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3. Randomized Controlled Trial of Difelikefalin for Chronic Pruritus in Hemodialysis Patients

Author

Aaronson, Michael, Alford, Kelly, Awad, Ahmed, Bhat, Premila, Broumand, Varshab, Calhoun, Wesley, Darwish, Riad, Dua, Sohan, Dukes, Carl, Erinle, Ayodele, Hadley, Alexander, Hsieh, John, Kashif, Mohammad, Kopyt, Nelson, Kumar, Jayant, Kusnir, Jorge, Lee, Jean, Maasarani, Essam, Miller, Richard, Mizani, M. Reza, Navarro, Jesus, Podoll, Amber, Pohlman, Thomas, Rivers, Denise, Robinson, Derrick, Rich, Lisa, Shirazian, Shayan, Silva, Arnold, Smith, Mark, Topf, Joel, Tumlin, James, Ungar, Scott, Zeig, Steven, Fishbane, Steven, Mathur, Vandana, Germain, Michael J., Bhaduri, Sarbani, Munera, Catherine, Spencer, Robert H., and Menzaghi, Frédérique

Published
2020
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4. Atrasentan and renal events in patients with type 2 diabetes and chronic kidney disease (SONAR): a double-blind, randomised, placebo-controlled trial

Author

Elbert, Alicia, Vallejos, Augusto, Alvarisqueta, Andres, Maffei, Laura, Juncos, Luis, de Arteaga, Javier, Greloni, Gustavo, Farias, Eduardo, Zucchini, Alfredo, Vogel, Daniel, Cusumano, Ana, Santos, Juan, Fraenkel, Margaret, Gallagher, Martin, Davis, Tim, Acharya, Shamasunder, Cooke, Duncan, Suranyi, Michael, Roger, Simon, Toussaint, Nigel, Pollock, Carol, Chan, Doris, Stranks, Stephen, MacIsaac, Richard, Endre, Zoltan, Schmidt, Alice, Prager, Rudolf, Mayer, Gert, Warling, Xavier, Jadoul, Michel, Hougardy, Jean, Vercammen, Chris, Van Vlem, Bruno, Gillard, Pieter, Costa e Forti, Adriana, Borges, Joao Lindolfo, Santos Canani, Luis, Eliaschewitz, Freddy, Leite, Silmara, Fraige Filho, Fadlo, Paschoalin, Raphael, Moura Neto, Jose Andrade, Deboni, Luciane, de Lourdes Noronha, Irene, Cercato, Cintia, Prompt, Carlos Alberto, Zanella, Maria, Rassi, Nelson, D'Avila, Domingos, Milagres, Rosangela, Felicio, Joao, Pecoits Filho, Roberto, Riella, Miguel Carlos, Salles, Joao, Keitel, Elizete, Draibe, Sergio, Amodeo, Celso, Youmbissi, Joseph, Roy, Louise, Cournoyer, Serge, Jolly, Shivinder, Pichette, Vincent, Nesrallah, Gihad, Bajaj, Harpreet Singh, Khandwala, Hasnain, Aronson, Ronnie, Goluch, Richard, Tam, Paul, Rabbat, Christian, Tobe, Sheldon, Bailey, Gordon, Chow, Stephen, Castillo, Alvaro, Danin Vargas, Alfredo, Gonzalez, Fernando, Munoz, Rodrigo, Gutierrez, Vicente, Godoy, Gonzalo, Zhao, Hongwen, Liu, Zhangsuo, Zhao, Minghui, Guo, Xiaohui, Su, Benli, Fu, Shuxia, Xu, Yan, Yang, Jinkui, Shi, Bingyin, Xiao, Guanqing, Shi, Wei, Hao, Chuanming, Xing, Changying, Hou, Fanfan, Luo, Qun, Li, Yuxiu, Ji, Linong, Zuo, Li, Wang, Song, Ni, Zhaohui, Ding, Guohua, Chen, Nan, Zhao, Jiajun, Jia, Weiping, Yu, Shengqiang, Weng, Jian, Xu, Gang, Fu, Ping, Sun, Shiren, Liu, Bicheng, Ding, Xiaoqiang, Rychlik, Ivan, Oplustilova, Alexandra, Bartaskova, Dagmar, Honova, Vaclava, Chmelickova, Hana, Petr, Martin, Bucek, Petr, Tesar, Vladimir, Zahumensky, Emil, Povlsen, Johan, Egstrup, Kenneth, Oczachowska-Kulik, Anna, Rossing, Peter, Lahtela, Jorma, Strand, Jorma, Kantola, Ilkka, Petit, Catherine, Combe, Christian, Zaoui, Philippe, Esnault, Vincent, Urena Torres, Pablo, Halimi, Jean-Michel, Dussol, Bertrand, Bieler, Tasso, Budde, Klemens, Dellanna, Frank, Segiet, Thomas, Kosch, Christine, Schmidt-Guertler, Hans, Schenkenberger, Isabelle, Vielhauer, Volker, Pistrosch, Frank, Alscher, Mark, Hasslacher, Christoph, Hugo, Christian, Muehlfeld, Anja, Wanner, Christoph, Passadakis, Ploumis, Apostolou, Theofanis, Tentolouris, Nikolaos, Stefanidis, Ioannis, Mavromatidis, Konstantinos, Liakopoulos, Vasilios, Goumenos, Dimitrios, Siamopoulos, Konstantinos, Yeung, Vincent, Ozaki, Risa, Fung, Samuel, Tan, Kathryn, Tang, Sydney, Lui, Sing Leung, Cheung, Siu Fai, Sreenan, Seamus, Eustace, Joseph, O'Shea, Donal, Lavin, Peter, Stack, Austin, Yagil, Yoram, Wainstein, Julio, Knobler, Hilla, Cohen, Josef, Kenis, Irina, Daoud, Deeb, Bar-Dayan, Yosefa, Frajewicki, Victor, Adawi, Faiad, Gesualdo, Loreto, Santoro, Domenico, Marino, Francesco, Galfre, Andrea, Brunati, Chiara, Ruggenenti, Piero, Rombola, Giuseppe, Pugliese, Giuseppe, Ravera, Maura, Malberti, Fabio, Pontoriero, Giuseppe, Rampino, Teresa, De Cosmo, Salvatore, Esposito, Ciro, Nappi, Felice, Abaterusso, Cataldo, Conte, Giuseppe, Panichi, Vincenzo, Lauro, Davide, Capasso, Giovambattista, Russo, Domenico, Anzai, Jiichi, Naka, Motoji, Ato, Keita, Tsujimoto, Tetsuro, Nimura, Toshinori, Nakashima, Eitaro, Takeda, Tetsuro, Fujii, Shinya, Kobayashi, Kunihisa, Iwaoka, Hideaki, Nagayama, Koji, Harada, Hiroyuki, Maeda, Hajime, Kishimoto, Rui, Iitsuka, Tadashi, Itabashi, Naoki, Furuya, Ryuichi, Maeda, Yoshitaka, Yamada, Daishiro, Sasaki, Nobuhiro, Sasaki, Hiromitsu, Ueda, Shinichiro, Kashihara, Naoki, Watanabe, Shuichi, Nakamura, Takehiro, Kanai, Hidetoshi, Makita, Yuichiro, Ono, Keiko, Iehara, Noriyuki, Goto, Daisuke, Kosuge, Keiichiro, Tsuchida, Kenichi, Sato, Toshiaki, Sekikawa, Takashi, Okamoto, Hideki, Tanaka, Tsuyoshi, Ikeda, Naoko, Tadika, Takenobu, Mukasa, Koji, Osonoi, Takeshi, Hirano, Fuminori, Nishimura, Motonobu, Yambe, Yuko, Tanaka, Yukio, Ujihara, Makoto, Sakai, Takashi, Imura, Mitsuo, Umayahara, Yutaka, Makino, Shinya, Nakazawa, Jun, Yamaguchi, Yukinari, Kashine, Susumu, Miyaoka, Hiroaki, Suzuki, Katsunori, Inoue, Toshihiko, Nagai, Sou, Sato, Nobuyuki, Yamamoto, Masahiro, Taya, Noriyasu, Fujita, Akira, Matsutani, Akira, Shibagaki, Yugo, Sato, Yuichi, Yamauchi, Akira, Tsutsui, Masahiro, Ishiko, Tamayo, Kaneko, Shizuka, Azuma, Nobuyuki, Matsuda, Hirofumi, Hashiguchi, Yasuhiro, Onishi, Yukiko, Tokui, Mikiya, Matsuhisa, Munehide, Kiyosue, Arihiro, Shinoda, Junji, Ishikawa, Kazuo, Ahmad, Ghazali, Vijayasingham, Shalini, Aziz, Nor Azizah, Hussein, Zanariah, Fung, Yin Khet, Hassan, Wan Hasnul Halimi Wan, Wong, Hin Seng, Goh, Bak Leong, Ali, Norhaliza Mohd, Merican, Nor Shaffinaz Yusuf Azmi, Vaithilingam, Indralingam, Nik Ahmad, Nik Nur Fatnoon, Adam, Noor, Sukor, Norlela, Vengadasalam, V Paranthaman P, Abdul Kadir, Khalid, Mohamed, Mafauzy, Renoirte Lopez, Karina, Leguizamo-Dimas, Aniceto, Chew Wong, Alfredo, Chevaile-Ramos, Jose, Gonzalez Gonzalez, Jose, Rico Hernandez, Raul, Nino-Cruz, Jose, Sauque Reyna, Leobardo, Gonzalez-Galvez, Guillermo, Madero Rovalo, Magdalena, Bochicchio-Ricardelli, Tomasso, Aldrete, Jorge, Carranza-Madrigal, Jaime, Vogt, Liffert, Smak Gregoor, Peter, Barendregt, JNM, Luik, Peter, Gansevoort, Ronald, Laverman, Gozewijn, Pilmore, Helen, Lunt, Helen, Baker, John, Miller, Steven, Rabindranath, Kannaiyan, Zapata-Rincon, Luis, Vargas-Gonzales, Rolando, Calderon Ticona, Jorge, Dextre Espinoza, Augusto, Burga Nunez, Jose, Zea-Nunez, Carlos Antonio, Herrada Orue, Benjamin, Medina-Santander, Boris, Delgado-Butron, Cesar, Farfan-Aspilcueta, Julio, Mazur, Stanislaw, Necki, Miroslaw, Wruk, Michal, Klodawska, Katarzyna, Popenda, Grazyna, Skokowska, Ewa, Arciszewska, Malgorzata, Wiecek, Andrzej, Ciechanowski, Kazimierz, Nowicki, Michal, Birne, Rita, Cabrita, Antonio, Ramos, Aura, Antunes Ferreira, Manuel Anibal, Matta Fontanet, Evelyn, Alcantara-Gonzalez, Altagracia Aurora, Comulada-Rivera, Angel, Galindo Ramos, Eugenia, Cangiano, Jose, Quesada-Suarez, Luis, Calderon Ortiz, Ricardo, Vazquez-Tanus, Jose, Burgos-Calderon, Rafael, Rosado, Carlos, Hancu, Nicolae, Pintilei, Ella, Mistodie, Cristina, Bako, Gabriel, Ionutiu, Lavinia, Petrica, Ligia, Timar, Romulus, Tuta, Liliana, Duma, Livia, Tutescu, Adriana, Ivanova, Svetlana, Essaian, Ashot, Zrazhevskiy, Konstantin, Tomilina, Natalia, Smolyarchuk, Elena, Kuzin, Anatoly, Lantseva, Olga, Karpova, Irina, Shamkhalova, Minara, Liberanskaya, Natalia, Yavdosyuk, Andrey, Shvarts, Yuri, Bardymova, Tatiana, Blagoveshchenskaya, Olga, Solovev, Oleg, Rechkova, Elena, Pikalova, Natalia, Pavlova, Maria, Kolmakova, Elena, Sayfutdinov, Rustam, Villevalde, Svetlana, Koziolova, Natalya, Martynenko, Vladimir, Marasaev, Vyacheslav, Maksudova, Adelya, Sigitova, Olga, Mordovin, Viktor, Klimontov, Vadim, Samoylova, Yulia, Karonova, Tatiana, Yeoh, Lee Ying, Teo, Boon Wee, Foo, Marjorie Wai Yin, Liew, Adrian, Tkac, Ivan, Oroszova, Aniko, Fekete, Jozef, Rosenberger, Jaroslav, Obetkova, Ida, Fulopova, Alla, Kolesarova, Eva, Raslova, Katarina, Smolko, Peter, Oksa, Adrian, Distiller, Larry, Trokis, Julien, Adams, Luthando, Makan, Hemant, Ramlachan, Padaruth, Mitha, Essack, Coetzee, Kathleen, Punt, Zelda, Bhorat, Qasim, Naiker, Puvenesvari, Ellis, Graham, Van Zyl, Louis, Lee, Kwan Woo, Kim, Min Seon, Yoo, Soon-Jib, Yoon, Kun Ho, Cho, Yong-Wook, Park, Tae-Sun, Kim, Sang Yong, Choi, Moon-Gi, Oh, Tae Keun, Lee, Kang-Wook, Shon, Ho Sang, Suh, Sung Hwan, Kim, Byung-Joon, Doo-Man, Kim, Yi, Joo Hark, Lee, Sang Ah, Cho, Ho Chan, Kim, Sin-Gon, Cha, Dae-Ryong, Seo, Ji A, Choi, Kyung Mook, Woo, Jeong-Taek, Ahn, Kyu Jeung, Lee, Jae Hyuk, Kim, In-Joo, Lee, Moon-Kyu, Jang, Hak Chul, Park, Kyong-Soo, Kim, Beom Seok, Mok, Ji Oh, Shin, Mijung, Yoon, Sun Ae, Nam-Goong, Il-Seong, Chung, Choon Hee, Yu, Tae Yang, Lee, Hyoung Woo, Soto Gonzalez, Alfonso, Almirall, Jaume, Egido, Jesus, Calero Gonzalez, Francesca, Fernandez Fresnedo, Gema, Valera Cortes, Ildefonso, Praga Terente, Manuel, Garcia Mendez, Isabel, Navarro Gonzalez, Juan, Herrero Calvo, Jose, Cigarran Guldris, Secundino, Prieto Velasco, Mario, Minguela Pesquera, Jose Ignacio, Galan, Antonio, Pascual, Julio, Marques Vidas, Maria, Martins Munoz, Judith, Rodriguez-Perez, Jose, Castro-Alonso, Cristina, Bonet Sol, Josep, Seron, Daniel, Fernandez Giraldez, Elvira, Arrieta Lezama, Javier, Montero, Nuria, Hernandez-Jaras, Julio, Santamaria Olmo, Rafael, Molas Coten, Jose Ramon, Hellberg, Olof, Fellstrom, Bengt, Bock, Andreas, Pei, Dee, Lin, Ching-Ling, Tien, Kai-Jen, Chen, Ching-Chu, Huang, Chien-Ning, Jiang, Ju-Ying, Wu, Du-An, Chu, Chih-Hsun, Tseng, Shih-Ting, Chen, Jung-Fu, Bau, Cho-Tsan, Sheu, Wayne, Wu, Mai-Szu, Sari, Ramazan, Sezer, Siren, Yildiz, Alaattin, Satman, Ilhan, Kalender, Betul, Mankovskyy, Borys, Fushtey, Ivan, Stanislavchuk, Mykola, Kolenyk, Mykola, Dudar, Iryna, Zolotaikina, Viktoriia, Abrahamovych, Orest, Kostynenko, Tetyana, Petrosyan, Olena, Kuskalo, Petro, Galushchak, Olga, Legun, Oleg, Topchii, Ivan, Martynyuk, Liliya, Stryzhak, Vasyl, Panina, Svitlana, Tkach, Sergii, Korpachev, Vadym, Maxwell, Peter, Gnudi, Luigi, Kon, Sui Phin, Tindall, Hilary, Kalra, Phillip, Mark, Patrick, Patel, Dipesh, El-Shahawy, Mohamed, Bai, Liqun, Nica, Romanita, Lien, Yeong-Hau, Menefee, Judson, Busch, Robert, Miller, Alan, Ahmed, Azazuddin, Arif, Ahmed, Lee, Joseph, Desai, Sachin, Bansal, Shweta, Bentsianov, Marie, Belledonne, Mario, Jere, Charles, Gaona, Raul, Greenwood, Gregory, Brusco, Osvaldo, Boiskin, Mark, Belo, Diogo, Minasian, Raffi, Atray, Naveen, Lawrence, Mary, Taliercio, John, Pergola, Pablo, Scott, David, Alvarez, German, Marder, Bradley, Powell, Thomas, Bakdash, Wa'el, Stoica, George, McFadden, Christopher, Rendell, Marc, Wise, Jonathan, Jones, Audrey, Jardula, Michael, Madu, Ivy-Joan, Varghese, Freemu, Tulloch, Brian, Ahmed, Ziauddin, Hames, Melanie, Nazeer, Imran, Shahid, Newman, John, Rekha, Montero, Manuel, Fitz-Patrick, David, Phillips, Lawrence, Guasch, Antonio, Christofides, Elena, Gundroo, Aijaz, Amin, Mohammad, Bowman-Stroud, Cynthia, Link, Michael, Mulloy, Laura, Nammour, Michael, Lalwani, Tarik, Hanson, Lenita, Whaley-Connell, Adam, Herman, Lee, Chatha, Rupi, Osama, Sayed, Liss, Kenneth, Kayali, Zeid, Bhargava, Anuj, Israel, Ezra, Peguero-Rivera, Alfredo, Fang, Michael, Slover, Judith, Barengolts, Elena, Flores, Jose, Muoneke, Rosemary, Savin, Virginia, Awua-Larbi, Stella, Levine, Andrew, Newman, George, Golestaneh, Laden, Bohm, Guillermo, Reisin, Efrain, Cruz, Lucita, Weiss, Robert, Zieve, Franklin, Horwitz, Edward, Chuang, Peale, Mersey, James, Manley, John, Graf, Ronald, Bedros, Fadi, Joshi, Sudhir, Frias, Juan, Assefi, Ali, O'Shaughnessy, Andrew, Brantley, Roman, Minga, Todd, Tietjen, David, Kantor, Samuel, Jamal, Aamir, Guadiz, Ramon, Hershon, Kenneth, Bressler, Peter, Kopyt, Nelson, Cathcart, Harold, Bloom, Scott, Reichel, Ronald, Nakhle, Samer, Dulude, Emily, Tarkan, Joshua, Baker, Penelope, Zeig, Steven, Moya Hechevarria, Jaynier, Ropero-Cartier, Armando, De la Calle, Gilda, Doshi, Ankur, Saba, Fadi, Sligh, Teresa, Shaw, Sylvia, Kumar, Jayant, Szerlip, Harold, Bayliss, George, Perlman, Alan, Sakhrani, Lakhi, Gouge, Steven, Argoud, Georges, Acosta, Idalia, Elder, John, Joshi, Sucharit, Sensenbrenner, John, Vicks, Steven, Mangoo-Karim, Roberto, Galphin, Claude, Leon-Forero, Carlos, Gilbert, John, Brown, Eric, Ijaz, Adeel, Butt, Salman, Markell, Mariana, Arauz-Pacheco, Carlos, Sloan, Lance, Alvarado, Odilon, Jabbour, Serge, Simon, Eric, Rastogi, Anjay, James, Sam, Bakris, George, Hall, Karen, Melish, John, Dixon, Brad, Adolphe, Allen, Kovesdy, Csaba, Beddhu, Srinivasan, Solomon, Richard, Fernando, Ronald, Levin, Ellis, Thakar, Charuhas, Robey, Brooks, Goldfarb, David, Fried, Linda, Maddukuri, Geetha, Thomson, Stephen, Annand, Andrew, Kronfli, Saeed, Kalirao, Paramjit, Schmidt, Rebecca, Dahl, Neera, Blumenthal, Samuel, Weinstein, Debra, Ostergaard, Ove, Weinstein, Talia, Ono, Yasuhiro, Yalcin, Murat, Karim, Shahana, Heerspink, Hiddo J L, Parving, Hans-Henrik, Andress, Dennis L, Correa-Rotter, Ricardo, Hou, Fan-Fan, Kitzman, Dalane W, Kohan, Donald, Makino, Hirofumi, McMurray, John J V, Melnick, Joel Z, Miller, Michael G, Pergola, Pablo E, Perkovic, Vlado, Yi, Tingting, Wigderson, Melissa, and de Zeeuw, Dick

Published
2019
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11. An open-label, sequential, dose-finding study of peginesatide for the maintenance treatment of anemia in chronic hemodialysis patients

Author

Besarab Anatole, Zeig Steven N, Martin Edouard R, Pergola Pablo E, Whittier Frederick C, Zabaneh Raja I, Schiller Brigitte, Mayo Martha, Francisco Carol A, Polu Krishna R, and Duliege Anne-Marie

Subjects
Anemia, Chronic kidney disease, Erythropoiesis-stimulating agent, Epoetin alfa, Hemodialysis, Peginesatide, Diseases of the genitourinary system. Urology, RC870-923
Abstract

Abstract Background Peginesatide is a peptide-based erythropoiesis-stimulating agent that was designed and engineered to stimulate specifically the erythropoietin receptor dimer that governs erythropoiesis. The primary objective of this phase 2 dose-finding study was to determine the once-monthly peginesatide dosing strategy that would maintain hemoglobin within ±1.0 g/dL of baseline values after conversion from epoetin alfa; the safety of peginesatide was evaluated concurrently. Methods Chronic hemodialysis patients on stable regimens of epoetin alfa were sequentially assigned to cohorts that differed on (1) how the peginesatide starting dose was determined (using a single epoetin alfa–to-peginesatide dose conversion ratio or a tiered, weight-based or absolute-dose conversion table) and on (2) whether or not a 1-week erythropoiesis-stimulating agent-free interval was used. Peginesatide doses were titrated to maintain hemoglobin levels within ±1.0 g/dL from baseline. Results A total of 164 patients were enrolled and received intravenous peginesatide every 4 weeks for up to 6 doses; the duration of the study including follow-up was ≤29 weeks. Overall, the proportion of patients with hemoglobin levels within ±1.0 g/dL of baseline increased over the course of the study from 39% (Weeks 2–13) to 54% (Weeks 18–25). Cohorts that used tiered dose conversion tables trended towards having more stable peginesatide doses than did those cohorts that used a single dose conversion ratio. Moreover, cohorts that used an erythropoiesis-stimulating agent-free interval did not have the substantial initial increase in hemoglobin levels that was seen in those cohorts that did not use such an interval. In this study, the safety profile of peginesatide was consistent with those of marketed erythropoiesis-stimulating agents. Conclusions The results of this study were used to guide the dosing regimens used subsequently in phase 3 studies. Once-monthly peginesatide is feasible in hemodialysis patients. Trial registration ClinicalTrials.gov registration: NCT00228449

Published
2012
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13. Daprodustat for anemia: a 24-week, open-label, randomized controlled trial in participants with chronic kidney disease.

Author

Holdstock, Louis, Cizman, Borut, Meadowcroft, Amy M, Biswas, Nandita, Johnson, Brendan M, Jones, Delyth, Kim, Sung Gyun, Zeig, Steven, Lepore, John J, and Cobitz, Alexander R

Abstract

Background This study assessed the short-term safety and efficacy of daprodustat (an oral hypoxia-inducible factor-prolyl hydroxylase inhibitor) to achieve a target hemoglobin in patients with anemia of chronic kidney disease (CKD). Methods Patients (n  = 252) with Stages 3–5 CKD not receiving dialysis were enrolled in this 24-week, multicenter trial [hemoglobin entry criteria: 8–10 g/dL (Cohort 1) or 8–11 g/dL (Cohort 2) for recombinant human erythropoietin (rhEPO)-naïve participants; 9–10.5 g/dL (Cohort 1) or 9–11.5 g/dL (Cohort 2) for rhEPO users]. rhEPO-naïve participants were randomized 3:1 to daprodustat (1, 2 or 4 mg) or control (rhEPO per standard of care). rhEPO users were randomized 1:1 to daprodustat 2 mg or control. Study medication was titrated to maintain hemoglobin 9–10.5 g/dL (Cohort 1) or 10–11.5 g/dL (Cohort 2). Hemoglobin, iron metabolism markers and safety parameters were measured every 4 weeks. Results Mean hemoglobin levels at Week 24 were 10.2 g/dL (Cohort 1) and 10.9 g/dL (Cohort 2) in the daprodustat group and 10.7 g/dL (Cohort 1) and 11.0 g/dL (Cohort 2) in the control group. Participants had hemoglobin levels within the target range a median of 82% and 66% of the time between Weeks 12 and 24 in the daprodustat and control groups, respectively. The adverse event profile was consistent with clinical events in the CKD population. Conclusions Daprodustat effectively maintained target hemoglobin over 24 weeks in CKD patients with anemia who were rhEPO naïve or had switched from existing rhEPO therapy. [ABSTRACT FROM AUTHOR]

Published
2019
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