Obrador, Gregorio
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Obrador, Gregorio
Official Name
Tomás Obrador Vera, Gregorio
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gobrador
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ORCID
Scopus Author ID
6602806471
Researcher ID
B-3054-2011

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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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The ASCEND-ND trial: study design and participant characteristics

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

Background: Anaemia is common in chronic kidney disease (CKD) and assessment of the risks and benefits of new therapies is important. Methods: The Anaemia Study in CKD: Erythropoiesis via a Novel prolyl hydroxylase inhibitor Daprodustat-Non-Dialysis (ASCEND-ND) trial includes adult patients with CKD Stages 3-5, not using erythropoiesis-stimulating agents (ESAs) with screening haemoglobin (Hb) 8-10 g/dL or receiving ESAs with screening Hb of 8-12 g/dL. Participants were randomized to daprodustat or darbepoetin alfa (1:1) in an open-label trial (steering committee- and sponsor-blinded), with blinded endpoint assessment. The co-primary endpoints are mean change in Hb between baseline and evaluation period (average over Weeks 28-52) and time to first adjudicated major adverse cardiovascular (CV) event. Baseline characteristics were compared with those of participants in similar anaemia trials. © The Author(s) 2021. Published by Oxford University Press on behalf of the ERA.

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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.

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The ASCEND-NHQ randomized trial found positive effects of daprodustat on hemoglobin and quality of life in patients with non-dialysis chronic kidney disease

2023 , Johansen, Kirsten L. , Cobitz, Alexander R. , Singh, Ajay K. , Macdougall, Iain C. , Lopes, Renato D. , Obrador, Gregorio , Kovesdy, Csaba P. , Israni, Rubeen , Jha, Vivekanand , Okoro, Tony , Sprys, Mike , Jolly, Shivinder , Lindsay, Alistair C. , Bhatt, Purav , Refoios Camejo, Rodrigo , Keeley, Tom , Cizman, Borut , Wheeler, David C.

The ASCEND-NHQ trial evaluated the effects of daprodustat on hemoglobin and the Medical Outcomes Study 36-item Short Form Survey (SF-36) Vitality score (fatigue) in a multicenter, randomized, double-blind, placebo-controlled trial. Adults with chronic kidney disease (CKD) stages 3-5, hemoglobin 8.5-10.0 g/dl, transferrin saturation 15% or more, and ferritin 50 ng/ml or more without recent erythropoiesis-stimulating agent use were randomized (1:1) to oral daprodustat or placebo to achieve and maintain target hemoglobin of 11-12 g/dl over 28 weeks. The primary endpoint was the mean change in hemoglobin between baseline and the evaluation period (Weeks 24-28). Principal secondary endpoints were proportion of participants with a 1 g/dl or more increase in hemoglobin and mean change in the Vitality score between baseline and Week 28. Outcome superiority was tested (1-sided alpha level of 0.025). Overall, 614 participants with non-dialysis-dependent CKD were randomized. The adjusted mean change in hemoglobin from baseline to the evaluation period was greater with daprodustat (1.58 vs 0.19 g/dl). The adjusted mean treatment difference (AMD) was significant at 1.40 g/dl (95% confidence interval 1.23, 1.56). A significantly greater proportion of participants receiving daprodustat showed a 1 g/dl or greater increase in hemoglobin from baseline (77% vs 18%). The mean SF-36 Vitality score increased by 7.3 and 1.9 points with daprodustat and placebo, respectively; a clinically and statistically significant 5.4 point Week 28 AMD increase. Adverse event rates were similar (69% vs 71%); relative risk 0.98, (95% confidence interval 0.88, 1.09). Thus, in participants with CKD stages 3-5, daprodustat resulted in a significant increase in hemoglobin and improvement in fatigue without an increase in the overall frequency of adverse events. Copyright © 2023 International Society of Nephrology. Published by Elsevier Inc. All rights reserved.

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Daprodustat for the Treatment of Anemia in Patients Not Undergoing Dialysis

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

Background: Daprodustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor. In patients with chronic kidney disease (CKD) who are not undergoing dialysis, the efficacy and safety of daprodustat, as compared with the conventional erythropoiesis-stimulating agent darbepoetin alfa, are unknown. Methods: In this randomized, open-label, phase 3 trial with blinded adjudication of cardiovascular outcomes, we compared daprodustat with darbepoetin alfa for the treatment of anemia in patients with CKD who were not undergoing dialysis. The primary outcomes were the mean change in the hemoglobin level from baseline to weeks 28 through 52 and the first occurrence of a major adverse cardiovascular event (MACE; a composite of death from any cause, nonfatal myocardial infarction, or nonfatal stroke). Copyright © 2021 Massachusetts Medical Society.

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Resumen de las Guías de práctica clínica KDIGO sobre el cuidado del receptor de trasplante renal

2011 , Kasiske, Bertram L. , Zeier, Martin G. , Chapman, Jeremy R. , Craig, Jonathan C. , Ekberg, Henrik , Garvey, Catherine A. , Green, Michael D. , Jha, Vivekanand , Josephson, Michelle A. , Kiberd, Bryce A. , Kreis, Henri A. , McDonald, Ruth A. , Newmann, John M. , Obrador, Gregorio , Vincenti, Flavio G. , Cheung, Michael , Earley, Amy , Raman, Gowri , Abariga, Samuel , Wagner, Martin , Balk, Ethan M.

La guía de práctica clínica 2009 Enfermedad Renal: Mejorando los Resultados Globales (KDIGO, por sus siglas en inglés) sobre el control, manejo y tratamiento de receptores de un trasplante renal, está destinada a ayudar al cuidado médico de adultos y niños después de un trasplante renal. El proceso de desarrollo de la guía se ha hecho con un enfoque basado en la evidencia y las recomendaciones sobre manejo se fundamentan en revisiones sistemáticas de ensayos clínicos relevantes sobre el tratamiento. La valoración crítica de la calidad de la evidencia y la fuerza de las recomendaciones se basan en los Grados de Recomendación, Valoración, Desarrollo y Evaluación (GRADE, por sus siglas en inglés). La guía ofrece recomendaciones para la inmunosupresión y el monitoreo del injerto, así como para la prevención y el tratamiento de infecciones, enfermedades cardiovasculares, neoplasias y otras complicaciones frecuentes en el receptor de un trasplante renal, como los trastornos hematológicos y óseos. Se discuten las limitaciones de la evidencia, especialmente debidas a la falta de resultados definitivos en ensayos clínicos, y se proporcionan sugerencias para futuras investigaciones. Este resumen contiene una breve descripción de la metodología y de las recomendaciones completas de las guías, pero no contiene la justificación y las referencias de cada recomendación, las cuales han sido publicadas en otra revista. ©Revista de nefrología, diálisis y transplante, Sociedad Argentina de Nefrología Argentina.

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KDIGO clinical practice guideline for the care of kidney transplant recipients: a summary

2010 , Kasiske, Bertram L. , Zeier, Martin G. , Chapman, Jeremy R. , Craig, Jonathan C. , Ekberg, Henrik , Garvey, Catherine A. , Green, Michael D. , Jha, Vivekanand , Josephson, Michelle A. , Kiberd, Bryce A. , Kreis, Henri A. , McDonald, Ruth A. , Newmann, John M. , Obrador, Gregorio , Vincenti, Flavio G. , Cheung, Michael , Earley, Amy , Raman, Gowri , Abariga, Samuel , Wagner, Martin , Balk, Ethan M.

The 2009 Kidney Disease: Improving Global Outcomes (KDIGO) clinical practice guideline on the monitoring, management, and treatment of kidney transplant recipients is intended to assist the practitioner caring for adults and children after kidney transplantation. The guideline development process followed an evidence-based approach, and management recommendations are based on systematic reviews of relevant treatment trials. Critical appraisal of the quality of the evidence and the strength of recommendations followed the Grades of Recommendation Assessment, Development, and Evaluation (GRADE) approach. The guideline makes recommendations for immunosuppression and graft monitoring, as well as prevention and treatment of infection, cardiovascular disease, malignancy, and other complications that are common in kidney transplant recipients, including hematological and bone disorders. Limitations of the evidence, especially the lack of definitive clinical outcome trials, are discussed and suggestions are provided for future research. This summary includes a brief description of methodology and the complete guideline recommendations but does not include the rationale and references for each recommendation, which are published elsewhere. © Kidney International

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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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Daprodustat for the Treatment of Anemia in Patients Undergoing Dialysis

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

Background: Among patients with chronic kidney disease (CKD), the use of recombinant human erythropoietin and its derivatives for the treatment of anemia has been linked to a possibly increased risk of stroke, myocardial infarction, and other adverse events. Several trials have suggested that hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitors (PHIs) are as effective as erythropoiesis-stimulating agents (ESAs) in increasing hemoglobin levels. Methods: In this randomized, open-label, phase 3 trial, we assigned patients with CKD who were undergoing dialysis and who had a hemoglobin level of 8.0 to 11.5 g per deciliter to receive an oral HIF-PHI (daprodustat) or an injectable ESA (epoetin alfa if they were receiving hemodialysis or darbepoetin alfa if they were receiving peritoneal dialysis). The two primary outcomes were the mean change in the hemoglobin level from baseline to weeks 28 through 52 (noninferiority margin, −0.75 g per deciliter) and the first occurrence of a major adverse cardiovascular event (a composite of death from any cause, nonfatal myocardial infarction, or nonfatal stroke), with a noninferiority margin of 1.25. Copyright © Massachusetts Medical Society.

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Associations of Haemoglobin Values and Rate of Changes With MACE in the ASCEND-ND Randomised Clinical Trial

2022 , Singh, Ajay K. , Macdougall, Iain C. , Johansen, Kirsten , Jha, Vivekanand , Correa-Rotter, Ricardo , Del Vecchio, Lucia , Cases Amenos, Aleix , Robertson, Michele , Mallett, Steve , Bailey, Christine K. , Cobitz, Alexander , Obrador, Gregorio

Background and aims: Rapid changes in haemoglobin (Hb) following treatment with erythropoiesis-stimulating agents (ESAs) in patients with anaemia of chronic kidney disease (CKD) have been suggested to be associated with adverse outcomes [1–3]. This exploratory post-hoc analysis was performed to investigate the association between absolute Hb values or Hb changes over a 4-week period and the occurrence of first adjudicated major adverse cardiovascular event (MACE) in CKD patients not on dialysis who were treated with either daprodustat or darbepoetin. Method: ASCEND-ND was an event driven, cardiovascular outcomes trial conducted in over 30 countries that randomized 3872 CKD patients not on dialysis with baseline Hb of 8–10 g/dL if not on a prior ESA, or 8–11 g/dL if receiving an ESA, to receive either oral, once-daily daprodustat (1937 patients) or subcutaneous darbepoetin (1935 patients). Available doses were daprodustat 1–24 mg once-daily and darbepoetin 20–400 µg total 4-weekly dose. The study was recently reported to have met the co-primary endpoints of non-inferiority for first occurrence of adjudicated MACE and mean Hb change from baseline to weeks 28 through 52 [4]. MACE was a composite of death from any cause, non-fatal myocardial infarction or non-fatal stroke, and events were adjudicated by an independent clinical events committee blinded to treatment assignment. In this exploratory post-hoc analysis, we examined the associations of post-randomization absolute Hb values and Hb changes categorized into quintiles (see Table 1) with first adjudicated MACE. Each patient's time in the study, prior to a first MACE or end of follow-up, was divided into distinct 4-week intervals, with each interval associated with a particular post-randomization Hb value and rate of change. Separately for each treatment group, these 4-week periods were grouped according to quintiles of Hb values, and MACE rates were calculated for each quintile. This analysis was repeated using quintiles derived from Hb rate of decrease and increase. MACEs that occurred prior to Week 4, the first scheduled post-randomization Hb collection, were not included in the analysis. Copyright © Oxford University Press

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