Efficacy and safety of finerenone in subjects with type 2 diabetes mellitus and the clinical diagnosis of diabetic kidney disease

• Register: EUCTR
• Last refreshed on: 19 April 2022
• Main ID: EUCTR2015-000990-11-NL
• Date of registration: 26/08/2015
• Prospective Registration: Yes
• Primary sponsor: Bayer AG
• Public title: Efficacy and safety of finerenone in subjects with type 2 diabetes mellitus and the clinical diagnosis of diabetic kidney disease
• Scientific title: A randomized, double-blind, placebo-controlled, parallel-group, multicenter, event-driven Phase III study to investigate the efficacy and safety of finerenone, in addition to standard of care, on the progression of kidney disease in subjects with type 2 diabetes mellitus and the clinical diagnosis of diabetic kidney disease - FIDELIO-DKD
• Date of first enrolment: 17/09/2015
• Target sample size: 9600
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-000990-11
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Czechia, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, Vietnam

Contacts

• Name: Bayer Clinical Trials Contact
• Affiliation: Bayer AG

• Name: Bayer Clinical Trials Contact
• Affiliation: Bayer AG

Key inclusion & exclusion criteria

Inclusion criteria:
- Men or women aged 18 years and older. The lower age limit may be higher if legally required in the participating country.
- Women of childbearing potential can only be included in the study if a pregnancy test is negative at the Screening Visit and if they agree to use adequate contraception. Adequate contraception is defined as any combination of at least 2 effective methods of birth control, of which at least one is a physical barrier (e.g. condoms with hormonal contraception or implants or combined oral contraceptives, certain intrauterine devices). Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate) or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL [for US only: FSH levels > 40 mIU/mL and estradiol < 20 pg/mL] or have had surgical treatment such as bilateral tubal ligation, bilateral ovarectomy, or hysterectomy.
- Subjects with type 2 diabetes mellitus as defined by the American Diabetes Association
- Subjects with a clinical diagnosis of DKD based on either of the following criteria at the Run-in and Screening Visit:
• Persistent high albuminuria defined as UACR of = 30 mg/g ( = 3.4 mg/mmol) but < 300 mg/g (< 33.9 mg/mmol) in 2 out of 3 first morning void samples and eGFR = 25 but < 60 mL/min/1.73 m2 and presence of diabetic retinopathy in the medical history
OR
• Persistent very high albuminuria defined as UACR of = 300 mg/g (= 33.9 mg/mmol) in 2 out of 3 first morning void samples and eGFR = 25 but < 75 mL/min/1.73 m2
- Prior treatment with ACEIs and ARBs as follows:
• For at least 4 weeks prior to the Run-in Visit, subjects should be treated with either an ACEI or ARB, or both
• Starting with the Run in Visit, subjects should be treated with only an ACEI or ARB
• For at least 4 weeks prior to the Screening Visit, subjects should be treated with the maximum tolerated labeled dose (but not below the minimal labeled dose) of only an ACEI or an ARB (not both) preferably without any adjustments to dose or choice of agent or to any other antihypertensive or antiglycemic treatment
- Serum potassium = 4.8 mmol/L at both the Run-in and the Screening Visit

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 4400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5200

Exclusion criteria:
- Known significant non-diabetic renal disease, including clinically relevant renal artery stenosis
- HbA1c > 12% (> 108 mmol/mol) at the Run-in Visit or Screening Visit
- Uncontrolled arterial hypertension with mean sitting systolic blood pressure (SBP) = 170 mmHg or mean sitting diastolic blood pressure (DBP) = 110 mmHg at the Run in Visit or mean sitting SBP = 160 mmHg or mean sitting DBP = 100 mmHg at the Screening Visit
- Subjects with a clinical diagnosis of chronic heart failure with reduced ejection fraction (HFrEF) and persistent symptoms (New York Heart Association class II-IV) at the Run in Visit (class 1A recommendation for MRAs)
- Dialysis for acute renal failure within 12 weeks prior to the Run-in Visit
- Renal allograft in place or a scheduled kidney transplant within the next 12 months from the Run in Visit



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Type II Diabetes Mellitus and Diabetic Kidney Disease
MedDRA version: 21.1 Level: PT Classification code 10061835 Term: Diabetic nephropathy System Organ Class: 10038359 - Renal and urinary disorders

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Intervention(s)

Product Name: BAY 94-8862 IR tablet 10 mg
Product Code: BAY 94-8862 coated tablet 10 mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Finerenone
CAS Number: 1050477-31-0
Current Sponsor code: BAY 94-8862 micronized
Other descriptive name: BAY 94-8862
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Product Name: BAY 94-8862 IR tablet 20 mg
Product Code: BAY 94-8862 coated tablet 20 mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Finerenone
CAS Number: 1050477-31-0
Current Sponsor code: BAY 94-8862 micronized
Other descriptive name: BAY 94-8862
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): Time to the first occurrence of the composite endpoint of onset of kidney failure, a sustained decrease of eGFR = 40% from baseline over at least 4 weeks and renal death.

Timepoint(s) of evaluation of this end point: From randomization (Visit 1) until the end of study following the study termination decision, approximately from 16 to 40 months

Secondary Objective: Determine whether, in addition to SoC, finerenone compared to placebo:
• Delays the time to first occurrence of the following composite endpoint: cardiovascular (CV) death or non-fatal CV events (i.e. non fatal myocardial infarction, non-fatal stroke, hospitalization for heart failure [HF])
• Delays the time to all-cause mortality
• Delays the time to all-cause hospitalizations
• Change in UACR from baseline to Month 4
• Delays the time to first occurrence of the following composite endpoint:
onset of kidney failure, a sustained decrease in eGFR of =57% from baseline over at least 4 weeks or renal death.

Main Objective: Demonstrate whether, in addition to standard of care (SoC), finerenone is superior to placebo in delaying the progression of kidney disease, as measured by the composite endpoint of time to first occurrence of kidney failure, a sustained decrease of eGFR = 40% from baseline over at least 4 weeks or renal death

Secondary Outcome(s)

Secondary end point(s): - Time to first occurrence of the following composite endpoint: cardiovascular death or non-fatal cardiovascular events (myocardial infarction, stroke, hospitalization for heart failure)
- Time to all-cause mortality
- Time to all-cause hospitalizations
- Change in UACR from baseline to Month 4*
- Time to first occurrence of the following composite endpoint:onset of kidney failure, a sustained decrease in eGFR of =57% from baseline over at least 4 weeks or renal death.

Timepoint(s) of evaluation of this end point: For all endpoints:
From randomization (Visit 1) until the end of study following the study termination decision, approximately from 16 to 40 months

Except *
At baseline / randomization (Visit 1) and Month 4

Secondary ID(s)

2015-000990-11-DK

BAY94-8862/16244

Source(s) of Monetary Support

Bayer AG

Ethics review

Status: Approved
Approval date: 17/09/2015
Contact:

Results

• Results available: Yes
• Date Posted: 22/04/2021
• Date Completed: 14/04/2020
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-000990-11/results