Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00559273 · OUTCOME

Percentage of Participants With Hemoglobin (Hb) Response

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
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Baseline up to Week 28

What was measured

Hb response was an observed increase in Hb greater than or equal to (\>=) 1.0 gram per deciliter (g/dL) from baseline and an Hb concentration \>= 10.0 g/dL before the end of the study without red blood cells (RBC) transfusion before response.

Analysis population: Intent-to-treat (ITT) population included all randomized participants. Participants were analyzed according to the study treatment assigned.

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

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Mircera94.12Not reported89.1397.28Not reported
Darbepoetin Alfa93.51Not reported88.3896.84Not reported

Source statistical analyses

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

  1. group Description
    The p-value was the probability that the number of responders is greater than or equal to the observed number, although the true response rate was smaller or equal to 60%. Null hypothesis (H0): p-value \<=0.6; alternate hypothesis (H1): p-value \>0.6.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
  2. group Description
    The p-value was the probability that the number of responders is greater than or equal to the observed number, although the true response rate was smaller or equal to 60%. Null hypothesis (H0): p-value \<=0.6; alternate hypothesis (H1): p-value \>0.6.
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
Complete source fields
analyses
  1. group Description
    The p-value was the probability that the number of responders is greater than or equal to the observed number, although the true response rate was smaller or equal to 60%. Null hypothesis (H0): p-value \<=0.6; alternate hypothesis (H1): p-value \>0.6.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
  2. group Description
    The p-value was the probability that the number of responders is greater than or equal to the observed number, although the true response rate was smaller or equal to 60%. Null hypothesis (H0): p-value \<=0.6; alternate hypothesis (H1): p-value \>0.6.
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        89.13
        upper Limit
        97.28
        value
        94.12
      2. group Id
        OG001
        lower Limit
        88.38
        upper Limit
        96.84
        value
        93.51
denoms
  1. counts
    1. group Id
      OG000
      value
      153
    2. group Id
      OG001
      value
      154
    units
    Participants
description
Hb response was an observed increase in Hb greater than or equal to (\>=) 1.0 gram per deciliter (g/dL) from baseline and an Hb concentration \>= 10.0 g/dL before the end of the study without red blood cells (RBC) transfusion before response.
dispersion Type
95% Confidence Interval
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
NUMBER
population Description
Intent-to-treat (ITT) population included all randomized participants. Participants were analyzed according to the study treatment assigned.
reporting Status
POSTED
time Frame
Baseline up to Week 28
title
Percentage of Participants With Hemoglobin (Hb) Response
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice