Clinical trial NCT02540993: Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Event-driven Phase 3 Study to Investigate the Safety and Efficacy 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Kidney Disease
Keywords: CKD
Diabetic Kidney Disease
Type 2 Diabetes
Kidney diseases
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2015-09-04
Enrollment: 5734
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study was to demonstrate whether, in addition to standard of care, 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 estimated glomerular filtration rate (eGFR) ≥40% from baseline over at least 4 weeks, or renal death.


Eligibility criteria: Inclusion Criteria:

* Men or women ≥18 years of age
* Type 2 diabetes mellitus (T2D) as defined by the American Diabetes Association
* Diagnosis of chronic kidney disease (CKD) with at least one of the following criteria at run-in and screening visits:

  * persistent high albuminuria (UACR ≥30 to \<300 mg/g in 2 out of 3 first morning void samples) and estimated glomerular filtration rate (eGFR) ≥25 but \<60 mL/min/1.73 m² (CKD EPI) and presence of diabetic retinopathy or
  * persistent very high albuminuria (UACR ≥300 mg/g in 2 out of 3 first morning void samples) and eGFR ≥25 to \<75 mL/min/1.73 m² (CKD-EPI)
* Prior treatment with angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (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

Exclusion Criteria:

* Known significant non-diabetic renal disease, including clinically relevant renal artery stenosis
* Uncontrolled arterial hypertension (ie, mean sitting systolic blood pressure (SBP) ≥170 mmHg, sitting diastolic blood pressure (DBP) ≥110 mmHg at run-in visit, or mean sitting SBP ≥160 mmHg, sitting DBP ≥100 mmHg at screening)
* Glycated hemoglobin (HbA1c) \>12%
* Mean SBP \< 90 mmHg at the run-in visit or at the screening visit
* Clinical diagnosis of chronic heart failure with reduced ejection fraction (HFrEF) and persistent symptoms (New York Heart Association \[NYHA\] class II - IV) at run-in visit (class 1A recommendation for mineralcorticoid receptor antagonists \[MRAs\])
* Stroke, transient ischemic cerebral attack, acute coronary syndrome, or hospitalization for worsening heart failure, in the last 30 days prior to the screening visit
* Dialysis for acute renal failure within 12 weeks of run-in visit
* Renal allograft in place or scheduled within next 12 months from the run-in visit

Primary outcomes:
measure: 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, or Renal Death
timeFrame: From randomization up until the first occurrence of the primary renal composite endpoint, or censoring at the end of the study, with an average follow-up time of 32 months
Secondary outcomes:
measure: The First Occurrence of the Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, or Hospitalization for Heart Failure
timeFrame: From randomization up until the first occurrence of the key secondary CV composite endpoint, or censoring at the end of the study, with an average of 32 months
measure: All-cause Mortality
timeFrame: From randomization up until death due to any cause, or censoring at the end of the study visit, with an average of 32 months
measure: All-cause Hospitalization
timeFrame: From randomization up until the first occurrence of the hospitalization due to any cause, or censoring at the end of study, with an average of 32 months
measure: Change in Urinary Albumin-to-creatinine Ratio (UACR) From Baseline to Month 4
timeFrame: From baseline up until Month 4
measure: The First Occurrence of the Composite Endpoint of Onset of Kidney Failure, a Sustained Decrease in eGFR of ≥57% From Baseline Over at Least 4 Weeks, or Renal Death
timeFrame: From randomization up until the first occurrence of the composite primary endpoint, or censoring at the end of the study, with an average of 32 months
Other outcomes:
Locations:
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country: Finland
city: Kajaani
country: Finland
city: Kerava
country: Finland
city: Klaukkala
country: Finland
city: Kuopio
country: Finland
city: Nurmijärvi
country: Finland
city: Oulu
country: Finland
city: Rauma
country: Finland
city: Seinäjoki
country: Finland
city: Tampere
country: Finland
city: Turku
country: Finland
city: Vantaa
country: Finland
city: Bois-guillaume
country: France
city: Bordeaux
country: France
city: Boulogne Sur Mer
country: France
city: Brest
country: France
city: COLMAR Cedex
country: France
city: Dijon
country: France
city: La Rochelle
country: France
city: La Tronche
country: France
city: Le Coudray
country: France
city: Le Creusot
country: France
city: Lyon Cedex
country: France
city: Mulhouse
country: France
city: Nîmes
country: France
city: Paris
country: France
city: PESSAC cedex
country: France
city: Saint Herblain
country: France
city: Saint Priest En Jarez
country: France
city: Tourcoing
country: France
city: Vandoeuvre-les-nancy
country: France
city: Venissieux
country: France
city: Heidelberg
country: Germany
state: Baden-Württemberg
city: Ludwigsburg
country: Germany
state: Baden-Württemberg
city: Schweinfurt
country: Germany
state: Bayern
city: Würzburg
country: Germany
state: Bayern
city: Elsterwerda
country: Germany
state: Brandenburg
city: Bad König
country: Germany
state: Hessen
city: Frankfurt
country: Germany
state: Hessen
city: Frankfurt
country: Germany
state: Hessen
city: Göttingen
country: Germany
state: Niedersachsen
city: Hannover
country: Germany
state: Niedersachsen
city: Aachen
country: Germany
state: Nordrhein-Westfalen
city: Bad Oeynhausen
country: Germany
state: Nordrhein-Westfalen
city: Bochum
country: Germany
state: Nordrhein-Westfalen
city: Dortmund
country: Germany
state: Nordrhein-Westfalen
city: Duesseldorf
country: Germany
state: Nordrhein-Westfalen
city: Düsseldorf
country: Germany
state: Nordrhein-Westfalen
city: Essen
country: Germany
state: Nordrhein-Westfalen
city: Münster
country: Germany
state: Nordrhein-Westfalen
city: Nettetal
country: Germany
state: Nordrhein-Westfalen
city: Witten
country: Germany
state: Nordrhein-Westfalen
city: Ludwigshafen
country: Germany
state: Rheinland-Pfalz
city: Mainz
country: Germany
state: Rheinland-Pfalz
city: Dresden
country: Germany
state: Sachsen
city: Dresden
country: Germany
state: Sachsen
city: Hoyerswerda
country: Germany
state: Sachsen
city: Leipzig
country: Germany
state: Sachsen
city: Leipzig
country: Germany
state: Sachsen
city: Jena
country: Germany
state: Thüringen
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Alexandroupolis
country: Greece
city: Athens
country: Greece
city: Athens
country: Greece
city: Chaidari
country: Greece
city: Larissa
country: Greece
city: Nea Ionia
country: Greece
city: Thessaloniki
country: Greece
city: Thessaloniki
country: Greece
city: Hong Kong
country: Hong Kong
city: Shatin
country: Hong Kong
city: Sheung Wan
country: Hong Kong
city: Wong Tai Sin
country: Hong Kong
city: Baja
country: Hungary
city: Balatonfured
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Eger
country: Hungary
city: Kistarcsa
country: Hungary
city: Nyiregyhaza
country: Hungary
city: Nyiregyhaza
country: Hungary
city: Papa
country: Hungary
city: Siofok
country: Hungary
city: Szeged
country: Hungary
city: Szekesfehervar
country: Hungary
city: Szentes
country: Hungary
city: Szombathely
country: Hungary
city: Veszprem
country: Hungary
city: Cork
country: Ireland
city: Dublin
country: Ireland
city: Dublin
country: Ireland
city: Galway
country: Ireland
city: Afula
country: Israel
city: Ashkelon
country: Israel
city: Beer Sheva
country: Israel
city: Hadera
country: Israel
city: Haifa
country: Israel
city: Holon
country: Israel
city: Jerusalem
country: Israel
city: Kfar Saba
country: Israel
city: Nahariya
country: Israel
city: Nahariya
country: Israel
city: Nazareth
country: Israel
city: Ramat Gan
country: Israel
city: Rehovot
country: Israel
city: Sakhnin
country: Israel
city: Tel Aviv
country: Israel
city: Tel Aviv
country: Israel
city: Tel Aviv
country: Israel
city: Tel Aviv
country: Israel
city: Tiberias
country: Israel
city: Zefat
country: Israel
city: Zerifin
country: Israel
city: Napoli
country: Italy
state: Campania
city: Bologna
country: Italy
state: Emilia-Romagna
city: Parma
country: Italy
state: Emilia-Romagna
city: Reggio Emilia
country: Italy
state: Emilia-Romagna
city: Genova
country: Italy
state: Liguria
city: Genova
country: Italy
state: Liguria
city: Bergamo
country: Italy
state: Lombardia
city: Bergamo
country: Italy
state: Lombardia
city: Bergamo
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Monza Brianza
country: Italy
state: Lombardia
city: Torino
country: Italy
state: Piemonte
city: Torino
country: Italy
state: Piemonte
city: Cagliari
country: Italy
state: Sardegna
city: Sassari
country: Italy
state: Sardegna
city: Catania
country: Italy
state: Sicilia
city: Messina
country: Italy
state: Sicilia
city: Padova
country: Italy
state: Veneto
city: Verona
country: Italy
state: Veneto
city: Nagoya
country: Japan
state: Aichi
city: Nagoya
country: Japan
state: Aichi
city: Nagoya
country: Japan
state: Aichi
city: Nagoya
country: Japan
state: Aichi
city: Nagoya
country: Japan
state: Aichi
city: Toyota
country: Japan
state: Aichi
city: Funabashi
country: Japan
state: Chiba
city: Ichikawa
country: Japan
state: Chiba
city: Matsuyama
country: Japan
state: Ehime
city: Matsuyama
country: Japan
state: Ehime
city: Chikushino
country: Japan
state: Fukuoka
city: Kasuga
country: Japan
state: Fukuoka
city: Kitakyushu
country: Japan
state: Fukuoka
city: Kitakyushu
country: Japan
state: Fukuoka
city: Kitakyushu
country: Japan
state: Fukuoka
city: Kitakyushu
country: Japan
state: Fukuoka
city: Shirakawa
country: Japan
state: Fukushima
city: Ogaki
country: Japan
state: Gifu
city: Maebashi
country: Japan
state: Gunma
city: Higashihiroshima
country: Japan
state: Hiroshima
city: Asahikawa
country: Japan
state: Hokkaido
city: Hakodate
country: Japan
state: Hokkaido
city: Obihiro
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Kobe
country: Japan
state: Hyogo
city: Naka
country: Japan
state: Ibaraki
city: Ushiku
country: Japan
state: Ibaraki
city: Komatsu
country: Japan
state: Ishikawa
city: Sanuki
country: Japan
state: Kagawa
city: Takamatsu
country: Japan
state: Kagawa
city: Takamatsu
country: Japan
state: Kagawa
city: Atsugi
country: Japan
state: Kanagawa
city: Fujisawa
country: Japan
state: Kanagawa
city: Kamakura
country: Japan
state: Kanagawa
city: Yokohama
country: Japan
state: Kanagawa
city: Yokohama
country: Japan
state: Kanagawa
city: Yokohama
country: Japan
state: Kanagawa
city: Tamana
country: Japan
state: Kumamoto
city: Yatsushiro
country: Japan
state: Kumamoto
city: Sasebo
country: Japan
state: Nagasaki
city: Beppu
country: Japan
state: Oita
city: Yufu
country: Japan
state: Oita
city: Nakagami-gun
country: Japan
state: Okinawa
city: Shimajiri
country: Japan
state: Okinawa
city: Suita
country: Japan
state: Osaka
city: Kawaguchi
country: Japan
state: Saitama
city: Sayama
country: Japan
state: Saitama
city: Otsu
country: Japan
state: Shiga
city: Iwata
country: Japan
state: Shizuoka
city: Oyama
country: Japan
state: Tochigi
city: Minato
country: Japan
state: Tokyo
city: Musashino
country: Japan
state: Tokyo
city: Shibuya-ku
country: Japan
state: Tokyo
city: Fukui
country: Japan
city: Fukui
country: Japan
city: Fukuoka
country: Japan
city: Fukuoka
country: Japan
city: Fukuoka
country: Japan
city: Kagoshima
country: Japan
city: Kumamoto
country: Japan
city: Kumamoto
country: Japan
city: Kumamoto
country: Japan
city: Nagasaki
country: Japan
city: Osaka
country: Japan
city: Osaka
country: Japan
city: Osaka
country: Japan
city: Osaka
country: Japan
city: Osaka
country: Japan
city: Saitama
country: Japan
city: Chuncheon Si
country: Korea, Republic of
state: Gang''weondo
city: Wonju
country: Korea, Republic of
state: Gang''weondo
city: Anyang-si
country: Korea, Republic of
state: Gyeonggido
city: Goyang-si
country: Korea, Republic of
state: Gyeonggido
city: Incheon Gwangyeogsi,
country: Korea, Republic of
state: Incheon Gwang''yeogsi
city: Seoul
country: Korea, Republic of
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
state: Seoul Teugbyeolsi
city: Busan
country: Korea, Republic of
city: Busan
country: Korea, Republic of
city: Daejeon
country: Korea, Republic of
city: Seoul,
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Kaunas
country: Lithuania
city: Kaunas
country: Lithuania
city: Kaunas
country: Lithuania
city: Klaipeda
country: Lithuania
city: Utena
country: Lithuania
city: Vilnius
country: Lithuania
city: Johor Bahru
country: Malaysia
city: Kelantan
country: Malaysia
city: Kelantan
country: Malaysia
city: Kuala Lumpur
country: Malaysia
city: Pahang
country: Malaysia
city: Perak
country: Malaysia
city: Perak
country: Malaysia
city: Pulau Pinang
country: Malaysia
city: Putrajaya
country: Malaysia
city: Selangor
country: Malaysia
city: Ciudad de México
country: Mexico
state: Distrito Federal
city: México D.F.
country: Mexico
state: Distrito Federal
city: México, D. F.
country: Mexico
state: Distrito Federal
city: México, D. F.
country: Mexico
state: Distrito Federal
city: Guadalajara
country: Mexico
state: Jalisco
city: Guadalajara
country: Mexico
state: Jalisco
city: Cuernavaca
country: Mexico
state: Morelos
city: Queretaro
country: Mexico
state: Querétaro
city: San Juan del Río
country: Mexico
state: Querétaro
city: Culiacán
country: Mexico
state: Sinaloa
city: Culiacán
country: Mexico
state: Sinaloa
city: Mazatlán
country: Mexico
state: Sinaloa
city: Puerto de Veracruz
country: Mexico
state: Veracruz
city: Xalapa
country: Mexico
state: Veracruz
city: Aguascalientes
country: Mexico
city: Chihuahua
country: Mexico
city: Ciudad de México
country: Mexico
city: Alkmaar
country: Netherlands
city: Almere
country: Netherlands
city: Amersfoort
country: Netherlands
city: Amsterdam
country: Netherlands
city: Amsterdam
country: Netherlands
city: Apeldoorn
country: Netherlands
city: Breda
country: Netherlands
city: Den Haag
country: Netherlands
city: Dordrecht
country: Netherlands
city: Eindhoven
country: Netherlands
city: Geleen
country: Netherlands
city: Groningen
country: Netherlands
city: Hoogeveen
country: Netherlands
city: Nieuwegein
country: Netherlands
city: Zwijndrecht
country: Netherlands
city: Auckland
country: New Zealand
city: Auckland
country: New Zealand
city: Christchurch
country: New Zealand
city: Hamilton
country: New Zealand
city: Hawkes Bay
country: New Zealand
city: Palmerston North
country: New Zealand
city: Tauranga
country: New Zealand
city: Wellington
country: New Zealand
city: Hamar
country: Norway
city: Hamar
country: Norway
city: Kløfta
country: Norway
city: Kristiansand
country: Norway
city: Levanger
country: Norway
city: Oslo
country: Norway
city: Oslo
country: Norway
city: Skedsmokorset
country: Norway
city: Trondheim
country: Norway
city: Ålesund
country: Norway
city: Iloilo City
country: Philippines
city: Marikina City
country: Philippines
city: Pasig City
country: Philippines
city: Quezon City
country: Philippines
city: Quezon City
country: Philippines
city: Quezon City
country: Philippines
city: Bialystok
country: Poland
city: Bydgoszcz
country: Poland
city: Chojnice
country: Poland
city: Gdansk
country: Poland
city: Gdynia
country: Poland
city: Katowice
country: Poland
city: Krakow
country: Poland
city: Krakow
country: Poland
city: Krakow
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Lodz
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Olsztyn
country: Poland
city: Poznan
country: Poland
city: Rzeszów
country: Poland
city: Skorzewo
country: Poland
city: Szczecin
country: Poland
city: Torun
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Wroclaw
country: Poland
city: Zabrze
country: Poland
city: Covilha
country: Portugal
state: Castelo Branco
city: Loures
country: Portugal
state: Lisboa
city: Matosinhos
country: Portugal
state: Porto
city: Funchal
country: Portugal
state: Região Autónoma Da Madeira
city: Torres Novas
country: Portugal
state: Santarém
city: Setubal
country: Portugal
state: Setúbal
city: Almada
country: Portugal
city: Amadora
country: Portugal
city: Braga
country: Portugal
city: Faro
country: Portugal
city: Leiria
country: Portugal
city: Lisboa
country: Portugal
city: Lisboa
country: Portugal
city: Lisboa
country: Portugal
city: Lisboa
country: Portugal
city: Porto
country: Portugal
city: Porto
country: Portugal
city: Viana do Castelo
country: Portugal
city: Cidra
country: Puerto Rico
city: San Juan
country: Puerto Rico
city: Alba-Iulia
country: Romania
state: Alba
city: Baia Mare
country: Romania
state: Maramures
city: Ploiesti
country: Romania
state: Prahova
city: Timisoara
country: Romania
state: Timis
city: Bucuresti
country: Romania
city: Bucuresti
country: Romania
city: Bucuresti
country: Romania
city: Bucuresti
country: Romania
city: Bucuresti
country: Romania
city: Bucuresti
country: Romania
city: Bucuresti
country: Romania
city: Cluj-Napoca
country: Romania
city: Galati
country: Romania
city: Iasi
country: Romania
city: Oradea
country: Romania
city: Satu Mare
country: Romania
city: Timisoara
country: Romania
city: Arkhangelsk
country: Russian Federation
city: Barnaul
country: Russian Federation
city: Chelyabinsk
country: Russian Federation
city: Irkutsk
country: Russian Federation
city: Izhevsk
country: Russian Federation
city: Kazan
country: Russian Federation
city: Kazan
country: Russian Federation
city: Kemerovo
country: Russian Federation
city: Kemerovo
country: Russian Federation
city: Kemerovo
country: Russian Federation
city: Kirov
country: Russian Federation
city: Krasnodar
country: Russian Federation
city: Krasnoyarsk
country: Russian Federation
city: Kursk
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Nizhny Novgorod
country: Russian Federation
city: Nizhny Novgorod
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Omsk
country: Russian Federation
city: Omsk
country: Russian Federation
city: Omsk
country: Russian Federation
city: Orenburg
country: Russian Federation
city: Perm
country: Russian Federation
city: Ryazan
country: Russian Federation
city: Saratov
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Stavropol
country: Russian Federation
city: Syktyvkar
country: Russian Federation
city: Voronezh
country: Russian Federation
city: Voronezh
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Yekaterinburg
country: Russian Federation
city: Singapore
country: Singapore
city: Singapore
country: Singapore
city: Singapore
country: Singapore
city: Singapore
country: Singapore
city: Singapore
country: Singapore
city: Bardejov
country: Slovakia
city: Nitra
country: Slovakia
city: Rimavska Sobota
country: Slovakia
city: Roznava
country: Slovakia
city: Zilina
country: Slovakia
city: Port Elizabeth
country: South Africa
state: Eastern Cape
city: Benoni
country: South Africa
state: Gauteng
city: Johannesburg
country: South Africa
state: Gauteng
city: Lenasia South
country: South Africa
state: Gauteng
city: Newtown
country: South Africa
state: Gauteng
city: Petoria
country: South Africa
state: Gauteng
city: Pretoria
country: South Africa
state: Gauteng
city: Pretoria
country: South Africa
state: Gauteng
city: Soweto
country: South Africa
state: Gauteng
city: Durban
country: South Africa
state: Kwazulu-Natal
city: Isipingo Rail
country: South Africa
state: Kwazulu-Natal
city: Tongaat
country: South Africa
state: Kwazulu-Natal
city: Middelburg
country: South Africa
state: Mpumalanga
city: Witbank
country: South Africa
state: Mpumalanga
city: Cape Town
country: South Africa
state: Western Cape
city: Cape Town
country: South Africa
state: Western Cape
city: Somerset West
country: South Africa
state: Western Cape
city: Worcester
country: South Africa
state: Western Cape
city: Pretoria
country: South Africa
city: Ferrol
country: Spain
state: A Coruña
city: Badalona
country: Spain
state: Barcelona
city: Manresa
country: Spain
state: Barcelona
city: Sant Joan Despi
country: Spain
state: Barcelona
city: Jerez de la Frontera
country: Spain
state: Cádiz
city: Burela
country: Spain
state: Lugo
city: Alcalá de Henares
country: Spain
state: Madrid
city: Boadilla del Monte
country: Spain
state: Madrid
city: Getafe
country: Spain
state: Madrid
city: Sagunto
country: Spain
state: Valencia
city: A Coruña
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Córdoba
country: Spain
city: Granada
country: Spain
city: Jaén
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Málaga
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Göteborg
country: Sweden
city: Göteborg
country: Sweden
city: Lund
country: Sweden
city: Lund
country: Sweden
city: Rättvik
country: Sweden
city: Skövde
country: Sweden
city: Stockholm
country: Sweden
city: Stockholm
country: Sweden
city: Stockholm
country: Sweden
city: Stockholm
country: Sweden
city: Uppsala
country: Sweden
city: Uppsala
country: Sweden
city: Örebro
country: Sweden
city: Örebro
country: Sweden
city: Liestal
country: Switzerland
state: Basel-Landschaft
city: Geneva
country: Switzerland
state: Genève
city: St. Gallen
country: Switzerland
state: Sankt Gallen
city: St. Gallen
country: Switzerland
state: Sankt Gallen
city: Olten
country: Switzerland
state: Solothurn
city: Frauenfeld
country: Switzerland
state: Thurgau
city: Lausanne
country: Switzerland
state: Vaud
city: Bern
country: Switzerland
city: Changhua
country: Taiwan
city: Kaohsiung
country: Taiwan
city: New Taipei City
country: Taiwan
city: Taichung
country: Taiwan
city: Taichung
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan
country: Taiwan
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Chiangmai
country: Thailand
city: Khon Kaen
country: Thailand
city: Ankara
country: Turkey
city: Antalya
country: Turkey
city: Edirne
country: Turkey
city: Izmir
country: Turkey
city: Kayseri
country: Turkey
city: Kocaeli
country: Turkey
city: Malatya
country: Turkey
city: Samsun
country: Turkey
city: Sivas
country: Turkey
city: Cherkasy
country: Ukraine
city: Chernivtsi
country: Ukraine
city: Dnipro
country: Ukraine
city: Dnipro
country: Ukraine
city: Ivano-Frankivsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kiev
country: Ukraine
city: Kiev
country: Ukraine
city: Kiev
country: Ukraine
city: Kiev
country: Ukraine
city: Kiev
country: Ukraine
city: Kyiv
country: Ukraine
city: Lviv
country: Ukraine
city: Mykolayiv
country: Ukraine
city: Ternopil
country: Ukraine
city: Uzhgorod
country: Ukraine
city: Vinnytsia
country: Ukraine
city: Zaporizhzhya
country: Ukraine
city: Zaporizhzhya
country: Ukraine
city: Llanelli
country: United Kingdom
state: Carmarthenshire
city: Leicester
country: United Kingdom
state: Leicestershire
city: Salford
country: United Kingdom
state: Manchester
city: Liverpool
country: United Kingdom
state: Merseyside
city: Northampton
country: United Kingdom
state: Northamptonshire
city: Carshalton
country: United Kingdom
state: Surrey
city: Newcastle Upon Tyne
country: United Kingdom
state: Vale Of Glamorgan, The
city: Chichester
country: United Kingdom
state: West Sussex
city: Bristol
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Middlesborough
country: United Kingdom
city: Portsmouth
country: United Kingdom
city: Ha Noi
country: Vietnam
city: Ha Noi
country: Vietnam
city: Ho Chi Minh City
country: Vietnam
city: Ho Chi Minh City
country: Vietnam
city: Ho Chi Minh City
country: Vietnam
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Bakris GL, Agarwal R, Anker SD, Pitt B, Ruilope LM, Nowack C, Kolkhof P, Ferreira AC, Schloemer P, Filippatos G; on behalf of the FIDELIO-DKD study investigators; FIDELIO-DKD study investigators. Design and Baseline Characteristics of the Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease Trial. Am J Nephrol. 2019;50(5):333-344. doi: 10.1159/000503713. Epub 2019 Oct 25.
citation: Bakris GL, Agarwal R, Anker SD, Pitt B, Ruilope LM, Rossing P, Kolkhof P, Nowack C, Schloemer P, Joseph A, Filippatos G; FIDELIO-DKD Investigators. Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes. N Engl J Med. 2020 Dec 3;383(23):2219-2229. doi: 10.1056/NEJMoa2025845. Epub 2020 Oct 23.
citation: Filippatos G, Anker SD, Agarwal R, Pitt B, Ruilope LM, Rossing P, Kolkhof P, Schloemer P, Tornus I, Joseph A, Bakris GL; FIDELIO-DKD Investigators. Finerenone and Cardiovascular Outcomes in Patients With Chronic Kidney Disease and Type 2 Diabetes. Circulation. 2021 Feb 9;143(6):540-552. doi: 10.1161/CIRCULATIONAHA.120.051898. Epub 2020 Nov 16.
citation: Pitt B, Agarwal R, Anker SD, Ruilope LM, Rossing P, Ahlers C, Brinker M, Joseph A, Lambelet M, Lawatscheck R, Filippatos GS; FIDELIO-DKD and FIGARO-DKD Investigators. Association of Finerenone Use With Reduction in Treatment-Emergent Pneumonia and COVID-19 Adverse Events Among Patients With Type 2 Diabetes and Chronic Kidney Disease: A FIDELITY Pooled Secondary Analysis. JAMA Netw Open. 2022 Oct 3;5(10):e2236123. doi: 10.1001/jamanetworkopen.2022.36123.
citation: Ruilope LM, Agarwal R, Anker SD, Filippatos G, Pitt B, Rossing P, Sarafidis P, Schmieder RE, Joseph A, Rethemeier N, Nowack C, Bakris GL; FIDELIO-DKD Investigators. Blood Pressure and Cardiorenal Outcomes With Finerenone in Chronic Kidney Disease in Type 2 Diabetes. Hypertension. 2022 Dec;79(12):2685-2695. doi: 10.1161/HYPERTENSIONAHA.122.19744. Epub 2022 Oct 12.
citation: Rossing P, Burgess E, Agarwal R, Anker SD, Filippatos G, Pitt B, Ruilope LM, Gillard P, MacIsaac RJ, Wainstein J, Joseph A, Brinker M, Roessig L, Scott C, Bakris GL; FIDELIO-DKD Investigators. Finerenone in Patients With Chronic Kidney Disease and Type 2 Diabetes According to Baseline HbA1c and Insulin Use: An Analysis From the FIDELIO-DKD Study. Diabetes Care. 2022 Apr 1;45(4):888-897. doi: 10.2337/dc21-1944.
citation: Rossing P, Filippatos G, Agarwal R, Anker SD, Pitt B, Ruilope LM, Chan JCN, Kooy A, McCafferty K, Schernthaner G, Wanner C, Joseph A, Scheerer MF, Scott C, Bakris GL; FIDELIO-DKD Investigators. Finerenone in Predominantly Advanced CKD and Type 2 Diabetes With or Without Sodium-Glucose Cotransporter-2 Inhibitor Therapy. Kidney Int Rep. 2021 Oct 14;7(1):36-45. doi: 10.1016/j.ekir.2021.10.008. eCollection 2022 Jan.
citation: Agarwal R, Anker SD, Filippatos G, Pitt B, Rossing P, Ruilope LM, Boletis J, Toto R, Umpierrez GE, Wanner C, Wada T, Scott C, Joseph A, Ogbaa I, Roberts L, Scheerer MF, Bakris GL. Effects of canagliflozin versus finerenone on cardiorenal outcomes: exploratory post hoc analyses from FIDELIO-DKD compared to reported CREDENCE results. Nephrol Dial Transplant. 2022 Jun 23;37(7):1261-1269. doi: 10.1093/ndt/gfab336.
citation: Filippatos G, Bakris GL, Pitt B, Agarwal R, Rossing P, Ruilope LM, Butler J, Lam CSP, Kolkhof P, Roberts L, Tasto C, Joseph A, Anker SD; FIDELIO-DKD Investigators. Finerenone Reduces New-Onset Atrial Fibrillation in Patients With Chronic Kidney Disease and Type 2 Diabetes. J Am Coll Cardiol. 2021 Jul 13;78(2):142-152. doi: 10.1016/j.jacc.2021.04.079. Epub 2021 May 17.
citation: Erraez S, Lopez-Mesa M, Gomez-Fernandez P. Mineralcorticoid receptor blockers in chronic kidney disease. Nefrologia (Engl Ed). 2021 May-Jun;41(3):258-275. doi: 10.1016/j.nefro.2020.10.001. Epub 2020 Dec 24. English, Spanish.
citation: Agarwal R, Anker SD, Bakris G, Filippatos G, Pitt B, Rossing P, Ruilope L, Gebel M, Kolkhof P, Nowack C, Joseph A; FIDELIO-DKD and FIGARO-DKD Investigators. Investigating new treatment opportunities for patients with chronic kidney disease in type 2 diabetes: the role of finerenone. Nephrol Dial Transplant. 2022 May 25;37(6):1014-1023. doi: 10.1093/ndt/gfaa294.
citation: Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10(10):CD007004. doi: 10.1002/14651858.CD007004.pub4.