Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00559273 · OUTCOME

Change in Hemoglobin (Hb) Concentration Between Baseline and Evaluation Period

A Study of Subcutaneous Mircera Once Monthly in the Treatment of Anemia in Participants With Chronic Kidney Disease Not on Dialysis · Source last updated 2016-11-01

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

Measure
MEAN
Unit
g/dL
Interval / dispersion
Standard Deviation
Time frame
Baseline (measurements at Week -2, Week -1 and Day 1) and Evaluation Period (Week 22, Week 24, Week 26, Week 28)

What was measured

A time adjusted average baseline Hb concentration was calculated using the trapezoid rule from all available Hb measurements taken during the baseline period. The average evaluation period Hb concentration for each individual was calculated using the same method, from all their available measurements taken during the 2 month evaluation period (Week 21 to 28). The change in Hb concentration between the baseline and evaluation period was calculated by subtracting the baseline Hb from the evaluation period Hb. All blood samples for Hb measurements were taken prior to study drug administration.

Analysis population: ITT population. Here, N (number of participants analyzed)=participants evaluable for this measure. Missing data were imputed using last value carried forward.

Groups in this outcome

Mircera

Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.

Darbepoetin Alfa

Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Mircera150
Darbepoetin Alfa151

Reported measurements

Source class 1
Values in g/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mircera1.661.18Not reportedNot reportedNot reported
Darbepoetin Alfa1.690.95Not reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    -0.252
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.180
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    0.1097
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    MIRCERA treatment was regarded as non-inferior to the darbepoetin alfa reference group if the lower limit of the CI was greater than -0.75 g/dL.
    non Inferiority Type
    NON_INFERIORITY_OR_EQUIVALENCE
    p Value
    <0.0001
    param Type
    Adjusted Mean Difference
    param Value
    -0.036
    statistical Method
    ANCOVA
    tested Non Inferiority
    true
Complete source fields
analyses
  1. ci Lower Limit
    -0.252
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.180
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    0.1097
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    MIRCERA treatment was regarded as non-inferior to the darbepoetin alfa reference group if the lower limit of the CI was greater than -0.75 g/dL.
    non Inferiority Type
    NON_INFERIORITY_OR_EQUIVALENCE
    p Value
    <0.0001
    param Type
    Adjusted Mean Difference
    param Value
    -0.036
    statistical Method
    ANCOVA
    tested Non Inferiority
    true
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.18
        value
        1.66
      2. group Id
        OG001
        spread
        0.95
        value
        1.69
denoms
  1. counts
    1. group Id
      OG000
      value
      150
    2. group Id
      OG001
      value
      151
    units
    Participants
description
A time adjusted average baseline Hb concentration was calculated using the trapezoid rule from all available Hb measurements taken during the baseline period. The average evaluation period Hb concentration for each individual was calculated using the same method, from all their available measurements taken during the 2 month evaluation period (Week 21 to 28). The change in Hb concentration between the baseline and evaluation period was calculated by subtracting the baseline Hb from the evaluation period Hb. All blood samples for Hb measurements were taken prior to study drug administration.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
    id
    OG000
    title
    Mircera
  2. description
    Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
    id
    OG001
    title
    Darbepoetin Alfa
param Type
MEAN
population Description
ITT population. Here, N (number of participants analyzed)=participants evaluable for this measure. Missing data were imputed using last value carried forward.
reporting Status
POSTED
time Frame
Baseline (measurements at Week -2, Week -1 and Day 1) and Evaluation Period (Week 22, Week 24, Week 26, Week 28)
title
Change in Hemoglobin (Hb) Concentration Between Baseline and Evaluation Period
type
PRIMARY
unit Of Measure
g/dL

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice