Observational study on the use of Finerenone in patients with chronic kidney disease and type 2 diabetes.
FINE-REAL: A Non-interventional Study Providing Insights Into the Use of Finerenone in a Routine Clinical Setting
This study looks at how well the drug Finerenone works for adults with chronic kidney disease and type 2 diabetes who have recently started taking it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 4500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bayer Industry-sponsored |
| Locations | 68 sites (Huntsville, Alabama and 67 other locations) |
| Trial ID | NCT05348733 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather information on the use of the drug Finerenone in patients diagnosed with chronic kidney disease (CKD) associated with type 2 diabetes (T2D). Participants will be adults who have started treatment with Finerenone within 8 weeks prior to or after signing informed consent. The study will monitor the effects of Finerenone, which works by blocking mineralocorticoid receptors to potentially reduce kidney damage. The goal is to better understand the drug's effectiveness in a routine medical care setting.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a diagnosis of chronic kidney disease associated with type 2 diabetes.
Not a fit: Patients who are currently participating in another investigational trial or have contraindications to Finerenone will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of Finerenone in managing kidney disease in patients with type 2 diabetes.
How similar studies have performed: While this study is observational, similar studies on Finerenone have shown promising results in managing kidney disease in diabetic patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult participants of all genders (≥18 years old) * Diagnosis of CKD associated with T2D based on assessment by physician. * Treatment according to local marketing authorization, finerenone 20 or 10 mg.Treatment should have been started up to 8 weeks before or after the ICF is signed. * Decision to initiate treatment with finerenone must be made before ICF is signed. * Signed informed consent Exclusion Criteria: * Participation in an investigational trial at any time during the course of this study * Contra-indications according to the local label.
Where this trial is running
Huntsville, Alabama and 67 other locations
- Nephrology Consultants LLC — Huntsville, Alabama, United States (Active_not_recruiting)
- AKDHC Medical Research Servies LLC — Phoenix, Arizona, United States (Active_not_recruiting)
- Harrisburg Family Medical Center — Harrisburg, Arkansas, United States (Active_not_recruiting)
- Kidney Disease Medical Group — Glendale, California, United States (Active_not_recruiting)
- Renal Consultants Medical Group — Granada Hills, California, United States (Active_not_recruiting)
- Keck School of Medicine of University of Southern California — Los Angeles, California, United States (Withdrawn)
- UCSF Nephrology Clinic — San Francisco, California, United States (Withdrawn)
- University of Central Florida College of Medicine — Orlando, Florida, United States (Active_not_recruiting)
- Gulf View Medical — Port Charlotte, Florida, United States (Active_not_recruiting)
- Hanson Clinical Research Center — Port Charlotte, Florida, United States (Active_not_recruiting)
- Metabolic Research Institute — West Palm Beach, Florida, United States (Active_not_recruiting)
- Ellipsis Group — Alpharetta, Georgia, United States (Withdrawn)
- Augusta University — Augusta, Georgia, United States (Active_not_recruiting)
- Coastal Medical Research — Brunswick, Georgia, United States (Active_not_recruiting)
- Caritas Medical Center — Stockbridge, Georgia, United States (Active_not_recruiting)
- Herman Clinical Research LLC — Suwanee, Georgia, United States (Active_not_recruiting)
- Laurie Tom, MD — Honolulu, Hawaii, United States (Active_not_recruiting)
- Pacific Diabetes & Endocrine Center — Honolulu, Hawaii, United States (Active_not_recruiting)
- Cook County Health — Chicago, Illinois, United States (Withdrawn)
- Jesse Brown VA Medical Center — Chicago, Illinois, United States (Withdrawn)
- Medico — Chicago, Illinois, United States (Active_not_recruiting)
- Nephrology Associates Northern Illinois and Indiana — Hinsdale, Illinois, United States (Active_not_recruiting)
- Kidney and Hypertension Center of Wabash Valley LLC — Terre Haute, Indiana, United States (Active_not_recruiting)
- University of Iowa Preventive Intervention Clinic — Iowa City, Iowa, United States (Withdrawn)
- Northwest Louisiana Nephrology — Shreveport, Louisiana, United States (Withdrawn)
- Ochsner Medical Foundation — Slidell, Louisiana, United States (Active_not_recruiting)
- University of Maryland Midtown Professionals Group Healthcare — Baltimore, Maryland, United States (Active_not_recruiting)
- NECCR Primacare Research, LLC — Fall River, Massachusetts, United States (Active_not_recruiting)
- Healthy Heart Cardiology — Grand Rapids, Michigan, United States (Active_not_recruiting)
- Care Access Research - Minneapolis — Minneapolis, Minnesota, United States (Active_not_recruiting)
- Jackson Medical Mall University Home Dialysis Clinic — Jackson, Mississippi, United States (Withdrawn)
- Nephrology and Hypertension Associates — Tupelo, Mississippi, United States (Active_not_recruiting)
- Renown Regional Medical Center — Reno, Nevada, United States (Active_not_recruiting)
- The EnLyv Clinics — Edison, New Jersey, United States (Active_not_recruiting)
- Gaffney Health Services — Charlotte, North Carolina, United States (Not_yet_recruiting)
- Bland Clinic — Greensboro, North Carolina, United States (Active_not_recruiting)
- Ardmore Medical Research — Winston-Salem, North Carolina, United States (Active_not_recruiting)
- Panoramic Health — Providence, Rhode Island, United States (Active_not_recruiting)
- DarSalud Care / LifeDOC Research — Memphis, Tennessee, United States (Active_not_recruiting)
- Academy of Diabetes Thyroid and Endocrine — El Paso, Texas, United States (Active_not_recruiting)
- AA Medical Research Center — Flint, Texas, United States (Active_not_recruiting)
- Prolato Clinical Research — Houston, Texas, United States (Withdrawn)
- Clinical Research Stategies Inc — Houston, Texas, United States (Active_not_recruiting)
- RGV Endocrine Center — McAllen, Texas, United States (Active_not_recruiting)
- Dallas Renal Group — Plano, Texas, United States (Active_not_recruiting)
- Tranquil Clinical Research — Webster, Texas, United States (Active_not_recruiting)
- University of Utah — Salt Lake City, Utah, United States (Withdrawn)
- Washington Nephrology Associates — Alexandria, Virginia, United States (Withdrawn)
- MultiCare Endocrinology Specialists Tacoma — Tacoma, Washington, United States (Active_not_recruiting)
- Many Locations — Multiple Locations, Argentina (Recruiting)
+18 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Bayer Clinical Trials Contact
- Email: clinical-trials-contact@bayer.com
- Phone: (+)1-888-84 22937
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.