NCT04707768

Study Evaluating the Efficacy and Safety of Dose Conversion From a Long-acting Erythropoiesis-stimulating Agent (Mircera®) to Three Times Weekly Oral Vadadustat for the Maintenance Treatment of Anemia in Hemodialysis Subjects

A Randomized, Open-label, Active-controlled Study Evaluating the Efficacy and Safety of Dose Conversion From a Long-acting Erythropoiesis-stimulating Agent (Mircera®) to Three Times Weekly Oral Vadadustat for the Maintenance Treatment of Anemia in Hemodialysis Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 456 (actual)
• Sponsor: Akebia Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will be conducted to demonstrate the efficacy and safety of vadadustat administered three times weekly (TIW) compared to a long-acting erythropoiesis-stimulating agent (ESA) (Mircera®) for the maintenance treatment of anemia in hemodialysis participants.

Detailed description

Following randomization, there will be 2 periods during the study: * Conversion and Maintenance Period (Weeks 0 to 52): There will be a primary efficacy evaluation period (Weeks 20 to 26) and a secondary efficacy evaluation period (Weeks 46 to 52). * Safety Follow-up Period (Early Termination \[ET\] and Follow-Up): post-treatment safety follow-up visit (ET/End of Treatment \[EOT\] +4 weeks) either in person or via telephone.

Conditions

• Anemia Associated With Chronic Kidney Disease (CKD)

Interventions

Type	Name	Description
DRUG	Vadadustat	oral tablets
DRUG	Mircera®	intravenous administration

Timeline

• Start date: 2021-06-18
• Primary completion: 2023-01-06
• Completion: 2023-01-30
• First posted: 2021-01-13
• Last updated: 2025-01-15
• Results posted: 2025-01-15

Locations

58 sites across 1 country: United States

Regulatory

• FDA-regulated drug study