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NCT01677286 · OUTCOME

Amyloid Nephropathy: Creatinine Clearance

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
ml/min
Interval / dispersion
Standard Deviation
Time frame
12 months

What was measured

Creatinine clearance (ml/min) and proteinuria (g/day) were assessed at baseline, 6 and 12 months, with change at change at end of study reported

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 collected data.

Groups in this outcome

Amyloid Nephropathy

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 Nephropathy10

Reported measurements

Source class 1
Values in ml/min · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Amyloid Nephropathy82.448.0Not reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    -13.12
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -1.67
    group Description
    Creatinine clearance, 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
    0.017
    param Type
    Change in outcome measure
    param Value
    -7.39
    statistical Comment
    degrees of freedom = 10
    statistical Method
    Mixed Models Analysis
Complete source fields
analyses
  1. ci Lower Limit
    -13.12
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -1.67
    group Description
    Creatinine clearance, 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
    0.017
    param Type
    Change in outcome measure
    param Value
    -7.39
    statistical Comment
    degrees of freedom = 10
    statistical Method
    Mixed Models Analysis
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        48.0
        value
        82.4
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    units
    Participants
description
Creatinine clearance (ml/min) and proteinuria (g/day) were assessed at baseline, 6 and 12 months, with change at change at end of study reported
dispersion Type
Standard Deviation
groups
  1. description
    Patients with predominant amyloid kidney involvement at enrollment.
    id
    OG000
    title
    Amyloid Nephropathy
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 collected data.
reporting Status
POSTED
time Frame
12 months
title
Amyloid Nephropathy: Creatinine Clearance
type
PRIMARY
unit Of Measure
ml/min

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

Preserved source evidence · Not medical advice