Clinical trial • Endocrinology|Nephrology

EMPAGLIFLOZIN for Chronic kidney disease

Clinical trial of EMPAGLIFLOZIN for Chronic kidney disease.

Overview

Trial Therapeutic Area
Endocrinology|Nephrology
Trial Disease
Chronic kidney disease
Drug Modality
Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
25-07-2025
First CTIS Authorization Date
06-11-2025

Trial design

Randomised, open-label, placebo matching empagliflozin (placebo tablets) versus empagliflozin (study product / jardiance 10 mg film-coated tablets listed); route oral. dose and study schedule not specified in the available record.-controlled trial in Germany, France, Sweden and others.

Randomised
Yes
Open Label
Yes
Comparator
Placebo matching empagliflozin (placebo tablets) versus empagliflozin (study product / Jardiance 10 mg film-coated tablets listed); route oral. Dose and study schedule not specified in the available record.
Target Sample Size
70

Eligibility

Recruits 70 paediatric patients.

Vulnerable Population
Paediatric population aged 2–17 years. Informed consent must be provided by the patient’s parent(s) or legal guardian; patient assent is required and will be sought according to the patient's age, level of maturity, competence and capacity. Age-specific assent and parental/guardian information/ICF documents are provided.

Inclusion criteria

  • {"criterion_text":"-Signed and dated written informed consent provided by the patient’s parent(s) (or legal guardian) and patient’s assent in accordance with International Council for Harmonisation Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial (informed assent will be sought according to the patient’s age, level of maturity, competence, and capacity)."}
  • {"criterion_text":"-Age 2 to 17 years at screening Visit 1."}
  • {"criterion_text":"-CKD of any underlying aetiology defined by (as measured by central laboratory at screening Visit 1): eGFR (U25Crea) ≥20 to <90 mL/min/1.73 m2 with a UACR ≥300 mg/g"}
  • {"criterion_text":"-Participants must be on a stable dose of maximally tolerated SoC therapy for 30 days before screening Visit 1, with no plans to change the dose throughout the duration of the placebo-controlled portion of the trial. SoC is anticipated to include a single RAAS inhibitor, such as angiotensin receptor blockers (ARB) or angiotensin converting enzyme inhibitors (ACEi), as appropriate and as tolerated. Additional use of a mineralocorticoid receptor antagonist (MRA, including finerenone if available) is permitted if needed and the dose is stable for 30 days before screening Visit 1 and no planned dose changes for the placebo-controlled portion of the trial"}
  • {"criterion_text":"-Participants receiving daily immunosuppressive therapy for an underlying immunological cause of CKD must be on a stable dose for the duration specified for each drug, prior to screening and must remain on a stable regimen throughout the placebo-controlled period of the trial."}
  • {"criterion_text":"-Further inclusion criteria apply"}

Exclusion criteria

  • {"criterion_text":"-Confirmed type 1 or type 2 diabetes mellitus."}
  • {"criterion_text":"-History of ketoacidosis within 8 weeks prior to Visit 1 and up to randomisation."}
  • {"criterion_text":"-Chronic dialysis or functioning kidney transplant or scheduled for transplantation throughout the duration of the trial."}
  • {"criterion_text":"-Diagnosis of uncontrolled metabolic bone disease (at the Investigator’s discretion)."}
  • {"criterion_text":"-\"Body mass index (BMI) ≤10th percentile for children ≥4 years of age and ≤25th percentile for children <4 years of age according to Centers for Disease Control and Prevention (CDC) growth chart at screening Visit 1.\""}
  • {"criterion_text":"-Gastrointestinal disorders that might interfere with trial drug absorption according to investigator assessment."}
  • {"criterion_text":"-Presence of acute or active UTI with signs or symptoms of an active UTI or therapeutic treatment for an active UTI within 14 days before screening Visit 1."}
  • {"criterion_text":"-Severe, uncontrolled hypertension (based on investigator’s judgement)."}
  • {"criterion_text":"-Further exclusion criteria apply."}

Endpoints

Primary endpoints

  • {"endpoint_text":"-Change from Day 1 to the Week 24 visit in UACR [mg/g]","definition_or_measurement_approach":"Change from baseline (Day 1) to Week 24 in urine albumin-to-creatinine ratio (UACR), measured in mg/g (central laboratory)."}
  • {"endpoint_text":"-Change from Day 1 to the Week 24 visit in urine glucose [mmol/L]","definition_or_measurement_approach":"Change from baseline (Day 1) to Week 24 in urine glucose, measured in mmol/L."}

Secondary endpoints

  • {"endpoint_text":"-Change in eGFR (U25Crea) over time during treatment with empagliflozin","definition_or_measurement_approach":"Serial change in estimated glomerular filtration rate (eGFR, U25Crea) over treatment period (method: central laboratory eGFR calculation as specified)."}
  • {"endpoint_text":"-Annual rate of change in eGFR (U25Crea) from Week 8 to Week 24, including treatment effect extrapolation from (adult) EMPA-KIDNEY data","definition_or_measurement_approach":"Calculated annual rate of eGFR change between Week 8 and Week 24; analysis may include extrapolation using adult EMPA-KIDNEY treatment effect data."}
  • {"endpoint_text":"-Change from Day 1 to the Week 24 visit in UPCR","definition_or_measurement_approach":"Change from baseline (Day 1) to Week 24 in urine protein-to-creatinine ratio (UPCR)."}
  • {"endpoint_text":"-The observed predose plasma concentrations of empagliflozin at Week 26","definition_or_measurement_approach":"Observed predose (trough) plasma concentrations of empagliflozin measured at Week 26 (pharmacokinetic sampling)."}
  • {"endpoint_text":"-Occurrence of at least one SAE or AE of special interest (AESI) per participant between Day 1 and the Week 24 visit, and between the Week 24 visit and end of treatment (EoT) +7 days residual effect period (REP)","definition_or_measurement_approach":"Safety endpoint counting participants with at least one serious adverse event (SAE) or adverse event of special interest (AESI) in the specified periods (Day 1 to Week 24; Week 24 to EoT +7d REP)."}

Recruitment

Digital Remote Recruitment
True, recruitment includes digital methods such as country-specific websites, online infogetters, digital toolkits, social media campaigns (Facebook, Instagram, TikTok), display advertising, and web cookie/privacy policies to support online recruitment.
Planned Sample Size
70
Recruitment Window Months
43
Consent Approach
Informed consent must be provided in writing by the patient’s parent(s) or legal guardian prior to inclusion; assent from the child/adolescent is required and will be sought according to age, maturity, competence and capacity. Age-specific assent and parental/guardian ICF documents are provided (multiple country-language versions and age-group versions, e.g., assent documents for 2–6 years, 6–11, 12–17 etc.). Documents are available in multiple languages aligned to participating countries.

Methods

  • Country-specific recruitment arrangements documents and materials (k1/k2) were prepared for multiple countries (e.g., BE, FR, DE, SE, ES, IT, NL, PT, HU, PL).
  • Digital advertising: display ads and digital creatives (examples: display adv 728x90, 300x250, 160x600), social media assets (Facebook feed, Facebook story, Instagram feed, Instagram story, TikTok in-feed) - country-specific assets present (SE, ES, PL, NL, etc.).
  • Web/online methods: study websites, web privacy and cookie policies, digital toolkit and infogetter materials for online recruitment (country-specific).
  • Printed materials and posters: recruitment posters, info brochures, participant study guides, posters localized per country.
  • Healthcare professional channels: physician referral letters and GP letters (e.g., PL and IT materials).
  • Participant-facing materials for children/families: coloring book, birthday card, thank-you card, participant study guide, scout/brochure and subject cards tailored for paediatric participants and caregivers.
  • Email and direct communication: scoutpass/mailers and email communications (country-specific templates).
  • Multimedia: video scripts and storyboards for use in outreach materials (country-specific).

Geography

Total Number Of Sites
42
Total Number Of Participants
55

Germany

Earliest CTIS Part Ii Submission Date
10-10-2025
Latest Decision Or Authorization Date
19-03-2026
Processing Time Days
160
Number Of Sites
4
Number Of Participants
5

Sites

Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
UniversitPädiatrisches Klinisch-Pharmakologisches Studienzentrum (paedKliPS)
Contact Person Name
Elke Wühl
Site Name
University Hospital Cologne AöR
Department Name
Klinik und Poliklinik für Kinder- und Jugendmedizin, Klinisches Studienzentrum Pädiatrie
Contact Person Name
Lutz Weber
Contact Person Email
lutz.weber@uk-koeln.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
KfH-Nierenzentrum für Kinder und Jugendliche
Contact Person Name
Marcus Weitz
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Klinik für Kinder- und Jugendmedizin, ped.UCiT-Studiencentrum
Contact Person Name
Jun Oh
Contact Person Email
j.oh@uke.de

France

Earliest CTIS Part Ii Submission Date
23-09-2025
Latest Decision Or Authorization Date
19-03-2026
Processing Time Days
177
Number Of Sites
6
Number Of Participants
8

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Néphrologie Pédiatrique
Contact Person Name
Olivia Boyer
Contact Person Email
olivia.boyer@aphp.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Néphrologie Pédiatrique
Contact Person Name
Mathilde Cailliez
Contact Person Email
mathilde.cailliez@ap-hm.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Néphrologie Pédiatrique
Contact Person Name
Tim Ulinski
Contact Person Email
tim.ulinski@aphp.fr
Site Name
Hospices Civils De Lyon
Department Name
Néphrologie Pédiatrique
Contact Person Name
Justine Bacchetta
Contact Person Email
justine.bacchetta@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Service de Pédiatrie - Néphrologie, Médecine interne et Hypertension
Contact Person Name
Thomas Simon
Contact Person Email
simon.t@chu-toulouse.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Service Néphrologie Pédiatrique
Contact Person Name
Gwenaelle Roussey

Sweden

Earliest CTIS Part Ii Submission Date
10-10-2025
Latest Decision Or Authorization Date
24-03-2026
Processing Time Days
165
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
Behandlingsvägen 7, BK
Contact Person Name
Per Brandström
Contact Person Email
per.brandstrom@vgregion.se
Site Name
Karolinska University Hospital
Department Name
Barnmedicin Dagvård
Contact Person Name
Peter Barany

Spain

Earliest CTIS Part Ii Submission Date
10-10-2025
Latest Decision Or Authorization Date
25-03-2026
Processing Time Days
166
Number Of Sites
4
Number Of Participants
5

Sites

Site Name
Assistance Publique Hopitaux De Paris (site listed under Spain group)
Department Name
Néphrologie Pédiatrique
Contact Person Name
Olivia Boyer
Contact Person Email
olivia.boyer@aphp.fr
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Servicio Nefrología Pediátrica
Contact Person Name
Francisco De La Cerda
Contact Person Email
olivia.boyer@aphp.fr
Site Name
Hospital Universitario Regional De Malaga
Department Name
Nefrología Pediátrica
Contact Person Name
Francisco Antonio Nieto
Site Name
Hospital Universitari Vall D Hebron
Department Name
Nefrología Pediátrica
Contact Person Name
Gema Ariceta Iraola
Contact Person Email
gema.ariceta@vallhebron.cat

Hungary

Earliest CTIS Part Ii Submission Date
16-09-2025
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
192
Number Of Sites
3
Number Of Participants
2

Sites

Site Name
University Of Pecs
Department Name
Department of Paediatrics
Contact Person Name
Tamas Decsi
Contact Person Email
decsi.tamas@pte.hu
Site Name
University Of Debrecen
Department Name
Department of Pediatrics
Contact Person Name
Tamás Szabó
Contact Person Email
szabotamas@med.unideb.hu
Site Name
Semmelweis University
Department Name
Pediatric Centre, Bokay Street Department
Contact Person Name
Gyorgy Reusz
Contact Person Email
reusz.gyorgy@semmelweis.hu

Belgium

Earliest CTIS Part Ii Submission Date
14-10-2025
Latest Decision Or Authorization Date
23-03-2026
Processing Time Days
160
Number Of Sites
5
Number Of Participants
10

Sites

Site Name
CHC MontLegia
Department Name
Département d'Oncologie/Hématologie Adulte
Contact Person Name
Laure Collard
Contact Person Email
laure.collard@chc.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Nobel 1, ingang 7, route 7030, t.a.v. Daphné Christiaens / Elke Colman
Contact Person Name
Ann Raes
Contact Person Email
Ann.Raes@uzgent.be
Site Name
UZ Leuven
Department Name
Petit-CRU, Rode route - Poort 4 - Niveau 2
Contact Person Name
Detlef Böckenhauer
Contact Person Email
detlef.bockenhauer@uzleuven.be
Site Name
Association Hospitaliere De Bruxelles Hopital Universitaire Des Enfants Reine Fabiola
Department Name
Pediatric department
Contact Person Name
Benedetta Chiodini
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Pneumology, level -2
Contact Person Name
Nathalie Godefroid

Italy

Earliest CTIS Part Ii Submission Date
07-08-2025
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
264
Number Of Sites
4
Number Of Participants
6

Sites

Site Name
Azienda Ospedaliera di Padova
Department Name
UOC Nefrologia Pediatrica
Contact Person Name
Enrico Vidali
Contact Person Email
enrico.vidal@aopd.veneto.it
Site Name
Ospedale Pediatrico Bambino Gesu
Department Name
Divisione di Nefrologia e Dialisi
Contact Person Name
Francesco Emma
Contact Person Email
francesco.emma@opbg.net
Site Name
IRCCS Istituto Giannina Gaslini
Department Name
UOC di Nefrologia e Trapianto Rene
Contact Person Name
Andrea Angeletti
Contact Person Email
andreaangeletti@gaslini.org
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Pediatric Nephrology, Dialysis and Transplantation Unit
Contact Person Name
Giovanni Montini
Contact Person Email
giovanni.montini@unimi.it

Netherlands

Earliest CTIS Part Ii Submission Date
03-11-2025
Latest Decision Or Authorization Date
19-03-2026
Processing Time Days
136
Number Of Sites
5
Number Of Participants
7

Sites

Site Name
Radboud universitair medisch centrum Stichting
Department Name
Radboudumc Pediatric Research Unit, Afdeling Kindergeneeskunde
Contact Person Name
Michiel Schreuder
Site Name
Universitair Medisch Centrum Utrecht
Department Name
locatie WKZ Trialbureau
Contact Person Name
Gerrit Van den Berg
Contact Person Email
G.vandenBerg-8@umcutrecht.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Afdeling kindernefrologie, kamer Sp- 2430
Contact Person Name
Miriam Mooij
Contact Person Email
m.mooij@erasmusmc.nl
Site Name
Amsterdam UMC Stichting
Department Name
Locatie AMC
Contact Person Name
Rik Westland
Contact Person Email
ri.westland@amsterdamumc.nl
Site Name
Universitair Medisch Centrum Groningen
Department Name
Support Clinical Trials, office/room 3th floor 3.054) Entrance 43
Contact Person Name
Valentina Gracchi
Contact Person Email
v.gracchi@umcg.nl

Portugal

Earliest CTIS Part Ii Submission Date
09-09-2025
Latest Decision Or Authorization Date
20-03-2026
Processing Time Days
192
Number Of Sites
4
Number Of Participants
4

Sites

Site Name
Unidade Local De Saude De Coimbra E.P.E.
Department Name
Unidade de Nefrologia Pediátrica
Contact Person Name
Catarina Neves
Contact Person Email
catarinarneves@hotmail.com
Site Name
Unidade Local De Saude De Santo Antonio E.P.E.
Department Name
Serviço de Pediatria
Contact Person Name
Maria Faria
Contact Person Email
mariasameirofaria@gmail.com
Site Name
Unidade Local De Saude De Sao Jose E.P.E.
Department Name
Serviço de Pediatria Médica
Contact Person Name
Rute Baptista
Contact Person Email
rute.baeta.baptista@gmail.com
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Unidade de Nefrologia Pediátrica
Contact Person Name
Patrícia Reis
Contact Person Email
pcr.patricia@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
03-11-2025
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
176
Number Of Sites
5
Number Of Participants
6

Sites

Site Name
Uniwersytecki Szpital Dzieciecy W Lublinie
Department Name
Department of Pediatric Nephrology
Contact Person Name
Przemyslaw Sikora
Contact Person Email
przemyslaw.sikora@umlub.pl
Site Name
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department Name
Clinic Department of Pediatric Nephrology
Contact Person Name
Katarzyna Kilis-Pstrusinska
Site Name
Instytut Pomnik Centrum Zdrowia Dziecka
Department Name
Nephrology, Kidney Transplantation and Arterial Hypertension Department
Contact Person Name
Mieczyslaw Litwin
Contact Person Email
m.litwin@ipczd.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Department of Kidney Diseases and Hypertension in Children and Adolescents
Contact Person Name
Ilona Zagozdzon
Contact Person Email
Ilona.zagozdzon@gumed.edu.pl
Site Name
Ludwik Rydygier Provincial Hospital in Toruń
Department Name
Clinical Department of Paediatrics and Nephrology, Specialist Hospital for children and adults
Contact Person Name
Roman Stankiewicz
Contact Person Email
rstan2@wp.pl

Sponsor

Primary sponsor

Full Name
Boehringer Ingelheim International GmbH
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Contract research organisations

Name
IQVIA Limited
Responsibilities
Sponsor duties codes: 1, 12, 15 (including 'Start-up & Contract negotiation'); contact: josephine.kench@iqvia.com

Third parties

  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Sponsor duties codes: 1, 12, 15 (code 15: \"Start-up & Contract negotiation\")","organisation_type":"Pharmaceutical company"}

Co-sponsors

  • Boehringer Ingelheim Espana S.A.

Investigational products

Investigational Product Name
Jardiance 10 mg film-coated tablets
Active Substance
EMPAGLIFLOZIN
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Marketing authorisation present (EU/1/14/930/018)
Investigational Product Name
empagliflozin
Active Substance
EMPAGLIFLOZIN
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Investigational Product Name
Placebo matching empagliflozin, film-coated tablets
Modality
Other
Combination Treatment
Yes

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