CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Mirceradrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03552393
NCT03552393Phase 2Completed
CompareCT.gov

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.

Hoffmann-La Roche·interventional·Posted Jun 11, 2018·Updated Mar 7, 2022

In Brief

A Phase 2 clinical trial evaluating Mircera for Anemia and Renal Insufficiency, Chronic. Completed, enrolled 40 participants across 22 sites in 7 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnemia, Renal Insufficiency, Chronic
CountriesFrance, Hungary, Italy, Lithuania, Poland, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJun 11, 2018
Enrollment StartAug 3, 2018
Primary CompletionJul 19, 2021
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 8.1 years ago

Interventions

Mirceradrug

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.