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NCT01083849 · OUTCOME

Number of Participants With Elevated Calcium-Phosphorus Product

Long-Term Therapy Outcomes When Treating Chronic Kidney Disease (CKD) Patients With Paricalcitol in German and Austrian Clinical Practice · Source last updated 2014-12-19

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Months 0, 3, 6, 9, and 12

What was measured

Elevated Calcium-Phosphorus Product was defined as having a calcium-phosphate product level greater than 65 mg\^2/dL\^2, in one measurement. Serum calcium-phosphorus product was measured at every study visit.

Analysis population: The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.

Groups in this outcome

Paricalcitol Pre-dialysis Group

Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.

Paricalcitol Dialysis Group

Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.

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

Analysis denominator · Participants

GroupSource count
Paricalcitol Pre-dialysis Group96
Paricalcitol Dialysis Group637

Reported measurements

Month 0
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paricalcitol Pre-dialysis Group5Not reportedNot reportedNot reportedNot reported
Paricalcitol Dialysis Group102Not reportedNot reportedNot reportedNot reported
Month 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paricalcitol Pre-dialysis Group6Not reportedNot reportedNot reportedNot reported
Paricalcitol Dialysis Group97Not reportedNot reportedNot reportedNot reported
Month 6
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paricalcitol Pre-dialysis Group7Not reportedNot reportedNot reportedNot reported
Paricalcitol Dialysis Group101Not reportedNot reportedNot reportedNot reported
Month 9
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paricalcitol Pre-dialysis Group6Not reportedNot reportedNot reportedNot reported
Paricalcitol Dialysis Group89Not reportedNot reportedNot reportedNot reported
Month 12
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Paricalcitol Pre-dialysis Group4Not reportedNot reportedNot reportedNot reported
Paricalcitol Dialysis Group78Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        102
    title
    Month 0
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        97
    title
    Month 3
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        101
    title
    Month 6
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        89
    title
    Month 9
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        78
    title
    Month 12
denoms
  1. counts
    1. group Id
      OG000
      value
      96
    2. group Id
      OG001
      value
      637
    units
    Participants
description
Elevated Calcium-Phosphorus Product was defined as having a calcium-phosphate product level greater than 65 mg\^2/dL\^2, in one measurement. Serum calcium-phosphorus product was measured at every study visit.
groups
  1. description
    Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
    id
    OG000
    title
    Paricalcitol Pre-dialysis Group
  2. description
    Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
    id
    OG001
    title
    Paricalcitol Dialysis Group
param Type
NUMBER
population Description
The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.
reporting Status
POSTED
time Frame
Months 0, 3, 6, 9, and 12
title
Number of Participants With Elevated Calcium-Phosphorus Product
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice