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
- Diseases
- Chronic kidney disease
- 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
Sites (89)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Konvent Der Barmherzigen Brueder Coordinator of this site? Confirm its status | Linz | Austria | Completed |
| Noe LGA Gesundheit Region Mitte GmbH Coordinator of this site? Confirm its status | St. Poelten | Austria | Completed |
| Klinik Landstrabe Coordinator of this site? Confirm its status | Vienna | Austria | Completed |
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Completed |
| Imed19-privat Coordinator of this site? Confirm its status | Vienna | Austria | Completed |
| Klinik Hietzing Coordinator of this site? Confirm its status | Vienna | Austria | Completed |
| Klinikum Wels-Grieskirchen GmbH Coordinator of this site? Confirm its status | Wels | Austria | Completed |
| Individual Practice For Specialized Medical Care Dr. Nikolay Kostadinov EOOD Coordinator of this site? Confirm its status | Burgas | Bulgaria | Completed |
| Medical Center Viva Phoenix OOD Coordinator of this site? Confirm its status | Dobrich | Bulgaria | Completed |
| Medical Center Exacta Medica OOD Coordinator of this site? Confirm its status | Pleven | Bulgaria | Completed |
| Medicinski Centar Hipokrat-N EOOD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Completed |
| Kalimat Medical Center Ltd. Coordinator of this site? Confirm its status | Sofia | Bulgaria | Completed |
| - Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| - Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| - Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Waterloo | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| - Coordinator of this site? Confirm its status | Changzhou | China | Unknown status |
| - Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| - Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital General Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Completed |
| University Hospital Son Espases Coordinator of this site? Confirm its status | Palma | Spain | Completed |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Completed |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Completed |
| - Coordinator of this site? Confirm its status | Dundee | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Newquay | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Unknown status |
| University Hospital Consorziale Policlinico Coordinator of this site? Confirm its status | Bari | Italy | Completed |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Completed |
| IRCCS Ospedale Policlinico San Martino Coordinator of this site? Confirm its status | Genoa | Italy | Completed |
| Azienda Ospedaliero Universitaria Maggiore della Carità Coordinator of this site? Confirm its status | Novara | Italy | Completed |
| Azienda Ospedaliero Universitaria Parma Coordinator of this site? Confirm its status | Parma | Italy | Completed |
| Istituti Clinici Scientifici Maugeri In Forma Abbreviata Istituti Clinici Scientifici Maugeri O Anche Ics Maugeri O Maugeri S.p.A. Sb Coordinator of this site? Confirm its status | Pavia | Italy | Completed |
| - Coordinator of this site? Confirm its status | Ageo | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Fujisawa-shi | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Koga-shi | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Koshigaya-shi | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Kumamoto | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Nagasaki | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Okinawa-shi | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Takamatsu | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Zentsuji-shi | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Ipoh | Malaysia | Unknown status |
| - Coordinator of this site? Confirm its status | Johor Bahru | Malaysia | Unknown status |
| - Coordinator of this site? Confirm its status | Kajang | Malaysia | Unknown status |
| - Coordinator of this site? Confirm its status | Kota Bharu | Malaysia | Unknown status |
| - Coordinator of this site? Confirm its status | Kuala Terengganu | Malaysia | Unknown status |
| Kresmed Sp. z o. o. Coordinator of this site? Confirm its status | Bialystok | Poland | Completed |
| Centrum Badan Klinicznych PI-House sp. z o.o. Coordinator of this site? Confirm its status | Gdansk | Poland | Completed |
| Mcbk s.c. Iwona Czajkowska Anna Podrazka Szczepaniak Coordinator of this site? Confirm its status | Grodzisk Mazowiecki | Poland | Completed |
| Centrum Medyczne Medyk Sp. z o.o. Sp. K. Coordinator of this site? Confirm its status | Lezajsk | Poland | Completed |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi Coordinator of this site? Confirm its status | Lodz | Poland | Completed |
| Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna A Wittek H Rudzki Sp. j. Coordinator of this site? Confirm its status | Ruda Śląska | Poland | Completed |
| Uniwersytecki Szpital Kliniczny Nr 2 PUM w Szczecinie Coordinator of this site? Confirm its status | Szczecin | Poland | Completed |
| Med Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Icz Healthcare Sp. z o.o. Coordinator of this site? Confirm its status | Zywiec | Poland | Completed |
| - Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| - Coordinator of this site? Confirm its status | New Taipei City | Taiwan | Unknown status |
| - Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| - Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| - Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| - Coordinator of this site? Confirm its status | Annapolis | United States | Unknown status |
| - Coordinator of this site? Confirm its status | El Paso | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Glendale | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Hialeah | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Miami Lakes | United States | Unknown status |
| - Coordinator of this site? Confirm its status | New Bern | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Norfolk | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Ogden | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| - Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Sheffield | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Waterbury | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Haiphong | Vietnam | Unknown status |
| - Coordinator of this site? Confirm its status | Hochiminh City | Vietnam | Unknown status |
| - Coordinator of this site? Confirm its status | Ho Chi Minh City | Vietnam | Unknown status |
| - Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| - Coordinator of this site? Confirm its status | Gaziantep | Turkey (Türkiye) | Unknown status |
| - Coordinator of this site? Confirm its status | Kahramanmaraş | Turkey (Türkiye) | Unknown status |
| - Coordinator of this site? Confirm its status | Kayseri | Turkey (Türkiye) | Unknown status |
| - Coordinator of this site? Confirm its status | Kocaeli | Turkey (Türkiye) | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.