Anemia Studies in CKD: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat- Iron (ASCEND: Fe)
Status:
Recruiting
Trial end date:
2021-11-10
Target enrollment:
Participant gender:
Summary
Daprodustat administration has the potential, by virtue of increasing hypoxia-inducible
factor (HIF) levels, to increase oral iron absorption and incorporation into hemoglobin
(Hgb). Therefore, the purpose of this study is to compare the effect of daprodustat to rhEPO
(i.e., epoetin alfa or darbepoetin alfa) on non-heme oral iron absorption using stable
isotopic iron (57Fe and 58Fe) by measuring incorporation of iron in erythrocytes. This study
will be a randomized, repeat dose, open label, two period cross-over study in adult, male and
female participants with anemia associated with chronic kidney disease who are not on
dialysis currently treated with stable doses less than or equal to (<=) 50 percent (%) change
in 4-weekly dose) for at least 8 weeks prior to and including the screening period, of rhEPO
(i.e., epoetin alfa or darbepoetin alfa). Sufficient participants will be enrolled such that
at least 12 participants comprise the Evaluable Population. The study will compare the
fractional iron absorption between treatment arms (daprodustat and rhEPO [i.e., epoetin alfa
or darbepoetin alfa]) and will evaluate the difference is equal/not equal to zero.
Approximate duration of study participation will be up to 73 days.
Phase:
Phase 2
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Darbepoetin alfa Epoetin Alfa Iron Proton Pump Inhibitors