Please select the arm or intervention descriptions that belong to the clinical trial below.
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
Brief 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.


Options:
A: Arm Label: AKB-6548 240 mg; Type: EXPERIMENTAL; Interventions: Drug: AKB-6548 | Arm Label: AKB-6548 370 mg; Type: EXPERIMENTAL; Interventions: Drug: AKB-6548 | Arm Label: AKB-6548 500 mg; Type: EXPERIMENTAL; Interventions: Drug: AKB-6548 | Arm Label: AKB-6548 630 mg; Type: EXPERIMENTAL; Interventions: Drug: AKB-6548 | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: AKB-6548; Assigned to Arm(s): AKB-6548 240 mg, AKB-6548 370 mg, AKB-6548 500 mg, AKB-6548 630 mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
B: Arm Label: Daprodustat in ND participants; Type: EXPERIMENTAL; Interventions: Drug: 1 to 4 mg tablets of GSK1278863, Drug: 6 mg GSK1278863 tablet | Arm Label: Epoetin beta pegol in ND participants; Type: ACTIVE_COMPARATOR; Interventions: Drug: Epoetin beta pegol | Arm Label: Daprodustat in PD participants; Type: EXPERIMENTAL; Interventions: Drug: 1 to 4 mg tablets of GSK1278863, Drug: 6 mg GSK1278863 tablet | Intervention Type: DRUG; Name: 1 to 4 mg tablets of GSK1278863; Assigned to Arm(s): Daprodustat in ND participants, Daprodustat in PD participants | Intervention Type: DRUG; Name: 6 mg GSK1278863 tablet; Assigned to Arm(s): Daprodustat in ND participants, Daprodustat in PD participants | Intervention Type: DRUG; Name: Epoetin beta pegol; Assigned to Arm(s): Epoetin beta pegol in ND participants
C: Arm Label: Daprodustat; Type: EXPERIMENTAL; Interventions: Drug: Daprodustat, Drug: Placebo, Drug: Iron therapy | Arm Label: rhEPO; Type: ACTIVE_COMPARATOR; Interventions: Drug: rhEPO, Drug: Placebo, Drug: Iron therapy | Intervention Type: DRUG; Name: Daprodustat; Assigned to Arm(s): Daprodustat | Intervention Type: DRUG; Name: rhEPO; Assigned to Arm(s): rhEPO | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Daprodustat, rhEPO | Intervention Type: DRUG; Name: Iron therapy; Assigned to Arm(s): Daprodustat, rhEPO
D: Arm Label: rhEPO+57Fe followed by Daprodustat+58Fe; Type: EXPERIMENTAL; Interventions: Drug: Daprodustat, Drug: rhEPO, Drug: Ferrous sulfate containing the stable iron isotope (57Fe), Drug: Ferrous sulfate containing the stable iron isotope (58Fe) | Arm Label: rhEPO+58Fe followed by Daprodustat+57Fe; Type: EXPERIMENTAL; Interventions: Drug: Daprodustat, Drug: rhEPO, Drug: Ferrous sulfate containing the stable iron isotope (57Fe), Drug: Ferrous sulfate containing the stable iron isotope (58Fe) | Arm Label: Daprodustat+57Fe followed by rhEPO+58Fe; Type: EXPERIMENTAL; Interventions: Drug: Daprodustat, Drug: rhEPO, Drug: Ferrous sulfate containing the stable iron isotope (57Fe), Drug: Ferrous sulfate containing the stable iron isotope (58Fe) | Arm Label: Daprodustat+58Fe followed by rhEPO+57Fe; Type: EXPERIMENTAL; Interventions: Drug: Daprodustat, Drug: rhEPO, Drug: Ferrous sulfate containing the stable iron isotope (57Fe), Drug: Ferrous sulfate containing the stable iron isotope (58Fe) | Intervention Type: DRUG; Name: Daprodustat; Assigned to Arm(s): Daprodustat+57Fe followed by rhEPO+58Fe, Daprodustat+58Fe followed by rhEPO+57Fe, rhEPO+57Fe followed by Daprodustat+58Fe, rhEPO+58Fe followed by Daprodustat+57Fe | Intervention Type: DRUG; Name: rhEPO; Assigned to Arm(s): Daprodustat+57Fe followed by rhEPO+58Fe, Daprodustat+58Fe followed by rhEPO+57Fe, rhEPO+57Fe followed by Daprodustat+58Fe, rhEPO+58Fe followed by Daprodustat+57Fe | Intervention Type: DRUG; Name: Ferrous sulfate containing the stable iron isotope (57Fe); Assigned to Arm(s): Daprodustat+57Fe followed by rhEPO+58Fe, Daprodustat+58Fe followed by rhEPO+57Fe, rhEPO+57Fe followed by Daprodustat+58Fe, rhEPO+58Fe followed by Daprodustat+57Fe | Intervention Type: DRUG; Name: Ferrous sulfate containing the stable iron isotope (58Fe); Assigned to Arm(s): Daprodustat+57Fe followed by rhEPO+58Fe, Daprodustat+58Fe followed by rhEPO+57Fe, rhEPO+57Fe followed by Daprodustat+58Fe, rhEPO+58Fe followed by Daprodustat+57Fe

Answer: D