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NCT03552393 · FLOW

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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. · Source last updated 2022-03-07

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Mircera was administered subcutaneously once every 4 weeks.
    id
    FG000
    title
    Mircera
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Kidney Transplant
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Prohibited Medication
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        40
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        38
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Core Period
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Kidney Transplant
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        25
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        21
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      type
      NOT COMPLETED
    title
    Safety Extension Period
pre Assignment Details
A total of 40 pediatric participants (ages 3 months to 17 years) with a diagnosis of anemia due to chronic kidney disease (CKD) who may or may not have been on dialysis at the time of study start were switched from stable subcutaneous (SC) maintenance treatment with epoetin alfa/beta or darbepoetin to methoxy polyethylene glycol-epoetin beta (Mircera).
recruitment Details
The core study was 23 weeks and consisted of three periods: screening (3 weeks), dose titration (16 weeks) and evaluation (4 weeks). Participants completing the 20 weeks of treatment with hemoglobin (Hb) within +/- 1g/dL of their baseline and within the target range of 10-12 g/dL were eligible to enter an optional 24-week safety extension period.
Complete source fields
groups
  1. description
    Mircera was administered subcutaneously once every 4 weeks.
    id
    FG000
    title
    Mircera
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Kidney Transplant
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Prohibited Medication
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        40
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        38
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Core Period
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Kidney Transplant
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        25
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        21
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      type
      NOT COMPLETED
    title
    Safety Extension Period
pre Assignment Details
A total of 40 pediatric participants (ages 3 months to 17 years) with a diagnosis of anemia due to chronic kidney disease (CKD) who may or may not have been on dialysis at the time of study start were switched from stable subcutaneous (SC) maintenance treatment with epoetin alfa/beta or darbepoetin to methoxy polyethylene glycol-epoetin beta (Mircera).
recruitment Details
The core study was 23 weeks and consisted of three periods: screening (3 weeks), dose titration (16 weeks) and evaluation (4 weeks). Participants completing the 20 weeks of treatment with hemoglobin (Hb) within +/- 1g/dL of their baseline and within the target range of 10-12 g/dL were eligible to enter an optional 24-week safety extension period.

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Preserved source evidence · Not medical advice