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    Clinical Trial Results:
    An Open Label, Intra-Subject Dose Escalation Study of CCX140-B in Subjects with Primary Focal Segmental Glomerulosclerosis (FSGS) and Nephrotic Syndrome

    Summary
    EudraCT number
    		 2017-003022-32
    Trial protocol
    		 PL  
    Global end of trial date
    24 Jun 2020

    Results information
    Results version number
    		 v2(current)
    This version publication date
    14 Sep 2023
    First version publication date
    01 Nov 2022
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    additional clarification added

    Trial information

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    Trial identification
    Sponsor protocol code
    CL012_140
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03703908
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 IND: 134007
    Sponsors
    Sponsor organisation name
    ChemoCentryx, Inc.
    Sponsor organisation address
    835 Industrial Road, San Carlos, United States, 94070
    Public contact
    Clinical Trials Disclosure, ChemoCentryx, clinicaltrials@chemocentryx.com
    Scientific contact
    Clinical Trials Disclosure, ChemoCentryx, clinicaltrials@chemocentryx.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    27 Jan 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Jun 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Jun 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The Primary Efficacy Objective is to evaluate the effect of CCX140-B on proteinuria in subjects with primary FSGS with nephrotic syndrome.
    Protection of trial subjects
    The study was conducted in accordance with the Declaration of Helsinki and with all applicable laws and regulations of the locale and country where the study was conducted, and in compliance with Good Clinical Practice Guidelines. Only subjects that met all the study inclusion and none of the exclusion criteria were entered in the study. The rationale of the study, procedural details, and investigational goals were explained to each subject, along with potential risks and benefits. Each subject was assured of his/her right to withdraw from the study at any time.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Sep 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 1
    Country: Number of subjects enrolled
    United States: 4
    Worldwide total number of subjects
    5
    EEA total number of subjects
    1
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    5
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 17 subjects were screened and 10 (58.8%) subjects failed screening due to not meeting inclusion/exclusion criteria, and 2 (11.88%) failed due to other reasons (one per sponsor request and one due to the Coronavirus Disease Pandemic).

    Pre-assignment
    Screening details
    		 The Screening Period was up to 28 days. Subjects visited the study centre during screening and on Day 1 (baseline), at pre-specified time points throughout Dose Escalation, and through Week 12.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Escalation Study of CCX140 B
    Arm description
    		 All enrolled subjects will initially be treated with the active study medication CCX140-B at a dose of 5 mg twice daily. Dose will increase in a step-wise fashion up to 15 mg twice daily.
    Arm type
    		 Sequential

    Investigational medicinal product name
    CCX140-B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Eligible subjects started treatment with CCX140-B at 5 mg twice daily. CCX140-B was taken orally without food, at least 1 hour before a meal. The dose was increased in a stepwise manner to 15 mg twice daily.

    Number of subjects in period 1
    		Escalation Study of CCX140 B
    Started
    5
    Completed
    2
    Not completed
    3
         Consent withdrawn by subject
    1
         Progression of renal disease
    1
         Lack of efficacy
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 5 5
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 5 5
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 37.6 ( 18.65 ) -
    Gender categorical
    Units: Subjects
        Female
    		 1 1
        Male
    		 4 4
    Race
    Units: Subjects
        White
    		 4 4
        Other
    		 1 1
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 2 2
        Not Hispanic or Latino
    		 3 3
    Country
    Units: Subjects
        Poland
    		 1 1
        United States
    		 4 4
    Podocyte effacement
    Based on electron microscopy
    Units: Subjects
        <30%
    		 1 1
        ≥30%
    		 4 4
    Glomeruli showing segmental lesions
    Units: Subjects
        ≤1
    		 1 1
        >1
    		 4 4
    Concomitant use of glucocorticoids and/or immunosuppressive medications
    Units: Subjects
        Yes
    		 4 4
        No
    		 1 1
    Concomitant use of ACE inhibitor or ARB
    ACE = angiotensin-converting enzyme; ARB = angiotensin receptor blocker
    Units: Subjects
        Yes
    		 5 5
        No
    		 0 0
    All calcineurin inhibitors combined
    Includes cyclosporin or tacrolimus
    Units: Subjects
        Yes
    		 2 2
        No
    		 3 3
    Concomitant use of rituximab or other anti-CD20
    Units: Subjects
        Yes
    		 0 0
        No
    		 5 5
    Age at diagnosis of FSGS
    FSGS= focal segmental glomerulosclerosis
    Units: Years
        arithmetic mean (standard deviation)
    		 35.2 ( 19.18 ) -
    Duration of FSGS
    Duration of FSGS was calculated from the time of first diagnosis based on renal biopsy.
    Units: Months
        arithmetic mean (standard deviation)
    		 29.4 ( 16.32 ) -
    Baseline UPCR – morning void
    UPCR= urinary protein:creatinine ratio
    Units: g protein/g creatinine
        arithmetic mean (standard deviation)
    		 5.71 ( 1.563 ) -
    Baseline UPCR – 24-hour
    Units: g protein/g creatinine
        arithmetic mean (standard deviation)
    		 4.80 ( 1.376 ) -
    Baseline UACR – morning void
    UACR= urinary albumin:creatinine ratio
    Units: g protein/g creatinine
        arithmetic mean (standard deviation)
    		 4.12 ( 1.394 ) -
    Baseline UACR – 24-hour
    Units: g protein/g creatinine
        arithmetic mean (standard deviation)
    		 3.24 ( 1.316 ) -
    Baseline eGFR (CKD-EPI Creatinine-Cystatin C)
    eGFR= estimated glomerular filtration rate; CKD-EPI = Chronic Kidney Disease Epidemiology Collaboration
    Units: CKD-EPI Creatinine-Cystatin C
        arithmetic mean (standard deviation)
    		 50.60 ( 23.923 ) -
    Baseline eGFR (MDRD Creatinine)
    MDRD = Modification of Diet in Renal Disease
    Units: MDRD Creatinine
        arithmetic mean (standard deviation)
    		 54.40 ( 26.245 ) -

    End points

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    End points reporting groups
    Reporting group title
    Escalation Study of CCX140 B
    Reporting group description
    		 All enrolled subjects will initially be treated with the active study medication CCX140-B at a dose of 5 mg twice daily. Dose will increase in a step-wise fashion up to 15 mg twice daily.

    Primary: Median Reduction from Baseline of Urine Protein to Creatinine Ratio (UPCR) of at least 20%

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    End point title
    		 Median Reduction from Baseline of Urine Protein to Creatinine Ratio (UPCR) of at least 20% [1]
    End point description
    Median reduction from baseline of UPCR of at least 20%, i.e., ≥20%, by Week 12.
    End point type
    Primary
    End point timeframe
    Baseline to week 12
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses has been performed.
    End point values
    		 Escalation Study of CCX140 B
    Number of subjects analysed
    5
    Units: g protein/g creatinine
        arithmetic mean (standard deviation)
    -1.3100 ( 3.76247 )
    No statistical analyses for this end point

    Secondary: Achievement of Partial Remission or Complete Remission of UPCR Through Week 12 and Through the End of Treatment

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    End point title
    		 Achievement of Partial Remission or Complete Remission of UPCR Through Week 12 and Through the End of Treatment
    End point description
    Partial and complete remission were defined as follows: Partial remission (included all of the following): Reduction from baseline by ≥50% in urine protein:creatinine ratio (UPCR) Reduction in UPCR to a level that was <3.5 g/g Subject could not have been a treatment failure Complete remission (included all of the following): Reduction in UPCR to <0.3 g/g Serum albumin within normal range For subjects with abnormal serum creatinine levels at baseline, return to normal levels For subjects with normal serum creatinine levels at baseline, final value within 20% of baseline levels Subject could not have been a treatment failure
    End point type
    Secondary
    End point timeframe
    Baseline to week 12
    End point values
    		 Escalation Study of CCX140 B
    Number of subjects analysed
    5
    Units: Participants
        Complete remission at Week 12
    0
        Complete remission at End of Treatment
    0
        Partial remission at Week 12
    1
        Partial remission at End of Treatment
    0
    No statistical analyses for this end point

    Secondary: Change From Baseline in Urine Protein:Creatinine Ratio (UPCR) Over Time

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    End point title
    		 Change From Baseline in Urine Protein:Creatinine Ratio (UPCR) Over Time
    End point description
    Mean change from baseline in urinary protein:creatinine ratio (UPCR) over time
    End point type
    Secondary
    End point timeframe
    Baseline to week 12 and week 52
    End point values
    		 Escalation Study of CCX140 B
    Number of subjects analysed
    3 [2]
    Units: g protein/g creatinine
    arithmetic mean (standard deviation)
        CCX140-B Week 52
    -0.4985 ( 3.37926 )
        CCX140-B Week 12
    -1.3100 ( 3.76247 )
    Notes
    [2] - Week 12 = 3 subjects Week 52 = 2 subjects
    No statistical analyses for this end point

    Secondary: Proportion of Subjects With Achievement of Complete Remission During the Treatment Period

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    End point title
    		 Proportion of Subjects With Achievement of Complete Remission During the Treatment Period
    End point description
    Complete remission is defined as reduction in urine protein:creatinine ratio (UPCR) to <0.3 g/g, normal serum albumin, and normal serum creatinine levels or within 20% of baseline levels.
    End point type
    Secondary
    End point timeframe
    Baseline to week 52
    End point values
    		 Escalation Study of CCX140 B
    Number of subjects analysed
    5
    Units: Participants
        Achieved complete remission
    0
        Did not achieve complete remission
    5
    No statistical analyses for this end point

    Secondary: Assessment of Time to and Proportion of Subjects With Achievement of Partial Remission during the treatment period

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    End point title
    		 Assessment of Time to and Proportion of Subjects With Achievement of Partial Remission during the treatment period
    End point description
    Partial remission is defined as reduction from baseline by ≥50% in UPCR, reduction in UPCR to a level that was <3.5 g/g.
    End point type
    Secondary
    End point timeframe
    Baseline to week 52
    End point values
    		 Escalation Study of CCX140 B
    Number of subjects analysed
    0 [3]
    Units: Participants
    Notes
    [3] - Due to the small sample size and early termination of the study, no data was available
    No statistical analyses for this end point

    Secondary: Time to Rescue Therapy

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    End point title
    		 Time to Rescue Therapy
    End point description
    Based on Investigator or physician initiation of glucocorticoids or new immunosuppressive agents or new major treatment modalities (e.g. plasmapheresis, dialysis)
    End point type
    Secondary
    End point timeframe
    Baseline to week 52
    End point values
    		 Escalation Study of CCX140 B
    Number of subjects analysed
    0 [4]
    Units: Participants
    Notes
    [4] - Due to the small sample size and early termination of the study, no data was available
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline for the eGFR CKD-EPI Creatinine Equation Over Time

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    End point title
    		 Mean Change From Baseline for the eGFR CKD-EPI Creatinine Equation Over Time
    End point description
    CKD-EPI = Chronic Kidney Disease Epidemiology Collaboration; eGFR = estimated glomerular filtration rate
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12 and Week 52
    End point values
    		 Escalation Study of CCX140 B
    Number of subjects analysed
    4
    Units: mL/min/1.73m²
    arithmetic mean (full range (min-max))
        CCX140-B Week 12
    -14.50 (-27.0 to -6.0)
        CCX140-B Week 52
    -15.0 (-15.0 to -15.0)
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline for eGFR CKD-EPI Creatinine-Cystatin C Equation Over Time

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    End point title
    		 Mean Change From Baseline for eGFR CKD-EPI Creatinine-Cystatin C Equation Over Time
    End point description
    CKD-EPI = Chronic Kidney Disease Epidemiology Collaboration; eGFR = estimated glomerular filtration rate
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12 and Week 52
    End point values
    		 Escalation Study of CCX140 B
    Number of subjects analysed
    4
    Units: ml/min/1.73 m²
    arithmetic mean (full range (min-max))
        CCX140-B Week 12
    -2.25 (-18.0 to 13.0)
        CCX140-B Week 52
    -8.0 (-8.0 to -8.0)
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline for the MDRD Creatinine Equation Over Time

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    End point title
    		 Mean Change From Baseline for the MDRD Creatinine Equation Over Time
    End point description
    MDRD = Modification of Diet in Renal Disease. The mean eGFR (using the MDRD Creatinine equation) change from baseline to Week 12 and Week 52
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12 and Week 52
    End point values
    		 Escalation Study of CCX140 B
    Number of subjects analysed
    4
    Units: ml/min/1.73 m²
    arithmetic mean (full range (min-max))
        CCX140-B Week 12
    -12.75 (-24.0 to -5.0)
        CCX140-B Week 52
    -13.00 (-13.00 to -13.00)
    No statistical analyses for this end point

    Secondary: Effect of CCX140-B Treatment on Quality of Life Endpoint SF-36V2

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    End point title
    		 Effect of CCX140-B Treatment on Quality of Life Endpoint SF-36V2
    End point description
    Summary of the Effect of CCX140-B Treatment on Quality of Life Endpoints SF-36V2 for the overall trial SF-36v2: Medical Outcomes Survey Short Form-36 version 2. SF-36v2 measures each of the following eight health domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Scores on each item are summed and averaged. The SF-36v2 component domain scores range from 0 (worst health) to 100 (best health).
    End point type
    Secondary
    End point timeframe
    Baseline to Week 52
    End point values
    		 Escalation Study of CCX140 B
    Number of subjects analysed
    5 [5]
    Units: Score on a scale
    0
    Notes
    [5] - No summary data collected for these results.
    No statistical analyses for this end point

    Secondary: Effect of CCX140-B Treatment on Quality of Life Endpoint EQ-5D-5L for the Overall Trial

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    End point title
    		 Effect of CCX140-B Treatment on Quality of Life Endpoint EQ-5D-5L for the Overall Trial
    End point description
    Summary of the Effect of CCX140-B Treatment on Quality of Life Endpoint EQ-5D-5L for the overall trial EQ-5D-5L: EuroQuality of Life-5 Domains-5 Levels. The EQ-5D-5L consists of : the EQ-5D descriptive system. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The answers given can be converted into an Index Score ranging from 0 for death to 1 for perfect health.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 52
    End point values
    		 Escalation Study of CCX140 B
    Number of subjects analysed
    5 [6]
    Units: Score on a scale
    0
    Notes
    [6] - No summary data collected for these results
    No statistical analyses for this end point

    Secondary: Changes to Laboratory Parameters Related to Renal Function Including Serum Albumin, Creatinine, Cystatin C, Urinary Albumin:Creatinine Ratio, Total 24-hour Protein Excretion During the Trial

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    End point title
    		 Changes to Laboratory Parameters Related to Renal Function Including Serum Albumin, Creatinine, Cystatin C, Urinary Albumin:Creatinine Ratio, Total 24-hour Protein Excretion During the Trial
    End point description
    Changes to laboratory parameters related to renal function including serum albumin, creatinine, cystatin C, urinary albumin:creatinine ratio, total 24-hour protein excretion during the trial
    End point type
    Secondary
    End point timeframe
    Baseline to Day 57
    End point values
    		 Escalation Study of CCX140 B
    Number of subjects analysed
    0 [7]
    Units: Number of subjects
        CCX140-B
    Notes
    [7] - no patients were analysed
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline for eGFR Using the CKD-EPI Cystatin C Equation Over Time

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    End point title
    		 Mean Change From Baseline for eGFR Using the CKD-EPI Cystatin C Equation Over Time
    End point description
    eGFR-Estimated Glomerular Filtration Rate;CKD-EPI=Chronic Kidney Disease Epidemiology Collaboration
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12 and Week 52
    End point values
    		 Escalation Study of CCX140 B
    Number of subjects analysed
    4
    Units: mL/min/1.73m²
    arithmetic mean (full range (min-max))
        CCX140-B Week 12
    7.50 (-11.0 to 37.0)
        CCX140-B Week 52
    -2.00 (-2.0 to -2.0)
    No statistical analyses for this end point

    Secondary: Time Taken of Subjects to Achieve Complete Remission During the Treatment Period

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    End point title
    		 Time Taken of Subjects to Achieve Complete Remission During the Treatment Period
    End point description
    Complete remission is defined as reduction in urine protein:creatinine ratio (UPCR) to <0.3 g/g, normal serum albumin, and normal serum creatinine levels or within 20% of baseline levels.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 52
    End point values
    		 Escalation Study of CCX140 B
    Number of subjects analysed
    5 [8]
    Units: Participants
    0
    Notes
    [8] - No subjects achieved complete remission
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 to week 52
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Escalation Study of CCX140 B
    Reporting group description
    		 All enrolled subjects will initially be treated with the active study medication CCX140-B at a dose of 5 mg twice daily. Dose will increase in a step-wise fashion up to 15 mg twice daily.

    Serious adverse events
    		 Escalation Study of CCX140 B
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 5 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Escalation Study of CCX140 B
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 5 (80.00%)
    Investigations
    Amylase increased
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Blood potassium increased
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Lipase increased
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Laceration
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Nervous system disorders
    Hypoaesthesia
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Ophthalmoplegic migraine
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    2
    Oedema peripheral
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Pyrexia
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    3
    Tongue discomfort
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    3
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Nasal congestion
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Renal and urinary disorders
    End stage renal disease
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Renal impairment
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Limb discomfort
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Muscular weakness
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Tendonitis
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Pulpitis dental
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    2
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Hyperlipidaemia
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Hyperphosphataemia
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Apr 2018
    Amendment 1.0 Moved partial and complete remission from primary to secondary objectives and redefined them and evaluated median reduction of UPCR as primary efficacy Added several equations to calculate eGFR equations based on FDA recommendation in study CL011_140 The full list of conditions for subjects being allowed to enter the extended treatment was provided Emphasis added on the importance of 24h urine collection Language added in Dose Modification Based on PK Exposure section Changes made to exclusion numbering as well as addition of exclusion Histological FSGS subtype of collapsing variant Addition of History of gastrointestinal conditions, and medications to exclusion criteria Additional information added for concomitant medications Updated guidelines for reporting of pregnancies and special situation reporting and updated contact information (Medpace) for SAE reporting Addition of Clinical Pharmacologist to SRC and Rescue Therapy Clarifications made throughout for: Dose and dose adjustments Dose modification rules for individual subjects Standardization of all titration requirements on day 43 or beyond, and extended treatment period with the initial treatment period. Adjustment from at least 30% to ≥20% reduction in UPCR The acronym ACTG-BPNS was changed to ACTG-BPNST Detail added onto primary FSGS factors Further clarification made on exclusions i.e. intended exclusion/use of calcineurin inhibitors, or other immunotherapy, Glucocorticoids, addition of international normalized ratio (INR) blood-clotting test, change of QTc to QTcF, two separate criteria for drug exclusion and medication exclusion and CYP3A4 inhibitors and inducers excluded. Removed references to the CTCAE in adverse event reporting Clarity added to the time and events table and footnotes As well as additional administrative and grammatical changes throughout.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The study was terminated early due to data from CL011_140 study showing that CCX140-B didn’t demonstrate a meaningful reduction in proteinuria relative to the control group after 12 weeks of blinded treatment.
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