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Obrador, Gregorio
The ASCEND-ND trial: study design and participant characteristics
How important is transfusion avoidance in 2013?
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.
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.