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NCT00559273 · OUTCOME

Hemoglobin (Hb) Concentration Over the Time

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, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and final visit (Week 29)

What was measured

The hemoglobin concentration was measured in g/dL every 2 weeks and at final visit.

Analysis population: ITT population. Here, n=number of evaluable participants at specified time point, respectively for each group.

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
Mircera153
Darbepoetin Alfa154

Reported measurements

Baseline (n=153, 154)
Values in g/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mircera9.530.74Not reportedNot reportedNot reported
Darbepoetin Alfa9.530.65Not reportedNot reportedNot reported
Week 2 (n=149, 151)
Values in g/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mircera10.220.91Not reportedNot reportedNot reported
Darbepoetin Alfa10.140.93Not reportedNot reportedNot reported
Week 4 (n=149, 148)
Values in g/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mircera10.371.17Not reportedNot reportedNot reported
Darbepoetin Alfa10.741.02Not reportedNot reportedNot reported
Week 6 (n=149, 148)
Values in g/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mircera10.941.23Not reportedNot reportedNot reported
Darbepoetin Alfa11.281.08Not reportedNot reportedNot reported
Week 8 (n=148, 147)
Values in g/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mircera11.081.29Not reportedNot reportedNot reported
Darbepoetin Alfa11.741.05Not reportedNot reportedNot reported
Week 10 (n=150, 146)
Values in g/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mircera11.361.27Not reportedNot reportedNot reported
Darbepoetin Alfa11.781.02Not reportedNot reportedNot reported
Week 12 (n=149, 145)
Values in g/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mircera11.241.17Not reportedNot reportedNot reported
Darbepoetin Alfa11.821.03Not reportedNot reportedNot reported
Week 14 (n=145, 143)
Values in g/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mircera11.531.11Not reportedNot reportedNot reported
Darbepoetin Alfa11.811.04Not reportedNot reportedNot reported
Week 16 (n=144, 145)
Values in g/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mircera11.501.16Not reportedNot reportedNot reported
Darbepoetin Alfa11.761.06Not reportedNot reportedNot reported
Week 18 (n=144, 141)
Values in g/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mircera11.411.04Not reportedNot reportedNot reported
Darbepoetin Alfa11.450.94Not reportedNot reportedNot reported
Week 20 (n=142, 140)
Values in g/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mircera11.140.92Not reportedNot reportedNot reported
Darbepoetin Alfa11.340.81Not reportedNot reportedNot reported
Week 22 (n=142, 138)
Values in g/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mircera11.391.02Not reportedNot reportedNot reported
Darbepoetin Alfa11.430.86Not reportedNot reportedNot reported
Week 24 (n=140, 140)
Values in g/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mircera11.060.98Not reportedNot reportedNot reported
Darbepoetin Alfa11.261.00Not reportedNot reportedNot reported
Week 26 (n=139, 136)
Values in g/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mircera11.170.96Not reportedNot reportedNot reported
Darbepoetin Alfa11.240.94Not reportedNot reportedNot reported
Week 28 (n=139, 136)
Values in g/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mircera11.080.97Not reportedNot reportedNot reported
Darbepoetin Alfa11.480.91Not reportedNot reportedNot reported
Week 29 (n=151, 151)
Values in g/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mircera11.071.10Not reportedNot reportedNot reported
Darbepoetin Alfa11.311.12Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.74
        value
        9.53
      2. group Id
        OG001
        spread
        0.65
        value
        9.53
    title
    Baseline (n=153, 154)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.91
        value
        10.22
      2. group Id
        OG001
        spread
        0.93
        value
        10.14
    title
    Week 2 (n=149, 151)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.17
        value
        10.37
      2. group Id
        OG001
        spread
        1.02
        value
        10.74
    title
    Week 4 (n=149, 148)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.23
        value
        10.94
      2. group Id
        OG001
        spread
        1.08
        value
        11.28
    title
    Week 6 (n=149, 148)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.29
        value
        11.08
      2. group Id
        OG001
        spread
        1.05
        value
        11.74
    title
    Week 8 (n=148, 147)
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.27
        value
        11.36
      2. group Id
        OG001
        spread
        1.02
        value
        11.78
    title
    Week 10 (n=150, 146)
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.17
        value
        11.24
      2. group Id
        OG001
        spread
        1.03
        value
        11.82
    title
    Week 12 (n=149, 145)
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.11
        value
        11.53
      2. group Id
        OG001
        spread
        1.04
        value
        11.81
    title
    Week 14 (n=145, 143)
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.16
        value
        11.50
      2. group Id
        OG001
        spread
        1.06
        value
        11.76
    title
    Week 16 (n=144, 145)
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.04
        value
        11.41
      2. group Id
        OG001
        spread
        0.94
        value
        11.45
    title
    Week 18 (n=144, 141)
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.92
        value
        11.14
      2. group Id
        OG001
        spread
        0.81
        value
        11.34
    title
    Week 20 (n=142, 140)
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.02
        value
        11.39
      2. group Id
        OG001
        spread
        0.86
        value
        11.43
    title
    Week 22 (n=142, 138)
denoms
  1. counts
    1. group Id
      OG000
      value
      153
    2. group Id
      OG001
      value
      154
    units
    Participants
description
The hemoglobin concentration was measured in g/dL every 2 weeks and at final visit.
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 evaluable participants at specified time point, respectively for each group.
reporting Status
POSTED
time Frame
Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and final visit (Week 29)
title
Hemoglobin (Hb) Concentration Over the Time
type
SECONDARY
unit Of Measure
g/dL

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

Preserved source evidence · Not medical advice