Study design and baseline characteristics of patients on dialysis in the ASCEND-D trial.
Nephrol Dial Transplant
; 37(5): 960-972, 2022 04 25.
Article
em En
| MEDLINE
| ID: mdl-33744933
ABSTRACT
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.RESULTS:
The median age of patients was 58 years, 43% were female; 67% were White and 16% were Black. The median Hb at baseline was 10.4 g/dL. Among randomized patients, 89% were receiving hemodialysis and 11% peritoneal dialysis. Among key comorbidities, 42% reported a history of diabetes mellitus and 45% a history of CV disease. Median blood pressure was 134/74 mmHg. The median weekly dose of epoetin was 5751 units. Intravenous and oral iron uses were noted in 64 and 11% of patients, respectively. Baseline demographics were similar to patients with CKD G5D enrolled in other CVOTs and renal patient registries.CONCLUSIONS:
ASCEND-D will evaluate the efficacy and safety of daprodustat compared with epoetin alfa or darbepoetin alfa in the treatment of patients with anemia with CKD G5D.This trial is registered with ClinicalTrials.gov NCT02879305. EudraCT Number 2016-000541-31; Sponsor Protocol Number 200807.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Eritropoetina
/
Insuficiência Renal Crônica
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Hematínicos
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Anemia
Tipo de estudo:
Clinical_trials
/
Etiology_studies
/
Guideline
Limite:
Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Nephrol Dial Transplant
Ano de publicação:
2022
Tipo de documento:
Article