Clinical trial NCT03819153: A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease
Official title: Effect of Semaglutide Versus Placebo on the Progression of Renal Impairment in Subjects With Type 2 Diabetes and Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2019-01-28
Enrollment: 3533
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 researchers are doing this study to see if semaglutide can slow down the growth and worsening of chronic kidney disease in people with type 2 diabetes. Participants will get semaglutide (active medicine) or placebo ('dummy medicine'). This is known as participants' study medicine - which treatment participants get is decided by chance. Semaglutide is a medicine, doctors can prescribe in some countries for the treatment of type 2 diabetes. Participants will get the study medicine in a pen. Participants will use the pen to inject the medicine in a skin fold once a week. The study will close when there is enough information collected to show clear result of the study. The total time participants will be in this study is about 3 to 5 years, but it could be longer.


Eligibility criteria: Inclusion Criteria:

* Male or female, age above or equal to 18 years at the time of signing informed consent. Japan: Male or female, age above or equal to 20 years at the time of signing informed consent
* Diagnosed with type 2 diabetes mellitus
* HbA1c less than or equal to 10% (less than or equal to 86 mmol/mol)
* Renal impairment defined either by:

  1. serum creatinine-based eGFR greater than or equal to 50 and less than or equal to 75 mL/min/1.73 m\^2 (CKD-EPI) and UACR greater than 300 and less than 5000 mg/g or
  2. serum creatinine-based eGFR greater than or equal to 25 and less than 50 mL/min/1.73 m\^2 (CKD-EPI) and UACR greater than 100 and less than 5000 mg/g
* Treatment with maximum labelled or tolerated dose of a renin-angiotensin-aldosterone system (RAAS) blocking agent including an angiotensin converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), unless such treatment is contraindicated or not tolerated. Treatment dose must be stable for at least 4 weeks prior to the date of the laboratory assessments used for determination of the inclusion criteria for renal impairment and kept stable until screening

Exclusion Criteria:

* Congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations
* Use of any glucagon-like peptide-1 (GLP-1) receptor agonist within 30 days prior to screening
* Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 60 days prior to the day of screening
* Presently classified as being in New York Heart Association (NYHA) Class IV heart failure
* Planned coronary, carotid or peripheral artery revascularisation
* Current (or within 90 days) chronic or intermittent haemodialysis or peritoneal dialysis
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination

Primary outcomes:
measure: Number of Participants From Time of Randomization to First Occurrence of Onset of Persistent ≥50% Reduction in eGFR(CKD-EPI); Onset of Persistent eGFR(CKD-EPI) <15mL/Min/1.73m^2; Initiation of Chronic Renal Replacement Therapy; Renal Death; CV Death
timeFrame: From Week 0 up to Week 234
Secondary outcomes:
measure: Annual Rate of Change in eGFR (CKD-EPI) (Total eGFR Slope)
timeFrame: From Week 0 up to Week 234
measure: Number of Participants From Time of Randomization to Occurrence of Onset of Persistent ≥50% Reduction in eGFR (CKD-EPI)
timeFrame: From Week 0 up to Week 234
measure: Number of Participants From Time of Randomization to Occurrence of Onset of Persistent eGFR (CKD-EPI) <15mL/Min/1.73m^2
timeFrame: From Week 0 up to Week 234
measure: Number of Participants From Time of Randomization to Occurrence of Initiation of Chronic Renal Replacement Therapy
timeFrame: From Week 0 up to Week 234
measure: Number of Participants From Time of Randomization to Occurrence of Renal Death
timeFrame: From Week 0 up to Week 234
measure: Number of Participants From Time of Randomization to Occurrence of CV Death
timeFrame: From Week 0 up to Week 234
measure: Annual Rate of Change in eGFR (Chronic Kidney Disease CKD-EPI) (Chronic eGFR Slope)
timeFrame: Week 12, Week 234
measure: Change From Baseline in eGFR (CKD-EPI) at Week 12
timeFrame: Baseline (Week 0), Week 12
measure: Change From Baseline in eGFR (Cystatin C CKD-EPI) at Week 104
timeFrame: Baseline (Week 0), Week 104
measure: Change From Baseline in Urinary Albumin-to-creatinine Ratio (UACR) at Week 104: Ratio to Baseline
timeFrame: Baseline (Week 0), Week 104
measure: Number of Participants From Time of Randomization to Time to First Occurrence of a Major Adverse Cardiovascular Event (MACE): Acute Myocardial Infarction (Non Fatal); Non-fatal Stroke; and CV Death
timeFrame: From Week 0 up to Week 234
measure: Number of Participants From Time of Randomization to Time to Occurrence of All-cause Death
timeFrame: From Week 0 up to Week 234
measure: Number of Participants From Time of Randomization to Time to Occurrence of Each of the Individual Components of the Confirmatory Secondary MACE Endpoint: Non-fatal Myocardial Infarction
timeFrame: From Week 0 up to Week 234
measure: Number of Participants From Time of Randomization to Time to Occurrence of Each of the Individual Components of the Confirmatory Secondary MACE Endpoint: Non-fatal Stroke
timeFrame: From Week 0 up to Week 234
measure: Number of Participants From Time of Randomization to Time to First Occurrence of Major Adverse Limb Events (MALE): Acute Limb Ischaemia Hospitalization and Chronic Limb Ischaemia Hospitalization
timeFrame: From Week 0 up to Week 234
measure: Number of Participants With Acute Limb Ischaemia Hospitalization and Chronic Limb Ischaemia Hospitalization
timeFrame: From Week 0 up to Week 234
measure: Change From Baseline in Body Weight at Week 104
timeFrame: Baeline (Week 0), Week 104
measure: Change From Baseline in Glycosylated Haemoglobin (HbA1c) at Week 104
timeFrame: Baseline (Week 0), Week 104
measure: Change From Baseline in Systolic Blood Pressure at Week 104
timeFrame: Baseline (Week 0), Week 104
measure: Change From Baseline in Diastolic Blood Pressure at Week 104
timeFrame: Baseline (Week 0), Week 104
measure: Number of Severe Hypoglycaemic Episodes
timeFrame: From Week 0 up to Week 234
Other outcomes:
Locations:
city: Tuscumbia
country: United States
facility: Dr. Terence Hart
state: Alabama
city: Chula Vista
country: United States
facility: California Inst Of Renal Res
state: California
city: Concord
country: United States
facility: John Muir Physician Network
state: California
city: Concord
country: United States
facility: John Muir Physicians Network
state: California
city: Fresno
country: United States
facility: Valley Research
state: California
city: La Mesa
country: United States
facility: California Institute of Renal Research
state: California
city: Lancaster
country: United States
facility: First Valley Med Grp Lancaster
state: California
city: Lincoln
country: United States
facility: Clinical Trials Research_Sacramento
state: California
city: Loma Linda
country: United States
facility: VA Loma Linda Hlthcr Sys
state: California
city: Long Beach
country: United States
facility: Long Beach Center For Clinical Research
state: California
city: Long Beach
country: United States
facility: VA Long Beach Healthcare System
state: California
city: Los Angeles
country: United States
facility: Academic Medical Research Institute
state: California
city: Northridge
country: United States
facility: Valley Renal Medical Group Research
state: California
city: Palm Springs
country: United States
facility: Desert Oasis Hlthcr Med Group
state: California
city: Port Hueneme
country: United States
facility: Saviers Medical Group
state: California
city: Rialto
country: United States
facility: Inland Empire Clin Trials LLC
state: California
city: Roseville
country: United States
facility: Sierra Clinical Research
state: California
city: San Diego
country: United States
facility: California Research Foundation
state: California
city: San Dimas
country: United States
facility: N America Res Inst - San Dimas
state: California
city: San Ramon
country: United States
facility: NorCal Endocrinology and Internal Medicine
state: California
city: Torrance
country: United States
facility: Lundquist Inst-Biomed Innovtn
state: California
city: West Hills
country: United States
facility: San Fernando Valley Hlth Inst
state: California
city: Aurora
country: United States
facility: Rocky Mount Reg VA Med-DN
state: Colorado
city: Denver
country: United States
facility: Creekside Endocrine Associates, PC
state: Colorado
city: Clearwater
country: United States
facility: BayCare Medical Group - Endocrinology
state: Florida
city: Coral Gables
country: United States
facility: Horizon Rs Grp, Coral Gbls
state: Florida
city: Delray Beach
country: United States
facility: Cesar Figueroa M.D. P.A.
state: Florida
city: Fleming Island
country: United States
facility: Northeast Research Institute
state: Florida
city: Hialeah
country: United States
facility: Palmetto Medical General Plaza
state: Florida
city: Hollywood
country: United States
facility: Encore Medical Research LLC
state: Florida
city: Homestead
country: United States
facility: Homestead Associates In Research
state: Florida
city: Miami Lakes
country: United States
facility: San Marcus Res Clin Miami Lakes
state: Florida
city: Miami Lakes
country: United States
facility: Floridian Clinical Research, LLC
state: Florida
city: Miami
country: United States
facility: Life Spring Research
state: Florida
city: Miami
country: United States
facility: Oceane 7 Medical & Research Center, Inc.
state: Florida
city: Miami
country: United States
facility: International Physicians Research
state: Florida
city: Miramar
country: United States
facility: South Broward Research LLC
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research, Inc.
state: Florida
city: Port Charlotte
country: United States
facility: Hanson Clinical Research Center
state: Florida
city: Saint Augustine
country: United States
facility: Northeast Research Institute
state: Florida
city: Sarasota
country: United States
facility: Cardiovascular Ctr of Sarasota
state: Florida
city: Winter Haven
country: United States
facility: Clinical Research of Cent FL
state: Florida
city: Alpharetta
country: United States
facility: Ellipsis Group
state: Georgia
city: Augusta
country: United States
facility: Southeastern Clinical Research Institute, LLC
state: Georgia
city: Roswell
country: United States
facility: Endocrine Research Solutions
state: Georgia
city: Meridian
country: United States
facility: Solaris Clinical Research
state: Idaho
city: Nampa
country: United States
facility: Saltzer Medical Group Research
state: Idaho
city: Chicago
country: United States
facility: Apex Medical Research Inc
state: Illinois
city: Gurnee
country: United States
facility: Clinical Invest Special_Gurnee
state: Illinois
city: Gurnee
country: United States
facility: North Suburban Nephrology LLC
state: Illinois
city: Skokie
country: United States
facility: Endeavor Health
state: Illinois
city: Valparaiso
country: United States
facility: Velocity Clin. Res Valparaiso
state: Indiana
city: Council Bluffs
country: United States
facility: West Broadway Clinic
state: Iowa
city: Paducah
country: United States
facility: Four Rivers Clinical Research Inc
state: Kentucky
city: Beltsville
country: United States
facility: Metropolitan Cardiovascular Consultants, LLC
state: Maryland
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Buckley
country: United States
facility: Northern Pines Hlth Ctr, PC
state: Michigan
city: Flint
country: United States
facility: Aa Mrc Llc
state: Michigan
city: Flint
country: United States
facility: Elite Research Center
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Kansas City
country: United States
facility: Clinical Research Consultants, LLC
state: Missouri
city: Saint Louis
country: United States
facility: Washington University_St. Louis_0
state: Missouri
city: Omaha
country: United States
facility: Univ of Nebraska Medical CTR
state: Nebraska
city: Albuquerque
country: United States
facility: Renal Medicine Associates
state: New Mexico
city: Albany
country: United States
facility: Albany Medical College - Endo
state: New York
city: Mineola
country: United States
facility: NYU Langone Neph Associates
state: New York
city: New York
country: United States
facility: NYU Nephrology Associates
state: New York
city: West Seneca
country: United States
facility: Southgate Medical Group, LLP
state: New York
city: Chapel Hill
country: United States
facility: UNC Diabetes Care Center_Chapel Hill
state: North Carolina
city: Morehead City
country: United States
facility: Carteret Medical Group
state: North Carolina
city: Morganton
country: United States
facility: Burke Primary Care
state: North Carolina
city: New Bern
country: United States
facility: Eastern Nephr Assoc, PLLC
state: North Carolina
city: Whiteville
country: United States
facility: Whiteville Medical Associates
state: North Carolina
city: Wilmington
country: United States
facility: Accellacare
state: North Carolina
city: Winston-Salem
country: United States
facility: Brookview Hills Research Associates, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Veterans Affairs Medical Center
state: Ohio
city: Maumee
country: United States
facility: Advanced Med Res Maumee
state: Ohio
city: Norman
country: United States
facility: Alliance for Multispec Res
state: Oklahoma
city: Beaver
country: United States
facility: Heritage Valley Medical Group Inc
state: Pennsylvania
city: Jersey Shore
country: United States
facility: Lycoming Internal Medicine, Inc.
state: Pennsylvania
city: Philadelphia
country: United States
facility: Northeast Endocrine Metabolic Associates
state: Pennsylvania
city: Little River
country: United States
facility: Main Street Physician's Care
state: South Carolina
city: Murrells Inlet
country: United States
facility: The Diabetes Center, LLC
state: South Carolina
city: Myrtle Beach
country: United States
facility: Family Medicine of SayeBrook LLC
state: South Carolina
city: Orangeburg
country: United States
facility: SC Nephrology and Hypertension
state: South Carolina
city: Bartlett
country: United States
facility: AM Diabetes And Endocrinology Center
state: Tennessee
city: Chattanooga
country: United States
facility: Univ Diab & Endo Consultants
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Medical Center_Nashville
state: Tennessee
city: Austin
country: United States
facility: Central Texas Clinical Research
state: Texas
city: Austin
country: United States
facility: Texas Diabetes & Endocrinology, P.A._Austin
state: Texas
city: Austin
country: United States
facility: Research Management, Inc
state: Texas
city: Corpus Christi
country: United States
facility: Osvaldo A. Brusco MD PA
state: Texas
city: Dallas
country: United States
facility: Baylor Jack and Jane Hamilton
state: Texas
city: Dallas
country: United States
facility: Research Institute Of Dallas
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Med Cntr
state: Texas
city: El Paso
country: United States
facility: MedResearch Inc
state: Texas
city: El Paso
country: United States
facility: Academy of Diabetes, T&E
state: Texas
city: Houston
country: United States
facility: Juno Research, LLC_Houston
state: Texas
city: Houston
country: United States
facility: Juno Research, LLC_Houston
state: Texas
city: Houston
country: United States
facility: Southwest Clinical Trials
state: Texas
city: Houston
country: United States
facility: Southwest Houston Research Ltd
state: Texas
city: Rockwall
country: United States
facility: Carlos Arauz-Pacheco Md, Pa
state: Texas
city: San Antonio
country: United States
facility: Univ Of Texas Hlth Science Cntr
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: San Antonio
country: United States
facility: Briggs Clinical Research, LLC
state: Texas
city: San Antonio
country: United States
facility: VIP Trials
state: Texas
city: San Antonio
country: United States
facility: NE Clin Res of San Antonio
state: Texas
city: Sugar Land
country: United States
facility: Simcare Medical Research, LLC
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah School of Medicine
state: Utah
city: South Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
city: Norfolk
country: United States
facility: York Clinical Research LLC
state: Virginia
city: Richmond
country: United States
facility: McGuire VA Medical Center
state: Virginia
city: Salem
country: United States
facility: VA Medical Center_Salem
state: Virginia
city: Winchester
country: United States
facility: Amherst Family Practice P.C.
state: Virginia
city: Olympia
country: United States
facility: Capital Clin Res Ctr,LLC
state: Washington
city: Spokane
country: United States
facility: MultiCare Inst for Res & Innov
state: Washington
city: Tacoma
country: United States
facility: Universal Research Group
state: Washington
city: Villa Dominico
country: Argentina
facility: Centro de Estudios Renales e Hipertensión Arterial
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Centro Diabetológico y Nuticional Dr Alejandro Chertkoff
city: Buenos Aires
country: Argentina
facility: Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli
city: Caba
country: Argentina
facility: FEPREVA
city: Caba
country: Argentina
facility: Centro de Investigación Clínica
city: Caba
country: Argentina
facility: Glenny Corp. S.A
city: Caba
country: Argentina
facility: Medical Center of Diabetes and Nutrition
city: Gosford
country: Australia
facility: Gosford Renal Research
state: New South Wales
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital_Northmead
state: New South Wales
city: Milton
country: Australia
facility: Core Research Centre
state: Queensland
city: Clayton
country: Australia
facility: Monash Health Nephrology
state: Victoria
city: Fitzroy
country: Australia
facility: St Vincent's Hospital_Fitzroy_0
state: Victoria
city: Melbourne
country: Australia
facility: Monash University Clinical Trial Centre
state: Victoria
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital
state: Victoria
city: Bonheiden
country: Belgium
facility: Imeldaziekenhuis - Bonheiden - Department of Endocrinology
city: Brussel
country: Belgium
facility: Universitair Ziekenhuis Brussel - Diabeteskliniek
city: Brussel
country: Belgium
facility: UZ Brussel - Universitair Ziekenhuis Brussel
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc - Serv Endocrinologie - Diabétologie
city: Edegem
country: Belgium
facility: UZA - UZ Antwerpen - Department of Endocrinology
city: Gent
country: Belgium
facility: UZ Gent - Endocrinologie - Diabetologie
city: Leuven
country: Belgium
facility: UZ Leuven - Endocrinology
city: Liège
country: Belgium
facility: Centre hospitalier universitaire de Liège (CHU de Liège)
city: Roeselare
country: Belgium
facility: AZ Delta - Roeselare
city: Fortaleza
country: Brazil
facility: Instituto de Ensino e Pesquisa Clínica do Ceará Ltda
state: Ceara
city: Curitiba
country: Brazil
facility: Instituto Pró-Renal Brasil
state: Parana
city: Porto Alegre
country: Brazil
facility: Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
state: Rio Grande Do Sul
city: Santo André
country: Brazil
facility: Hospital e Maternidade Dr. Christovão da Gama S.A.
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Instituto de Pesquisa Clinica (IPEC)
state: Sao Paulo
city: São Paulo
country: Brazil
facility: CPQuali Pesquisa Clínica Ltda
state: Sao Paulo
city: São Paulo
country: Brazil
facility: CPCLIN - Centro de Pesquisas Clínicas
state: Sao Paulo
city: Bahia
country: Brazil
facility: Centro Médico Hospital da Bahia
city: Kozloduy
country: Bulgaria
facility: Medical centre "Zdrave 1" OOD
city: Plovdiv
country: Bulgaria
facility: UMHAT "Kaspela", Depart. Endocrinology and Metab. Diseases
city: Sliven
country: Bulgaria
facility: MHAT "Dr. Ivan Seliminski"-Sliven
city: Smolyan
country: Bulgaria
facility: "Nader Yabrudi - ASMPVBE Individual practice"
city: Sofia
country: Bulgaria
facility: UMHAT Aleksandrovska
city: Sofia
country: Bulgaria
facility: Medical Center Synexus Sofia
city: Stara Zagora
country: Bulgaria
facility: Medical Center "Nov Rehabilitatsionen center" EOOD
city: Calgary
country: Canada
facility: LMC Clin Res Inc. Calgary
state: Alberta
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Red Deer
country: Canada
facility: The Bailey Clinic
state: Alberta
city: Vancouver
country: Canada
facility: BC Diabetes Canada
state: British Columbia
city: Mount Pearl
country: Canada
facility: Commonwealth Medical Clinic
state: Newfoundland and Labrador
city: St. Johns
country: Canada
facility: Eastern Health Authority
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: QE II Health - Pharmacy
state: Nova Scotia
city: Brampton
country: Canada
facility: Dr. Harpreet Bajaj
state: Ontario
city: Brampton
country: Canada
facility: Aggarwal and Assoc Ltd.
state: Ontario
city: Burlington
country: Canada
facility: JBN Medical Diagnostic Services Inc.
state: Ontario
city: Concord
country: Canada
facility: LMC Clin Res Inc. Thornhill
state: Ontario
city: Etobicoke
country: Canada
facility: LMC Endo Ctr (Etobicoke) Ltd
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Med Res Group
state: Ontario
city: Hamilton
country: Canada
facility: Premier Clinical Trial Research Network (PCTRN)
state: Ontario
city: London
country: Canada
facility: Milestone Research
state: Ontario
city: Nepean
country: Canada
facility: LMC Research Inc. Ottawa
state: Ontario
city: Oshawa
country: Canada
facility: Lakeridge Health
state: Ontario
city: Oshawa
country: Canada
facility: Dr. James Cha
state: Ontario
city: Oshawa
country: Canada
facility: King Street Research
state: Ontario
city: Sarnia
country: Canada
facility: Bluewater Clin Res Group, Inc.
state: Ontario
city: Sarnia
country: Canada
facility: Bluewater Clin Res Group,Inc
state: Ontario
city: Stoney Creek
country: Canada
facility: Winterberry Family Medicine
state: Ontario
city: Toronto
country: Canada
facility: LMC Endo Centres Ltd.(Bayview)
state: Ontario
city: Toronto
country: Canada
facility: UHN-Toronto General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: Dr Anil K Gupta Med Prof Corp
state: Ontario
city: Toronto
country: Canada
facility: Dr. Anil K Gupta Med Prof Corp
state: Ontario
city: Laval
country: Canada
facility: Ctr de rech Clin de Laval
state: Quebec
city: Montreal
country: Canada
facility: Clinique de Recherche Medpharmgene Inc.
state: Quebec
city: Montreal
country: Canada
facility: Applied Med Inf Res
state: Quebec
city: Montreal
country: Canada
facility: Centre Medical Acadie
state: Quebec
city: Quebec
country: Canada
facility: Centre de Recherche Saint-Louis
city: Beijing
country: China
facility: Peking University People's Hospital-Endocrinology
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Pinggu Hospital-Endocrinology
state: Beijing
city: Zhenjiang
country: China
facility: The Affiliated Hospital of Jiangsu University-Endocrinology
state: Jiangsu
city: Ji'nan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Annonay cedex
country: France
facility: Centre Hospitalier Ardeche Nord
city: BRON cedex
country: France
facility: Hospices Civils de Lyon-Hopital Cardiologique Louis Pradel-2
city: Caen
country: France
facility: Centre Hospitalier Universitaire de Caen Normandie- Cote de Nacre-1
city: Grenoble - Cédex 09
country: France
facility: Centre Hospitalier Universitaire Grenoble Alpes-Site Nord Michallon-2
city: La Roche-sur-yon
country: France
facility: Centre Hospitalier Departemental Vendee- La Roche Sur Yon
city: Le Coudray
country: France
facility: Les Hopitaux de Chartres-Hopital Louis Pasteur
city: Le Creusot
country: France
facility: Groupe Sos Sante-Hopital Le Creusot-Hotel Dieu-1
city: Le Creusot
country: France
facility: Groupe SOS Santé Hôtel Dieu
city: Paris
country: France
facility: Fondation Rothschild
city: Reims
country: France
facility: Centre Hospitalier Universitaire Reims-Hopital Maison Blanche
city: Saint Herblain
country: France
facility: Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec-1
city: Saint Herblain
country: France
facility: Hôpital Nord Laënnec- Service D'Endocrinologie
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-2
city: Venissieux
country: France
facility: Centre de Recherche Clinique Portes Du Sud
city: Bad Mergentheim
country: Germany
facility: Diabetespraxis Mergentheim
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW - Bad Oeynhausen
city: Düsseldorf
country: Germany
facility: DaVita Clinical Research Deutschland GmbH
city: Erlangen
country: Germany
facility: Medizinische Klinik 4, Universitätsklinikum Erlangen
city: Essen
country: Germany
facility: InnoDiab Forschung GmbH
city: Essen
country: Germany
facility: Praxis Dr. med. M. Esser
city: Hamburg
country: Germany
facility: Wendisch/Dahl Hamburg
city: Münster
country: Germany
facility: Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
city: Saint Ingbert-Oberwürzbach
country: Germany
facility: Zentrum für klinische Studien Alexander Segner
city: Athens
country: Greece
facility: University Hospital of Athens ATTIKON
state: Attica
city: Athens
country: Greece
facility: Iatriko Psychicou Private Clinic
city: Athens
country: Greece
facility: General hospital of Athens 'G.Gennimatas'
city: Athens
country: Greece
facility: Iatriko Athinon 'Palaiou Falirou'
city: Athens
country: Greece
facility: General Hospital of Athens "Laiko", Nephrology Clinic
city: Lamia
country: Greece
facility: General Hospital of Lamia
city: Rio, Patra
country: Greece
facility: General University Hospital of Patras,Nephrology clinic
city: Thessaloniki
country: Greece
facility: AHEPA General University Hospital
city: Thessaloniki
country: Greece
facility: "Ippokrateio" G.H. of Thessaloniki
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki "Ippokrateio"
city: Thessaloniki
country: Greece
facility: EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
city: Thessaloniki
country: Greece
facility: "Thermi" Private Hosital
city: Thessaloniki
country: Greece
facility: Genl Hosp of Thessaloniki, Papageorgiou ,Nephrology clinic
city: Pécs
country: Hungary
facility: PTE-AOK II. Belgyogyaszati Klinika es Nephrologiai Centrum
state: Baranya Vármegye
city: Baja
country: Hungary
facility: Lausmed Kft.
state: Bács-Kiskun Vármegye
city: Debrecen
country: Hungary
facility: Belinus Bt.
state: Hajdu-Bihar Varmegye
city: Siófok
country: Hungary
facility: Siófoki Kórház, Diabetológiai Szakrendelés
state: Somogy Vármegye
city: Nyíregyháza
country: Hungary
facility: Borbánya Praxis E.Ü. Kft.
state: Szabolcs-Szatmar Varmegye
city: Budapest
country: Hungary
facility: Péterfy Sándor utcai Kórház
city: Budapest
country: Hungary
facility: MED-TIMA Kft.
city: Debrecen
country: Hungary
facility: Belinus Bt.
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Központ Belgyógyászati Klinika D épület
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Központ Belgyógyászati Klinika
city: Gyula
country: Hungary
facility: Békés Megyei Központi Kórház
city: Siófok
country: Hungary
facility: Siófoki Kórház, Diabetológiai Szakrendelés
city: Szombathely
country: Hungary
facility: Markusovszky Egyetemi Oktatókórház
city: Szombathely
country: Hungary
facility: Markusovszky Egyetemi Oktatókórház
city: Guntur
country: India
facility: Endolife Specialty Hospitals
state: Andhra Pradesh
city: New Delhi
country: India
facility: Max Super Speciality Hospital, Saket
state: Delhi
city: Bangalore
country: India
facility: Ramaiah Memorial Hospital
state: Karnataka
city: Bangalore
country: India
facility: BGS Global Hospitals
state: Karnataka
city: Bangalore
country: India
facility: Lifecare Hospital and Research Centre
state: Karnataka
city: Kochi
country: India
facility: Amrita Institute Of Medical Sciences & Research Centre
state: Kerala
city: Kozhikode
country: India
facility: Calicut Medical College
state: Kerala
city: Mumbai
country: India
facility: Seth GS medical college and KEM Hospital
state: Maharashtra
city: Pune
country: India
facility: Poona hospital and research centre
state: Maharashtra
city: Chennai
country: India
facility: The Madras Medical Mission
state: Tamil Nadu
city: Hyderabad
country: India
facility: Osmania General Hospital
state: Telangana
city: Lucknow
country: India
facility: MV Hospital and Research Centre
state: Uttar Pradesh
city: Lucknow
country: India
facility: Ajanta ResearchCentre
state: Uttar Pradesh
city: Lucknow
country: India
facility: Sanjay Gandhi Postgraduate Institute of Medical Sciences
state: Uttar Pradesh
city: Lucknow
country: India
facility: Sanjay Gandhi Postgraduate Institute of Medical Science
state: Uttar Pradesh
city: Kolkata
country: India
facility: Apollo Multispeciality Hospital, Kolkata
state: West Bengal
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
city: Holon
country: Israel
facility: Diabetes Clinic Wolfson MC
city: Jerusalem
country: Israel
facility: Diabetes Unit Hadassah Ein Karem MC
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Rehovot
country: Israel
facility: Kaplan Medical Center_Rehovot
city: Milano
country: Italy
facility: Istituto Scientifico San Raffaele
state: MI
city: Palermo
country: Italy
facility: AOUPol.Giaccone UOC Malattie Endocrine,Ricambio e Nutrizione
state: PA
city: Pisa
country: Italy
facility: Presidio Ospedaliero Cisanello
state: PI
city: Bergamo
country: Italy
facility: AO Papa Giovanni XXIII UOC malattie Endocrine 1-Diabetologia
city: Bergamo
country: Italy
facility: Azienda Ospedaliera Papa Giovanni XXIII
city: Milano
country: Italy
facility: Ospedale Maggiore Policlinico UO Endocrinologia Diabetolgia
city: Milano
country: Italy
facility: Azienda Ospedaliera Luigi Sacco
city: Roma
country: Italy
facility: Azienda Ospealiero Universitaria Policlinico Umberto I
city: Roma
country: Italy
facility: Azienda Ospedaliero - Universitaria Sant'Andrea
city: Koriyama-shi
country: Japan
facility: Seino Internal Medicine Clinic
state: Fukushima, Japan
city: Sapporo-shi, Hokkaido
country: Japan
facility: Manda Memorial Hospital
state: Hokkaido, Japan
city: Kumamoto-shi
country: Japan
facility: Jinnouchi Hospital
state: Kumamoto, Japan
city: Miyazaki-shi
country: Japan
facility: Heiwadai Hospital
state: Miyazaki
city: Chiba
country: Japan
facility: New Tokyo Heart Clinic
city: Fukui
country: Japan
facility: Fukui Prefectural Hospital_Fukui
city: Fukuoka
country: Japan
facility: Fukuoka Tokushukai Hospital
city: Gunma
country: Japan
facility: Kawada Clinic
city: Hokkaido
country: Japan
facility: Sasaki Hospital Internal Medicine
city: Hokkaido
country: Japan
facility: Sasaki Internal Medicine
city: Ibaraki,
country: Japan
facility: Nishiyamado Keiwa Hospital
city: Ibaraki
country: Japan
facility: Naka Kinen Clinic
city: Ishikawa
country: Japan
facility: Kanazawa Medical University Hospital
city: Kanagawa
country: Japan
facility: Yokohama Minoru Clinic
city: Kanagawa
country: Japan
facility: H.E.C Science Clinic
city: Kanagawa
country: Japan
facility: Shonan Takai Clinic
city: Kyoto
country: Japan
facility: Uji Tokushukai Medical Center
city: Okayama
country: Japan
facility: Kawasaki Medical School Hospital
city: Osaka
country: Japan
facility: Takatsuki Red Cross Hospital
city: Saitama
country: Japan
facility: Shimizu Clinic Fusa
city: Tochigi
country: Japan
facility: Oyama East Clinic
city: Tokyo
country: Japan
facility: Tokyo Center Clinic
city: Tokyo
country: Japan
facility: Fukuwa Clinic
city: Tokyo
country: Japan
facility: Juntendo University Hospital_Tokyo
city: Tokyo
country: Japan
facility: The University of Tokyo Hospital
city: Tokyo
country: Japan
facility: Kato Clinic of Internal Medicine
city: Tokyo
country: Japan
facility: Sugawara Clinic
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
state: Wilayah Persekutuan Kuala Lumpur
city: Alor Setar
country: Malaysia
facility: Hospital Sultanah Bahiyah
city: Ipoh, Perak
country: Malaysia
facility: Hospital Raja Permaisuri Bainun Ipoh
city: Kuching
country: Malaysia
facility: Sarawak General Hospital
city: Pulau Pinang
country: Malaysia
facility: Hospital Pulau Pinang
city: Serdang
country: Malaysia
facility: Hospital Serdang
city: Actopan
country: Mexico
facility: Centro de Atención al Diabetico
state: Hidalgo
city: Guadalajara
country: Mexico
facility: Inst. Jaliscience de Investigacion en Diabetes y Obesidad SC
state: Jalisco
city: Distrito Federal
country: Mexico
facility: Instituto Nacional de Nutricion - Unidad de Inv de Enf Metab
state: México, D.F.
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Médicas y Nutrición_Mexico City
state: México, D.F.
city: Culiacán
country: Mexico
facility: Centro para el Desarrollo de la Medicina y la Asistencia
state: Sinaloa
city: Ciudad Madero
country: Mexico
facility: Centro de Estudios de Investigación Metabólicos y Cardio
state: Tamaulipas
city: Alkmaar
country: Netherlands
facility: Noordwest Ziekenhuisgroep
city: Almelo
country: Netherlands
facility: Ziekenhuis Groep Twente Almelo
city: Almere
country: Netherlands
facility: EB Flevo Research BV
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum
city: Amsterdam
country: Netherlands
facility: OLVG West
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC Lokatie VUMC
city: Arnhem
country: Netherlands
facility: Rijnstate Ziekenhuis
city: Hilversum
country: Netherlands
facility: Tergooi, locatie Hilversum
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
city: Bialystok
country: Poland
facility: Osteo Medic s.c. Artur Racewicz Jerzy Supronik
city: Kielce
country: Poland
facility: NZOZ WITAMED Poradnia Diabetologiczna
city: Olsztyn
country: Poland
facility: Wojewodzki Szpital Specjalistyczny w Olsztynie
city: Radom
country: Poland
facility: Centrum Medyczne "Diabetika"
city: Szczecin
country: Poland
facility: Uniwersytecki Szpital Kliniczny Nr 2 PUM W Szczecinie
city: Warszawa
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Warszawie
city: Warszawa
country: Poland
facility: Miedzyleski Szpital Specjalistyczny, Oddzial Nefrologiczny
city: Zabrze
country: Poland
facility: Prywatny Gabinet Janusz Gumprecht
city: Barnaul
country: Russian Federation
facility: Reg. State Budget Healthc. Inst. Regional Clinical Hospital
city: Barnaul
country: Russian Federation
facility: City Hospital #5
city: Chelyabinsk
country: Russian Federation
facility: Road Clinical Hospital at station Chelyabinsk
city: Kazan
country: Russian Federation
facility: PIH "Clin Hosp "RZD-Medicina" former Kazan OJSC Rus Railways
city: Kemerovo
country: Russian Federation
facility: SAHI Kuzbass Hospital(former Regional clinical hospital)
city: Moscow
country: Russian Federation
facility: National Medical Research Center of Endocrinology
city: Novosibirsk
country: Russian Federation
facility: LLC RC Medical
city: Novosibirsk
country: Russian Federation
facility: Limited Law Company "Healthy Family" Medicine Center"
city: Penza
country: Russian Federation
facility: Penza Regional Clinical Hospital named after N.N. Burdenko
city: Saint Petersburg
country: Russian Federation
facility: Aurora MedFort LLC
city: Saint-Petersburg
country: Russian Federation
facility: Joint Stock Company "Modern Medical Technologies"
city: Saint-Petersburg
country: Russian Federation
facility: Limited Liability Company "Energiya Zdoroviya"
city: Saint-Petersburg
country: Russian Federation
facility: Medinet LLC
city: Samara
country: Russian Federation
facility: LLC "Endocrinolog"
city: Saratov
country: Russian Federation
facility: SHI Saratov City Clinical Hospital #9
city: Saratov
country: Russian Federation
facility: Regional clinical cardiology dispensary
city: Stavropol
country: Russian Federation
facility: Regional Endocrinological Dispensary
city: Ulianovsk
country: Russian Federation
facility: Ulianovsk Regional Clinical Hospital
city: Voronezh
country: Russian Federation
facility: Voronezh Regional Clinical Consultive-diagnostic Centre
city: Yaroslavl
country: Russian Federation
facility: Solovyev Clinical Emergency Hospital
city: Yoshkar-Ola
country: Russian Federation
facility: Polyclinic #2 in Yoshkar-Ola
city: Bratislava
country: Slovakia
facility: MEDISPEKTRUM s.r.o.
city: Kosice
country: Slovakia
facility: FMC - dialyzacne sluzby, s.r.o.
city: Lubochna
country: Slovakia
facility: Narodny Endokrinologicky a diabetologicky ustav
city: Lucenec
country: Slovakia
facility: IN-DIA s.r.o.
city: Nitra
country: Slovakia
facility: DIABETIK s.r.o.
city: Presov
country: Slovakia
facility: Diabetologicka ambulancia MEDIKARD, s.r.o.
city: Trebisov
country: Slovakia
facility: ARETEUS s.r.o.
city: Zilina
country: Slovakia
facility: MUDr. Jana Rociakova s.r.o., ambulancia vnutorneho lekarstva
city: Zilina
country: Slovakia
facility: FMC- dialyzacne sluzby, s.r.o.
city: Zilina
country: Slovakia
facility: MEDIVASA, s.r.o., Diabetologicka ambulancia
city: Benoni
country: South Africa
facility: Diabetes Care Centre & CDE Centre
state: Gauteng
city: Cosmo City
country: South Africa
facility: LCS Clinical Research Unit
state: Gauteng
city: Johannesburg
country: South Africa
facility: Soweto Clinical Trial Centre
state: Gauteng
city: Johannesburg
country: South Africa
facility: Hemant Makan
state: Gauteng
city: Johannesburg
country: South Africa
facility: Wits Bara Clinical Trial Site
state: Gauteng
city: Durban
country: South Africa
facility: Dr A Amod
state: KwaZulu-Natal
city: Durban
country: South Africa
facility: Precise Clinical Solutions (Pty) Ltd
state: KwaZulu-Natal
city: Cape Town
country: South Africa
facility: Tiervlei Trial Centre
state: Western Cape
city: Cape Town
country: South Africa
facility: Prof Rayner_Division of Nephrology
state: Western Cape
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Burela
country: Spain
facility: Hospital Público da Mariña
city: Getafe
country: Spain
facility: Hospital Universitario de Getafe
city: Lugo
country: Spain
facility: Hospital Ribera Polusa
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitario Doctor Peset
city: Bangkoknoi, Bangkok
country: Thailand
facility: Siriraj Hospital_Bangkoknoi, Bangkok
state: Bangkok
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital
state: Mueang Chiang Mai District
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital-nephrology
state: Rajathewee
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital-Division of Nephrology
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital_Bangkok
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital-nephrology
city: Bangkok
country: Thailand
facility: Siriraj Hospital-Nephro
city: Ankara
country: Turkey
facility: Ankara Universitesi Ibni Sina Hastanesi
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Fakultesi Nefroloji Bilim Dali
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty- Nephrology
city: Antalya
country: Turkey
facility: Akdeniz Universitesi Hastanesi Nefroloji Bilim Dali
city: Aydin
country: Turkey
facility: Aydin Adnan Menderes University Nephrology
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical Faculty
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Istanbul Tip Fakultesi- Nefroloji
city: Istanbul
country: Turkey
facility: Goztepe Egitim Arastirma Hastanesi Nefroloji
city: Istanbul
country: Turkey
facility: T.C. Saglik Bakanligi Pendik Egitim ve Arastirma Hastanesi
city: Izmir
country: Turkey
facility: Ege University Medical Faculty
city: Kahramanmaras
country: Turkey
facility: Kahramanmaras Sutcu Imam University
city: Kocaeli
country: Turkey
facility: Kocaeli University Nephrology Department
city: Dnipro
country: Ukraine
facility: SI "Institute of Medical and Social Problems of Disability"
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivsk Regional Clinical Hospital
city: Kharkiv
country: Ukraine
facility: CNPI "Kharkiv City Clinical Hospital #27"
city: Kharkiv
country: Ukraine
facility: SI "National Institute of Therapy n.a. L.T. Malaya of NAMSU"
city: Kyiv
country: Ukraine
facility: Institute of Endocrinology and Metabolism of AMSU
city: Poltava
country: Ukraine
facility: CI "1st City Clinical Hospital of Poltava City Council"
city: Zaporizhia
country: Ukraine
facility: CI "Zaporizhia city clinical hospital #10"
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
city: Birmingham
country: United Kingdom
facility: Diabetes Centre, Heartlands Hospital, Birmingham
city: Cardiff
country: United Kingdom
facility: Ely Bridge Surgery
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: Glasgow
country: United Kingdom
facility: Glasgow Clinical Research Facility
city: Ipswich
country: United Kingdom
facility: The Diabetes Centre
city: London
country: United Kingdom
facility: North Middlesex Hospital
city: London
country: United Kingdom
facility: Royal Free - Diabetes
city: Stevenage
country: United Kingdom
facility: Lister Hospital
city: Tooting
country: United Kingdom
facility: St Georges Hospital
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 1452)
role: STUDY_DIRECTOR
References:
citation: Rossing P, Baeres FMM, Bakris G, Bosch-Traberg H, Gislum M, Gough SCL, Idorn T, Lawson J, Mahaffey KW, Mann JFE, Mersebach H, Perkovic V, Tuttle K, Pratley R. The rationale, design and baseline data of FLOW, a kidney outcomes trial with once-weekly semaglutide in people with type 2 diabetes and chronic kidney disease. Nephrol Dial Transplant. 2023 Aug 31;38(9):2041-2051. doi: 10.1093/ndt/gfad009.
citation: Cohen S, Sternlicht H, Bakris GL. Mineralocorticoid Receptor Antagonists in the Treatment of Diabetic Kidney Disease: Their Application in the Era of SGLT2 Inhibitors and GLP-1 Receptor Agonists. Curr Diab Rep. 2022 May;22(5):213-218. doi: 10.1007/s11892-022-01461-4. Epub 2022 Apr 20.