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Trial record 2 of 3 for:    fidelio-dkd

Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease (FIDELIO-DKD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02540993
Recruitment Status : Completed
First Posted : September 4, 2015
Results First Posted : July 19, 2021
Last Update Posted : July 19, 2021
Sponsor:
Information provided by (Responsible Party):
Bayer

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: Finerenone (BAY94-8862) Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5734 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 17, 2015
Actual Primary Completion Date : April 14, 2020
Actual Study Completion Date : April 14, 2020


Arm Intervention/treatment
Experimental: Finerenone (BAY94-8862)
Participants received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy
Drug: Finerenone (BAY94-8862)
Oral tablet; starting dose at 10 mg for subjects with an eGFR between 25 to < 60 mL/min/1.73m² at the Screening Visit; starting dose at 20 mg for subjects with an eGFR ≥ 60 mL/min/1.73m² at the Screening Visit; dose could be up-titrated from Month 1 onwards or down-titrated at any time during the study; once daily in the morning, until the trial was completed provided there were no safety grounds for discontinuing treatment

Placebo Comparator: Placebo
Participants received matching placebo once daily in addition to standard of care therapy
Drug: Placebo
Matching placebo, oral tablet, once daily in the morning, until the trial was completed provided there were no safety grounds for discontinuing treatment




Primary Outcome Measures :
  1. 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 [ Time Frame: 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 ]
    Count of participants and time from randomization to the first occurrence of the primary renal composite outcome, onset of kidney failure, a sustained decrease of eGFR ≥40% from baseline over at least 4 weeks, or renal death were evaluated. Number of participants with the outcome event is reported as descriptive result and hazard ratio is reported as statistical analysis.


Secondary Outcome Measures :
  1. The First Occurrence of the Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, or Hospitalization for Heart Failure [ Time Frame: 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 ]
    Count of participants and time from randomization to the first occurrence of the key secondary cardiovascular (CV) composite outcome, CV death, non-fatal myocardial infarction (MI), non-fatal stroke, or hospitalization for heart failure were evaluated. Number of participants with the outcome event is reported as descriptive result and hazard ratio is reported as statistical analysis.

  2. All-cause Mortality [ Time Frame: From randomization up until death due to any cause, or censoring at the end of the study visit, with an average of 32 months ]
    Count of participants and time from randomization until death due to any cause were evaluated. Number of participants with outcome death is reported as descriptive result and hazard ratio is reported as statistical analysis. Number of participants with outcome death reported here includes deaths occurred after randomization until the end of the study visit. Deaths after end of study visit are not included in this table.

  3. All-cause Hospitalization [ Time Frame: 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 ]
    Count of participants and time from randomization to the first occurrence of a hospitalization event were evaluated. Number of participants with the event is reported as descriptive result and hazard ratio is reported as statistical analysis.

  4. Change in Urinary Albumin-to-creatinine Ratio (UACR) From Baseline to Month 4 [ Time Frame: From baseline up until Month 4 ]
    First morning void urine samples were collected to evaluate the urinary albumin-to-creatinine ratio (UACR). Month 4 was the visit closest to day 120 within a time window of 120 ± 30 days after randomization. If no measurements were available in this time window, the participant was excluded from this analysis. Ratio of UACR at Month 4 to UACR at baseline is reported as the change.

  5. 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 [ Time Frame: 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 ]
    Count of participants and time from randomization to the first occurrence of the secondary renal composite outcome, onset of kidney failure, a sustained decrease in eGFR of ≥57% from baseline over at least 4 weeks, or renal death were evaluated. Number of participants with the outcome event is reported as descriptive result and hazard ratio is reported as statistical analysis.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02540993


Locations
Show Show 978 study locations
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
  Study Documents (Full-Text)

Documents provided by Bayer:
Study Protocol  [PDF] February 26, 2019
Statistical Analysis Plan  [PDF] February 14, 2020

Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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:; Augusto Vallejos (Argentina); Richard MacIsaac (Australia); Guntram Schernthaner (Austria); Pieter Gillard (Belgium); Maria Eugenia F. Canziani (Brazil); Theodora Temelkova-Kurktschiev (Bulgaria); Ellen Burgess and Sheldon Tobe (Canada); Fernando González (Chile); Zhi-Hong Liu (China); Andrés Ángelo Cadena Bonfanti and Carlos Francisco Jaramillo (Colombia); Martin Prazny (Czech Republic); Peter Rossing (Denmark); Jorma Strand (Finland); Michel Marre (France); Roland Schmieder and Christoph Wanner (Germany); Pantelis A. Sarafidis (Greece); Juliana Chan (Hong Kong); László Rosivall (Hungary); Joseph Eustace (Ireland); Ehud Grossman and Yoram Yagil (Israel); Giuseppe Remuzzi (Italy); Daisuke Koya and Takashi Wada (Japan); Magdalena Madero Rovalo (Mexico); Ron Gansevoort and Adriaan Kooy (Netherlands); Trine Finnes (Norway); Froilan De Leon (Philippines); Janusz Gumprecht (Poland); Fernando Teixeira e Costa (Portugal); Alexander Dreval (Russia); Anantharaman Vathsala (Singapore); Aslam Amod (South Africa); Sin Gon Kim and Byung Wan Lee (South Korea); Julio Pascual Santos (Spain); Bengt-Olov Tengmark (Sweden); Michel Burnier (Switzerland); Chien-Te Lee (Taiwan); Sukit Yamwong (Thailand); Ramazan Sari (Turkey); Kieran McCafferty (United Kingdom); Borys Mankovsky (Ukraine); Sharon Adler, Linda Fried, Robert Toto, and Mark Williams (United States); Tran Quang Khanh (Vietnam); National lead investigators:; Augusto Vallejos (Argentina); Richard MacIsaac (Australia); Guntram Schernthaner (Austria); Pieter Gillard (Belgium); Maria Eugenia F. Canziani (Brazil); Theodora Temelkova-Kurktschiev (Bulgaria); Ellen Burgess and Sheldon Tobe (Canada); Fernando González (Chile); Zhi-Hong Liu (China); Andrés Ángelo Cadena Bonfanti and Carlos Francisco Jaramillo (Colombia); Martin Prazny (Czech Republic); Peter Rossing (Denmark); Jorma Strand (Finland); Michel Marre (France); Roland Schmieder and Christoph Wanner (Germany); Pantelis A. Sarafidis (Greece); Juliana Chan (Hong Kong); László Rosivall (Hungary); Joseph Eustace (Ireland); Ehud Grossman and Yoram Yagil (Israel); Giuseppe Remuzzi (Italy); Daisuke Koya and Takashi Wada (Japan); Magdalena Madero Rovalo (Mexico); Ron Gansevoort and Adriaan Kooy (Netherlands); Trine Finnes (Norway); Froilan De Leon (Philippines); Janusz Gumprecht (Poland); Fernando Teixeira e Costa (Portugal); Alexander Dreval (Russia); Anantharaman Vathsala (Singapore); Aslam Amod (South Africa); Sin Gon Kim and Byung Wan Lee (South Korea); Julio Pascual Santos (Spain); Bengt-Olov Tengmark (Sweden); Michel Burnier (Switzerland); Chien-Te Lee (Taiwan); Sukit Yamwong (Thailand); Ramazan Sari (Turkey); Kieran McCafferty (United Kingdom); Borys Mankovsky (Ukraine); Sharon Adler, Linda Fried, Robert Toto, and Mark Williams (United States); Tran Quang Khanh (Vietnam); Diego Aizenberg; Inés Bartolacci; Diego Besada; Julio Bittar; Mariano Chahin; Alicia Elbert; Elizabeth Gelersztein; Alberto Liberman; Laura Maffei; Federico Pérez Manghi; Hugo Sanabria; Augusto Vallejos; Gloria Viñes; Alfredo Wassermann; Walter Abhayaratna; Shamasunder Acharya; Elif Ekinci; Darren Lee; Richard MacIsaac; Peak Mann Mah; Craig Nelson; David Packham; Alexia Pape; Simon Roger; Hugo Stephenson; Michael Suranyi; Gary Wittert; Elizabeth Vale; Martin Clodi; Christoph Ebenbichler; Evelyn Fliesser-Görzer; Ursula Hanusch; Michael Krebs; Karl Lhotta; Bernhard Ludvik; Gert Mayer; Peter Neudorfer; Bernhard Paulweber; Rudolf Prager; Wolfgang Preiß; Friedrich Prischl; Gerit-Holger Schernthaner; Harald Sourij; Martin Wiesholzer; Peter Doubel; Wendy Engelen; Pieter Gillard; Jean-Michel Hougardy; Jean-Marie Krzesinski; Bart Maes; Marijn Speeckaert; Koen Stas; Luc van Gaal; Hilde Vanbelleghem; Daniela Antunes; Roberto Botelho; Claudia Brito; Luis Canani; Maria Eugenia Canziani; Maria Cerqueira; Rogerio de Paula; Freddy Eliaschewitz; Carlos Eduardo Figueiredo; Adriana Forti; Miguel Hissa; Maurilo Leite Jr; Emerson Lima; Irene Noronha; Bruno Paolino; Nathalia Paschoalin; Raphael Paschoalin; Roberto Pecoits Filho; Marcio Pereira; Evandro Portes; Dalton Precoma; Rosangela Rea; Miguel Riella; Joao Eduardo Salles; Eduardo Vasconcellos; Sergio Vencio; Emiliya Apostolova; Radostina Boshnyashka; Ghassan Farah; Dimitar Georgiev; Valentina Gushterova; Neli Klyuchkova; Mariya Lucheva; Petya Manova; Dotska Minkova; Boyan Nonchev; Mariyana Pichmanova; Zhulieta Prakova; Rangel Rangelov; Rosen Rashkov; Pavel Stanchev; Bilyana Stoyanovska-Elencheva; Zhivko Tagarev; Theodora Temelkova-Kurktschieva; Svetla Vasileva; Mariana Yoncheva-Mihaylova; Paul Barre; Brian Carlson; James Conway; Serge Cournoyer; Richard Dumas; Sameh Fikry; Richard Goluch; Pavel Hamet; Randolph Hart; Sam Henein; Joanne Liutkus; Francois Madore; Valdemar Martinho; Giuseppe Mazza; Philip McFarlane; Dennis O'Keefe; Sean Peterson; Daniel Schwartz; Daniel Shu; Andrew Steele; Guy Tellier; Karthik Tennankore; Sheldon Tobe; George Tsoukas; Richard Tytus; Louise Vitou; Michael Walsh; Stanley Weisnagel; Igor Wilderman; Jean-Francois Yale; Jorge Cobos; Juan Godoy; Fernando González; Sergio Lobos; Juan Carlos Palma; Juan Carlos Prieto; Eliana Reyes; Carmen Romero; Victor Saavedra; Mario Vega; Ruifang Bu; Hanqing Cai; Nan Chen; Qinkai Chen; Dejun Chen; Jinluo Cheng; Youping Dong; Junwu Dong; Tianjun Guan; Chuanming Hao; Wen Huang; Fangfang Jiang; Minxiang Lei; Ling Li; Zhonghe Li; Xuemei Li; Jingmei Li; Yan Li; Xinling Liang; Bo Liang; Fang Liu; Yinghong Liu; Yuantao Liu; Zhihong Liu; Gang Long; Guoyuan Lu; Weiping Lu; Yibing Lu; Ping Luo; Jianhua Ma; Zhaohui Mo; Jianying Niu; Ai Peng; Jiansong Shen; Feixia Shen; Bingyin Shi; Qing Su; Zhuxing Sun; Shuifu Tang; Nanwei Tong; Hao Wang; Xinjun Wang; Lihua Wang; Guixia Wang; Jianqin Wang; Yangang Wang; Li Wang; Jiali Wei; Tianfeng Wu; Chaoqing Wu; Changying Xing; Fei Xiong; Xudong Xu; Ning Xu; Tiekun Yan; Jinkui Yang; Aiping Yin; Longyi Zeng; Hao Zhang; Yanlin Zhang; Ying Zhang; Wenjing Zhao; Zhiquan Zhao; Hongguang Zheng; Ling Zhong; Dalong Zhu; Yongze Zhuang; Clara Arango; Sandra Barrera; Nelly Beltrán López; Diego Benitez; Guillermo Blanco; Andrés Cadena; Julian Coronel; Carlos Cure; Carlos Durán; Alexander González; Gustavo Guzmán; Eric Hernández; Jaime Ibarra; Carlos Jaramillo; Nicolás Jaramillo; William Kattah; Dora Molina; Gregorio Sánchez; Mónica Terront; Freddy Trujillo; Miguel Urina; Ruben Vargas; Iván Villegas; Hernán Yupanqui; Dino Alferi; Michal Brada; Jiri Brezina; Petr Bucek; Tomas Edelsberger; Drahomira Gulakova; Jitka Hasalova Zapletalova; Olga Hola; Lucie Hornova; Jana Houdova; Helena Hrmova; David Karasek; Sarka Kopecka; Richard Kovar; Eva Krcova; Jiri Kuchar; Vlasta Kutejova; Hana Lubanda; Ivo Matyasek; Magdalena Mokrejsova; Libor Okenka; Martin Prazny; Jiri Pumprla; Pavel Tomanek; Jesper Bech; Jens Faber; Gunnar Gislason; Jørgen Hangaard; Grzegorz Jaroslaw Pacyk; Claus Juhl; Thure Krarup; Morten Lindhardt; Sten Madsbad; Joan Nielsen; Ulrik Pedersen-Bjergaard; Per Poulsen; Ole Rasmussen; Peter Rossing; Karoline Schousboe; Mikko Honkasalo; Kari Humaloja; Kristiina Kananen; Ilkka Kantola; Arvo Koistinen; Pirkko Korsoff; Jorma Lahtela; Sakari Nieminen; Tuomo Nieminen; Karita Sadeharju; Jorma Strand; Sakari Sulosaari; Bertrand Cariou; François Chantrel; Sylvaine Clavel; Christian Combe; Jean-Pierre Fauvel; Karim Gallouj; Didier Gouet; Bruno Guerci; Dominique Guerrot; Maryvonne Hourmant; Alexandre Klein; Christophe Mariat; Michel Marre; Rafik Mesbah; Yannick Le Meur; Arnaud Monier; Olivier Moranne; Pierre Serusclat; Benoit Vendrely; Bruno Verges; Philippe Zaoui; Christoph Axthelm; Andreas Bergmann; Andreas L. Birkenfeld; Hermann Braun; Klaus Busch; Christel Contzen; Stefan Degenhardt; Karl Derwahl; Thomas Giebel; Andreas Hagenow; Hermann Haller; Christoph Hasslacher; Thomas Horacek; Wolfgang Jungmair; Christof Kloos; Thorsten Koch; Thilo Krüger; Anja Mühlfeld; Joachim Müller; Andreas Pfützner; Frank Pistrosch; Ludger Rose; Lars Rump; Volker Schettler; Ingolf Schiefke; Heike Schlichthaar; Bernd Schröppel; Thomas Schürholz; Helena Sigal; Lutz Stemler; Georg Strack; Heidrun Täschner; Nicole Toursarkissian; Diethelm Tschöpe; Achim Ulmer; Markus van der Giet; Christoph Wanner; Bernhard R. Winkelmann; Ioannis Boletis; Erifili Hatziagelaki; Ioannis Ioannidis; Theodora Kounadi; Ioanna Makriniotou; Dorothea Papadopoulou; Aikaterini Papagianni; Ploumis Passadakis; Ioannis Stefanidis; Tai Pang Ip; Paul Lee; On Yan Andrea Luk; Angela Wang; Vincent Yeung; Dora Bajcsi; Peter Danos; Eleonora Harcsa; Szilvia Kazup; Katalin Keltai; Robert Kirschner; Julianna Kiss; Laszlo Kovacs; Beata Lamboy; Botond Literati-Nagy; Margit Mileder; Laszlo Nagy; Ebrahim Noori; Gabor Nyirati; Gizella Petro; Karoly Schneider; Albert Szocs; Szilard Vasas; Krisztina Wudi; Zsolt Zilahi; Marianna Zsom; Joe Eustace; John Holian; Donal Reddan; Yvonne O'Meara; Rosane Abramof Ness; Faiad Adawi; Zaher Armaly; Shaul Atar; Sydney Ben Chetrit; Noa Berar Yanay; Gil Chernin; Mahmud Darawsha; Shai Efrati; Mazen Elias; Evgeny Farber; Mariela Glandt; Ehud Grossman; Majdi Halabi; Khaled Khazim; Idit Liberty; Ofri Mosenzon; Assy Nimer; Doron Schwartz; Julio Wainstein; Yoram Yagil; Robert Zukermann; Aneliya Ilieva Parvanova; Angelo Avogaro; Giovanni Giorgio Battaglia; Maurizio Tiziano Bevilacqua; Enzo Bonora; Carlo Antonio Bossi; Paolo Calabrò; Franco Luigi Cavalot; Roberto Cimino; Mario Gennaro Cozzolino; Salvatore David; Michele Emdin; Enrico Fiaccadori; Paolo Fiorina; Carlo Bruno Giorda; Maria Cristina Gregorini; Gaetano La Manna; Davide Carlo Maggi; Roberta Manti; Giancarla Meregalli; Antonello Pani; Norberto Perico; PierMarco Piatti; Antonio Pisani; Antonio Ettore Pontiroli; Paola Ponzani; Gennaro Santorelli; Domenico Santoro; Renzo Scanziani; Ugo Teatini; Giancarlo Tonolo; Roberto Trevisan; Anna Maria Veronelli; Giorgio Luciano Viviani; Hideo Araki; Osamu Ebisui; Naruhiro Fujita; Ryuichi Furuya; Yoshiyuki Hamamoto; Masahiro Hatazaki; Terumasa Hayashi; Takayuki Higashi; Yoshihide Hirohata; Shuji Horinouchi; Masayuki Inagaki; Masao Ishii; Tamayo Ishiko; Hideaki Jinnouchi; Hidetoshi Kanai; Daisuke Kanda; Hideo Kanehara; Masayuki Kashima; Kiyoe Kato; Takeshi Katsuki; Katsunori Kawamitsu; Satsuki Kawasaki; Fumi Kikuchi; Hidetoshi Kikuchi; Kunihisa Kobayashi; Junko Koide; Miyuki Kubota; Yoshiro Kusano; Hajime Maeda; Sunao Matsubayashi; Kazunari Matsumoto; Yasuto Matsuo; Naoki Matsuoka; Hiroaki Miyaoka; Satoshi Murao; Mikihiro Nakayama; Jun Nakazawa; Takashi Nomiyama; Masayuki Noritake; Takayuki Ogiwara; Hiroshi Ohashi; Hideki Okamoto; Takeshi Osonoi; Nobuhiro Sasaki; Taiji Sekigami; Taro Shibasaki; Hirotaka Shibata; Junji Shinoda; Hiroshi Sobajima; Kazuya Sugitatsu; Toshiyuki Sugiura; Toru Sugiyama; Daisuke Suzuki; Hiroyuki Suzuki; Masaaki Suzuki; Asami Takeda; Asami Tanaka; Seiichi Tanaka; Izumi Tsunematsu; Makoto Ujihara; Daishiro Yamada; Masayo Yamada; Kazuo Yamagata; Ken Yamakawa; Fumiko Yamakawa; Yoshimitsu Yamasaki; Yuko Yambe; Taihei Yanagida; Hidekatsu Yanai; Tetsuyuki Yasuda; Dovile Kriauciuniene; Jurate Lasiene; Antanas Navickas; Lina Radzeviciene; Egle Urbanaviciene; Gediminas Urbonas; Audrone Velaviciene; Rohana Abd Ghani; Nor Azizah Aziz; Li Yuan Lee; Chek Loong Loh; Norhaliza Mohd Ali; Nurain Mohd Noor; Nik Nur Fatnoon Nik Ahmad; Jeyakantha Ratnasingam; Wan Hasnul Halimi Bin Wan Hasan; Wan Mohd Izani Wan Mohamed; Sandro Avila Pardo; Miriam Bastidas Adrian; Alfredo Chew Wong; Jorge Escobedo de la Peña; Guillermo Fanghänel Salmón; Guillermo González Gálvez; Ramiro Gutiérrez Ochoa; Saúl Irizar Santana; Magdalena Madero Rovalo; Gustavo Méndez Machado; Luis Nevarez Ruiz; Denisse Ramos Ibarra; Gabriel Ramos López; Leobardo Sauque Reyna; Gustavo Solache Ortiz; Rafael Valdez Ortiz; Juan Villagordoa Mesa; R.C. Bakker; J.N.M. Barendregt; A.H. Boonstra; Willem Bos; C.B. Brouwer; M. van Buren; Ron Gansevoort; Adriaan Kooy; Marielle Krekels; Ruud J.M. van Leendert; Louis A.G. Lieverse; P.T. Luik; E. Lars Penne; Peter Smak Gregoor; Liffert Vogt; John Baker; Veronica Crawford; Rick Cutfield; Peter Dunn; Jeremy Krebs; Kingsley Nirmalaraj; Russell Scott; Nine Smuts; Erik Eriksen; Trine Finnes; Hans Høivik; Thomas Karlsson; Peter Scott Munk; Maria Radtke; Knut Risberg; Jan Rocke; Leidulv Solnør; Aud-Eldrid Stenehjem; Anne-Beathe Tafjord; Glenda Pamugas; Araceli Panelo; Ronald Perez; Maribel Tanque; Louie Tirador; Michael Villa; Patrycja Butrymowicz; Kazimierz Ciechanowski; Grazyna Cieslik; Edward Franek; Janusz Gumprecht; Michal Hoffmann; Jolanta Krzykowska; Ilona Kurnatowska; Katarzyna Landa; Adam Madrzejewski; Katarzyna Madziarska; Stanislaw Mazur; Piotr Napora; Michal Nowicki; Anna Ocicka-Kozakiewicz; Barbara Rewerska; Teresa Rusicka; Jan Ruxer; Ewa Skokowska; Andrzej Stankiewicz; Tomasz Stompor; Agnieszka Tiuryn-Petrulewicz; Katarzyna Wasilewska; Bogna Wierusz-Wysocka; Renata Wnetrzak-Michalska; Edgar Almeida; Rosa Ballesteros; Carlos Barreto; Idalina Beirao; Rita Birne; Cesar Esteves; Jose Guia; Susana Heitor; Olinda Marques; Pedro Melo; Fernando Nolasco; Amalia Pereira; Cristina Roque; Francisco Rosario; Gil Silva; Ana Silva; Fernando Teixeira e Costa; Ana Vila Lobos; Gregorio Cortes-Maisonet; Amaury Roman-Miranda; Adrian Albota; Cornelia Bala; Hortensia Barbonta; Elena Caceaune; Doina Catrinoui; Ciprian Constantin; Adriana Dumitrescu; Nicoleta Mindrescu; Cristina Mistode; Gabriela Negrisanu; Adriana Onaca; Silvia Paveliu; Ella Pintilei; Lavinia Pop; Amorin Popa; Alexandrina Popescu; Gabriela Radulian; Iosif Szilagyi; Liana Turcu; Georgeta Vacaru; Adrian Vlad; Mikhail Antsiferov; Mikhail Arkhipov; Andrey Babkin; Olga Barbarash; Vitaliy Baranov; Elena Chernyavskaya; Arkadiy Demko; Alexander Dreval; Anton Edin; Polina Ermakova; Valentin Fadeev; Albert Galyavich; Leyla Gaysina; Ivan Gordeev; Irina Ipatko; Marina Kalashnikova; Yuriy Khalimov; Vadim Klimontov; Zhanna Kobalava; Elena Kosmacheva; Natalya Koziolova; Lyudmila Kvitkova Sergey Levashov; Roman Libis; Vyacheslav Marasaev; Natalia Malykh; Vladimir Martynenko; Sofya Malyutina; Imad Merai; Ashot Mkrtumyan; Galina Nechaeva; Nina Petunina; Shamil Palyutin; Leonid Pimenov; Elena Rechkova; Tatyana Rodionova; Oksana Rymar; Ruslan Sardinov; Olga Semenova; Alexander Sherenkov; Oleg Solovev; Elena Smolyarchuk; Leonid Strongin; Olga Ukhanova; Nadezhda Verlan; Natalya Vorokhobina; Davyd Yakhontov; Sergey Yakushin; Elena Zakharova; Alsu Zalevskaya; Olga Zanozina; Elena Zhdanova; Larisa Zhukova; Tatyana Zykova; Chee Fang Sum; Sufi Muhummad Suhail; Ru San Tan; Anantharaman Vathsala; Edmund Wong; Jana Babikova; Ingrid Buganova; Andrej Dzupina; Zuzana Ochodnicka; Dalibor Sosovec; Denisa Spodniakova; Fayzal Ahmed; Aslam Amod; Sindeep Bhana; Larry Distiller; Dirkie Jansen van Rensburg; Mukesh Joshi; Shaifali Joshi; Deepak Lakha; Essack Mitha; Gracjan Podgorski; Naresh Ranjith; Brian Rayner; Paul Rheeder; Mohamed Sarvan; Mary Seeber; Heidi Siebert; Mohammed Tayob; Julien Trokis; Dorothea Urbach; Louis van Zyl; Bum-Soon Choi; 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Sue Kirkman; Nelson Kopyt; Wayne Kotzker; Csaba Kovesdy; Camil Kreit; Arvind Krishna; Saeed Kronfli; Keung Lee; Derek LeJeune; Brenda Lemus; Carlos Leon-Forero; Douglas Linfert; Henry Lora; Alexander Lurie; Geetha Maddukuri; Alexander Magno; Louis Maletz; Sreedhar Mandayam; Mariana Markell; Ronald Mayfield; Caroline Mbogua; Dierdre McMullen; Carl Meisner; Stephen Minton; Bharat Mocherla; Rajesh Mohandas; Manuel Montero; Moustafa Moustafa; Salil Nadkarni; Samer Nakhle; Jesus Navarro; Nilda Neyra; Romanita Nica; Philip Nicol; Paul Norwood; Visal Numrungroad; Richard O'Donovan; A. Odugbesan; Jorge Paoli-Bruno; Samir Parikh; Rakesh Patel; Aldo Peixoto; Pablo Pergola; Alan Perlman; Karlton Pettis; Roberto Pisoni; Mirela Ponduchi; Jorge Posada; Sharma Prabhakar; Jai Radhakrishnan; Mahboob Rahman; Rupesh Raina; Anjay Rastogi; Efrain Reisin; Marc Rendell; David Robertson; Michael Rocco; Hugo Romeu; Sylvia Rosas; Jack Rosenfeld; Dennis Ross; Jeffrey Rothman; Lance Rudolph; Yusuf Ruhullah; Gary Ruoff; Jeffrey Ryu; Mandeep Sahani; Ramin Sam; Garfield Samuels; William Sanchez; Vladimir Santos; Scott Satko; Sanjeev Saxena; David Scott; Gilberto Seco; Melvin Seek; Harvey Serota; Tariq Shafi; Nauman Shahid; Michael Shanik; Santosh Sharma; Arjun Sinha; James Smelser; Mark Smith; Kyaw Soe; Richard Solomon; Eugene Soroka; Joseph Soufer; Bruce Spinowitz; Leslie Spry; Rosa Suarez; Bala Subramanian; Harold Szerlip; Aparna Tamirisa; Stephen Thomson; Tuan-Huy Tran; Richard Treger; Gretel Trullenque; Thomas Turk; Guillermo Umpierrez; Daniel Urbach; Martin Valdes; Shujauddin Valika; Damaris Vega; Peter Weissman; Adam Whaley-Connell; Jonathan Winston; Jonathan Wise; Alan Wynne; Steven Zeig; Phuong Chu; Lam Van Hoang; Tran Khanh; Nguyen Thi Phi Nga; Pham Nguyen Son; Lan Phuong Tran. 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.

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02540993    
Other Study ID Numbers: 16244
2015-000990-11 ( EudraCT Number )
First Posted: September 4, 2015    Key Record Dates
Results First Posted: July 19, 2021
Last Update Posted: July 19, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
CKD
Diabetic Kidney Disease
Type 2 Diabetes
Kidney diseases
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Diabetic Nephropathies
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency
Diabetes Complications