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NCT01273597 · OUTCOME

Time (in Weeks) From Treatment Initiation to Achieving Maintenance Dose of Zemplar (Paricalcitol Injection)

Observational Study to Evaluate the Time to Achieving the Maintenance Dose of Zemplar® (Paricalcitol Injection) in the Treatment of Patients Suffering From End-stage Renal Disease and Severe Over-reactivity of the Parathyroid Glands · Source last updated 2013-01-18

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

Measure
MEAN
Unit
weeks
Interval / dispersion
Standard Deviation
Time frame
6 months

What was measured

Maintenance dose is defined as weekly dose of paricalcitol that results in at least 2 consecutive intact parathyroid hormone (iPTH) values within the target therapeutic range of 150 - 300 pg/mL, corresponding to 15.9 - 31.8 pmol/L.

Analysis population: Participants who achieved maintenance dose of Zemplar (paricalcitol injection)

Groups in this outcome

End-stage Kidney Disease With Secondary Hyperparathyroidism

Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)

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

Analysis denominator · Participants

GroupSource count
End-stage Kidney Disease With Secondary Hyperparathyroidism16

Reported measurements

Source class 1
Values in weeks · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
End-stage Kidney Disease With Secondary Hyperparathyroidism12.27.6Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        7.6
        value
        12.2
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    units
    Participants
description
Maintenance dose is defined as weekly dose of paricalcitol that results in at least 2 consecutive intact parathyroid hormone (iPTH) values within the target therapeutic range of 150 - 300 pg/mL, corresponding to 15.9 - 31.8 pmol/L.
dispersion Type
Standard Deviation
groups
  1. description
    Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
    id
    OG000
    title
    End-stage Kidney Disease With Secondary Hyperparathyroidism
param Type
MEAN
population Description
Participants who achieved maintenance dose of Zemplar (paricalcitol injection)
reporting Status
POSTED
time Frame
6 months
title
Time (in Weeks) From Treatment Initiation to Achieving Maintenance Dose of Zemplar (Paricalcitol Injection)
type
PRIMARY
unit Of Measure
weeks

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

Preserved source evidence · Not medical advice