Clinical trial • Phase III • Cardiology

DAPAGLIFLOZIN for Chronic kidney disease | Kidney failure | Heart failure

Phase III trial of DAPAGLIFLOZIN for Chronic kidney disease | Kidney failure | Heart failure.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Chronic kidney disease | Kidney failure | Heart failure
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
18-12-2023
First CTIS Authorization Date
07-02-2024

Trial design

Randomised, placebo for dapagliflozin film-coated tablets 10 mg (matching placebo) once daily versus dapagliflozin 10 mg once daily-controlled Phase III trial across 92 sites in Belgium, Netherlands, Spain and others.

Randomised
Yes
Comparator
Placebo for dapagliflozin film-coated tablets 10 mg (matching placebo) once daily versus Dapagliflozin 10 mg once daily
Target Sample Size
1560

Stratification factors

  • predialysis
  • peritoneal dialysis
  • hemodialysis
  • kidney transplant recipient
  • centre
  • type 2 diabetes mellitus status (yes/no)

Eligibility

Recruits 1560 Mentally incapacitated subjects (i.e. not able to sign informed consent) are excluded. Participants must be ≥18 years and willing to sign informed consent. No vulnerable populations are selected in the protocol; consent is provided by the adult participant (no assent procedures specified)..

Pregnancy Exclusion
Current pregnancy, lactation or women of child-bearing potential (WOCBP) unless using highly-effective contraceptive measurements7 until 4 weeks after last intake of the study medication
Vulnerable Population
Mentally incapacitated subjects (i.e. not able to sign informed consent) are excluded. Participants must be ≥18 years and willing to sign informed consent. No vulnerable populations are selected in the protocol; consent is provided by the adult participant (no assent procedures specified).

Inclusion criteria

  • {"criterion_text":"- In order to be eligible to participate in the randomized controlled double blind trial subject must meet the criteria for one of the three strata: Patients with advanced CKD i.e. an eGFR ≤25 mL/min/1.73m2; Hemo- and peritoneal dialysis patients (at least 3 months after start of dialysis); transplant patients with an eGFR ≤45 mL/min/1.73m2 (at least 6 months after transplantation)"}
  • {"criterion_text":"- Age ≥18 years"}
  • {"criterion_text":"- Willing to sign informed consent"}
  • {"criterion_text":"- Pre-dialysis patients with eGFR ≤25 mL/min/1.73m2 have to be on a stable dose (no changes in dose or type of drug) of ACEis or ARBs for at least 4 weeks prior to the screening visit to be eligible to proceed to the randomization visit unless there is documented evidence that the patient does not tolerate an ACEi or an ARB. These subjects will maintain their stable doses of ACEis or ARBs throughout the trial (when possible and tolerated by the patient). ACEi or ARBs are not required for patients on maintenance dialysis or kidney transplant recipients."}

Exclusion criteria

  • {"criterion_text":"- Mentally incapacitated subjects (i.e. not able to sign informed consent)"}
  • {"criterion_text":"- History of severe noncompliance to medical regimens or unwillingness to comply with the study protocol."}
  • {"criterion_text":"- Current pregnancy, lactation or women of child-bearing potential (WOCBP) unless using highly-effective contraceptive measurements7 until 4 weeks after last intake of the study medication"}
  • {"criterion_text":"- Presence of other transplanted organ besides a kidney transplant"}
  • {"criterion_text":"- Severe lactose intolerance (of note: The study medication contains so little lactose that most people with lactose intolerance do not suffer from this.)"}
  • {"criterion_text":"- Autosomal Dominant Polycystic Kidney Disease (ADPKD) treated with tolvaptan"}
  • {"criterion_text":"- Diagnosis of type 1 diabetes mellitus"}
  • {"criterion_text":"- Concurrent treatment with SGLT2 inhibitor"}
  • {"criterion_text":"- History of ≥2 urinary tract / genital infections during the last six months"}
  • {"criterion_text":"- Life expectancy <6 months in the opinion of the treating physician."}
  • {"criterion_text":"- Scheduled start of dialysis within 3 months or scheduled kidney transplantation within 6 months"}
  • {"criterion_text":"- patients treated for a renal indication during the last 6 months with a course of systemic immunosuppressive agents or intensification of treatment with systemic immunosuppressive agents, such as patients with a kidney transplant and acute rejection or patients with GPA (Morbus Wegener) and a recent flare. Of note, this implies that patients receiving non-systemic immunosuppression (e.g. topical, ophthalmic, rectal, intra-articular or inhaled corticosteroids) are allowed to participate, as well as patients having received a short course of oral/IV steroids within 6 months prior to screening for non-renal indications (e.g. for gout or an asthma flare) as well as patients receiving during the last 6 months stable low-dose immunosuppression for whatever reason (e.g. kidney transplant recipients, patients with GPA, patients with gout)."}
  • {"criterion_text":"- Active malignancy aside from treated squamous cell or basal cell carcinoma of the skin."}
  • {"criterion_text":"- History of severe hypersensitivity or known severe hepatic impairment (Child-Pugh class C)"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Time to the composite endpoint of all-cause mortality, kidney failure (chronic dialysis, kidney transplantation or death due to kidney failure), and hospitalization for heart failure","definition_or_measurement_approach":"Time-to-event composite endpoint measured as time from randomization to first occurrence of any component: all-cause mortality; kidney failure (chronic dialysis, kidney transplantation or death due to kidney failure); or hospitalization for heart failure."}

Secondary endpoints

  • {"endpoint_text":"- Time to kidney failure (in advanced CKD and transplant patients only)","definition_or_measurement_approach":"Time-to-event measured from randomization to onset of kidney failure (as defined: chronic dialysis, kidney transplantation or death due to kidney failure) in the specified subgroups."}
  • {"endpoint_text":"- Time to the first occurrence of heart failure hospitalization","definition_or_measurement_approach":"Time-to-event measured from randomization to first hospitalization for heart failure."}
  • {"endpoint_text":"- Time to all-cause death","definition_or_measurement_approach":"Time-to-event measured from randomization to death from any cause."}
  • {"endpoint_text":"- In addition, it will be investigated whether dapagliflozin is superior to placebo in reducing the incidence of the composite outcome of all-cause mortality, kidney failure, or heart failure hospitalization in each of the three subpopulations.","definition_or_measurement_approach":"Subgroup analyses of the primary composite endpoint in three predefined subpopulations: advanced CKD (eGFR ≤25 mL/min/1.73m2), dialysis patients, and transplant patients with eGFR ≤45 mL/min/1.73m2."}

Recruitment

Registry Or Advocacy Recruitment
True - Stichting Dianet | Diakonessenhuis
Planned Sample Size
1560
Recruitment Window Months
52
Consent Approach
Participants must be aged ≥18 and willing to sign informed consent. Mentally incapacitated subjects unable to sign informed consent are excluded. Subject information and informed consent forms (L1_SIS and ICF) are provided for adult participants and are available in multiple language versions (documents in NL, DE, FR, ES, EN are present in the dossier).

Geography

Total Number Of Sites
92
Total Number Of Participants
1560

Belgium

Earliest CTIS Part Ii Submission Date
07-10-2024
Latest Decision Or Authorization Date
18-09-2025
Processing Time Days
346
Number Of Sites
8
Number Of Participants
160

Sites

Site Name
Universitair Ziekenhuis Antwerpen
Department Name
Nephrology
Contact Person Name
Rowena Vleut
Contact Person Email
Rowena.Vleut@uza.be
Site Name
Imelda
Department Name
Nephrology
Contact Person Name
Wim Lemahieu
Contact Person Email
wim.lamahieu@imelda.be
Site Name
Katholieke Universiteit te Leuven
Department Name
Nephrology
Contact Person Name
Dirk Kuypers
Contact Person Email
Dirk.Kuypers@uzleuven.be
Site Name
UZ Brussel
Department Name
Nephrology
Contact Person Name
Karlien Francois
Contact Person Email
karlien.francois@uzbrussel.be
Site Name
Jessa Ziekenhuis
Department Name
Nephrology
Contact Person Name
Bart de Moor
Contact Person Email
info@jessazh.be
Site Name
Algemeen Ziekenhuis Groeninge
Department Name
Nephrology
Contact Person Name
Gert Meeus
Contact Person Email
gert.meeus@azgroeninge.be
Site Name
Algemeen Ziekenhuis Delta
Department Name
Nephrology
Contact Person Name
Bart Maes
Contact Person Email
bart.maes@azdelta.be
Site Name
AZ Glorieux
Department Name
Nephrology
Contact Person Name
Ellen Mahieu
Contact Person Email
Ellen.mahieu@azglorieux.be

Netherlands

Earliest CTIS Part Ii Submission Date
17-01-2024
Latest Decision Or Authorization Date
03-10-2025
Processing Time Days
625
Number Of Sites
51
Number Of Participants
900

Sites

Site Name
Medisch Centrum Leeuwarden B.V.
Department Name
interne geneeskunde
Contact Person Name
Aaltje Adema
Contact Person Email
Wetenschap@mclacademie.nl
Site Name
Amsterdam UMC
Department Name
interne geneeskunde
Contact Person Name
Lily Jakulj
Contact Person Email
l.jakulj@amsterdamumc.nl
Site Name
Universitair Medisch Centrum Groningen
Department Name
interne geneeskunde
Contact Person Name
Ron Gansevoort
Contact Person Email
renal.lifecycle.trial@umcg.nl
Site Name
Stichting Viecuri Medisch Centrum voor Noord-Limburg
Department Name
Nefrologie
Contact Person Name
Marc Hermans
Contact Person Email
marchermans@viecuri.nl
Site Name
Sint Franciscus Vlietland Groep Stichting
Department Name
interne geneeskunder
Contact Person Name
Joep van der Leeuw
Site Name
Ziekenhuisgroep Twente Stichting
Department Name
interne geneeskunde
Contact Person Name
Goos Laverman
Contact Person Email
g.laverman@zgt.nl
Site Name
Amphia Hospital
Department Name
interne geneeskunde
Principal Investigator Name
Ronald van Etten
Principal Investigator Email
rvanetten@amphia.nl
Contact Person Name
Lily Jakulj
Contact Person Email
rvanetten@amphia.nl
Site Name
Ziekenhuis Amstelland
Department Name
nefrologie
Contact Person Name
Fenna van Breda
Contact Person Email
g.vanbreda@amsterdamumc.nl
Site Name
Stichting Dianet
Department Name
Nephrology
Contact Person Name
Susan Logtenberg
Contact Person Email
slogtenberg@diakhuis.nl
Site Name
Isala Klinieken Stichting
Contact Person Name
Aaltje Adema
Contact Person Email
f.waanders@isala.nl
Site Name
Bernhoven B.V.
Contact Person Name
Yvonne de Waal
Contact Person Email
research@bernhoven.nl
Site Name
Noordwest Ziekenhuisgroep Stichting
Department Name
interne geneeskunde
Contact Person Name
Willem Bax
Contact Person Email
noordwestacademie@nwz.nl
Site Name
Admiraal de Ruijter ziekenhuis
Department Name
Nefrologie
Principal Investigator Name
L. Huang
Principal Investigator Email
communicatie@adrz.nl
Contact Person Name
L. Huang
Contact Person Email
communicatie@adrz.nl
Site Name
Flevoziekenhuis Stichting
Department Name
interne geneeskunde
Principal Investigator Name
Arnold Boonstra
Principal Investigator Email
wetenschapsbureau@flevoziekenhuis.nl
Contact Person Name
Arnold Boonstra
Site Name
Elyse klinieken voor nierzorg
Principal Investigator Name
Jeroen Slebe
Principal Investigator Email
locatiekerkrade@elyseklinieken.nl
Contact Person Name
Jeroen Slebe
Site Name
Sint Franciscus Vlietland Groep Stichting (Rotterdam)
Department Name
interne geneeskunde
Principal Investigator Name
Joep van der Leeuw
Principal Investigator Email
wetenschapsbureau@franciscus.nl
Contact Person Name
Joep van der Leeuw
Site Name
Universitair Medisch Centrum Utrecht
Department Name
Nefrologie
Principal Investigator Name
Alferso Abrahams
Principal Investigator Email
A.C.Abrahams@umcutrecht.nl
Contact Person Name
Alferso Abrahams
Contact Person Email
A.C.Abrahams@umcutrecht.nl
Site Name
Bravis Ziekenhuis
Department Name
Interne Geneeskunde
Principal Investigator Name
Marga Eshuis
Principal Investigator Email
m.eshuis@bravis.nl
Contact Person Name
Marga Eshuis
Contact Person Email
m.eshuis@bravis.nl
Site Name
Diakonessenhuis Stichting
Department Name
Nephrology
Principal Investigator Name
Susan Logtenberg
Principal Investigator Email
slogtenberg@diakhuis.nl
Contact Person Name
Susan Logtenberg
Contact Person Email
slogtenberg@diakhuis.nl
Site Name
Catharina Ziekenhuis Stichting
Department Name
interne geneeskunde
Principal Investigator Name
Stijn Konings
Principal Investigator Email
stijn.konings@catharinaziekenhuis.nl
Contact Person Name
Stijn Konings
Site Name
Spaarne Gasthuis
Department Name
interne geneeskunde
Principal Investigator Name
Joost van der Heijden
Principal Investigator Email
WetenschapsBureau@spaarnegasthuis.nl
Contact Person Name
Joost van der Heijden
Site Name
Jeroen Bosch Ziekenhuis
Department Name
Nephrology
Principal Investigator Name
Ellen Hoogeveen
Principal Investigator Email
E.Hoogeveen@jbz.nl
Contact Person Name
Ellen Hoogeveen
Contact Person Email
E.Hoogeveen@jbz.nl
Site Name
Sint Antonius Ziekenhuis Stichting
Department Name
Interne Geneeskunde/nefrologie
Principal Investigator Name
Gurby Ocak
Principal Investigator Email
interne-r&D@antoniusziekenhuis.nl
Contact Person Name
Gurby Ocak
Site Name
Maxima Medisch Centrum
Department Name
Interne Geneeskunde
Principal Investigator Name
Sander Keet
Principal Investigator Email
lokaleuitvoerbaarheid@mmc.nl
Contact Person Name
Sander Keet
Contact Person Email
lokaleuitvoerbaarheid@mmc.nl
Site Name
Radboud universitair medisch centrum / RADBOUDUMC
Department Name
Nierziekten
Principal Investigator Name
Rob van Kruijsdijk
Principal Investigator Email
Rob.vanKruijsdijk@radboudumc.nl
Contact Person Name
Rob van Kruijsdijk
Site Name
Ziekenhuis St Jansdal
Department Name
interne geneeskunde
Principal Investigator Name
Alexander Later
Principal Investigator Email
research-internegeneeskunde@stjansdal.nl
Contact Person Name
Alexander Later
Site Name
University Hospital Maastricht
Department Name
Interne Geneeskunde
Principal Investigator Name
Marielle Gelens
Principal Investigator Email
m.gelens@mumc.nl
Contact Person Name
Marielle Gelens
Contact Person Email
m.gelens@mumc.nl
Site Name
Stichting Martini Ziekenhuis
Principal Investigator Name
Wilbert Janssen
Principal Investigator Email
wetenschap@mzh.nl
Contact Person Name
Wilbert Janssen
Contact Person Email
wetenschap@mzh.nl
Site Name
Zuyderland Medisch Centrum Stichting
Principal Investigator Name
Frank Stifft
Principal Investigator Email
f.stifft@zuyderland.nl
Contact Person Name
Frank Stifft
Contact Person Email
f.stifft@zuyderland.nl
Site Name
Spaarne Gasthuis (Hoofddorp)
Principal Investigator Name
Joost van der Heijden
Principal Investigator Email
WetenschapsBureau@spaarnegasthuis.nl
Contact Person Name
Joost van der Heijden
Site Name
Maasstad Ziekenhuis Stichting
Principal Investigator Name
Martijn van Alphen
Principal Investigator Email
researchinterne@maasstadziekenhuis.nl
Contact Person Name
Martijn van Alphen
Site Name
Gelre Hospitals
Principal Investigator Name
P.A. Rootjes
Principal Investigator Email
Research_Interne@gelre.nl
Contact Person Name
P.A. Rootjes
Contact Person Email
Research_Interne@gelre.nl
Site Name
Stichting Dianet (Amsterdam site)
Department Name
Department of Nephrology
Principal Investigator Name
Lily Jakulj
Principal Investigator Email
lily.jakulj@dianet.nl
Contact Person Name
Lily Jakulj
Contact Person Email
lily.jakulj@dianet.nl
Site Name
Academisch Ziekenhuis Leiden
Principal Investigator Name
Aiko de Vries
Principal Investigator Email
a.p.j.de_vries@lumc.nl
Contact Person Name
Aiko de Vries
Contact Person Email
a.p.j.de_vries@lumc.nl
Site Name
Laurentius Ziekenhuis Roermond
Department Name
interne geneeskunde
Principal Investigator Name
Jeroen Huitema
Principal Investigator Email
jeroen.huitema@lzr.nl
Contact Person Name
Jeroen Huitema
Contact Person Email
jeroen.huitema@lzr.nl
Site Name
Wilhelmina Ziekenhuis Assen
Department Name
Internal medicine
Principal Investigator Name
S. de Boer
Principal Investigator Email
communicatie@wza.nl
Contact Person Name
S. de Boer
Contact Person Email
communicatie@wza.nl
Site Name
OLVG Stichting
Principal Investigator Name
Carl Siegert
Principal Investigator Email
c.siegert@olvg.nl
Contact Person Name
Carl Siegert
Contact Person Email
c.siegert@olvg.nl
Site Name
Alrijne Zorggroep Stichting
Department Name
Internal medicine
Principal Investigator Name
J.T. Jonker
Principal Investigator Email
info@alrijne.nl
Contact Person Name
J.T. Jonker
Contact Person Email
info@alrijne.nl
Site Name
Medical Center Haaglanden
Department Name
interne geneeskunde
Principal Investigator Name
Laima Siddiqi
Principal Investigator Email
l.siddiqi@haaglandenmc.nl
Contact Person Name
Laima Siddiqi
Contact Person Email
l.siddiqi@haaglandenmc.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
interne geneeskunde
Principal Investigator Name
Dennis Hesselink
Principal Investigator Email
research.niertransplantatie@erasmusmc.nl
Contact Person Name
Dennis Hesselink
Site Name
Ziekenhuis Nij Smellinghe
Department Name
Interne geneeskunde
Principal Investigator Name
Roelant van Eps
Principal Investigator Email
info@nijsmellinghe.nl
Contact Person Name
Roelant van Eps
Contact Person Email
info@nijsmellinghe.nl
Site Name
Meander Medisch Centrum
Department Name
Researchbureau Interne geneeskunde, Geriatrie en MDL
Principal Investigator Name
Peter Luik
Principal Investigator Email
researchbureauint@meandermc.nl
Contact Person Name
Peter Luik
Contact Person Email
researchbureauint@meandermc.nl
Site Name
Flevoziekenhuis Stichting (second entry)
Department Name
interne geneeskunde
Principal Investigator Name
Arnold Boonstra
Principal Investigator Email
wetenschapsbureau@flevoziekenhuis.nl
Contact Person Name
Arnold Boonstra
Site Name
Haga Hospital
Department Name
Nephrology
Principal Investigator Name
J. Balak
Principal Investigator Email
J.BaIak@haqaziekenhuis.nl
Contact Person Name
J. Balak
Contact Person Email
J.BaIak@haqaziekenhuis.nl
Site Name
Dialysecentrum Groningen
Department Name
Nefrologie
Principal Investigator Name
Akin Oezyilmaz
Principal Investigator Email
info@dcg.nl
Contact Person Name
Akin Oezyilmaz
Contact Person Email
info@dcg.nl
Site Name
Tergooiziekenhuizen
Department Name
Interne geneeskunde
Principal Investigator Name
Marcel Schouten
Principal Investigator Email
maschouten@tergooi.nl
Contact Person Name
Marcel Schouten
Contact Person Email
maschouten@tergooi.nl
Site Name
Saxenburgh Medisch Centrum
Department Name
Interne Geneeskunde
Principal Investigator Name
Julide Bayrak
Principal Investigator Email
research@sxb.nl
Contact Person Name
Julide Bayrak
Contact Person Email
research@sxb.nl
Site Name
Medisch Spectrum Twente
Department Name
interne geneeskunde
Principal Investigator Name
Niels Brinkman
Principal Investigator Email
J.Brinkman@mst.nl
Contact Person Name
Niels Brinkman
Contact Person Email
J.Brinkman@mst.nl
Site Name
Reinier de Graaf Groep
Department Name
interne geneeskunde
Principal Investigator Name
Henk Boom
Principal Investigator Email
wetenschapsbureau@rdgg.nl
Contact Person Name
Henk Boom
Contact Person Email
wetenschapsbureau@rdgg.nl
Site Name
Albert Schweitzer Ziekenhuis
Department Name
Interne geneeskunder
Principal Investigator Name
Jeroen van der Net
Principal Investigator Email
j.b.vandernet@asz.nl
Contact Person Name
Jeroen van der Net
Contact Person Email
j.b.vandernet@asz.nl
Site Name
Deventer Ziekenhuis
Department Name
Interne Geneeskunde
Principal Investigator Name
Anita van Eck van der Sluijs
Principal Investigator Email
o.dialyse@dz.nl
Contact Person Name
Anita van Eck van der Sluijs
Contact Person Email
o.dialyse@dz.nl

Spain

Earliest CTIS Part Ii Submission Date
27-11-2024
Latest Decision Or Authorization Date
22-09-2025
Processing Time Days
299
Number Of Sites
17
Number Of Participants
250

Sites

Site Name
Hospital Germans Trias I Pujol
Department Name
Nephrology
Principal Investigator Name
Maria Troya Saborido
Principal Investigator Email
mitroya.germanstrias@gencat.cat
Contact Person Name
Maria Troya Saborido
Site Name
Clinica Universidad De Navarra
Principal Investigator Name
Nuria Fernandéz
Principal Investigator Email
nrgarcia@unav.es
Contact Person Name
Nuria Fernandéz
Contact Person Email
nrgarcia@unav.es
Site Name
Hospital Son Llatzer
Department Name
Nephrology
Principal Investigator Name
Juan Buades Fuster
Principal Investigator Email
jbfuster@hsll.es
Contact Person Name
Juan Buades Fuster
Contact Person Email
jbfuster@hsll.es
Site Name
Hospital Clinic De Barcelona
Department Name
Nephrology
Principal Investigator Name
Jose Jesus Broseta Monzo
Principal Investigator Email
jjbroseta@clinic.cat
Contact Person Name
Jose Jesus Broseta Monzo
Contact Person Email
jjbroseta@clinic.cat
Site Name
Hospital Del Mar
Department Name
Nephrology
Principal Investigator Name
Anna Bruxeda i Porras
Principal Investigator Email
abuxeda@psmar.cat
Contact Person Name
Anna Bruxeda i Porras
Contact Person Email
abuxeda@psmar.cat
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Nephrology
Principal Investigator Name
Marta Blanco Pardo
Principal Investigator Email
martabp94@gmail.com
Contact Person Name
Marta Blanco Pardo
Contact Person Email
martabp94@gmail.com
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Nephrology
Principal Investigator Name
María Vidas
Principal Investigator Email
mmvidas@gmail.com
Contact Person Name
María Vidas
Contact Person Email
mmvidas@gmail.com
Site Name
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Department Name
Nephrology
Principal Investigator Name
Maria Martin Conde
Principal Investigator Email
mlmartin.lleida.ics@gencat.cat
Contact Person Name
Maria Martin Conde
Contact Person Email
mlmartin.lleida.ics@gencat.cat
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Nephrology
Principal Investigator Name
Alberto Ortiz
Principal Investigator Email
aortiz@fjd.es
Contact Person Name
Alberto Ortiz
Contact Person Email
aortiz@fjd.es
Site Name
University Hospital Son Espases
Department Name
Nephrology
Principal Investigator Name
Maria Munar Vila
Principal Investigator Email
mariaa.munar@ssib.es
Contact Person Name
Maria Munar Vila
Contact Person Email
mariaa.munar@ssib.es
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Nephrology
Principal Investigator Name
MArían Goicoechea Diezhandino
Principal Investigator Email
marian.goicoechea@salud.madrid.org
Contact Person Name
MArían Goicoechea Diezhandino
Site Name
Bellvitge University Hospital
Department Name
Nephrology
Principal Investigator Name
Josep Cruzado
Principal Investigator Email
jmcruzado@bellvitgehospital.cat
Contact Person Name
Josep Cruzado
Site Name
Hospital Universitario Dr Peset Aleixandre
Department Name
Nephrology
Principal Investigator Name
Asunción Calabuig
Principal Investigator Email
asanchoc2@gmail.com
Contact Person Name
Asunción Calabuig
Contact Person Email
asanchoc2@gmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Nephrology
Principal Investigator Name
María Romeo
Principal Investigator Email
mariajose.soler@vallhebron.cat
Contact Person Name
María Romeo
Contact Person Email
mariajose.soler@vallhebron.cat
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Nephrology
Principal Investigator Name
Beatriz Sánchez Alamo
Principal Investigator Email
bsalamo@salud.madrid.org
Contact Person Name
Beatriz Sánchez Alamo
Contact Person Email
bsalamo@salud.madrid.org
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Nephrology
Principal Investigator Name
Mercedes Salgueira
Principal Investigator Email
salgueiramer@gmail.com
Contact Person Name
Mercedes Salgueira
Contact Person Email
salgueiramer@gmail.com
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Nephrology
Principal Investigator Name
Jose Gorriz
Principal Investigator Email
jlgorriz@gmail.com
Contact Person Name
Jose Gorriz
Contact Person Email
jlgorriz@gmail.com

Germany

Earliest CTIS Part Ii Submission Date
17-01-2024
Latest Decision Or Authorization Date
30-01-2026
Processing Time Days
744
Number Of Sites
16
Number Of Participants
250

Sites

Site Name
Universitat Heidelberg
Department Name
Studienzentrum U. von der Emde
Principal Investigator Name
Claudia Sommerer
Principal Investigator Email
claudia.sommerer@med.uni-heidelberg.de
Contact Person Name
Claudia Sommerer
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Medizinische Klinik IV
Principal Investigator Name
Nils Heyne
Principal Investigator Email
Nils.Heyne@med.uni-tuebingen.de
Contact Person Name
Nils Heyne
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Medizinische Klinik und Poliklinik I
Principal Investigator Name
Christoph Wanner
Principal Investigator Email
Wanner_C@ukw.de
Contact Person Name
Christoph Wanner
Contact Person Email
Wanner_C@ukw.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik für Innere Medizin I
Principal Investigator Name
Bernd Schroeppel
Principal Investigator Email
bernd.schroeppel@uniklinik-ulm.de
Contact Person Name
Bernd Schroeppel
Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Abteilung f. Nephrologie
Principal Investigator Name
Bernhard Banas
Principal Investigator Email
bernhard.banas@ukr.de
Contact Person Name
Bernhard Banas
Contact Person Email
bernhard.banas@ukr.de
Site Name
Nephrologisches Zentrum Villingen-Schwenningen
Department Name
Studienzentrum
Principal Investigator Name
Bernd Hohenstein
Principal Investigator Email
hohenstein@nephrologie-vs.de
Contact Person Name
Bernd Hohenstein
Contact Person Email
hohenstein@nephrologie-vs.de
Site Name
Universitaetsklinikum Jena KöR
Department Name
Klinik fuer Innere Medizin III
Principal Investigator Name
Martin Busch
Principal Investigator Email
Martin.Busch@med.uni-jena.de
Contact Person Name
Martin Busch
Contact Person Email
Martin.Busch@med.uni-jena.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Medizinische Klinik mit Schwerpunkt Nephrologie und Internistische Intensivmedizin
Principal Investigator Name
Klemens Budde
Principal Investigator Email
klemens.budde@charite.de
Contact Person Name
Klemens Budde
Contact Person Email
klemens.budde@charite.de
Site Name
MVZ Diagnostik und Schmerztherapie Helle-Mitte GmbH
Department Name
Praxis für Dialyse und Nierenkrankheiten
Principal Investigator Name
Wolfgang Seeger
Principal Investigator Email
drseeger@t-online.de
Contact Person Name
Wolfgang Seeger
Contact Person Email
drseeger@t-online.de
Site Name
Kidney Center Wiesbaden-Rheumatology
Principal Investigator Name
Frank Strutz
Principal Investigator Email
Strutz@nephrologie-wiesbaden.de
Contact Person Name
Frank Strutz
Site Name
Dialysezentrum Heilbronn
Department Name
Nephrology
Principal Investigator Name
Michael Schoemig
Principal Investigator Email
info@dialyse-heilbronn.de
Contact Person Name
Michael Schoemig
Contact Person Email
info@dialyse-heilbronn.de
Site Name
Zentrum Fuer Nieren Hochdruck Und Stoffwechselerkrankungen
Department Name
Studienzentrum
Principal Investigator Name
Georg Schlieper
Principal Investigator Email
dr.schlieper@dialyse-hannover.de
Contact Person Name
Georg Schlieper
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
I. Medizinische Klinik und Poliklinik
Principal Investigator Name
Julia Weinmann-Menke
Principal Investigator Email
julia.weinmann-menke@unimedizin-mainz.de
Contact Person Name
Julia Weinmann-Menke
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Nephrologie
Principal Investigator Name
Malte Kluger
Principal Investigator Email
m.kluger@uke.de
Contact Person Name
Malte Kluger
Contact Person Email
m.kluger@uke.de
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Klinik fuer Nephrologie
Principal Investigator Name
Johannes Stegbauer
Principal Investigator Email
johannes.stegbauer@med.uni-duesseldorf.de
Contact Person Name
Johannes Stegbauer
Site Name
Universitaetsklinikum Halle (Saale) AöR
Department Name
Klinik und Poliklinik für Innere Medizin II
Principal Investigator Name
Matthias Grindt
Principal Investigator Email
Matthias.Girndt@uk-halle.de
Contact Person Name
Matthias Grindt
Contact Person Email
Matthias.Girndt@uk-halle.de
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Medizinische Klinik 4
Principal Investigator Name
Mario Schiffer
Principal Investigator Email
Mario.Schiffer@uk-erlangen.de
Contact Person Name
Mario Schiffer
Contact Person Email
Mario.Schiffer@uk-erlangen.de

Sponsor

Primary sponsor

Full Name
Universitair Medisch Centrum Groningen
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

Third parties

  • {"country":"","full_name":"AstraZeneca","duties_or_roles":"Source of monetary support","organisation_type":""}
  • {"country":"","full_name":"Dutch Kidney Foundation","duties_or_roles":"Source of monetary support","organisation_type":""}

Investigational products

Investigational Product Name
DAPAGLIFLOZIN
Active Substance
DAPAGLIFLOZIN
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Starting Dose
10 mg once daily
Dose Levels
10 mg
Frequency
once daily
Maximum Dose
10 mg
Investigational Product Name
Placebo for dapagliflozin film-coated tablets 10 mg
Modality
Other
Starting Dose
matching placebo 10 mg once daily
Dose Levels
matching placebo 10 mg
Frequency
once daily

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