Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Repeat Dose, Open Label, Parallel Group, Multi-center Study to Evaluate the Effect of Daprodustat Compared to Darbepoetin Alfa on Forearm Blood Flow in Participants With Anemia of Chronic Kidney Disease That Are Not Dialysis Dependent
Brief Summary: Daprodustat has demonstrated an ability to effectively raise hemoglobin concentrations with lower erythropoietin (EPO) levels than those observed after administration of recombinant human erythropoietin (rhEPOs). Therefore, daprodustat has the potential to treat anemia of chronic kidney disease (CKD) with a lower cardiovascular (CV) risk than is observed with the rhEPOs. While the effect of rhEPOs on endothelial function has been assessed, to date the effect of daprodustat or other prolyl hydroxylase inhibitor (PHI) compounds on endothelial function has not. Therefore, the purpose of this study is to compare the effect of daprodustat to darbepoetin alfa on endothelial function by assessing FBF in participants with anemia of CKD by using venous occlusion plethysmography as a means to estimate the potential for daprodustat to have a lower risk of CV events as compared to rhEPO.

This study will use a randomized, repeat dose, open label, parallel group design, in adult, not on-dialysis, male and female participants with anemia of CKD that are currently not treated with rhEPOs.

The study will comprise of three study periods: a screening period starting up to 30 days prior to Day 1, a 42 day (6 week) treatment period, and a follow-up visit up to 14 days later. The total duration of participants involvement is up to 14 weeks (including screening and follow up visit). Approximately 50 participants will be randomized to either daprodustat or darbepoetin alfa.


Options:
A: Arm Label: Daprodustat; Type: EXPERIMENTAL; Interventions: Drug: Daprodustat, Drug: Placebo, Drug: Iron Therapy | Arm Label: Darbepoetin alfa; Type: ACTIVE_COMPARATOR; Interventions: Drug: Darbepoetin alfa, Drug: Placebo, Drug: Iron Therapy | Intervention Type: DRUG; Name: Daprodustat; Assigned to Arm(s): Daprodustat | Intervention Type: DRUG; Name: Darbepoetin alfa; Assigned to Arm(s): Darbepoetin alfa | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Daprodustat, Darbepoetin alfa | Intervention Type: DRUG; Name: Iron Therapy; Assigned to Arm(s): Daprodustat, Darbepoetin alfa
B: Arm Label: Participants receiving Daprodustat; Type: EXPERIMENTAL; Interventions: Drug: Daprodustat, Drug: Acetylcholine, Drug: Sodium nitroprusside, Drug: L-N-monomethyl arginine acetate (L-NMMA) | Arm Label: Participants receiving Darbepoetin alfa; Type: ACTIVE_COMPARATOR; Interventions: Drug: Darbepoetin alfa, Drug: Acetylcholine, Drug: Sodium nitroprusside, Drug: L-N-monomethyl arginine acetate (L-NMMA) | Intervention Type: DRUG; Name: Daprodustat; Assigned to Arm(s): Participants receiving Daprodustat | Intervention Type: DRUG; Name: Darbepoetin alfa; Assigned to Arm(s): Participants receiving Darbepoetin alfa | Intervention Type: DRUG; Name: Acetylcholine; Assigned to Arm(s): Participants receiving Daprodustat, Participants receiving Darbepoetin alfa | Intervention Type: DRUG; Name: Sodium nitroprusside; Assigned to Arm(s): Participants receiving Daprodustat, Participants receiving Darbepoetin alfa | Intervention Type: DRUG; Name: L-N-monomethyl arginine acetate (L-NMMA); Assigned to Arm(s): Participants receiving Daprodustat, Participants receiving Darbepoetin alfa
C: Arm Label: Molidustat (BAY85-3934); Type: EXPERIMENTAL; Interventions: Drug: Molidustat (BAY85-3934) | Intervention Type: DRUG; Name: Molidustat (BAY85-3934); Assigned to Arm(s): Molidustat (BAY85-3934)
D: Arm Label: GSK1278863 4 mg; Type: EXPERIMENTAL; Interventions: Drug: GSK1278863 | Arm Label: GSK1278863 6 mg; Type: EXPERIMENTAL; Interventions: Drug: GSK1278863 | Arm Label: GSK1278863 8 mg; Type: EXPERIMENTAL; Interventions: Drug: GSK1278863 | Arm Label: GSK1278863 10 mg; Type: EXPERIMENTAL; Interventions: Drug: GSK1278863 | Arm Label: GSK1278863 12 mg; Type: EXPERIMENTAL; Interventions: Drug: GSK1278863 | Arm Label: Control; Type: ACTIVE_COMPARATOR; Interventions: Drug: Placebo, Drug: rhEPO | Intervention Type: DRUG; Name: GSK1278863; Assigned to Arm(s): GSK1278863 10 mg, GSK1278863 12 mg, GSK1278863 4 mg, GSK1278863 6 mg, GSK1278863 8 mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Control | Intervention Type: DRUG; Name: rhEPO; Assigned to Arm(s): Control

Answer: B