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NCT06350123CompletedPhase 2

Efficacy, Safety and Tolerability of Balcinrenone/Dapagliflozin Compared to Dapagliflozin in Adults With Chronic Kidney Disease

A Phase IIb, Multicenter, Randomised, Double-Blind, Dose-finding Study to Evaluate the Efficacy, Safety and Tolerability of Balcinrenone in Combination With Dapagliflozin Compared With Dapagliflozin in Patients With Chronic Kidney Disease and Albuminuria

Source: ClinicalTrials.gov · Last updated 26 Jun 2026

Brief summary (registry, in English)

The purpose of the study is to evaluate the efficacy, safety and tolerability of balcinrenone/dapagliflozin compared with dapagliflozin alone on patients with chronic kidney disease (CKD) and albuminuria. This study will evaluate the effect of the balcinrenone/dapagliflozin on urinary albumin-to-creatinine ratio (UACR), compared with dapagliflozin in patients with CKD. This is a dose-finding study aiming to identify an optimal dose of balcinrenone/dapagliflozin for a future Phase III study in patients with CKD.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
324 (actual)
First submitted
2 Apr 2024
Start date
May 2024
Primary completion date
May 2025
Lead sponsor
AstraZeneca
NCT number
NCT06350123
EU CT number
2023-509709-63-00

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 324
  • From May 2024 to the primary completion date, May 2025
  • 89 sites in 15 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (89)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Konvent Der Barmherzigen Brueder
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LinzAustriaCompleted
Noe LGA Gesundheit Region Mitte GmbH
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St. PoeltenAustriaCompleted
Klinik Landstrabe
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ViennaAustriaCompleted
Medical University of Vienna
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ViennaAustriaCompleted
Imed19-privat
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ViennaAustriaCompleted
Klinik Hietzing
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ViennaAustriaCompleted
Klinikum Wels-Grieskirchen GmbH
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WelsAustriaCompleted
Individual Practice For Specialized Medical Care Dr. Nikolay Kostadinov EOOD
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BurgasBulgariaCompleted
Medical Center Viva Phoenix OOD
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DobrichBulgariaCompleted
Medical Center Exacta Medica OOD
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PlevenBulgariaCompleted
Medicinski Centar Hipokrat-N EOOD
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PlovdivBulgariaCompleted
Kalimat Medical Center Ltd.
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SofiaBulgariaCompleted
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Porto AlegreBrazilUnknown status
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São PauloBrazilUnknown status
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LondonCanadaUnknown status
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MontrealCanadaUnknown status
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QuébecCanadaUnknown status
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WaterlooCanadaUnknown status
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ChangchunChinaUnknown status
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ChangzhouChinaUnknown status
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ShanghaiChinaUnknown status
-
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TianjinChinaUnknown status
Hospital Clinic de Barcelona
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BarcelonaSpainCompleted
Hospital Universitari Vall d'Hebron
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BarcelonaSpainCompleted
Hospital General Universitario Reina Sofia
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CórdobaSpainCompleted
University Hospital Son Espases
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PalmaSpainCompleted
University Hospital Virgen Del Rocio S.L.
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SevillaSpainCompleted
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainCompleted
-
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DundeeUnited KingdomUnknown status
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LondonUnited KingdomUnknown status
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NewquayUnited KingdomUnknown status
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NottinghamUnited KingdomUnknown status
University Hospital Consorziale Policlinico
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BariItalyCompleted
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyCompleted
IRCCS Ospedale Policlinico San Martino
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GenoaItalyCompleted
Azienda Ospedaliero Universitaria Maggiore della Carità
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NovaraItalyCompleted
Azienda Ospedaliero Universitaria Parma
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ParmaItalyCompleted
Istituti Clinici Scientifici Maugeri In Forma Abbreviata Istituti Clinici Scientifici Maugeri O Anche Ics Maugeri O Maugeri S.p.A. Sb
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PaviaItalyCompleted
-
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AgeoJapanUnknown status
-
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Fujisawa-shiJapanUnknown status
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FukuokaJapanUnknown status
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Koga-shiJapanUnknown status
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Koshigaya-shiJapanUnknown status
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KumamotoJapanUnknown status
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NagasakiJapanUnknown status
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NagoyaJapanUnknown status
-
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Okinawa-shiJapanUnknown status
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TakamatsuJapanUnknown status
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Zentsuji-shiJapanUnknown status
-
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IpohMalaysiaUnknown status
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Johor BahruMalaysiaUnknown status
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KajangMalaysiaUnknown status
-
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Kota BharuMalaysiaUnknown status
-
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Kuala TerengganuMalaysiaUnknown status
Kresmed Sp. z o. o.
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BialystokPolandCompleted
Centrum Badan Klinicznych PI-House sp. z o.o.
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GdanskPolandCompleted
Mcbk s.c. Iwona Czajkowska Anna Podrazka Szczepaniak
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Grodzisk MazowieckiPolandCompleted
Centrum Medyczne Medyk Sp. z o.o. Sp. K.
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LezajskPolandCompleted
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
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LodzPolandCompleted
Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna A Wittek H Rudzki Sp. j.
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Ruda ŚląskaPolandCompleted
Uniwersytecki Szpital Kliniczny Nr 2 PUM w Szczecinie
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SzczecinPolandCompleted
Med Sp. z o.o.
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WarsawPolandCompleted
Icz Healthcare Sp. z o.o.
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ZywiecPolandCompleted
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Kaohsiung CityTaiwanUnknown status
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New Taipei CityTaiwanUnknown status
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TaichungTaiwanUnknown status
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TainanTaiwanUnknown status
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TaipeiTaiwanUnknown status
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AnnapolisUnited StatesUnknown status
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El PasoUnited StatesUnknown status
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GlendaleUnited StatesUnknown status
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HialeahUnited StatesUnknown status
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HoustonUnited StatesUnknown status
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Miami LakesUnited StatesUnknown status
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New BernUnited StatesUnknown status
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NorfolkUnited StatesUnknown status
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OgdenUnited StatesUnknown status
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Salt Lake CityUnited StatesUnknown status
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San AntonioUnited StatesUnknown status
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SheffieldUnited StatesUnknown status
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WaterburyUnited StatesUnknown status
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HaiphongVietnamUnknown status
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Hochiminh CityVietnamUnknown status
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Ho Chi Minh CityVietnamUnknown status
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AnkaraTurkey (Türkiye)Unknown status
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GaziantepTurkey (Türkiye)Unknown status
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KahramanmaraşTurkey (Türkiye)Unknown status
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KayseriTurkey (Türkiye)Unknown status
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KocaeliTurkey (Türkiye)Unknown status

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This page is information, not medical advice. Discuss any trial with your doctor.