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    Clinical Trial Results:
    A Prospective, Randomized, Open, Blinded Endpoint (PROBE), Clinical Trial to Assess The Renal and Humoral Effects of Sevelamer Carbonate in Patients with Chronic Kidney Disease and Residual Proteinuria Despite Best Available Treatment

    Summary
    EudraCT number
    		 2012-005416-26
    Trial protocol
    		 IT  
    Global end of trial date
    21 Sep 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Dec 2019
    First version publication date
    18 Dec 2019
    Other versions
    Summary report(s)
    		 Article

    Trial information

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    Trial identification
    Sponsor protocol code
    ANSWER
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02464891
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Istituto di Ricerche Farmacologiche Mario Negri IRCCS
    Sponsor organisation address
    via G.B. Camozzi, 3, Ranica BG, Italy, 24020
    Public contact
    Dep. Renal Medicine, Clinical Research Center for Rare Disease "Aldo & Cele Daccò", 0039 03545351, piero.ruggenenti@marionegri.it
    Scientific contact
    Dep. Renal Medicine, Clinical Research Center for Rare Disease "Aldo & Cele Daccò", 0039 03545351, piero.ruggenenti@marionegri.it
    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 Sep 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Sep 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Sep 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the effect of 3-month Sevelamer carbonate therapy compared to standard therapy on 24 h urinary protein excretion in patients with Chronic Kidney Disease (CKD) and residual proteinuria despite optimized Renin Angiotensin System (RAS) inhibitor therapy:
    Protection of trial subjects
    The study was conducted in conformance with Good Clinica Practice standards and applicable country regulations regarding ethical committee review, informed consent and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Nov 2013
    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
    Italy: 53
    Worldwide total number of subjects
    53
    EEA total number of subjects
    53
    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)
    36
    From 65 to 84 years
    17
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 2 Italian centers (Clinical Research Center for Rare Diseases Aldo e Cele Daccò, Ranica, Bergamo, and Bianchi-Melacrino-Morelli Hospital, Nephrology Unit, Reggio Calabria) were activated rispectively between November 2013 and December 2014.

    Pre-assignment
    Screening details
    		 72 subjects were screened for inclusion in the study. 53 subjects were randomized. Of those not randomized, 9 did not meet inclusion criteria, 3 were lost to follow up and 7 declined to participate.

    Period 1
    Period 1 title
    Treatment period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Renvela
    Arm description
    		 Patients who met the selection criteria and were on maximal tolerated doses of ramipril and irbesartan were initially stratified according to serum phosphate level ≤4 or >4 mg/dL. Each group was then randomly assigned to 1 of 2 treatment sequences: (1) 3 months of treatment with sevelamer carbonate, 1,600 mg, 3 times per day during meals, followed by a 1- month washout, and 3 months without sevelamer; or (2) 3 months without sevelamer, followed by a 1-month washout, and 3 months of treatment with sevelamer carbonate, 1,600 mg, 3 times daily.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Renvela
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1600 mg, 3 times per day during meals,

    Arm title
    		 No Renvela
    Arm description
    		 Patients who met the selection criteria and were on maximal tolerated doses of ramipril and irbesartan were initially stratified according to serum phosphate level ≤4 or >4 mg/dL. Each group was then randomly assigned to 1 of 2 treatment sequences: (1) 3 months of treatment with sevelamer carbonate, 1,600 mg, 3 times per day during meals, followed by a 1- month washout, and 3 months without sevelamer; or (2) 3 months without sevelamer, followed by a 1-month washout, and 3 months of treatment with sevelamer carbonate, 1,600 mg, 3 times daily.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Renvela No Renvela
    Started
    53
    53
    Completed
    49
    53
    Not completed
    4
    0
         Adverse event, non-fatal
    4
    -
    Period 2
    Period 2 title
    Washout Period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Washout Period
    Arm description
    		 Patients who met the selection criteria and were on maximal tolerated doses of ramipril and irbesartan were initially stratified according to serum phosphate level ≤4 or >4 mg/dL. Each group was then randomly assigned to 1 of 2 treatment sequences: (1) 3 months of treatment with sevelamer carbonate, 1,600 mg, 3 times per day during meals, followed by a 1- month washout, and 3 months without sevelamer; or (2) 3 months without sevelamer, followed by a 1-month washout, and 3 months of treatment with sevelamer carbonate, 1,600 mg, 3 times daily.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Washout Period
    Started
    53
    Completed
    53

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment period
    Reporting group description
    		 -

    Reporting group values
    		 Treatment period Total
    Number of subjects
    		 53 53
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 38 38
        From 65-84 years
    		 15 15
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 55 ± 17 -
    Gender categorical
    Units: Subjects
        Female
    		 11 11
        Male
    		 42 42
    Body mass Index
    Units: Kg/m2
        arithmetic mean (standard deviation)
    		 27 ± 4 -
    Systolic Blood Pressure
    Units: mm Hg
        arithmetic mean (standard deviation)
    		 128 ± 22 -
    Diastolic Blood Pressure
    Units: mm Hg
        arithmetic mean (standard deviation)
    		 73 ± 10 -
    Pulse Rate
    Units: Beats/min
        arithmetic mean (standard deviation)
    		 69 ± 11 -
    Creatinine
    Units: mg/dl
        median (inter-quartile range (Q1-Q3))
    		 1.6 (1 to 2.3) -
    Phosphate
    Units: mg/dl
        arithmetic mean (standard deviation)
    		 3.8 ± 0.6 -
    Calcium
    Units: mg/dl
        arithmetic mean (standard deviation)
    		 9.2 ± 0.4 -
    PTH
    Units: pg/dL
        arithmetic mean (standard deviation)
    		 70 ± 33 -
    Magnesium
    Units: mg/dL
        arithmetic mean (standard deviation)
    		 1.97 ± 0.22 -
    Cholesterol
    Units: mg/dL
        arithmetic mean (standard deviation)
    		 181 ± 38 -
    LDL cholestrol
    Units: mg/dL
        arithmetic mean (standard deviation)
    		 113 ± 33 -
    Triglycerides
    Units: mg/dL
        median (inter-quartile range (Q1-Q3))
    		 114 (88 to 159) -
    Albumin
    Units: g/dL
        arithmetic mean (standard deviation)
    		 3.6 ± 0.4 -
    Hemoglobin
    Units: g/dL
        arithmetic mean (standard deviation)
    		 12.9 ± 1.8 -
    Urine Protein
    Units: g/24 H
        median (inter-quartile range (Q1-Q3))
    		 1.54 (0.97 to 2.59) -
    Urine Albumin
    Units: µg/min
        median (inter-quartile range (Q1-Q3))
    		 829 (481 to 1372) -
    mGFR
    Units: mL/min/1.73m2
        arithmetic mean (standard deviation)
    		 49.3 ± 23.5 -
    Fractional Albumin clearance
    Units: absolute value x 1000000
        median (inter-quartile range (Q1-Q3))
    		 43 (18 to 93) -

    End points

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    End points reporting groups
    Reporting group title
    Renvela
    Reporting group description
    		 Patients who met the selection criteria and were on maximal tolerated doses of ramipril and irbesartan were initially stratified according to serum phosphate level ≤4 or >4 mg/dL. Each group was then randomly assigned to 1 of 2 treatment sequences: (1) 3 months of treatment with sevelamer carbonate, 1,600 mg, 3 times per day during meals, followed by a 1- month washout, and 3 months without sevelamer; or (2) 3 months without sevelamer, followed by a 1-month washout, and 3 months of treatment with sevelamer carbonate, 1,600 mg, 3 times daily.

    Reporting group title
    No Renvela
    Reporting group description
    		 Patients who met the selection criteria and were on maximal tolerated doses of ramipril and irbesartan were initially stratified according to serum phosphate level ≤4 or >4 mg/dL. Each group was then randomly assigned to 1 of 2 treatment sequences: (1) 3 months of treatment with sevelamer carbonate, 1,600 mg, 3 times per day during meals, followed by a 1- month washout, and 3 months without sevelamer; or (2) 3 months without sevelamer, followed by a 1-month washout, and 3 months of treatment with sevelamer carbonate, 1,600 mg, 3 times daily.
    Reporting group title
    Washout Period
    Reporting group description
    		 Patients who met the selection criteria and were on maximal tolerated doses of ramipril and irbesartan were initially stratified according to serum phosphate level ≤4 or >4 mg/dL. Each group was then randomly assigned to 1 of 2 treatment sequences: (1) 3 months of treatment with sevelamer carbonate, 1,600 mg, 3 times per day during meals, followed by a 1- month washout, and 3 months without sevelamer; or (2) 3 months without sevelamer, followed by a 1-month washout, and 3 months of treatment with sevelamer carbonate, 1,600 mg, 3 times daily.

    Primary: Urinary protein 24 H

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    End point title
    		 Urinary protein 24 H
    End point description
    End point type
    Primary
    End point timeframe
    Changes in 24-hour proteinuria at the end of the 2 treatment periods with sevelamer or without sevelamer compared to each pretreatment period. Three consecutive 24-hour proteinuria measurements were obtained at each visit and the mean of the 3 samples
    End point values
    		 Renvela No Renvela
    Number of subjects analysed
    49
    53
    Units: g/24 H
        median (inter-quartile range (Q1-Q3))
    1.36 (0.77 to 2.6)
    1.48 (0.81 to 2.77)
    Statistical analysis title
    		 Change in Urine Proteine Excretion 24 H
    Statistical analysis description
    changes in 24-hour proteinuria at the end of the 2 treatment periods with sevelamer or without sevelamer compared to each pretreatment period. Three consecutive 24-hour proteinuria measurements were obtained at each visit and the mean of the 3 samples was used.
    Comparison groups
    Renvela v No Renvela
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.1 [2]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [1] - Wilcoxon signed rank test performed between pre-post treatment period.
    [2] - P= 0.1 refered to Renvela vs non-Renvela period; differences between pre and post renvela treatment reported a p = 0.1; differences between pre and post non-renvela treatment reported a p = 0.5.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The adverse events will be reported during whole study up to 30 days after last dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Renvela
    Reporting group description
    		 Patients who met the selection criteria and were on maximal tolerated doses of ramipril and irbesartan were initially stratified according to serum phosphate level ≤4 or >4 mg/dL. Each group was then randomly assigned to 1 of 2 treatment sequences: (1) 3 months of treatment with sevelamer carbonate, 1,600 mg, 3 times per day during meals, followed by a 1- month washout, and 3 months without sevelamer; or (2) 3 months without sevelamer, followed by a 1-month washout, and 3 months of treatment with sevelamer carbonate, 1,600 mg, 3 times daily.

    Reporting group title
    No Renvela
    Reporting group description
    		 Patients who met the selection criteria and were on maximal tolerated doses of ramipril and irbesartan were initially stratified according to serum phosphate level ≤4 or >4 mg/dL. Each group was then randomly assigned to 1 of 2 treatment sequences: (1) 3 months of treatment with sevelamer carbonate, 1,600 mg, 3 times per day during meals, followed by a 1- month washout, and 3 months without sevelamer; or (2) 3 months without sevelamer, followed by a 1-month washout, and 3 months of treatment with sevelamer carbonate, 1,600 mg, 3 times daily.

    Serious adverse events
    		 Renvela No Renvela
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 53 (3.77%)
    2 / 53 (3.77%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon adenoma
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Brain Hemorrage
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Renvela No Renvela
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    35 / 53 (66.04%)
    30 / 53 (56.60%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    5 / 53 (9.43%)
    7 / 53 (13.21%)
         occurrences all number
    5
    8
    Claudicatio intermittens
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    legs edema
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    Allergic reaction
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Worsening symptoms of prostatic hypertrophy
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Common cold, cough, pharyngitis or bronchitis
         subjects affected / exposed
    5 / 53 (9.43%)
    7 / 53 (13.21%)
         occurrences all number
    5
    7
    Psychiatric disorders
    Dysphoria
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Increase of CPK levels
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Tendor tear, joint or traumatic pain
         subjects affected / exposed
    1 / 53 (1.89%)
    4 / 53 (7.55%)
         occurrences all number
    1
    4
    Cardiac disorders
    Sinus bradicardia
         subjects affected / exposed
    2 / 53 (3.77%)
    1 / 53 (1.89%)
         occurrences all number
    2
    1
    Ventricular, Supraventricular extrasystoles
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    Atrial fibrillation
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Hypertensive cardiopathy
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Nervous system disorders
    Syncope or dizziness
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 53 (1.89%)
         occurrences all number
    1
    2
    Headache
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Leg paresthesia
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    1 / 53 (1.89%)
    3 / 53 (5.66%)
         occurrences all number
    1
    3
    Ear and labyrinth disorders
    Otitis media
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Eye disorders
    Retinal exudates
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Gatroenteritis, diarrhea, abdominal pain
         subjects affected / exposed
    7 / 53 (13.21%)
    2 / 53 (3.77%)
         occurrences all number
    9
    2
    Constipation
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    lumbar pain or muscle pain
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    Vomiting
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Meteorism
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Pancreatic cyst
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Dermatitis and eczema
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    Renal and urinary disorders
    Urinary tract infection or dysuria
         subjects affected / exposed
    3 / 53 (5.66%)
    0 / 53 (0.00%)
         occurrences all number
    3
    0
    Worsening of renal function
         subjects affected / exposed
    2 / 53 (3.77%)
    1 / 53 (1.89%)
         occurrences all number
    2
    1
    Relapse of nephrotic syndrome
         subjects affected / exposed
    0 / 53 (0.00%)
    2 / 53 (3.77%)
         occurrences all number
    0
    2
    Endocrine disorders
    Thyroiditis
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    Infections and infestations
    Flulike syndrome or fever (unspecified)
         subjects affected / exposed
    2 / 53 (3.77%)
    3 / 53 (5.66%)
         occurrences all number
    2
    4
    Dental infection, dental abscess or toothache
         subjects affected / exposed
    2 / 53 (3.77%)
    1 / 53 (1.89%)
         occurrences all number
    2
    1
    Metabolism and nutrition disorders
    Metabolic acidosis
         subjects affected / exposed
    2 / 53 (3.77%)
    1 / 53 (1.89%)
         occurrences all number
    2
    1
    Hyperphosphataemia
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Hypospermia
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Hypoglycaemia
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Hyperkalaemia
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Dyslipidemia
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Vitamin D deficiency
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Feb 2014
    The amendment makes the following changes without modifying the study design and without adding risk to patients: 1) possibility to include in the study

    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.
    Short treatment duration, lower pretreatment proteinuria than expected

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/31027883
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