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Efficacy and safety of aldosterone synthase inhibition with and without empagliflozin for chronic kidney disease: a randomised, controlled, phase 2 trial
Sibylle J. Hauske, María Eugênia Fernandes Canziani, Maria Luiza Caramori, David Z.I. Cherney, Lisa Cronin, Hiddo J.L. Heerspink, Christian Hugo, Masaomi Nangaku, Ricardo Correa‐Rotter, Arnold Silva, Shimoli Shah, Zhichao Sun, Dorothea Urbach, Dick de Zeeuw, Peter Rossing, Cheuk‐Chun Szeto, Diego Echeverri, Edouard Martin, Ming Li Yee, William Wah, Ray Wang, Bobby Chacko, Shriram Swaminathan, Richard J. MacIsaac, Hikaru Hashimura, Glenn M. Ward, Katrien De Vusser, Kathleen Claes, Dirk Kuypers, Björn Meijers, Amaryllis H. Van Craenenbroeck, Robert Hilbrands, Corinne Debroye, Karl Martin Wissing, Michel Jadoul, Nathalie Demoulin, Serge Treille de Grandsaigne, Ishak Beklevic, Diane Marcoux, F Liénart, Claude Daper, V de Brouckère, Mercédès Heureux, João Soares Felício, Karem Miléo Felício, Daniella Leite, Franciane Trindade Cunha de Melo, Natércia Neves Marques de Queiroz, Ana Carolina Souza, Jocyelle Vieira, Roberto Jorge da Silva Franco, Adriana Aparecida Mendes, Giovana Picolli, Luís Henrique Santos Canani, Carla Sartori, Adriana Valenti, Freddy G. Eliaschewitz, Renata Luísa Bona, Denise Reis Franco, Denise Ludovico Costa de Castro, Vanessa Magalhaes, Marcelo G. de Oliveira, Célia Regina Sampaio, Guilherme Visconti, Bruno Halpern, Camila Nihei, Bruna V. Pessoa, Carlos Eduardo Seraphim, Daniel Barbedo Vasconcelos Santos, Cláudia Brito, J. B. Douverny, Marina Colella, Cristina Gazeta, Monique Vercia, Renato Watanabe, Theodora Temelkova, Dimo Kjurkchiev, Silviya Statkova, Iliya Popov, Radosveta Radeva, Lachezar Arabadzhiev, Mariya Binova, Aleksandar Bosilkov, Neli Koleva-Stoicheva, Ivaylo Ivanov, З. А. Иванова, Viktoria Kotseva, Petar Spasov, Ivaylo Tsvetkov, Shivinder Jolly, G. HOWARD BAILEY, Zhiming Ye, Jianying Niu, Hongmei Li, Qing Wu, Bing Liao, Chuan‐Ming Hao, Lingyun Lai, Yunyu Xu, Min Zhang, Yiwen Li, Bo Liu, Lina Shao, Wei Chen, Haishan Wu, Marian Pirchala, Iva Skarpova, Marketa Hraskova, Simoneta Soukupova, Lucie Veberova, Tomas Drasnar, Matej Falc, Blazej Racz, Stepan Votocek, Danica Weissova, Lenka Syc-Krivanova, Dagmar Slezak, Ilkka Kantola, Sakari Nieminen, Milla Anttonen, Jyrki Taurio, Jorma Lahtela, Vasileios Tsimihodimos, Olga Balafa, Evangelia Dounousi, S.-F. Sakkou, Nikolaοs Tentolouris, Christos Siafarikas, Evangelia Siami, Ioannis Doupis, Theodoros Angelopoulos, Christodoulos Georgoulias, Dénes Páll, Regina Esze, Tamás Köbling, Zita Váradi, Noémi Zsíros, Viktor Vass, Tímea Baló, Erika Csanyi, Ivan Ory, István Páll, Valentina Patai, Zsuzsanna Zeak, István Takács, Ákos Pethő, Balázs Szili, László Korányi, Katalin Bezzegh, József Pauer, Eva Péterfai, L. Könyves, Brigitta Szoke, Csaba Hajdú, K Kálmán, Raj Kumar Yadav, Navneet Saxena, Meenakshi Bhattacharya, Bal Krishan Sharma, Nihal Thomas, Felix Jebasingh K, Nitin Kapoor, Mathews Edatharayil Kurian, Jinson Paul, Priyadharshini Ramesh, Sheeba Varghese, Nobuyuki Shibusawa, Hiroshi Nishi, Nobuyasu Noritake, Oda T, Hideki Okamoto, Hirotake Kasuga, Hiroshi Hori, Yukiko Ito, Toshihiro Mizukoshi, Hideto Ishii, Seung Hyeok Han, Hyung Woo Kim, Kook‐Hwan Oh, Seung Seok Han, Sang Youb Han, Dae Ryong, Soon Kil Kwon, Hyunjeong Cho, Hye‐Young Kim, Sun Moon Kim, Jung Pyo Lee, Jeonghwan Lee, Li Yuan Lee, Meng Lee Chang, S T Laang, Zhao Zhi Tan, H Ahmad Rosdi, Siti Hafizah Mohammad Ismail, Devamalar Simatherai, Ju Fan Tay, Fook Sem Wong Eddie, S. Yakob, Noorhafini Abdul Sukur, Amalina Anuar, Syaliza Md. Rasid, Irma Liyana Mushaddik, Ruslinda Mustafar, Muhammad Yusuf Abu Shamsi, Voon Ken Fong, Lydia Kamaruzaman, Rozita Mohd, Wan Rohaslizan Wan Daud, Wan Hasnul Halimi Wan Hassan, Suhaidarwani Ab Hamid, Muhammad Abdullah, Mohd Yusran Yusoff, Gandhibabu Ramanathan, K Lee, Wan Fadhilah Wan Ismail, Enrique Villegas, Rubria Ramirez Baez, Jorge Vital Lopez, Cristhian Arias Delgadillo, Marisol Herrera Marmolejo, R. Perez, Melchor Alpízar Salazar, Ana Flores Montealegre, Jose Galvan Magaña, Minerva Gutierrez Tlapale, D Munguia, Bartlomiej J. Witczak, Lasse G. Gøransson, Inga Strand Thorsen, Clodoaido Caringal, Mario Villardo, Ronaldo Nunes Toledo, Emerlinda Fausto Dijamco, Norman Cornelio De Asis, Angelica Kuizon, Elizabeth Catindig, Ronald Perez, Grace Aquitania, Jimrie David Pableo, Jay Karlou Sanchez, Ewa Czernecka, Aleksandra Cegiel, Dorota Knychas, Malgorzata Ochnio, Monika Kuligowska-Jakubowska, Marek Cesarz, Milena Kowalewska-Celejewska, Anna Masajtis‐Zagajewska, Łukasz Jankowski, Marcin Ojrzanowski, Magdalena Olszewska-Jander, Ewa Skokowska, Malgorzata Giermakowska-Samek, Elżbieta Luchowska, Renata Patkowska, Marzenna Sekulska, Dorota Marczuk-Krynicka, Andrzej Marciniak, Michal Barwijuk, Marcin Myślicki, Michał Siek, Danuta Wrońska, Jadwiga Tomsia-Goncerz, Krzysztof Wronski, Roman Junik, Szymon Dzialak, Ewelina Kurlapska, Wieslaw Malecha, Szymon Suwała, Patrícia Branco, Rita Birne, João Raposo, Marta Ferreira, Henrique Alexandrino, Helena Alves, Sara Fernandes Correia, Maria João Oliveira, Patrícia Tavares, Kathleen Coetzee, Sue Blignaut, Winifred Viljoen, Elsje Louise Potgieter, E. Malherbe, Elena Gomá-Garcés, M. Perez, Rafael Santamaría, Isabel López, Victoria Pendón de Mier, Cristian Rodelo‐Haad, María Marqués, Esther Domènech, J.M.a Muniesa Portolés, María José Soler, Irene Agraz, María Azancot, Sheila Bermejo, Mónica Bolufer, Marina López, Natàlia Ramos, David Toapanta, Secundino Cigarrán, Juan Carlos Primo, Luis Enrique Pérez, María Rebollido Fernández, Helene Holmer, Annette Bruchfeld, Justus Rofors, Bengt-Olov Tengmark, Grégoire Wuerzner, Garazi Leanizbarrutia, Savaş Öztürk, Nurana Guler, Seda Şafak, Keung Lee, Stephen Campbell, Imran Siddiqui, Nadia Abbasi, Faiza Tahir, Masoud Azizad, Timothy Jackson, Brian Everhart, M. H. Oliver, William L. Rust, Matthew Sniezek, Ahmed Arif, Mohammed Syed, Nitin Bhasin, Michael Bien, Claudio Gallego, Aamir Jamal, M. O. Moghadam, Abid Rizvi, Amna Rizvi, Syed A. A. Rizvi, Christopher Wong, Kathryn Jean Lucas, Andrea Buery, Ku-Lang Chang, Claire Presswood, Justin S. Smith, Ankur Doshi, Manish Parikh, Jeannine Wallace, Arvind Krishna, Heidi Daugherty, Aaron Fearday, Christopher Keller, Jerry Meng, Alexandra Nielsen, Sergio Rovner, Benito Marranzini, L. A. Selby, Zachary Yablon, Daphne Jean-Louis, Wayne Kotzker, Chabely Perez, Marc Richards, Reinaldo Rosario, Roy Marcus, Chike Nathan Okechukwu, Dennis L. Ross, Rachel Gromala, Matthew Reed, Lisa A. Weber, I Nazeer, Muhammad Ayaz Mir, Heidi Shea, Amanda Hart, J Wiebel, Laura Kooienga, Britt B. Newsome, Irina Suyumova, Germán Álvarez, Venkata Bireddy, M. Cecilia Lansang, Jose Mandry, Maria Betânia Galvão dos Santos Freire, Oscarina Herrera Albornoz, Anant Desai, D N Gandhi, Sibu Rajan, Louis Raymond, Jorge Posada, Luis Garcia-Mayol, Rodolfo Gutierrez-Alsina, Juan José Diaztagle Fernández, Kendaling Bruce, Juan C. Garnica Cuellar, Maria Ranz y Alvarez, Ines Bartolacci, Mauro Pautasso, Daniela Stoppa, Miguel C. Riella, Eleonóra Harcsa, Yuvraj Gulati, Denish Savalia, Prakash Khetan, Dhananjay Sinha, R. Niranjan, Babushri Srinivas Kedukodi, Fabiola Pazos, Aretha Gacutan-Liwag, Malgorzata Duszynska, Karolina Antkowiak-Piatyszek, Grzegorz Konieczny, Anna Sidorowicz-Białynicka, Agnieszka Ciesiolkiewicz-Wojcik, Marek Dwojak, Katarzyna Szymkowiak, Daria Gorczyca-Siudak, Marzena Janik-Palazzolo, Łukasz Siudak, Jaroslaw Opiela, Dariusz Iwanow, Monika Solkiewicz, Malgorzata Sipinska-Surzynska, Magdalena Olszanecka Glinianowicz, Izabela Rozmiłowska, Julian Trokis, Hans Prozesky, Lesley Burgess, Henry P Cyster, J. P. Jordaan, Hawa Mohamed, Christina Naude, Thembie Sitsila, Arvind Mehta, Bharat Mocherla, Sungchun Lee, Kenneth Boren, Lance Rudolph, Sabrina Benjamin, Danny Sugimoto, Jamal Hammoud, M. Bakleh, Yaseen Hashish, Jonathan Da Costa, M. Gold, Claudio Majul, J. Buscema, Maria Rosaria Gatto, Facundo Lombardi, Olga Páez, Pablo Puleio, A Alvarisqueta, Vanessa Pajon, Gabriel A. Suárez, Adrian Hernandez Gauna, Alejandro Pereyra, Elizabeth Gelersztein, Gina Campestri, Maria Gonzalez Santos, Julieta Sambresqui, Gustavo Catalano, Cecilia Igarzabal, Augusto Vallejos, Claudio Escobari, Rocio Marchetto, Mariano Chahin, Andrea L. Aguilera, Ana Comes, Silvia Rodriguez Segade, Claudia Baccaro, M Lacoste, Rubén Saurral, A. dos Santos Cristino, Dario Dran, Martín Koretzky, Juan Pablo Ponti, Alejandro Porto, Yasmin Tenaglia, Natacha Maldonado, Natalia Bertollo, Verónica Van Perdeck, Kai Lopau, Christoph Wanner, Florieke Berfelo, Christel Contzen, Abdulwahab Arbi, Young Hee Lee-Barkey, Aleksandra Maciejewska, Katrin Arélin, Hermann Haller, Jessica Kaufeld, Kai M. Schmidt‐Ott, Sven Heinrichs, Thilo Krüger, Chris Gebauer, Alexander Paliege, Elena Henkel, Christoph Axthelm, Karl-Michael Derwahl, Roberto Trevisan, Rosalia Bellante, Nicolò Borrella, A. Corsi, Loreto Gesualdo, Teodora Ardillo, Maria Ficarella, Sameh Fikry, Giuseppe Mazza, Lysane Poirier, Harpreet S. Bajaj, Erifili Hatziagelaki, Sokratis Katopodis, Spiros Katsoudas, Shuichi Yamaura, Tsutomu Shikano, Takahiro Tosaki, Otoya Miho, Naoki Tachibana, Wataru Yumita, Hiroshi Kado, Jesus Villarreal Martinez, Ernesto Soto Miranda, David Gonzalez Rodriguez, Araceli Panelo, Telma Santos, Ana Martins, Catarina Mateus, Fernando Teixeira e Costa, Sara Barreto, Joana Silva Costa, Francisco Ferrer, Joana Silva, Ahmed K. Awad, Shatha Khaleel, Ryan Lustig, Gajendra Maharjan, Jaynier Moya, Amit Johnsingh, Idalia Acosta, George Newman, A. L. J. Buckle, Kendra S. Hendon
Bibliographic record
VenueThe Lancet · 2023
Typearticle
Languageen
FieldMedicine
TopicHormonal Regulation and Hypertension
Canadian institutionsToronto General Hospital
FundersSteno Diabetes Center CopenhagenBoehringer Ingelheim
KeywordsEmpagliflozinMedicineAldosteroneKidney diseaseAldosterone synthaseRandomized controlled trialInternal medicinePharmacologyEndocrinologyDiabetes mellitusBlood pressure
Abstract
No abstract in any covered source. Its absence is recorded, not treated as a negative.
No abstract. This is not a gap in this database; OpenAlex has none either. 23.3% of the frame is in this state, and the screen finds HALF as much metaresearch here, so the absence is a measured bias rather than a missing field.
How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
metaresearch head score (Codex)0.003
metaresearch head score (Gemma)0.004
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Randomized trial · Consensus signal: Randomized trial
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.009
Threshold uncertainty score0.029
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.004 |
| Meta-epidemiology (narrow) | 0.003 | 0.001 |
| Meta-epidemiology (broad) | 0.006 | 0.004 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.004 | 0.006 |
| Insufficient payload (model declined to judge) | 0.009 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
Opus teacher head0.035
GPT teacher head0.319
Teacher spread0.284 · how far apart the two teachers sit on this one work
Validation status
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
The models applied no category: nothing in the taxonomy fit this work.
Study designRandomized trial
Domainnot available
GenreEmpirical
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".
Quick stats
Citations187
Published2023
Admission routes1
Has abstractno