Anemia Studies in CKD: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat- Iron (ASCEND: Fe)

Anemia Studies in CKD: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat- Iron (ASCEND: Fe)

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.


Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Participants will be randomly assigned either to remain on their current therapy (either epoetin alfa or darbepoetin alfa) or be switched to daprodustat in either of the treatment periods.
Masking: None (Open Label)
Masking Description: This is an Open-label study.
Primary Purpose: Treatment
Official Title: A Repeat Dose, Open Label, Two Period, Randomized, Cross Over Study to Compare the Effect of Daprodustat to Recombinant, Human Erythropoietin (rhEPO) on Oral Iron Absorption in Adult Participants With Anemia Associated With Chronic Kidney Disease Who Are Not on Dialysis
Actual Study Start Date: July 30, 2019
Estimated Primary Completion Date: June 3, 2022
Estimated Study Completion Date: June 3, 2022

Arm:
- Experimental: rhEPO+57Fe followed by Daprodustat+58Fe
- Experimental: rhEPO+58Fe followed by Daprodustat+57Fe
- Experimental: Daprodustat+57Fe followed by rhEPO+58Fe
- Experimental: Daprodustat+58Fe followed by rhEPO+57Fe

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