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Mineralocorticoid Receptor Antagonist
Finerenone for Chronic Kidney Disease in Type 1 Diabetes (FINE-ONE Trial)
Phase 3
Recruiting
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants with a clinical diagnosis of CKD and fulfilling both the criteria (central assessment): eGFR ≥25 and <90 mL/min/1.73 m^2 using CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) 2009 formula at the Screening visit, UACR ≥200 mg/g (22.6 mg/mmol) to <5000 mg/g (565 mg/mmol) at the Screening visit (geometric mean of the 3 measurements)
Participant must be ≥18 years of age (or the legal age of consent according to local legislation) at the time of signing the informed consent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline up to 7 months
Awards & highlights
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.
Who is the study for?
Adults with Type 1 diabetes and chronic kidney disease (CKD) who are on stable blood pressure medication can join. They must have a certain level of kidney function, protein in urine, and controlled blood sugar levels. People with heart failure needing specific treatments or those recently on certain diabetes medications cannot participate.Check my eligibility
What is being tested?
The trial is testing if Finerenone, which blocks proteins that may harm kidneys and the heart, is more effective than a placebo at slowing CKD progression in people with Type 1 diabetes. Participants will also continue their standard care treatments during the study.See study design
What are the potential side effects?
Potential side effects include medical problems arising from treatment (TEAEs), serious TEAEs requiring hospitalization or causing disability, and high potassium levels in the blood (hyperkalaemia).
FINE-ONE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have chronic kidney disease with specific kidney function and protein levels.
Select...
I am at least 18 years old or the legal age in my country.
FINE-ONE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline up to 7 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up to 7 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Urinary albumin-to-creatinine ratio (UACR)
Secondary outcome measures
Number of participants with Hyperkalaemia
Number of participants with treatment-emergent adverse events (TEAEs), Treatment-emergent serious adverse event (TESAEs)
FINE-ONE Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Finerenone armExperimental Treatment1 Intervention
Participants with eGFR ≥25 to <60 mL/min/1.73 m^2 at Screening visit will take Finerenone Dose A. Participants with eGFR ≥60 mL/min/1.73 m^2 at Screening visit will take Dose B. Up-titration and down-titration of study intervention will be based on local potassium and kidney function (eGFR) values. Treatment duration is 6 months.
Group II: Placebo armPlacebo Group1 Intervention
Participants will take Finerenone matching placebo for 6 months.
Find a Location
Who is running the clinical trial?
BayerLead Sponsor
2,240 Previous Clinical Trials
25,332,557 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo arm
- Group 2: Finerenone arm
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
Who else is applying?
What site did they apply to?
Morehouse School of Medicine | Clinical Research Centre
What portion of applicants met pre-screening criteria?
Did not meet criteria
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