NCT03960437 · OUTCOME

Percent Change in PTH Levels

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: percentage of change in PTH levels
Interval / dispersion: Standard Error
Time frame: Baseline and 9 months

What was measured

Mean percent change in parathyroid hormone (PTH) levels will be calculated.

Analysis population: Only includes participants who completed the study

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

Group	Source count
Study Participant	13

Reported measurements

Baseline

Values in percentage of change in PTH levels · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Study Participant	0	0	Not reported	Not reported	Not reported

6 months

Values in percentage of change in PTH levels · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Study Participant	-54.14	11.50	Not reported	Not reported	Not reported

9 months

Values in percentage of change in PTH levels · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Study Participant	-64.04	8.62	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
0
value
0
title
Baseline
categories
measurements
group Id
OG000
spread
11.50
value
-54.14
title
6 months
categories
measurements
group Id
OG000
spread
8.62
value
-64.04
title
9 months

denoms

counts
group Id
OG000
value
13
units
Participants

description

Mean percent change in parathyroid hormone (PTH) levels will be calculated.

dispersion Type

Standard Error

groups

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 study

reporting Status

POSTED

time Frame

Baseline and 9 months

title

Percent Change in PTH Levels

type

PRIMARY

unit Of Measure

percentage of change in PTH levels

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

Preserved source evidence · Not medical advice