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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
University of Alabama at Birmingham; Pediatric Nephrology
Change in Hemoglobin (Hb) Concentration Between the Baseline and the Evaluation Period for Each Patient
The Hb change from baseline was calculated on a per-participant basis using an individual's average for both the baseline and evaluation periods and taking the difference. The baseline period was defined as the time between the day of first study dose and the previous 35 days. The evaluation period was defined as the period between Week 17 and Week 21, inclusive.
Time frame: Baseline up to Week 21
Number of Participants With an Average Hb Concentration During the Evaluation Period Within ± 1 g/dL of Their Baseline Hb and Above, Within or Below the Range of 10-12 g/dL
Number of participants with an average Hb concentration during the evaluation period within ± 1 g/dL of their baseline Hb is reported as well as the number of participants with an average Hb concentration above, within or below the range of 10-12 g/dL. The evaluation period was defined as the period between Week 17 and Week 21 inclusive.
Time frame: Week 17 up to Week 21
Mean Hb Values and Change From Baseline
The mean Hb concentration over time and the mean change in Hb from baseline over time are presented.
Time frame: Baseline, Weeks 3, 5, 9, 13, 17, 19, 21, 25, 29, 33, 37, 41, 45
Change in Mircera Dose Over Time
A dose change was defined as a change in the administered dose strength compared to the preceding dose.
Time frame: Week 1 to Week 17
Ratio of Mircera Starting Dose (Week 1) to the Dose at Week 17
The ratio of Mircera dose was calculated as the median (min-max) ratio of starting dose (Week 1) to the dose at Week 17. Participants who withdrew before Week 17 or who were not administered a Mircera dose at Week 17 visit due to the applicable dose adjustment rules were excluded from the ratio computation.
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Birmingham, Alabama, United States
Loma Linda University health
Loma Linda, California, United States
Emory University School of Med; Pediatrics
Atlanta, Georgia, United States
Children'S Mercy Hospital; Pediatric Nephrology
Kansas City, Missouri, United States
RWJBarnabas Health
West Orange, New Jersey, United States
East Carolina University; Brody School of Medicine
Greenville, North Carolina, United States
UT Southwestern Medical Center; Pediatrics Dept.
Dallas, Texas, United States
Hopital Jeanne De Flandre; Pediatrie
Lille, France
Gh Necker Enfants Malades; Nephrologie
Paris, France
Höpital Hautepierre; Pediatrie 1
Strasbourg, France
...and 12 more locations
Time frame: Week 1, Week 17
Number of Participants With Adverse Events by Severity as Assessed by Highest World Health Organization (WHO) Toxicity Grade
An adverse event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product, any new disease, or exacerbation of existing disease (a worsening in the character, frequency, or severity of a known condition), recurrence of an intermittent medical condition or any deterioration in a laboratory value or other clinical test.
Time frame: Baseline up to Week 45
Bioavailability (F) of Mircera in Pediatric Participants Based on Population PK Model
Bioavailability (F) is defined as the percentage of the administered drug, that reaches the systemic circulation. A population PK model was developed for Mircera that adequately describes pediatric data: a 1-compartment model with first order absorption and elimination processes. The bioavailability (F) was estimated using all the data points listed under time frame using the population PK model.
Time frame: Pre-dose at Week 1, 9, 17; Post-dose at Week 3, Week 19 and additional sample taken between 24 hours and 5 days at participant's convenience