Ascertain the Optimal Starting Dose of Mircera Given Subcutaneously for Maintenance Treatment of Anemia in Pediatric Patients With Chronic Kidney Disease on Dialysis or Not Yet on Dialysis.

Summary

Ascertain the starting dose of Mircera given subcutaneously for the maintenance treatment of anemia in pediatric participants with chronic kidney disease (CKD) on dialysis or not yet on dialysis when switching from stable subcutaneous (SC) maintenance treatment with epoetin alfa, epoetin beta, or darbepoetin alfa.

Timeline

Start

2018-08-03

Primary completion

2021-07-19

Completion

2021-07-19

Outcome

Met primary endpoint

paper The study achieved its primary outcome: the mean change in hemoglobin concentration was an increase of 0.48g/dL PMID 36587890 ↗

paper the 95% confidence interval (0.15-0.82) and standard deviation (±1.03) were within the prespecified boundaries (-1 to 1g/dL and<1.5g/dL, respectively). PMID 36587890 ↗

Publications

• Warady BA, Meyer Reigner S, Tirodkar C, Drozdz D. Subcutaneous C.E.R.A. for the Maintenance Treatment of Anemia in Pediatric Patients With CKD: A Phase 2, Open-Label, Single-Arm, Multicenter Study. Am J Kidney Dis. 2023 Jun;81(6):684-694.e1. doi: 10.1053/j.ajkd.2022.11.006. Epub 2022 Dec 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	methoxy polyethylene glycol-epoetin beta	Protein / enzyme biologic	—	Subcutaneous

Indications