The ASCEND-ND trial: study design and participant characteristics.
Nephrol Dial Transplant
; 37(11): 2157-2170, 2022 10 19.
Article
in En
| MEDLINE
| ID: mdl-34865143
ABSTRACT
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 (11) 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.RESULTS:
Overall, 3872 patients were randomized from 39 countries (median age 67 years, 56% female, 56% White, 27% Asian and 10% Black). The median baseline Hb was 9.9 g/dL, blood pressure was 135/74 mmHg and estimated glomerular filtration rate was 18 mL/min/1.73 m2. Among randomized patients, 53% were ESA non-users, 57% had diabetes and 37% had a history of CV disease. At baseline, 61% of participants were using renin-angiotensin system blockers, 55% were taking statins and 49% were taking oral iron. Baseline demographics were similar to those in other large non-dialysis anaemia trials.CONCLUSION:
ASCEND-ND will define the efficacy and safety of daprodustat compared with darbepoetin alfa in the treatment of patients with anaemia associated with CKD not on dialysis.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Erythropoietin
/
Hydroxymethylglutaryl-CoA Reductase Inhibitors
/
Renal Insufficiency, Chronic
/
Prolyl-Hydroxylase Inhibitors
/
Hematinics
/
Anemia
Type of study:
Clinical_trials
/
Etiology_studies
Limits:
Aged
/
Female
/
Humans
/
Male
Language:
En
Journal:
Nephrol Dial Transplant
Journal subject:
NEFROLOGIA
/
TRANSPLANTE
Year:
2022
Document type:
Article
Affiliation country:
Australia
Publication country:
ENGLAND
/
ESCOCIA
/
GB
/
GREAT BRITAIN
/
INGLATERRA
/
REINO UNIDO
/
SCOTLAND
/
UK
/
UNITED KINGDOM