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Abstract: INFO10

Design and Rationale of FINE-REAL: A Prospective Study Providing Insights Into the Use of Finerenone in Routine Clinical Settings

Session Information

  • Informational Posters
    November 03, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
    Abstract Time: 10:00 AM - 12:00 PM

Category: Diabetic Kidney Disease

  • No subcategory defined

Authors

  • Nicholas, Susanne B., David Geffen School of Medicine at UCLA, Los Angeles, California, United States
  • Desai, Nihar, Section of Cardiovascular Medicine, Yale School of Medicine, Yale New Haven Hospital, New Haven, Connecticut, United States
  • Navaneethan, Sankar D., Section of Nephrology, Baylor College of Medicine, Houston, Texas, United States
  • Pantalone, Kevin M., Endocrinology and Metabolism Institute Cleveland Clinic, Cleveland, Ohio, United States
  • Wanner, Christoph, University Hospital Würzburg, Department of Medicine, Division of Nephrology, Würzburg, Germany
  • Hamacher, Stefanie, ClinStat GmbH, Cologne, Germany
  • Gay, Alain, Medical Affairs & Pharmacovigilance, Pharmaceuticals, Bayer AG, Berlin, Germany
  • Wheeler, David C., Department of Renal Medicine, University College London, London, United Kingdom
Description

Finerenone, a selective, nonsteroidal, mineralocorticoid receptor antagonist (MRA), has been recently approved for the treatment of chronic kidney disease (CKD) associated with type 2 diabetes (T2D) in the United States (US) and other countries. The approvals followed results from phase III clinical trials (FIDELIO-DKD [NCT02540993] and FIGARO-DKD [NCT02545049]). However, little is known about contemporary patterns of care of patients with CKD and T2D and the adoption of finerenone. The FINE-REAL study (NCT05348733) is the first prospective observational study in patients with CKD and T2D to provide insights into the use of the nonsteroidal MRA finerenone in routine clinical practice.
FINE-REAL is an international, prospective, multicenter, single-arm study of 36 months’ duration enrolling ~4,000 adults with CKD and T2D (Figure). The primary objective is to describe treatment patterns in patients with CKD and T2D treated with finerenone in routine clinical practice (Table). Secondary objectives include assessment of safety with finerenone. Other endpoints include characterization of healthcare resource utilization and occurrence of newly diagnosed diabetic retinopathy or its progression from baseline of existing diabetic retinopathy. A US-specific exploratory objective is to establish a biobank for future analyses.
FINE-REAL is the first prospective observational study with a nonsteroidal MRA in a population with CKD and T2D and is expected to provide meaningful insights into the treatment of CKD associated with T2D, as well as inform decision-making with respect to initiation of finerenone in patients with CKD and T2D.

Table. List of primary, secondary, and exploratory objectives
Primary objective: To describe treatment patterns in patients with CKD and T2D treated with finerenone, based on: Clinical characteristics of patients with CKD and T2D, reasons for introducing finerenone, reasons for discontinuation of finerenone, planned and actual duration of treatment with finerenone, dosing of finerenone, use of secondary therapies (concomitant medication) in patients with CKD and T2D
Secondary endpoints: Reported adverse events/serious adverse events overall and by Medical Dictionary for Regulatory Activities preferred term and reported hyperkalemia (leading to study drug discontinuation, dialysis, or hospitalization)
Further endpoints: Healthcare utilization (out-patient, emergency, and in-patient visits including reasons, duration, outcomes) and reported diabetic retinopathy and its progression if existing at time of informed consent
Exploratory objective: Establishment of a biobank to support future analyses (US patients only)

Funding

  • The FINE-REAL study is supported by Bayer AG. Medical writing support was provided by Moamen Hammad, PhD, and editorial support, including formatting, proofreading and submission, was provided by George Chappell, MSc, both of Scion, London, UK, supported by Bayer according to Good Publication Practice guidelines (https://www.acpjournals.org/doi/10.7326/M15-0288).
Abstract: INFO10

Design and Rationale of FINE-REAL: A Prospective Study Providing Insights Into the Use of Finerenone in Routine Clinical Settings

Session Information

  • Informational Posters
    November 04, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
    Abstract Time: 10:00 AM - 12:00 PM

Category:

  • No subcategory defined

Authors

  • Nicholas, Susanne B., David Geffen School of Medicine at UCLA, Los Angeles, California, United States
  • Desai, Nihar, Section of Cardiovascular Medicine, Yale School of Medicine, Yale New Haven Hospital, New Haven, Connecticut, United States
  • Navaneethan, Sankar D., Section of Nephrology, Baylor College of Medicine, Houston, Texas, United States
  • Pantalone, Kevin M., Endocrinology and Metabolism Institute Cleveland Clinic, Cleveland, Ohio, United States
  • Wanner, Christoph, University Hospital Würzburg, Department of Medicine, Division of Nephrology, Würzburg, Germany
  • Hamacher, Stefanie, ClinStat GmbH, Cologne, Germany
  • Gay, Alain, Medical Affairs & Pharmacovigilance, Pharmaceuticals, Bayer AG, Berlin, Germany
  • Wheeler, David C., Department of Renal Medicine, University College London, London, United Kingdom
Description

Finerenone, a selective, nonsteroidal, mineralocorticoid receptor antagonist (MRA), has been recently approved for the treatment of chronic kidney disease (CKD) associated with type 2 diabetes (T2D) in the United States (US) and other countries. The approvals followed results from phase III clinical trials (FIDELIO-DKD [NCT02540993] and FIGARO-DKD [NCT02545049]). However, little is known about contemporary patterns of care of patients with CKD and T2D and the adoption of finerenone. The FINE-REAL study (NCT05348733) is the first prospective observational study in patients with CKD and T2D to provide insights into the use of the nonsteroidal MRA finerenone in routine clinical practice.
FINE-REAL is an international, prospective, multicenter, single-arm study of 36 months’ duration enrolling ~4,000 adults with CKD and T2D (Figure). The primary objective is to describe treatment patterns in patients with CKD and T2D treated with finerenone in routine clinical practice (Table). Secondary objectives include assessment of safety with finerenone. Other endpoints include characterization of healthcare resource utilization and occurrence of newly diagnosed diabetic retinopathy or its progression from baseline of existing diabetic retinopathy. A US-specific exploratory objective is to establish a biobank for future analyses.
FINE-REAL is the first prospective observational study with a nonsteroidal MRA in a population with CKD and T2D and is expected to provide meaningful insights into the treatment of CKD associated with T2D, as well as inform decision-making with respect to initiation of finerenone in patients with CKD and T2D.

Table. List of primary, secondary, and exploratory objectives
Primary objective: To describe treatment patterns in patients with CKD and T2D treated with finerenone, based on: Clinical characteristics of patients with CKD and T2D, reasons for introducing finerenone, reasons for discontinuation of finerenone, planned and actual duration of treatment with finerenone, dosing of finerenone, use of secondary therapies (concomitant medication) in patients with CKD and T2D
Secondary endpoints: Reported adverse events/serious adverse events overall and by Medical Dictionary for Regulatory Activities preferred term and reported hyperkalemia (leading to study drug discontinuation, dialysis, or hospitalization)
Further endpoints: Healthcare utilization (out-patient, emergency, and in-patient visits including reasons, duration, outcomes) and reported diabetic retinopathy and its progression if existing at time of informed consent
Exploratory objective: Establishment of a biobank to support future analyses (US patients only)

Abstract: INFO10

Design and Rationale of FINE-REAL: A Prospective Study Providing Insights Into the Use of Finerenone in Routine Clinical Settings

Session Information

  • Informational Posters
    November 05, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
    Abstract Time: 10:00 AM - 12:00 PM

Category:

  • No subcategory defined

Authors

  • Nicholas, Susanne B., David Geffen School of Medicine at UCLA, Los Angeles, California, United States
  • Desai, Nihar, Section of Cardiovascular Medicine, Yale School of Medicine, Yale New Haven Hospital, New Haven, Connecticut, United States
  • Navaneethan, Sankar D., Section of Nephrology, Baylor College of Medicine, Houston, Texas, United States
  • Pantalone, Kevin M., Endocrinology and Metabolism Institute Cleveland Clinic, Cleveland, Ohio, United States
  • Wanner, Christoph, University Hospital Würzburg, Department of Medicine, Division of Nephrology, Würzburg, Germany
  • Hamacher, Stefanie, ClinStat GmbH, Cologne, Germany
  • Gay, Alain, Medical Affairs & Pharmacovigilance, Pharmaceuticals, Bayer AG, Berlin, Germany
  • Wheeler, David C., Department of Renal Medicine, University College London, London, United Kingdom
Description

Finerenone, a selective, nonsteroidal, mineralocorticoid receptor antagonist (MRA), has been recently approved for the treatment of chronic kidney disease (CKD) associated with type 2 diabetes (T2D) in the United States (US) and other countries. The approvals followed results from phase III clinical trials (FIDELIO-DKD [NCT02540993] and FIGARO-DKD [NCT02545049]). However, little is known about contemporary patterns of care of patients with CKD and T2D and the adoption of finerenone. The FINE-REAL study (NCT05348733) is the first prospective observational study in patients with CKD and T2D to provide insights into the use of the nonsteroidal MRA finerenone in routine clinical practice.
FINE-REAL is an international, prospective, multicenter, single-arm study of 36 months’ duration enrolling ~4,000 adults with CKD and T2D (Figure). The primary objective is to describe treatment patterns in patients with CKD and T2D treated with finerenone in routine clinical practice (Table). Secondary objectives include assessment of safety with finerenone. Other endpoints include characterization of healthcare resource utilization and occurrence of newly diagnosed diabetic retinopathy or its progression from baseline of existing diabetic retinopathy. A US-specific exploratory objective is to establish a biobank for future analyses.
FINE-REAL is the first prospective observational study with a nonsteroidal MRA in a population with CKD and T2D and is expected to provide meaningful insights into the treatment of CKD associated with T2D, as well as inform decision-making with respect to initiation of finerenone in patients with CKD and T2D.

Table. List of primary, secondary, and exploratory objectives
Primary objective: To describe treatment patterns in patients with CKD and T2D treated with finerenone, based on: Clinical characteristics of patients with CKD and T2D, reasons for introducing finerenone, reasons for discontinuation of finerenone, planned and actual duration of treatment with finerenone, dosing of finerenone, use of secondary therapies (concomitant medication) in patients with CKD and T2D
Secondary endpoints: Reported adverse events/serious adverse events overall and by Medical Dictionary for Regulatory Activities preferred term and reported hyperkalemia (leading to study drug discontinuation, dialysis, or hospitalization)
Further endpoints: Healthcare utilization (out-patient, emergency, and in-patient visits including reasons, duration, outcomes) and reported diabetic retinopathy and its progression if existing at time of informed consent
Exploratory objective: Establishment of a biobank to support future analyses (US patients only)