NCT05301517

A Study to Evaluate the Efficacy and Safety of Roxadustat for the Treatment of Anemia in Participants Receiving Chemotherapy Treatment for Non-Myeloid Malignancies

A Randomized, Open-label, Active-controlled, Multicenter Phase 3 Study to Investigate the Efficacy and Safety of Roxadustat for Treatment of Anemia in Subjects Receiving Chemotherapy Treatment for Non-Myeloid Malignancies

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 159 (actual)
• Sponsor: Kyntra Bio · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main goal of this study is to evaluate the efficacy of roxadustat for treatment of anemia in participants with non-myeloid malignancies receiving multi-cycle treatments of myelosuppressive chemotherapy.

Detailed description

Participants who are eligible for participation will be randomized to roxadustat and SEPO® (recombinant human erythropoietin-α \[rHuEPO-α\]), and undergo a 12-week treatment period followed by a 4-week follow-up period.

Conditions

• Chemotherapy Induced Anemia

Interventions

Type	Name	Description
DRUG	SEPO®	SEPO® will be administered per dose and schedule specified in the arm description.
DRUG	Roxadustat	Roxadustat will be administered per dose and schedule specified in the arm description.

Timeline

• Start date: 2022-03-16
• Primary completion: 2023-04-03
• Completion: 2023-04-21
• First posted: 2022-03-29
• Last updated: 2023-06-06

Locations

45 sites across 1 country: China