A Study to Investigate the Effect of Roxadustat Versus Recombinant Human Erythropoietin (rHuEPO) on Oral Iron Absorption in Chinese Patients With Anemia of Chronic Kidney Disease (CKD)

Phase 4 Completed 25 enrolled AstraZeneca Parexel · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a Phase IV, randomized, active-controlled, open-label, parallel design, multicenter prospective study to evaluate the effect of roxadustat versus rHuEPO treatment on the gastrointestinal (GI) iron absorption in patients with anemia of Stage 4 and Stage 5 CKD.

Timeline

Start: 2021-02-22
Primary completion: 2021-10-12
Completion: 2021-10-12

Outcome

Missed primary endpoint

registry analysis (other test); Roxadustat vs rHuEPO; p = 0.212; Difference in Estimate (LSM) 19.50 (95% CI -11.155 to 50.150); ANCOVA NCT04655027 ↗

paper Change from baseline to day 15 in serum iron AUC0-3h was not statistically significantly different between the roxadustat and rHuEPO groups. PMID 38280066 ↗

Publications

Wu H, Cheng H, Wang C, Yao L, Qin S, Zuo L, Hu Z, Zhang C, Wu Y, Hofherr A, Mohan K, Rush S, Li X. Roxadustat and Oral Iron Absorption in Chinese Patients with Anemia of Chronic Kidney Disease: A Randomized, Open-Label, Phase 4 Study (ALTAI). Adv Ther. 2024 Mar;41(3):1168-1183. doi: 10.1007/s12325-023-02741-5. Epub 2024 Jan 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Roxadustat	Small molecule	70 mg	Oral
Subject	Roxadustat	Small molecule	100 mg	Oral
Subject	Roxadustat	Small molecule	120 mg	Oral
Comparator	rHuEPO	Protein / enzyme biologic	6000 iu	Intravenous