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NCT01677286 · OUTCOME

Amyloid Nephropathy: Proteinuria

Safety and Effect of Doxycycline in Patients With Amyloidosis · Source last updated 2017-08-01

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

Measure
MEAN
Unit
g/day
Interval / dispersion
Standard Deviation
Time frame
Data were assessed at baseline, 6 and 12 months, with change at end of study reported

What was measured

Patients with predominant amyloid kidney involvement at enrollment.

Analysis population: Analysis is limited to the patients with predominant amyloid kidney involvement at enrollment. Mixed models analyses of change from baseline levels of creatinine clearance (ml/min) and proteinuria (g/day) were performed to include all data collected at baseline, 6 and 12 months.

Groups in this outcome

Amyloid Nephropathy: Proteinuria (g/Day)

Patients with predominant amyloid kidney involvement at enrollment.

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

Analysis denominator · Participants

GroupSource count
Amyloid Nephropathy: Proteinuria (g/Day)10

Reported measurements

Source class 1
Values in g/day · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Amyloid Nephropathy: Proteinuria (g/Day)5.913.85Not reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    -0.285
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.466
    group Description
    Proteinuria (g/24 hours), baseline versus end study levels.
    group Ids
    1. OG000
    non Inferiority Comment
    P-values and confidence intervals are not adjusted for multiple testing
    non Inferiority Type
    OTHER
    p Value
    0.603
    param Type
    Change in outcome measure
    param Value
    0.091
    statistical Comment
    degrees of freedom = 10
    statistical Method
    Mixed Models Analysis
Complete source fields
analyses
  1. ci Lower Limit
    -0.285
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.466
    group Description
    Proteinuria (g/24 hours), baseline versus end study levels.
    group Ids
    1. OG000
    non Inferiority Comment
    P-values and confidence intervals are not adjusted for multiple testing
    non Inferiority Type
    OTHER
    p Value
    0.603
    param Type
    Change in outcome measure
    param Value
    0.091
    statistical Comment
    degrees of freedom = 10
    statistical Method
    Mixed Models Analysis
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.85
        value
        5.91
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    units
    Participants
description
Patients with predominant amyloid kidney involvement at enrollment.
dispersion Type
Standard Deviation
groups
  1. description
    Patients with predominant amyloid kidney involvement at enrollment.
    id
    OG000
    title
    Amyloid Nephropathy: Proteinuria (g/Day)
param Type
MEAN
population Description
Analysis is limited to the patients with predominant amyloid kidney involvement at enrollment. Mixed models analyses of change from baseline levels of creatinine clearance (ml/min) and proteinuria (g/day) were performed to include all data collected at baseline, 6 and 12 months.
reporting Status
POSTED
time Frame
Data were assessed at baseline, 6 and 12 months, with change at end of study reported
title
Amyloid Nephropathy: Proteinuria
type
PRIMARY
unit Of Measure
g/day

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

Preserved source evidence · Not medical advice