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NCT03960437 · OUTCOME

Percent Change in Mean Hardness

The Effect of Etelcalcetide on CKD-MBD · Source last updated 2023-09-21

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

Measure
MEAN
Unit
percent of change in hardness
Interval / dispersion
Standard Error
Time frame
Baseline and 9 months

What was measured

Hardness will be measured by Ramen nano-indentation and mineralization measured by histomorphometry obtained (in GPa).

Analysis population: Only includes participants who completed the histomorphometry.

Groups in this outcome

Study Participant

Every study participant will receive etelcalcetide prescribed by their treating physician for the duration of the study. Etelcalcetide: Administered intravenously at the end of each dialysis session. Dosing ranges from 5 mg to 15 mg set by the patient's physician.

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

Analysis denominator · Participants

GroupSource count
Study Participant5

Reported measurements

Source class 1
Values in percent of change in hardness · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Study Participant2.688.92Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.92
        value
        2.68
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    units
    Participants
description
Hardness will be measured by Ramen nano-indentation and mineralization measured by histomorphometry obtained (in GPa).
dispersion Type
Standard Error
groups
  1. description
    Every study participant will receive etelcalcetide prescribed by their treating physician for the duration of the study. Etelcalcetide: Administered intravenously at the end of each dialysis session. Dosing ranges from 5 mg to 15 mg set by the patient's physician.
    id
    OG000
    title
    Study Participant
param Type
MEAN
population Description
Only includes participants who completed the histomorphometry.
reporting Status
POSTED
time Frame
Baseline and 9 months
title
Percent Change in Mean Hardness
type
PRIMARY
unit Of Measure
percent of change in hardness

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice