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Record W3200915536 · doi:10.1016/j.kint.2021.09.005

A pre-specified analysis of the Dapagliflozin and Prevention of Adverse Outcomes in Chronic Kidney Disease (DAPA-CKD) randomized controlled trial on the incidence of abrupt declines in kidney function

2021· article· en· W3200915536 on OpenAlexaff
Hiddo J.L. Heerspink, David Z.I. Cherney, Douwe Postmus, Bergur V. Stefánsson, Glenn M. Chertow, Jamie P. Dwyer, Tom Greene, Mikhail Kosiborod, Anna Maria Langkilde, John J.V. McMurray, Ricardo Correa‐Rotter, Peter Rossing, C. David Sjöström, Robert D. Toto, David C. Wheeler, Fan Fan Hou, Laura Maffei, Pablo Raffaele, S. Solís, César A. Arias, Dov Aizenberg, Carolina Lúquez, Cesar Javier Zaidman, Natalia Cluigt, M. Mayer, Andres Alvarisqueta, A. Wassermann, Rafaël Maldonado, J. Bittar, M. Maurich, L.E. Gaite, Néstor H. García, Louise E. Sivak, Pablo Ramallo, Juan Carlos Santos, Ruben Garcia Duran, Juan Oddino, A Marañón, Lília Nigro Maia, Dánae Duana Ávila, Elvino Barros, Maria H Vidotti, Daniel Panarotto, Irene de Lourdes Noronha, Luiz Alberto Andreotti Turatti, Luciane Mônica Deboni, María Eugênia Fernandes Canziani, Miguel C. Riella, Marcelo Rodrigues Bacci, Raphael Paschoalin, R. J. Franco, João Carlos Goldani, Eric St-Amour, Andrew Steele, R. Goldenberg, Sanjay Pandeya, Harpreet S. Bajaj, Stéphanie Kaiser, James Conway, Sharron Chow, G. HOWARD BAILEY, Jean‐Philippe Lafrance, Jonathan Winterstein, S. Cournoyer, D. Gaudet, F. Madore, Robyn L. Houlden, Aaron Dowell, Michel R. Langlois, Nicola Muirhead, Hasnain Khandwala, Adeera Levin, Ying Xue, Lingyan Zuo, Chuan‐Ming Hao, Zhaohui Ni, N. Chen, Yugang Dong, Rong Zhou, Xiao Xu, Yiping Zou, Chu Wang, Liu B, Qian Chen, Miao Lin, Qing Luo, D. Zhang, Jann‐Yuan Wang, M. Chen, Xinyue Wang, Anyuan Zhong, Junguo Dong, Chan Zhu, Tiekun Yan, Ping Luo, Pearl Pai, David K.B. Li, Rui Zhang, Jun Zhang, Mangmang Xu, Yong Zhuang, Yaozhong Kong, Xin Yao, Xiaomei Peng, Frederik Persson, Troels Krarup Hansen, Rikke Borg, Ulrik Pedersen‐Bjergaard, Daniel J. Hansen, M. Hornum, Hermann Haller, Gerhard Klausmann, Diethelm Tschöpe, Thilo Krüger, Peter L. Gross, Christian Hugo, Nicholas Obermüller, Ludger Rose, Patrick Mertens, Helga Zeller-Stefan, Andreas Fritsche, Lutz Renders, J Müller, Klemens Budde, Bernd Schröppel, István Wittmann, Péter Vörös, Ádám G. Tabák, Róbert Kirschner, Annamária Letoha, I. Balku, Zs. Hermányi, Gábor Zakar, I. Mezei, Gergely Nagy, J Lippai, Andrea H. Németh, Dinesh Khullar, Prakash Kikkeri Gowdaiah, Edwin Fernando Mervin, V. Rao, D. Dewan, K.R. Goplani, Vatsalya Maddi, Milind Vyawahare, Rakesh Pulichikkat, Rajendra Pandey, Sharad Kumar Sonkar, Vineet Gupta, Samagra Agarwal, Ananthi J. Asirvatham, Anita Ignatius, Sanjay Chaubey, Sreelatha Melemadathil, H. Alva, Y. Kadam, Hiroaki Shimizu, Atsushi Sueyoshi, Hiroaki Takeoka, Abe Y, Takumi Imai, Yukiko Onishi, Yasuko Fujita, Yukichi Tokita, Mitsuaki Oura, Y Makita, A. Idogaki, Ryo Koyama, H Kikuchi, Naoki Kashihara, Toshimasa Hayashi, Yukio Ando, Tsuyoshi Tanaka, Motohiro Shimizu, Sumi Hidaka, Tomohito Gohda, Kouichi Tamura, Masami Abe, Yoshito Kamijo, Toshiyuki Imasawa, Yasunori Takahashi, Mikihiro Nakayama, Masayoshi Tomita, F. Hirano, Yasushi Fukushima, Arihiro Kiyosue, Soichi Kurioka, E. Imai, Kazuo Kitagawa, Masako Waki, Jun Wada, K. Uehara, Hirotsugu Iwatani, Keiko Ota, Satomi Shibazaki, Kan Katayama, Ichiei Narita, Masahiro Iinuma, Satoko Matsueda, Shoji Sasaki, Akio Yokochi, Tatsuo Tsukamoto, Teizo Yoshimura, Shin‐Wook Kang, Sangmi Lee, Chun Sen Lim, Hee Seung Chin, Kwon Wook Joo, Seungyeup Han, Tara I. Chang, Sangshin Park, Hae‐Sim Park, C.W. Park, Byoung Geun Han, Dongchul Cha, Sung-Sik Yoon, Woo Joo Kim, Sang Wun Kim, Dong‐Ryeol Ryu, Sergio Saul Irizar Santana, G. Hernandez Llamas, N. Nicolas, Guillermo González-Gálvez, José Roberto Lazcano Soto, T. Bochicchio Riccardelli, E Llamas, Denisse Ramos Ibarra, Maira Gabrielle Silva Melo, José Gerardo González‐González, Jose Hector Sanchez Mijangos, Margarida Robalo, Armando García Castillo, Hélard Manrique, J. Farfan, Ramón Vargas, A. Valdivia, A. Dextre, Encarnación Moral Escudero, Jorge R Calderon Ticona, Louis Gonzales, Jaime Guerrero Villena, G. Molina, Alene Saavedra, Emanuel Pimenta Garrido, Hugo Arbañil, Sofia Marquez, J. Rodriguez, Rey Isidto, Agnes Jeans Villaflor, M.A. Gumba, Louie Tirador, Rhea Severina Comia, Rosa Allyn Sy, Mitchell Guanzon, Grace Aquitania, Norman Cornelio De Asis, Andréa Alice Silva, Carlos Romero, Maggie Lim, Romina A. Danguilan, Michał Nowicki, H Rudzki, Karenia Landa, Izabela Kucharczyk-Bauman, B. Gogola-Migdal, M. Golski, Anna Olech-Cudzik, Tomasz Stompór, T. Szczepanik, Beata Mikłaszewicz, R Ściborski, Marek Kuźniewski, Kazimierz Ciechanowski, Danuta Wrońska, Wiesław Klatko, Stanisław Mazur, Grazyna Popenda, Marcin Myślicki, L.Z. Bolieva, С. А. Бернс, А. S. Galyavich, Т. О. Абиссова, I. V. Karpova, D. Yu. Platonov, Н. А. Козиолова, Liudmila Kvitkova, Rostislav Nilk, T. Medina, А. П. Ребров, M. Rossovskaya, Irina Sinitsina, Еlena A. Vishneva, Н. Ш. Загидуллин, Т. И. Новикова, N Krasnopeeva, O. V. Magnitskaya, Natalia Antropenko, М. М. Батюшин, Verónica Escudero Quesada, Christophe Barrea, E. Espinel Garauz, Josep María Cruzado Garrit, J.L. Teruel, Secundino Cigarrán, Manuel Praga Terente, Nicolas-Roberto Robles Perez-Monteoliva, Alfonso González, Claudia Rodríguez, Hans Furuland, Abdallah Saeed, Karl Dreja, Jonas Spaak, Annette Bruchfeld, М. Kolesnyk, O. Levchenko, N. Pyvovarova, V.P. Stus, V. Doretskyy, N. Korobova, Olha Horoshko, І. П. Катеренчук, Yuriy Mostovoy, Mariya A. Orynchak, Oleg Legun, І. Dudar, Oleksandr Bilchenko, S. M. Аndreychyn, Andre Levchenko, Л.О. Зуб, N. M. Tereshchenko, И. И. Топчий, T. Ostapenko, S Bezuglova, M. Kopytsya, O. Turenko, Patrick B. Mark, J. Barratt, Sudhir Bhandari, Douglas D. Fraser, P A Kalra, Sui Phin Kon, Kieran McCafferty, Ashraf Mikhail, Odilon Alvarado, Ronald Anderson, Nabil Andrawis, Ahmed A. Arif, S.A. Benjamin, Gonzalo Carles Bueso, Robert S. Busch, Kate Carr, Paul Crawford, Nizar Daboul, Germán Calle, Bruno Delgado, Judith Earl, M. El-Shahawy, Ronald J. Graf, Gregory B. Greenwood, A Guevara, Eliana Wendland, Ronald K. Mayfield, M. Montero, D.J. Morin, Perinchery Narayan, Visal Numrungroad, Anand Reddy, K. Rajender Reddy, Mercedes B. Samson, Rogelio Trejo, Michelle Butcher, Jonathan Wise, L.R. Zemel, Marina Raikhel, D. Weinstein, P. Hernández, Alan Wynne, Bobby V. Khan, Gary Sterba, A. Jamal, David M. Ross, Sergio Rovner, Anjanette Tan, Fernando Ovalle, Rajesh Patel, Julie‐An Talano, D.R. Patel, Anna Burgner, Nabeel Aslam, Michael A. Elliott, Simin Göral, Anna Jovanovich, John Manley, Kausik Umanath, Dia Rose Waguespack, Daniel Weiner, Mingkai Yu, Lynda C. Schneider, Diana Jalal, Trang T. Le, Nhut Minh Nguyen, Hai V. Nguyen, Deanna D. Nguyen, Vincent Nguyen, T Do, Pao‐Hsien Chu, D. Ta, Nguyet Minh Thi Tran, Ba’ Pham, Marc A. Pfeffer, Stuart Pocock, Karl Swedberg, Jean L. Rouleau, Nish Chaturvedi, Peter Ivanovich, Andrew S. Levey, Heidi Christ‐Schmidt, Claes Held, Christina Christersson, Johannes F.E. Mann, Christoph Varenhorst

Bibliographic record

VenueKidney International · 2021
Typearticle
Languageen
FieldMedicine
TopicDiabetes Treatment and Management
Canadian institutionsUniversity of TorontoUniversity Health Network
FundersJanssen PharmaceuticalsNovo Nordisk FondenRelypsaCytokineticsAstellas PharmaSatellite HealthcareUniversity of GlasgowBristol-Myers SquibbAkebia TherapeuticsSteno Diabetes Center CopenhagenNovo NordiskReCor MedicalEli Lilly and CompanyAstraZenecaCSL BehringAlnylam PharmaceuticalsGilead SciencesNational Institute of Diabetes and Digestive and Kidney DiseasesSanofiGlaxoSmithKlineDefense Acquisition Program AdministrationAmgenAngionPfizer
KeywordsKidney diseaseDapagliflozinMedicineRenal functionIncidence (geometry)Adverse effectRandomized controlled trialInternal medicineIntensive care medicineAcute kidney injuryEndocrinologyDiabetes mellitusType 2 diabetes

Abstract

fetched live from OpenAlex

This pre-specified analysis of DAPA-CKD assessed the impact of sodium-glucose cotransporter 2 inhibition on abrupt declines in kidney function in high-risk patients based on having chronic kidney disease (CKD) and substantial albuminuria. DAPA-CKD was a randomized, double-blind, placebo-controlled trial that had a median follow-up of 2.4 years. Adults with CKD (urinary albumin-tocreatinine ratio 200-5000 mg/g and estimated glomerular filtration rate 25-75 mL/min/1.73m 2 ) were randomized to dapagliflozin 10 mg/day matched to placebo (2152 individuals each). An abrupt decline in kidney function was defined as a pre-specified endpoint of doubling of serum creatinine between two subsequent study visits. We also assessed a post-hoc analysis of investigator-reported acute kidney injury-related serious adverse events. Doubling of serum creatinine between two subsequent visits (median time-interval 100 days) occurred in 63 (2.9%) and 91 (4.2%) participants in the dapagliflozin and placebo groups, respectively (hazard ratio 0.68 [95% confidence interval 0.49, 0.94]). Accounting for the competing risk of mortality did not alter our findings. There was no heterogeneity in the effect of dapagliflozin on abrupt declines in kidney function based on baseline subgroups. Acute kidney injury-related serious adverse events were not significantly different and occurred in 52 (2.5%) and 69 (3.2%) participants in the dapagliflozin and placebo groups, respectively (0.77 [0.54, 1.10]). Thus, in patients with CKD and substantial albuminuria, dapagliflozin reduced the risk of abrupt declines in kidney function.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.001
metaresearch head score (Gemma)0.007
Version: codex-gemma-dda1882f352aValidation 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 score0.123
Threshold uncertainty score0.785

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0010.007
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0010.001
Bibliometrics0.0000.000
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.000
Insufficient payload (model declined to judge)0.0000.000

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 head0.015
GPT teacher head0.291
Teacher spread0.276 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one teacher head, 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

Citations94
Published2021
Admission routes1
Has abstractyes

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