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NCT02632786 · OUTCOME

Number of Participants With Renal Best Response and Non-Response

The PRONTO Study, a Global Phase 2b Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis · Source last updated 2019-04-05

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Baseline through 12 months of treatment

What was measured

Proteinuria and estimated Glomerular Filtration Rate (eGFR) response (Response or Non-Response \[Stable, Progression\]) from baseline through 12 months of treatment in subjects with renal involvement. Renal best response, as assessed by proteinuria, is defined as the most favorable category among response (ie, ≥30% decrease from baseline or \<0.5 g/24 hours postbaseline result if subject does not meet criteria for progression), stable (ie, neither response nor progression), and progression (ie, ≥25% decrease in eGFR from baseline) across all visits after the first infusion of study drug up to and through the end of the study. Subjects are considered non-responders until a response is achieved. Assessments that qualify as both a response and progression are counted as progression. Non-response is defined as either stable or progression.

Analysis population: Renal Evaluable Population

Groups in this outcome

NEOD001 24 mg/kg

NEOD001, 24 mg/kg IV every 4 weeks for 12 months

Placebo

Placebo, 0.9% Saline IV every 4 weeks 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
NEOD001 24 mg/kg13
Placebo18

Reported measurements

Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NEOD001 24 mg/kg7Not reportedNot reportedNot reportedNot reported
Placebo6Not reportedNot reportedNot reportedNot reported
Non-Response (Stable, Progression)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NEOD001 24 mg/kg6Not reportedNot reportedNot reportedNot reported
Placebo12Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    0.60
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    3.94
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.3529
    param Type
    Risk Ratio (RR)
    param Value
    1.54
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. ci Lower Limit
    0.60
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    3.94
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.3529
    param Type
    Risk Ratio (RR)
    param Value
    1.54
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        6
    title
    Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        12
    title
    Non-Response (Stable, Progression)
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    2. group Id
      OG001
      value
      18
    units
    Participants
description
Proteinuria and estimated Glomerular Filtration Rate (eGFR) response (Response or Non-Response \[Stable, Progression\]) from baseline through 12 months of treatment in subjects with renal involvement. Renal best response, as assessed by proteinuria, is defined as the most favorable category among response (ie, ≥30% decrease from baseline or \<0.5 g/24 hours postbaseline result if subject does not meet criteria for progression), stable (ie, neither response nor progression), and progression (ie, ≥25% decrease in eGFR from baseline) across all visits after the first infusion of study drug up to and through the end of the study. Subjects are considered non-responders until a response is achieved. Assessments that qualify as both a response and progression are counted as progression. Non-response is defined as either stable or progression.
groups
  1. description
    NEOD001, 24 mg/kg IV every 4 weeks for 12 months
    id
    OG000
    title
    NEOD001 24 mg/kg
  2. description
    Placebo, 0.9% Saline IV every 4 weeks for 12 months
    id
    OG001
    title
    Placebo
param Type
COUNT_OF_PARTICIPANTS
population Description
Renal Evaluable Population
reporting Status
POSTED
time Frame
Baseline through 12 months of treatment
title
Number of Participants With Renal Best Response and Non-Response
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice