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Study design and baseline characteristics of patients on dialysis in the ASCEND-D trial

2021 , Singh, Ajay K. , Blackorby, Allison , Cizman, Borut , Carroll, Kevin , Cobitz, Alexander R. , Davies, Rich , Jha, Vivekanand , Johansen, Kirsten L. , Lopes, Renato D. , Kler, Lata , Macdougall, Iain C. , McMurray, John J. V. , Meadowcroft, Amy M. , Obrador, Gregorio , Perkovic, Vlado , Solomon, Scott , Wanner, Christoph , Waikar, Sushrut S. , Wheeler, David C. , Wiecek, Andrzej

Background: The Anemia Studies in chronic kidney disease (CKD): Erythropoiesis via a Novel prolyl hydroxylase inhibitor Daprodustat-Dialysis (ASCEND-D) trial will test the hypothesis that daprodustat is noninferior to comparator epoetin alfa or darbepoetin alfa for two co-primary endpoints: hemoglobin (Hb) efficacy and cardiovascular (CV) safety. Methods: We report the trial design, key demographic, clinical and laboratory findings, and baseline therapies of 2964 patients randomized in the open-label (sponsor-blinded) active-controlled, parallel-group, randomized ASCEND-D clinical trial. We also compare baseline characteristics of ASCEND-D patients with patients who are on dialysis (CKD G5D) enrolled in other large CV outcome trials (CVOTs) and in the most relevant registries. © The Author(s) 2021. Published by Oxford University Press on behalf of the ERA-EDTA.

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Patient Perspectives on the Meaning and Impact of Fatigue in Hemodialysis: A Systematic Review and Thematic Analysis of Qualitative Studies

2019 , Jacobson, Jack , Ju, Angela , Baumgart, Amanda , Unruh, Mark , O’Donoghue, Donal , Obrador, Gregorio , Craig, Jonathan C. , Dapueto, Juan M. , Dew, Mary Amanda , Germain, Michael , Fluck, Richard , Davison, Sara N. , Jassal, Sarbjit Vanita , Manera, Karine , Smith, Alice C. , Tong, Allison

Rationale & objective: Fatigue is a highly prevalent and debilitating symptom in patients on hemodialysis therapy due to the uremic milieu, the hemodialysis treatment itself, and other comorbid conditions. However, fatigue remains underrecognized and the consequences are underappreciated because it may not be visible in clinical settings. This study aims to describe the experience that patients undergoing maintenance hemodialysis have with fatigue. Study design: Systematic review and thematic synthesis of qualitative studies. Setting & study populations: Patients undergoing hemodialysis. Search strategy & sources: MEDLINE, Embase, PsycINFO, CINAHL, reference lists, and PhD dissertations were searched from inception to October 2018. Data extraction: All text from the results/conclusion of the primary studies. Analytical approach: Thematic synthesis. Copyright © 2019 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

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Increasing access to integrated ESKD care as part of universal health coverage

2019 , Harris, David C.H. , Davies, Simon J. , Finkelstein, Fredric O. , Jha, Vivekanand , Donner, Jo-Ann , Abraham, Georgi , Bello, Aminu K. , Caskey, Fergus J. , García García, Guillermo , Harden, Paul , Hemmelgarn, Brenda , Johnson, David W. , Levin, Nathan W. , Luyckx, Valerie A. , Martin, Dominique E. , McCulloch, Mignon I. , Moosa, Mohammed Rafique , O’Connell, Philip J. , Okpechi, Ikechi G. , Pecoits-Filho, Roberto , Shah, Kamal D. , Sola, Laura , Swanepoel, Charles , Tonelli, Marcello , Twahir, Ahmed , Biesen, Wim van , Varghese, Cherian , Yang, Chih-Wei , Zuniga, Carlos , Abu Alfa, Ali K. , Aljubori, Harith M. , Alrukhaimi, Mona N. , Andreoli, Sharon P. , Ashuntantang, Gloria , Bellorin-Font, Ezequiel , Bernieh, Bassam , Ibhais, Fuad M. , Blake, Peter G. , Brown, Mark , Brown, Edwina , Bunnag, Sakarn , Mao Chan, Tak , Chen, Yuqing , Claure-Del Granado, Rolando , Claus, Stefaan , Collins, Allan , Couchoud, Cécile , Cueto-Manzano, Alfonso , Cullis, Brett , Douthat, Walter , Dreyer, Gavin , Eiam-Ong, Somchai , Eke, Felicia U. , Feehally, John , Ghnaimat, Mohammad A. , Goh, BakLeong , Hassan, Mohamed H. , Hou, Fan Fan , Jager, Kitty , Kalantar-Zadeh, Kamyar , Kazancioglu, Rumeyza T. , Levin, Adeera , Liew, Adrian , McKnight, Marla , Tadesse Mengistu, Yewondwassesn , Morton, Rachael L. , Muller, Elmi , Murtagh, Fliss E.M. , Naicker, Saraladevi , Nangaku, Masaomi , Niang, Abdou , Obrador, Gregorio , Ossareh, Shahrzad , Perl, Jeffrey , Rahman, Muhibur , Rashid, Harun Ur , Richards, Marie , Rondeau, Eric , Sahay, Manisha , Saleh, Abdulkarim , Schneditz, Daniel , Tchokhonelidze, Irma , Tesar, Vladimir , Trask, Michele , Tungsanga, Kriang , Vachharajani, Tushar , Walker, Rachael C. , Walker, Robert , Were, Anthony J.O. , Yao, Qiang , Yeates, Karen , Yu, Xueqing , Zakharova, Elena , Zemchenkov, Alexander , Zhao, Ming-Hui

The global nephrology community recognizes the need for a cohesive strategy to address the growing problem of end-stage kidney disease (ESKD). In March 2018, the International Society of Nephrology hosted a summit on integrated ESKD care, including 92 individuals from around the globe with diverse expertise and professional backgrounds. The attendees were from 41 countries, including 16 participants from 11 low- and lower-middle-income countries. The purpose was to develop a strategic plan to improve worldwide access to integrated ESKD care, by identifying and prioritizing key activities across 8 themes: (i) estimates of ESKD burden and treatment coverage, (ii) advocacy, (iii) education and training/workforce, (iv) financing/funding models, (v) ethics, (vi) dialysis, (vii) transplantation, and (viii) conservative care. Action plans with prioritized lists of goals, activities, and key deliverables, and an overarching performance framework were developed for each theme. Examples of these key deliverables include improved data availability, integration of core registry measures and analysis to inform development of health care policy; a framework for advocacy; improved and continued stakeholder engagement; improved workforce training; equitable, efficient, and cost-effective funding models; greater understanding and greater application of ethical principles in practice and policy; definition and application of standards for safe and sustainable dialysis treatment and a set of measurable quality parameters; and integration of dialysis, transplantation, and comprehensive conservative care as ESKD treatment options within the context of overall health priorities. Intended users of the action plans include clinicians, patients and their families, scientists, industry partners, government decision makers, and advocacy organizations. Implementation of this integrated and comprehensive plan is intended to improve quality and access to care and thereby reduce serious health-related suffering of adults and children affected by ESKD worldwide. Copyright © 2019 International Society of Nephrology. All rights reserved.

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Regional Variation of Erythropoiesis-Stimulating Agent Hyporesponsiveness in the Global Daprodustat Dialysis Study (ASCEND-D)

2023 , Macdougall, Iain C. , Meadowcroft, Amy M. , Blackorby, Allison , Cizman, Borut , Cobitz, Alexander R. , Godoy, Sergio , Jha, Vivekanand , Johansen, Kirsten L. , McMahon, Gearoid , Obrador, Gregorio , Wong, Muh Geot , Singh, Ajay K.

Introduction: Hyporesponsiveness to erythropoiesis-stimulating agents (ESAs) affects 10-15% of the chronic dialysis population. We explored baseline characteristics and predictors of ESA hyporesponsiveness in a global randomized cardiovascular outcomes study comparing an investigational hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), daprodustat, with conventional ESA treatment. Methods: ASCEND-D (NCT02879305) recruited 2,964 chronic dialysis patients receiving ESA treatment (standardized to weekly intravenous [IV] epoetin) who were iron replete at baseline. The primary ESA hyporesponsiveness definition was an ESA Resistance Index (ERI, ESA units/kg/week/hemoglobin g/L) ≥2 or IV standardized ESA dose ≥450 units/kg/week. Predictors of ESA hyporesponsiveness were determined using a multivariable regression model. Alternative hyporesponder definitions were explored. The Author(s). Published by S. Karger AG, Basel.

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The environment and kidney health: challenges and opportunities

2022 , Bharati, Joyita , Zavaleta-Cortijo, Carol , Bressan, Tiana , Shingada, Aakash , Obrador, Gregorio , Sola, Laura , Peiris, David , Miranda, J. Jaime , Jha, Vivekanand

The accelerating environmental degradation as a result of modernisation and climate change is an urgent threat to human health. Environment change can impact kidney health in a variety of ways such as water scarcity, global heating and changing biodiversity. Ever increasing industrialization of health care has a large carbon footprint, with dialysis being a major contributor. There have been calls for all stakeholders to adopt a ‘one health approach’ and develop mitigation and adaptation strategies to combat this challenge. Because of its exquisite sensitivity to various elements of environment change, kidney health can be a risk marker and a therapeutic target for such interventions. In this narrative review, we discuss the various mechanisms through which environmental change is linked to kidney health and the ways that the global kidney health communities can respond to environmental change. ©D.R. © por el sitio: Instituto Nacional de Salud Pública.