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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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Factors associated with the quality of the patient-doctor relationship: a cross-sectional study of ambulatory Mexican patients with rheumatic diseases

2021 , Pascual-Ramos, Virginia , Contreras-Yáñez, Irazú , Ortiz-Haro, Ana Belén , Molewijk, Albert Christiaan , Obrador, Gregorio , Agazzi, Evandro

Background: The patient-doctor relationship (PDR) is a complex phenomenon with strong cultural determinants, which impacts health-related outcomes and, accordingly, does have ethical implications. The study objective was to describe the PDR from medical encounters between 600 Mexican outpatients with rheumatic diseases and their attending rheumatologists, and to identify factors associated with a good PDR. Methods: A cross-sectional study was performed. Patients completed the PDRQ-9 (Patient-Doctor Relationship Questionnaire, 9 items), the HAQ-DI (Health Assessment Questionnaire Disability Index), the Short-Form 36 items (SF-36), a pain–visual analog scale, and the Ideal Patient Autonomy Scale. Relevant sociodemographic, disease-related, and treatment-related variables were obtained. Patients assigned a PDRQ-9 score to each patient-doctor encounter. Regression analysis was used to identify factors associated with a good PDR, which was defined based on a cutoff point established using the borderline performance method. Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.

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Current State and Challenges for Organ Donation and Transplantation in Mexico

2019 , Reyes-Acevedo, Rafael , Obrador, Gregorio , Alberú-Gómez, Josefina , Gracida-Juárez, Carmen , Madrigal, José André , Aburto-Morales, Salvador

Mexico, officially called the United Mexican States, is in the southern part of North America. It is a democratic republic comprised of 32 states, in addition to its capital, Mexico City. The Mexican territory has an area of 1 964 375 km2, which makes it the 14th biggest country in the world and the third largest in Latin America. Mexico borders the United States of America in the north and Guatemala and Belize in the south (Figure 1). It is the 11th most populous country in the world, with an estimated population of over 132 million people (as of 2018). Although most people speak Spanish, the official language, there are 67 indigenous dialects. In 2015, the Human Development Index was 0.762, ranking Mexico as number 77 worldwide. The Mexican economy is the second largest in Latin America and the 11th in the world. ©2019 Transplantation NLM (Medline).

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Trends in anemia at initiation of dialysis in the United States

2001 , Obrador, Gregorio , Roberts, Tricia , Peter, Wendy L. St. , Frazier, Eric , Pereira, Brian J.G. , Collins, Allan J.

Background: Anemia almost invariably develops in patients with chronic renal insufficiency (CRI) and is associated with a wide range of complications. The anemia of CRI can be effectively treated with recombinant human erythropoietin (rHuEPO). Recent studies suggest that the management of anemia of CRI is suboptimal in the United States. Methods: We examined the trends in hematocrit and rHuEPO use among all patients who started chronic dialysis therapy between April 1, 1995, and December 31, 1999, from the End-stage Renal Disease Medical Evidence Form 2728 submitted to the Health Care Financing Administration of the United States. Follow-up data containing hematocrit levels after initiation were obtained from the Medicare Part A institutional outpatient dialysis provider claims for 1990 to 1998 prevalent patients. © Kidney International

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A Decade After the KDOQI CKD Guidelines: A Perspective From Mexico

2012 , Obrador, Gregorio , Paniagua, Ramón

The impact after a decade of KDOQI (Kidney Disease Outcomes Quality Initiative) chronic kidney disease (CKD) guidelines1 in Mexico is difficult to assess because outcomes data are very limited. Indirect evidence suggests that the guidelines' terminology and therapeutic target recommendations have been widely disseminated among nephrologists, as judged by the content of conferences presented at annual meetings of the Mexican nephrological societies. There is only one study that has specifically addressed adherence to mineral metabolism guidelines in the Mexican population, but it is still unpublished (R.P., unpublished data, 2007). In this study, 753 prevalent dialysis patients were examined at baseline and after at least 12 months. The percentages of patients who had serum phosphorus, calcium, and parathyroid hormone values within the recommended KDOQI target were 35%, 32%, and 12%, respectively, and the most frequent abnormalities were hyperphosphatamia, hypercalcemia, and low parathyroid hormone level. ©American Journal of Kidney Diseases © 2012 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

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Patients with Fabry disease on dialysis in the United States

2002 , Thadhani, Ravi , Wolf, Myles , West, Michael L. , Tonelli, Marcello , Ruthazer, Robin , Pastores, Gregory M. , Obrador, Gregorio

Background: Fabry disease results from an X-linked deficiency of lysosomal alpha-galactosidase A and is a rare cause of end-stage renal disease. Little is known about the characteristics of patients with Fabry disease that initiate dialysis in the United States, although data from Europe suggests these individuals have a poor survival. Methods: Using the United States Renal Disease System database, we first studied in detail 42 Fabry patients who initiated dialysis between April 1995 (following the introduction of the new detailed HCFA 2728 form) and July 1998. To examine crude survival in a larger cohort, 95 Fabry patients were studied who initiated dialysis between 1985 and 1993, similar to the European Registry. Diabetic and non-diabetic controls matched by age, gender, race, year of dialysis initiation, and initial dialysis modality were examined for comparison. ©Copyright © Elsevier Inc.,

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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 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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Concordance among patients and physicians about their ideal of autonomy impacts the patient-doctor relationship: A cross-sectional study of Mexican patients with rheumatic diseases

2020 , Pascual-Ramos, Virginia , Contreras-Yáñez, Irazú , Ortiz-Haro, Ana Belén , Molewijk, Albert Christiaan , Obrador, Gregorio , Agazzi, Evandro

Introduction: In patient-doctor interaction both parties play a role. Primary objective was to determine if the concordance among rheumatologists and their patients of their ideal of autonomy was associated with a better patient-doctor relationship. Secondary objective was to describe factors associated to a patient paternalistic ideal of autonomy (PPIA). Materials and methods: This cross-sectional study had 3 steps. Step-1 consisted in translation/cultural local adaption of Ideal Patient Autonomy Scale (IPAS), a 14-items Dutch questionnaire. Step-2 consisted of IPAS validity and reliability in 201 outpatients. Step-3 consisted of the application of IPAS and the patient-doctor relationship questionnaire (PDRQ) to 601 outpatients with a medical encounter, and of IPAS to the 21 attending rheumatologists. Each patient-physician encounter was classified into with/without concordance in the ideal of autonomy and PRDQ scores were compared (Man Whitney U test). Regression analysis was used for associations. ©PLOS One

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How important is transfusion avoidance in 2013?

2013 , Macdougall, Iain C. , Obrador, Gregorio

Prior to the advent of recombinant erythropoietin in the late-1980s, blood transfusions were the mainstay of anaemia management in patients with end-stage renal failure, many of whom required “top-up” transfusions every 2 to 4 weeks to relieve the debilitating symptoms of severe anaemia. Erythropoietin therapy, however, allowed for the first time, such patients to achieve a sustained correction of anaemia, and there was a dramatic fall in both the use of red cell transfusions in dialysis units, as well as the associated transfusional iron overload prevalent in dialysis patients. Avoidance of blood transfusions improved access to, and outcomes of, kidney transplantation, due to reduced HLA sensitization. In recent years, however, there have been safety concerns regarding the use of erythropoiesis-stimulating agents (ESAs), and there are signs that the use of blood transfusions is once again increasing. The aim of this review is to reassess how important transfusion avoidance is in 2013, and whether we should still have the same concerns about HLA sensitization that we had 20 years ago. ©Nephrology Dialysis Transplantation.