Obrador, Gregorio
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Preferred name
Obrador, Gregorio
Official Name
Tomás Obrador Vera, Gregorio
Alternative Name
gobrador
Main Affiliation
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 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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