29th 2023 and last updated June 5th 2023; however, there are still 1784 other studies recruiting patients now."
What potential risks may be associated with a Finerenone arm for patients?
"Data surrounding the safety of Finerenone has been deemed adequate, therefore it was allocated a 3 on our team's scale. This trial being Phase 3 indicates that efficacy and safety have both undergone multiple rounds of evaluation."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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