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Mortality in Patients With Chronic Renal Disease Without Health Insurance in Mexico: Opportunities for a National Renal Health Policy

2018 , Valdez-Ortiz, Rafael , Navarro-Reynoso, Francisco , Olvera-Soto, Guadalupe , Martin-Alemañy, Geovana , Rodríguez-Matías, Adrian , Hernández-Arciniega, Clara Rocío , Cortes-Pérez, Mario , Chávez-López, Ernesto , García-Villalobos, Gloria , Hinojosa-Heredia, Héctor , Camacho-Aguirre, Ana Yetzin , Valdez-Ortiz, Ángel , Cantú Quintanilla, Guillermo Rafael , Gómez-Guerrero, Irma , Reding, Arturo , Pérez-Navarro, Monserrat , Obrador, Gregorio , Correa-Rotter, Ricardo

Despite a systematic increase in the coverage of patients with end-stage renal disease (ESRD) who have received dialytic therapies and transplantation over the past 2 decades, the Mexican health system currently still does not have a program to provide full coverage of ESRD. Our aim was to analyze mortality in patients with ESRD without health insurance.

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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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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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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.

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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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Anemia: An early complication of chronic renal insufficiency

2001 , Kazmi, Waqar H. , Kausz, Annamaria T. , Khan, Samina , Abichandani, Rekha , Ruthazer, Robin , Obrador, Gregorio , Pereira, Brian J.G.

The strong association between anemia and cardiovascular complications among patients with end-stage renal disease suggests that anemia during chronic renal insufficiency (CRI) may also have important consequences. We performed a retrospective cohort study to identify factors associated with severe anemia (hematocrit [Hct] < 30%) and examine anemia management practices in CRI. The CRI cohort was composed of 604 adult patients with elevated serum creatinine levels. There was a direct correlation between predicted glomerular filtration rate and Hct (r = 0.49) and an inverse correlation between serum creatinine level and Hct (r = −0.37). Anemia was noted early in CRI; 45% of patients with serum creatinine levels of 2 mg/dL or less had an Hct less than 36%, and 8% had an Hct less than 30%. During the course of the study, mean Hct decreased from 35.1% ± 5.6% to 31.8% ± 5.6%. Iron studies were obtained in only 19% of patients, and among these, the prevalence of iron deficiency (transferrin saturation < 20%) was 54%. Only 30% and 26% of patients were administered recombinant human erythropoietin (rHuEPO) and iron, respectively. Multivariate analyses showed that diabetes as the cause of renal disease, greater serum creatinine level, and having a single nephrology visit were associated with greater odds for the presence of anemia. A lower Hct and having a single nephrology visit were associated with greater odds for rHuEPO use. These results show that anemia begins early in the course of CRI, and management of anemia is suboptimal, even among patients under the care of nephrologists. Educational programs to optimize anemia management among patients with CRI are needed. © 2001 by the National Kidney Foundation, Inc.

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Prevalence of chronic kidney disease in the Kidney Early Evaluation Program (KEEP) México and comparison with KEEP US

2010 , Obrador, Gregorio , García-García, Guillermo , Villa, Antonio R. , Rubilar, Ximena , Olvera, Nadia , Ferreira, Evangelina , Virgen, Margarita , Gutiérrez-Padilla, José Alfonso , Plascencia-Alonso, Melissa , Mendoza-García, Martha , Plascencia-Pérez, Salvador

The National Kidney Foundation Kidney Early Evaluation Program (KEEP) is a free community screening program aimed at early detection of kidney disease among high-risk individuals. A pilot phase of KEEP México began in 2008 in México City and Jalisco State. Adults with diabetes, hypertension, or family history of diabetes, hypertension, or chronic kidney disease (CKD) were invited to participate through advertising campaigns. All participants completed a questionnaire. Blood pressure, weight, and height were measured; blood and urine tests included albuminuria and serum creatinine to estimate glomerular filtration rate using the Modification of Diet in Renal Disease Study equation. Mean age of KEEP México City and KEEP Jalisco participants was 46 and 53 years, respectively; >70% were women. CKD prevalence was 22% in KEEP México City and 33% in KEEP Jalisco, not significantly different from reported KEEP US prevalence of 26%. CKD stages 1 and 2 were more frequent in KEEP México and stage 3 in KEEP US. In KEEP México City, CKD prevalence was higher than the overall prevalence among participants with diabetes (38%) or diabetes and hypertension (42%). Most KEEP México participants were unaware of the CKD diagnosis, despite that 71% in KEEP México City had seen a doctor in the previous year. CKD is highly prevalent, underdiagnosed, and underrecognized among high-risk individuals in México. KEEP is an effective screening program that can successfully be adapted for use in México.

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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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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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Genetic and environmental risk factors for chronic kidney disease

2017 , Obrador, Gregorio , Schultheiss, Ulla T. , Kretzler, Matthias , Langham, Robyn G. , Nangaku, Masaomi , Pecoits-Filho, Roberto , Pollock, Carol , Rossert, Jerome , Correa-Rotter, Ricardo , Stenvinkel, Peter , Walker, Robert , Yang, Chih-Wei , Fox, Caroline S. , Köttgen, Anna

In order to change the current state of chronic kidney disease knowledge and therapeutics, a fundamental improvement in the understanding of genetic and environmental causes of chronic kidney disease is essential. This article first provides an overview of the existing knowledge gaps in our understanding of the genetic and environmental causes of chronic kidney disease, as well as their interactions. The second part of the article formulates goals that should be achieved in order to close these gaps, along with suggested timelines and stakeholders that are to be involved. A better understanding of genetic and environmental factors and their interactions that influence kidney function in healthy and diseased conditions can provide novel insights into renal physiology and pathophysiology and result in the identification of novel therapeutic or preventive targets to tackle the global public health care problem of chronic kidney disease. © Kidney International Supplements.