Clinical Trials

Date: 2016-11-24

Type of information: Initiation of the trial

phase: 3

Announcement: initiation of the trial

Company: GSK (UK)

Product: daprodustat

Action mechanism: hypoxia inducible factor (HIF) inhibitor. Daprodustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor. Prolyl hydroxylase inhibition promotes the production of red blood cells that carry oxygen to where it is needed, similar to the effects that occur in the body at high altitude.

Disease: anemia associated with chronic kidney disease

Therapeutic area: Kidney diseases - Renal diseases

Country: NCT02876835: Argentina,Australia,Austria,Belgium,Brazil,Bulgaria,Canada,Czechia,Denmark,Estonia,France,Germany,Greece,Hungary,Israel,Italy,Republic of Korea,Mexico,Netherlands,New Zealand,Poland,Portugal,Romania,Russian Federation, Singapore,South Africa,Spain,Sweden,Taiwan,Thailand,Turkey,Ukraine,UK, USA - NCT02879305 : Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Czechia, Denmark, Estonia, France, Germany, Greece, Israel, Italy, Republic of Korea, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russian Federation, Spain, Sweden, Taiwan, Ukraine, UK, USA

Trial details: The ASCEND-D study (Anaemia Studies in CKD: Erythropoiesis via a Novel PHI Daprodustat-Dialysis) is a randomised, open-label (sponsor blind), active-controlled, parallel-group, multi-centre, event-driven study in dialysis subjects with anaemia associated with chronic kidney disease to evaluate the safety and efficacy of daprodustat compared to recombinant human erythropoietin, following a switch from an erythropoietin-stimulating agent. The study aims to randomise approximately 3,000 subjects (1,500 per treatment arm). (NCT02879305). The ASCEND-ND study (Anaemia Studies in CKD: Erythropoiesis via a Novel PHI Daprodustat-Non-Dialysis) is a randomised, open-label (sponsor blind) active-controlled, parallel-group, multi-centre, event-driven study in non-dialysis subjects with anaemia associated with chronic kidney disease to evaluate the safety and efficacy of daprodustat compared to recombinant human erythropoietin. The study aims to randomise approximately 4,500 subjects (2,250 subjects per treatment arm). (NCT02876835).

Latest news:  

• • On November 24, 2016, GSK announced the start of a phase III development programme investigating daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), as a treatment for anaemia associated with chronic kidney disease (CKD).
• The phase III programme includes two studies evaluating the safety and efficacy of daprodustat compared to recombinant human erythropoietin:
• ASCEND-D (Anaemia Studies in CKD: Erythropoiesis via a Novel PHI Daprodustat-Dialysis) will enrol approximately 3,000 dialysis dependent subjects with anaemia associated with CKD switching from an erythropoietin-stimulating agent (ESA). ASCEND-ND (Anaemia Studies in CKD: Erythropoiesis via a Novel PHI Daprodustat-Non-Dialysis) will enrol approximately 4,500 non-dialysis dependent subjects with anaemia associated with CKD, and will include patients either switching from or naive to an ESA.
• For both studies, the co-primary endpoints are time to first occurrence of major adverse cardiovascular events and mean change in haemoglobin between the baseline and efficacy period (mean over Weeks 28-52). The studies will assess whether daprodustat is non-inferior to recombinant human erythropoietin on these endpoints as the primary analysis. If non-inferiority of the primary analysis is met, superiority will be assessed for the safety endpoint.
• The design of the phase III programme is based upon data from phase II clinical trials that were designed to characterise the dose-response relationship between daprodustat and haemoglobin at 4 weeks and assess the safety and tolerability of daprodustat following once-daily administration up to 24 weeks. Data from the 24-week phase II studies were presented at the American Society of Nephrology Kidney Week congress in Chicago, Illinois, earlier in November.

   

Is general: Yes