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NCT00559273 · OUTCOME

Time to Hemoglobin 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
MEDIAN
Unit
days
Interval / dispersion
95% Confidence Interval
Time frame
Baseline up to Week 28

What was measured

Time to Hb response is defined as the number of study days until the first occurrence of an Hb response. Participants without events were censored at the time of evaluation. Median and 95 percent (%) confidence interval (CI) were estimated using Kaplan-Meier Survival Analysis. Hb response was an observed increase in Hb \>=1.0 g/dL from baseline and an Hb concentration \>= 10.0 g/dL before the end of the study without RBC transfusion before response.

Analysis population: ITT population.

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 days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Mircera43Not reported3743Not reported
Darbepoetin Alfa29Not reported2941Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        37
        upper Limit
        43
        value
        43
      2. group Id
        OG001
        lower Limit
        29
        upper Limit
        41
        value
        29
denoms
  1. counts
    1. group Id
      OG000
      value
      153
    2. group Id
      OG001
      value
      154
    units
    Participants
description
Time to Hb response is defined as the number of study days until the first occurrence of an Hb response. Participants without events were censored at the time of evaluation. Median and 95 percent (%) confidence interval (CI) were estimated using Kaplan-Meier Survival Analysis. Hb response was an observed increase in Hb \>=1.0 g/dL from baseline and an Hb concentration \>= 10.0 g/dL before the end of the study without 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
MEDIAN
population Description
ITT population.
reporting Status
POSTED
time Frame
Baseline up to Week 28
title
Time to Hemoglobin Response
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice