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Vadadustat in Patients with Anemia and Non-Dialysis-Dependent CKD.
Vadadustat in Patients with Anemia and Non-Dialysis-Dependent CKD. The New England journal of medicine Chertow, G. M., Pergola, P. E., Farag, Y. M., Agarwal, R., Arnold, S., Bako, G., Block, G. A., Burke, S., Castillo, F. P., Jardine, A. G., Khawaja, Z., Koury, M. J., Lewis, E. F., Lin, T., Luo, W., Maroni, B. J., Matsushita, K., McCullough, P. A., Parfrey, P. S., Roy-Chaudhury, P., Sarnak, M. J., Sharma, A., Spinowitz, B., Tseng, C., Tumlin, J., Vargo, D. L., Walters, K. A., Winkelmayer, W. C., Wittes, J., Eckardt, K., PRO2TECT Study Group, Porto, A., Glenny, J., Alvarisqueta, A., Vallejos, A., Cusumano, C., Chacon, C., Garcia, C., Goycoa, C., Stoppa, D., Otreras, F., Gorosito, G., Beresan, H., MacKinnon, I., Resk, J., Santos, J., Bittar, J., Schiavi, L., Rista, L., Maurich, M., Mansilla, M., Pelagagge, M., Garcia, N., Penalba, N., Ramallo, P., Calella, P., Leon de la Fuente, R., Visco, V., Irish, A., McMahon, L., Mathew, M., Suranyi, M., Boudville, N., Phoon, R., Ford, S., McDonald, S., Ludvik, B., Wiesholzer, M., Costa E Forti, A., Sousa, A., Goncalves, B., Teles Barretto, C., Fraga, C., Rinaldi Dos Santos, D., Miltersteiner, D., D'Avila, D., Contieri, F., Veronese, F., Neto, G., Sander, G., de Lourdes Noronha, I., Rodrigues Bacci, M., Gomes Bastos, M., Mara da Silva, M., Canziani, M., Paschoalin, N., Simoes Pires von Eye, O., Macedo de Souza, P., Silva, P., Armani, R., Barbieri, D., Paschoalin, R., Montenegro, R. J., Franco, R., Pecoits Filho, R., Yamada, S., Duro Garcia, V., Vasileva, A., Angelova, A., Kostadinova, A., Kundurdziev, A., Bogov, B., Kostadinova, D., Popov, I., Ashikova, K., Nikolova-Dimitrova, M., Petrova-Obretenova, P., Rangelov, R., Boyadzhieva, S., Vasilev, S., Bakardzhiev, T., Staykova, T., Atanasova, V., Hristov, V., Iliev, V., Simeonov, V., Todorova, V., Hristozov, V., Ting, R., Boltansky Brenner, A., Schneider Contreras, H., Garcia Lozada, H., Rueda Hernandez, J., Terront Lozano, M., Parikova, A., Dusilova Sulkova, S., Tesar, V., Mariat, C., Thervet, E., Fessi, H., Kazes, I., Lang, P., Rosenberger, C., Draganova, D., Toussaint, K., Krueger, T., Ladanyi, A., Palinkas, A., Csiky, B., Literati-Nagy, B., Pall, D., Magyar, K., Major, L., Zsom, M., Molnar, M., Keresztesi, S., Zolyomi, S., Szabo, T., Szelestei, T., Nemeth, Z., Szigeti, Z., Beberashvili, I., Hassan, K., Assady, S., Yagil, Y., Naticchia, A., Gambaro, G., Esposito, C., Aucella, F., Garibotto, G., Nicola, L. D., Vecchio, L. D., Zacchia, M., Ondei, P., David, S., Yang, C., Koh, E., Song, H., Chin, H., Joo, K., Han, S., Jo, S., Han, S., Yoo, S., An, W., Kim, Y., Kim, T., Kim, Y., Ching, C., Ong, L., Mohd, R., Lim, S., Leguizamo Dimas, A., Calvo Vargas, C., Tellez Chavez, E., Pelayo Orozco, E., Flores Lozano, F., Murguia Martin, F., Quintana Pina, F., Sanchez Mijangos, J., Tamayo Y Orozco, J., Herrara Jimenez, L., Nevarez Ruiz, L., Islas Guerrero, M., Vazquez Contreras, P., Austria Garcia, P., Banda Elizondo, R., Orozco Castellanos, R., Monreal Puente, R., Avila Pardo, S., Irizar Santana, S., Irigoyen Monroy, V., Limas Juarez, A., Pescador Martinez, Y., Achim, C., Bogeanu, C., David, C., Peride, I., Bako, G., Petrica, L., Vishnevsky, A., Smirnov, A., Pichkov, D., Reznik, E., Vaskina, E., Tsyba, L., Rossovskaya, M., Fomina, N., Barysheva, O., Kostitsina, O., Lesnyak, O., Sigitova, O., Ageeva, T., Marasaev, V., Tirmenstajn-Jankovic, B., Maksic, D., Maric, I., Velickovic-Radovanovic, R., Damjanovic, T., Dimkovic, N., Lazarevic, T., Lezaic, V., Krajnakova, A., Bobak, L., Vojtko, M., Muranda, A., Rayner, B., Malan, D., Engelbrecht, J., van Zyl, L., Van Jaarsveld, M., Mollentze, W., Sarvan, M., Nortje, M., Makanda, M. B., Ayoob, N., Chelin, N., Welkovics, N., Naiker, P., Moodley, R., Arnold, S., Govind, U., Naidoo, V., Galan Serrano, A., Garcia Carro, C., Hernandez Marrero, D., Gonzalez Martinez, F., Sanjuan, J., Ballarin Castan, J., Molas Coten, J., Torras Ambros, J., Hernandez-Jaras, J., Santos, J. P., Baro Salvador, M., Munar Vila, M., Slon Roblero, M., Yildiz, A., Kalender, B., Duranay, M., Tuglular, S., Ursol, G., Dudar, I., Rudyk, I., Vyshnyvetskyy, I., Kolesnyk, M., Tryshchuk, N., Pyvovarova, N., Sydor, N., Legun, O., Levchenko, O., Lyulko, O., Godlevska, O., Matushchak, O., Abrahamovych, O., Yatsyshyn, R., Kolupayev, S., Kostynenko, T., Vizir, V., Maslovskyi, V., Stus, V., Mostovoy, Y., Mikhail, A., Vilar, E., Yaqoob, M., Wilkie, M., El Kossi, M., Kalra, P., Shah, S., Nossuli, A. K., Jamal, A., Buridi, A., Murillo, A., Khan, A., Ijaz, A., Aswad, A., Awad, A., Sawhney, A., Esquenazi, A., Velar, A., Sprague, A., O'Shaughnessy, A., Agarwal, A., Parikh, S., Terrelonge, A., Dhandayuthapani, A., Chauhan, R., Silva, A., Mehta, A., Chaudhry, A., Bailey, A., Buerkert, J., Jones, A., Turk, T., Torres Consuegra, A., Sachdeva, B., Mehta, B., Thajudeen, B., Roy-Chaudhury, P., Spinowitz, B., Voinescu, C. G., Leon-Forero, C., Martinez, C., Ortiz-Butcher, C., Hernandez, C., Montoya, M., Arora, C., Sun, C., Argyropoulos, C., Galphin, C., Gadegbeku, C., Kovesdy, C., Christiano, C., Checketts, D., Arfaania, D., Goldfarb, D., Scott, D., Tietjen, D., Whittman, D., Price, D., Rizos, D., Dev, D., Belo, D., Brandon, D., Lanier, D., Hopkins, E., Linfert, D., Shemin, D., Gonzalez, E., Cosby, J., Rodriguez-Araya, E., Brown, E., Galindo-Ramos, E., Al-Saghir, F., Bangash, F., Castillo, F., Cid, J., Trespalacios, F., Finkelstein, F., Varghese, F., Vaz, G., Ramamurthy, G., Garcia Saez, G., Fadda, G., Hon, G., Nassar, G., Bueso, G., Diaz, G., Varallo, G., Pitone, J., Alvarez, G., Hernandez, G., Hadi, G., De La Calle, G., Krishna, G., Allen, G. J., Greenwood, G., Stewart, D., Toka, H., Boghara, H., Kumar, H., Niegos, F., Brar, H., Hubert, H., Szerlip, H., Farooq, H., Gonzalez, H., Martinez, L., Cosma, I., Drakakis, J., Shirazian, S., Reich, J., Tumlin, J., Colomar, J., Kumar, J., Moya, J., Rimmer, J., Navarro, J., Li, J., Meyer, J., Topf, J., Pullman, J., Alvarez-Moreno, J., Loredo, J., Posada, J., Fernandez, J., Gandhi, K., Servilla, K., Mootoo, K., Hendon, K., Choi, K., Bashir, K., Shah, K., Lalwani, T., Chaudhary, K., Thomas, K. V., Kooienga, L., Block, G., Forgosh, L., Spry, L., Adan, L., Glaser, L., Schneider, L., Seney, F., Lewy Alterbaum, L., Diaz-Secades, L., Perez, G., Garcia-Mayol, L., Bodell, M., Martinson, M., Sahani, M., Montero, M., Sanchez, M., Chang, M., Guillen, M., Henriquez, M., Lawrence, M., Vernace, M., Chan, M., Anger, M., Levey, S., Chang, I., Fredericks, M., Germain, M., Hassman, M., Levine, M., Patel, M., Issa, M., Dhillon, M., Moustafa, M., Siddiqui, N., Vo, N., Shahid, N., Atray, N., Khosla, N., Chronos, N., Stankus, N., Daboul, N., Frontela, O., Mendez, J., Ayodeji, O., Adler, O., Pergola, P., Kalirao, P., Peters, P., Santos, P., Van Buren, P., Lazowski, P., Ranjan, P., Krish, P., Suchinda, P., Gonzalez, R., Grillo, R., Abdullah, R., Zabaneh, R., Alappan, R., Yalavarthy, R., Patak, R., Berenji, R., Guadiz, R., Mendez, R., Sastre, R., Gaona, R., John, R., Sothinathan, R., Darwish, R., O'Donovan, R., Sandler, R., Szewc, R., Manllo-Karim, R., Gupta, R., Afsari, R., Raina, R., Benjamin, S., Kronfli, S., Sonbol, S., Butt, S., Sader, S., Kantor, S., Anand, S., Sharma, S., Dua, S., Kharait, S., Mandayam, S., Sitar, S., Zeig, S., Handelsman, S., Clarke, S., Joshi, S., Lalla-Reddy, S., Lee, S., Mustafa, E., Boone, T., Hart, T., Pillai, U., Subramanian, V., Prasad, V., Din, Z. 2021; 384 (17): 1589–1600Abstract
BACKGROUND: Vadadustat is an oral hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitor, a class of drugs that stabilize HIF and stimulate erythropoietin and red-cell production.METHODS: In two phase 3, randomized, open-label, active-controlled, noninferiority trials, we compared vadadustat with the erythropoiesis-stimulating agent (ESA) darbepoetin alfa in patients with non-dialysis-dependent chronic kidney disease (NDD-CKD) not previously treated with an ESA who had a hemoglobin concentration of less than 10 g per deciliter and in patients with ESA-treated NDD-CKD and a hemoglobin concentration of 8 to 11 g per deciliter (in the United States) or 9 to 12 g per deciliter (in other countries). The primary safety end point, assessed in a time-to-event analysis, was the first major adverse cardiovascular event (MACE; a composite of death from any cause, nonfatal myocardial infarction, or nonfatal stroke), pooled across the two trials. Secondary safety end points included expanded MACE (MACE plus hospitalization for either heart failure or a thromboembolic event). The primary and key secondary efficacy end points in each trial were the mean change in hemoglobin concentration from baseline during two evaluation periods: weeks 24 through 36 and weeks 40 through 52.RESULTS: A total of 1751 patients with ESA-untreated NDD-CKD and 1725 with ESA-treated NDD-CKD underwent randomization in the two trials. In the pooled analysis, in which 1739 patients received vadadustat and 1732 received darbepoetin alfa, the hazard ratio for MACE was 1.17 (95% confidence interval [CI], 1.01 to 1.36), which did not meet the prespecified noninferiority margin of 1.25. The mean between-group differences in the change in the hemoglobin concentration at weeks 24 through 36 were 0.05 g per deciliter (95% CI, -0.04 to 0.15) in the trial involving ESA-untreated patients and -0.01 g per deciliter (95% CI, -0.09 to 0.07) in the trial involving ESA-treated patients, which met the prespecified noninferiority margin of -0.75 g per deciliter.CONCLUSIONS: Vadadustat, as compared with darbepoetin alfa, met the prespecified noninferiority criterion for hematologic efficacy but not the prespecified noninferiority criterion for cardiovascular safety in patients with NDD-CKD. (Funded by Akebia Therapeutics and Otsuka Pharmaceutical; PRO2TECT ClinicalTrials.gov numbers, NCT02648347 and NCT02680574.).
View details for DOI 10.1056/NEJMoa2035938
View details for PubMedID 33913637