NCT03552393

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.

An Open-Label, Single-Arm, Multicenter Study to Ascertain the Optimal Starting Dose of MIRCERA® Given Subcutaneously for the Maintenance Treatment of Anemia in Pediatric Patients With Chronic Kidney Disease on Dialysis or Not Yet on Dialysis.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 3 Months – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anemia
• Renal Insufficiency, Chronic

Interventions

Type	Name	Description
DRUG	Mircera	The initial dose of Mircera will be one of nine starting doses corresponding to the prefilled syringe strengths based on the total weekly erythropoiesis-stimulating agent (ESA) dose during the screening period.

Timeline

• Start date: 2018-08-03
• Primary completion: 2021-07-19
• Completion: 2021-07-19
• First posted: 2018-06-11
• Last updated: 2022-03-07
• Results posted: 2022-03-07

Locations

22 sites across 7 countries: United States, France, Hungary, Italy, Lithuania, Poland, Spain

Regulatory

• FDA-regulated drug study