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: 14 September 2015
• Main ID: EUCTR2015-000990-11-HU
• Date of registration: 13/07/2015
• Prospective Registration: Yes
• Primary sponsor: Bayer HealthCare 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: 08/09/2015
• Target sample size: 12800
• Recruitment status: Authorised-recruitment may be ongoing or finished
• 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

Countries of recruitment

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

Contacts

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

• Name: Bayer Clinical Trials Contact
• Affiliation: Bayer HealthCare 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 = 90 mL/min/1.73 m2 (CKD-EPI)
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 =60 mL/min/1.73 m2 (CKD-EPI)
-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 7630
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5170

Exclusion criteria:
- Known significant non-diabetic renal disease, including clinically relevant renal artery stenosis
- 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
- Clinical diagnosis of chronic HFrEF and persistent symptoms (NYHA class II – IV) at Run in visit (class 1A recommendation for MRAs)
- Dialysis for acute renal failure within 12 weeks of Run-in visit
- Renal allograft in place or scheduled kidney transplant within next 12 months from the Run-in visit
- HbA1c > 12% (> 108 mmol/mol) at the Run-in Visit or Screening Visit


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

Health Condition(s) or Problem(s) studied

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

Type II Diabetes Mellitus and Diabetic Kidney Disease
MedDRA version: 18.0 Level: PT Classification code 10061835 Term: Diabetic nephropathy System Organ Class: 10038359 - Renal and urinary disorders

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)

Main Objective: Demonstrate whether, in addition to standard of care, finerenone is superior to placebo in delaying the time to first occurrence of cardiovascular mortality and morbidity in subjects with type 2 diabetes mellitus and the clinical diagnosis of diabetic kidney disease.

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

Secondary Objective: •Delays the time to first occurrence of the following composite endpoint: onset of kidney failure, a sustained decrease in estimated glomerular filtration rate (eGFR) of =40% from baseline over at least 4 weeks or renal death
•Delays the time to all-cause hospitalization
•Delays the time to all-cause mortality
•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.

Timepoint(s) of evaluation of this end point: From randomization (Visit 1) until the end of study following the study termination decision, approximately from 18 to 36 months

Secondary Outcome(s)

Secondary end point(s): Time to first occurrence of the following composite endpoint:
onset of kidney failure, a sustained decrease of eGFR = 40% from baseline over at least 4 weeks or renal death
Time to all-cause hospitalization
Time to all-cause mortality
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 18 to 36 months

Except endpoint*:
Frombaseline / randomization to Month 4

Secondary ID(s)

BAY94-8862/16244

Source(s) of Monetary Support

Bayer HealthCare AG