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Study of the Intravitreal Plasma Kallikrein Inhibitor, KVD001, in Subjects With Center-involving Diabetic Macular Edema (ciDME)

Sponsor
KalVista Pharmaceuticals, Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03466099
Collaborator
(none)
129
Enrollment
35
Locations
3
Arms
19.7
Actual Duration (Months)
3.7
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a clinical study where patients with diabetes and a vision threatening eye condition called "Diabetic Macular Edema" receive four injections into the eye at monthly intervals. The patients will already have tried the standard of care without complete success. The patients will be randomized to receive either a high dose, a low dose or a sham control treatment. The study will evaluate whether the new treatment improves vision and whether it changes the underlying course of the disease in the eye.

Condition or Disease Intervention/Treatment Phase
  • Drug: KVD001 Injection
  • Other: Sham Procedure
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
129 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized Sham-controlled Double-masked Phase 2a Study of the Efficacy, Safety and Tolerability of the Intravitreal Plasma Kallikrein Inhibitor, KVD001, in Subjects With Center-involving Diabetic Macular Edema Who Have Had Prior Anti-vascular Endothelial Growth Factor Treatment
Actual Study Start Date :
Feb 16, 2018
Actual Primary Completion Date :
Oct 10, 2019
Actual Study Completion Date :
Oct 10, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: KVD001 Injection (high dose)

Drug: KVD001 Injection
Intravitreal KVD001 Injection
Other Names:
  • KVD001

    		•
    Experimental: KVD001 Injection (low dose)

    Drug: KVD001 Injection
    Intravitreal KVD001 Injection
    Other Names:
  • KVD001

    		•
    Sham Comparator: Sham Procedure

    Other: Sham Procedure
    Sham Procedure

    Outcome Measures

    Primary Outcome Measures

    1. BCVA [16 weeks]

      Change from Baseline in Best Corrected Visual Acuity (BCVA)

    Secondary Outcome Measures

    1. DRSS [16 weeks]

      Assessments of Diabetic Retinopathy Severity Score (DRSS, scale 10-85) to evaluate the percentage of eyes with a ≥2 step reduction in score from the baseline retinopathy severity as graded from fundus photography. Minimum and maximum values of the DRSS are 10 and 85, with the low end of the scale indicating absence of retinopathy which, as the score increases, so does the severity of the retinopathy such that a score of 85 is indicative of advanced proliferative diabetic retinopathy

    2. CST [16 weeks]

      Assessments of Central Subfold Thickness (CST) - analysis of covariance of change from baseline in the study eye at week 16

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Confirmed diagnosis of Type I or Type II diabetes mellitus (DM).

    • BCVA of ≥19 letters (~20/400) and ≤73 letters (~20/40) in the study eye and ≥34 letters(~20/200 or better) in the fellow eye.

    • Presence of ciDME in the study eye defined as CST ≥305 μm in women and ≥320 μm in men

    • Subjects first anti-VEGF injection in the study eye occurred ≤36 months.

    • Subjects have received at least 3 anti-vascular endothelial growth factor (VEGF) injections in the study eye within a 6-month period.

    • The last anti-VEGF injection in the study eye is ≥ 8 weeks.

    Exclusion Criteria:

    • Evidence of ocular pathology (e.g. visually significant cataract) that impacts subject's vision in the study eye from any cause other than DME.

    • Evidence/presence of amblyopia, vitreomacular traction, epiretinal membrane, foveal atrophy, or foveal ischemia, or any other condition in the macula that is thought to impair the subject's vision (other than DME).

    • Prior treatment with panretinal photocoagulation or focal grid macular photocoagulation in the study eye within the previous 3 months.

    • Prior treatment with intravitreal (IVT) steroid in the study eye (in the previous 3 months for triamcinolone, previous 6 months for Ozurdex and at any time for Iluvien).

    • Prior treatment with topical NSAIDs or topical steroids in the study eye within 1 month.

    • Prior treatment with systemic corticosteroids or systemic anti-VEGF therapy within 3 months.

    • Prior vitrectomy in the study eye.

    • Prior intraocular surgery in the study eye except for cataract surgery. Cataract surgery within the previous 6 months in the study eye is excluded.

    • Intraocular pressure (IOP) of >22 mmHg in the study eye or use of >2 antiglaucoma agents (combination agents count as 2 agents) in the study eye.

    • Evidence of infectious dacrocystitis, significant blepharitis, active conjunctivitis, infectious keratitis, or scleritis in either eye, or any other condition that might affect the safety of the IVT injection.

    • Current active proliferative diabetic retinopathy (PDR), active anterior segment neovascularization (ASNV), active retinal neovascularization, or the presence of vitreous hemorrhage in the study eye.

    • Poorly controlled DM.

    • Uncontrolled hypertension

    • Prior treatment with ocriplasminin the study eye within 3 months

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 KalVista Investigative Site Phoenix Arizona United States 85021
    2 KalVista Investigative Site Phoenix Arizona United States 85053
    3 KalVista Investigative Site Tucson Arizona United States 85704
    4 KalVista Investigative Site Arcadia California United States 91007
    5 KalVista Investigative Site Beverly Hills California United States 90211
    6 KalVista Investigative Site Palm Desert California United States 92260
    7 KalVista Investigative Site Palo Alto California United States 94303
    8 KalVista Investigative Site Sacramento California United States 95819
    9 KalVista Investigative Site Santa Ana California United States 92705
    10 KalVista Investigative Site Tustin California United States 92780
    11 KalVista Investigative Site Golden Colorado United States 80401
    12 KalVista Investigative Site Fort Myers Florida United States 33912
    13 KalVista Investigative Site Miami Florida United States 33126
    14 KalVista Investigative Site Miami Florida United States 33143
    15 KalVista Investigative Site Pensacola Florida United States 32503
    16 KalVista Investigative Site Winter Haven Florida United States 33880
    17 KalVista Investigative Site Augusta Georgia United States 30909
    18 KalVista Investigative Site Marietta Georgia United States 30060
    19 KalVista Investigative Site Indianapolis Indiana United States 46290
    20 KalVista Investigative Site Boston Massachusetts United States 02114
    21 KalVista Investigative Site Boston Massachusetts United States 02215
    22 KalVista Investigative Site Henderson Nevada United States 89052
    23 KalVista Investigative Site Lynbrook New York United States 11563
    24 KalVista Investigative Site Rochester New York United States 14459
    25 KalVista Investigative Site Cincinnati Ohio United States 45219
    26 KalVista Investigative Site Rapid City South Dakota United States 57701
    27 KalVista Investigative Site Abilene Texas United States 79606
    28 KalVista Investigative Site Arlington Texas United States 76012
    29 KalVIsta Investigative Site Austin Texas United States 78705
    30 KalVista Investigative Site Dallas Texas United States 75231
    31 KalVista Investigative Site Fort Worth Texas United States 76102
    32 KalVista Investigative Site San Antonio Texas United States 78240-1502
    33 KalVista Investigative Site San Antonio Texas United States 78240
    34 KalVista Investigative Site Charlottesville Virginia United States 22903
    35 KalVista Investigative Site Silverdale Washington United States 98383

    Sponsors and Collaborators

    • KalVista Pharmaceuticals, Ltd.

    Investigators

    • Study Director: Study Director, KalVista Pharmaceuticals

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    KalVista Pharmaceuticals, Ltd.
    ClinicalTrials.gov Identifier:
    NCT03466099
    Other Study ID Numbers:
    • KVD001-201
    First Posted:
    Mar 15, 2018
    Last Update Posted:
    Jan 28, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Macular Edema
    Edema

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail 130 Patients were randomized but one patient withdrew prior to receiving any study treatments
    Arm/Group Title KVD001 Injection (High Dose) KVD001 Injection (Low Dose) Sham Procedure
    Arm/Group Description KVD001 Injection: Intravitreal KVD001 6μg Injection administered to the study eye on Day 1 and Weeks 4, 8 and 12. KVD001 Injection: Intravitreal KVD001 3μg Injection administered to the study eye on Day 1 and Weeks 4, 8 and 12. Sham Procedure: Sham Procedure performed on the study eye on Day 1 and Weeks 4, 8 and 12 which involved preparing the study subject in the same manner as a real injection would be prepared (i.e., including but not limited to insertion of lid speculum, application of povidone-iodine, and subconjunctival injection of an anesthetic, all applied to the study eye) after which an empty syringe without an attached needle was pressed against the eye to mimic the pressure of an injection
    Period Title: Overall Study
    STARTED 41 44 45
    Treated 41 44 44
    COMPLETED 24 30 28
    NOT COMPLETED 17 14 17

    Baseline Characteristics

    Arm/Group Title KVD001 Injection (High Dose) KVD001 Injection (Low Dose) Sham Procedure Total
    Arm/Group Description KVD001 Injection: Intravitreal KVD001 Injection 6ug KVD001 Injection: Intravitreal KVD001 Injection 3ug Sham Procedure: Sham Procedure Total of all reporting groups
    Overall Participants 41 44 44 129
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    21
    51.2%
    27
    61.4%
    23
    52.3%
    71
    55%
    >=65 years
    20
    48.8%
    17
    38.6%
    21
    47.7%
    58
    45%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    63.2
    (9.58)
    61.1
    (10.67)
    64.6
    (8.62)
    63.0
    (9.70)
    Sex: Female, Male (Count of Participants)
    Female
    15
    36.6%
    20
    45.5%
    23
    52.3%
    58
    45%
    Male
    26
    63.4%
    24
    54.5%
    21
    47.7%
    71
    55%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    19
    46.3%
    7
    15.9%
    15
    34.1%
    41
    31.8%
    Not Hispanic or Latino
    22
    53.7%
    37
    84.1%
    29
    65.9%
    88
    68.2%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    1
    2.3%
    4
    9.1%
    5
    3.9%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    4
    9.8%
    5
    11.4%
    3
    6.8%
    12
    9.3%
    White
    37
    90.2%
    37
    84.1%
    37
    84.1%
    111
    86%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    1
    2.3%
    0
    0%
    1
    0.8%
    Iris color (Count of Participants)
    Black
    0
    0%
    1
    2.3%
    0
    0%
    1
    0.8%
    Blue
    9
    22%
    9
    20.5%
    6
    13.6%
    24
    18.6%
    Brown
    23
    56.1%
    24
    54.5%
    24
    54.5%
    71
    55%
    Hazel
    7
    17.1%
    7
    15.9%
    11
    25%
    25
    19.4%
    Green
    2
    4.9%
    2
    4.5%
    3
    6.8%
    7
    5.4%
    Gray
    0
    0%
    1
    2.3%
    0
    0%
    1
    0.8%
    Baseline Height (cm) (cm) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [cm]
    167.98
    (10.833)
    169.21
    (11.579)
    164.78
    (12.638)
    167.31
    (11.788)
    Baseline Weight (kg) (kg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg]
    88.88
    (13.605)
    94.94
    (26.404)
    85.34
    (20.139)
    89.74
    (21.083)
    Baseline BMI (kg/(m*m)) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg/(m*m)]
    31.71
    (5.367)
    33.00
    (7.728)
    31.58
    (6.999)
    32.11
    (6.778)

    Outcome Measures

    1. Primary Outcome
    Title BCVA
    Description Change from Baseline in Best Corrected Visual Acuity (BCVA)
    Time Frame 16 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title KVD001 Injection (High Dose) KVD001 Injection (Low Dose) Sham Procedure
    Arm/Group Description KVD001 Injection: Intravitreal KVD001 Injection 6ug KVD001 Injection: Intravitreal KVD001 Injection 3ug Sham Procedure: Sham Procedure
    Measure Participants 40 44 44
    Mean (Standard Deviation) [Letters]
    0.8
    (6.65)
    -0.3
    (8.36)
    -1.8
    (12.27)
    2. Secondary Outcome
    Title DRSS
    Description Assessments of Diabetic Retinopathy Severity Score (DRSS, scale 10-85) to evaluate the percentage of eyes with a ≥2 step reduction in score from the baseline retinopathy severity as graded from fundus photography. Minimum and maximum values of the DRSS are 10 and 85, with the low end of the scale indicating absence of retinopathy which, as the score increases, so does the severity of the retinopathy such that a score of 85 is indicative of advanced proliferative diabetic retinopathy
    Time Frame 16 weeks

    Outcome Measure Data

    Analysis Population Description
    FAS Population with observed data
    Arm/Group Title KVD001 Injection (High Dose) KVD001 Injection (Low Dose) Sham Procedure
    Arm/Group Description KVD001 Injection: Intravitreal KVD001 Injection 6ug KVD001 Injection: Intravitreal KVD001 Injection 3ug Sham Procedure: Sham Procedure
    Measure Participants 29 31 29
    Number (95% Confidence Interval) [percentage of participants]
    0
    0%
    3.2
    7.3%
    0
    0%
    3. Secondary Outcome
    Title CST
    Description Assessments of Central Subfold Thickness (CST) - analysis of covariance of change from baseline in the study eye at week 16
    Time Frame 16 weeks

    Outcome Measure Data

    Analysis Population Description
    FAS Population with LOCF
    Arm/Group Title KVD001 Injection (High Dose) KVD001 Injection (Low Dose) Sham Procedure
    Arm/Group Description KVD001 Injection: Intravitreal KVD001 Injection 6ug KVD001 Injection: Intravitreal KVD001 Injection 3ug Sham Procedure: Sham Procedure
    Measure Participants 40 44 44
    Mean (Standard Deviation) [μm]
    10.9
    (104.67)
    2.3
    (108.83)
    8.2
    (123.90)

    Adverse Events

    Time Frame 28 Weeks
    Adverse Event Reporting Description
    Arm/Group Title KVD001 Injection (High Dose) KVD001 Injection (Low Dose) Sham Procedure
    Arm/Group Description KVD001 Injection: Intravitreal KVD001 Injection 6ug KVD001 Injection: Intravitreal KVD001 Injection 3ug Sham Procedure: Sham Procedure
    All Cause Mortality
    KVD001 Injection (High Dose) KVD001 Injection (Low Dose) Sham Procedure
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/41 (0%) 0/44 (0%) 0/44 (0%)
    Serious Adverse Events
    KVD001 Injection (High Dose) KVD001 Injection (Low Dose) Sham Procedure
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 3/41 (7.3%) 3/44 (6.8%) 2/44 (4.5%)
    Cardiac disorders
    Angina pectoris 0/41 (0%) 0 0/44 (0%) 0 2/44 (4.5%) 2
    Gastrointestinal disorders
    Abdominal pain 1/41 (2.4%) 1 0/44 (0%) 0 0/44 (0%) 0
    Hepatobiliary disorders
    Chronic hepatic failure 1/41 (2.4%) 1 0/44 (0%) 0 0/44 (0%) 0
    Infections and infestations
    Appendicitis 0/41 (0%) 0 1/44 (2.3%) 1 0/44 (0%) 0
    Localized infection 0/41 (0%) 0 1/44 (2.3%) 1 0/44 (0%) 0
    Staphylococcal infection 1/41 (2.4%) 1 0/44 (0%) 0 0/44 (0%) 0
    Injury, poisoning and procedural complications
    Fall 1/41 (2.4%) 1 0/44 (0%) 0 0/44 (0%) 0
    Spinal fracture 0/41 (0%) 0 1/44 (2.3%) 1 0/44 (0%) 0
    Metabolism and nutrition disorders
    Hypoglycaemia 1/41 (2.4%) 1 0/44 (0%) 0 0/44 (0%) 0
    Nervous system disorders
    Cerebrovascular accident 1/41 (2.4%) 1 0/44 (0%) 0 0/44 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia aspiration 1/41 (2.4%) 1 0/44 (0%) 0 0/44 (0%) 0
    Vascular disorders
    Hypertension 1/41 (2.4%) 1 0/44 (0%) 0 0/44 (0%) 0
    Other (Not Including Serious) Adverse Events
    KVD001 Injection (High Dose) KVD001 Injection (Low Dose) Sham Procedure
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 22/41 (53.7%) 26/44 (59.1%) 23/44 (52.3%)
    Blood and lymphatic system disorders
    Anaemia 0/41 (0%) 0 1/44 (2.3%) 1 3/44 (6.8%) 3
    Monocytosis 0/41 (0%) 0 0/44 (0%) 0 1/44 (2.3%) 1
    Cardiac disorders
    Angina pectoris 0/41 (0%) 0 0/44 (0%) 0 1/44 (2.3%) 1
    Eye disorders
    Diabetic retinal oedema 0/41 (0%) 0 0/44 (0%) 0 1/44 (2.3%) 1
    Diabetic retinopathy 0/41 (0%) 0 1/44 (2.3%) 1 0/44 (0%) 0
    Macular oedema 1/41 (2.4%) 1 0/44 (0%) 0 0/44 (0%) 0
    Eye Pain 2/41 (4.9%) 2 3/44 (6.8%) 3 0/44 (0%) 0
    Retinal aneurysm 0/41 (0%) 0 1/44 (2.3%) 1 0/44 (0%) 0
    Retinopathy 0/41 (0%) 0 1/44 (2.3%) 1 0/44 (0%) 0
    Vitreous floaters 0/41 (0%) 0 0/44 (0%) 0 1/44 (2.3%) 1
    Visual impairment 0/41 (0%) 0 4/44 (9.1%) 4 1/44 (2.3%) 1
    Vitreous haemorrhage 1/41 (2.4%) 1 1/44 (2.3%) 1 1/44 (2.3%) 1
    Catatact 0/41 (0%) 0 0/44 (0%) 0 2/44 (4.5%) 3
    Eye irritation 2/41 (4.9%) 2 0/44 (0%) 0 0/44 (0%) 0
    Ocular discomfort 0/41 (0%) 0 1/44 (2.3%) 1 1/44 (2.3%) 1
    Vision blurred 1/41 (2.4%) 1 1/44 (2.3%) 1 0/44 (0%) 0
    Visual acuity reduced 0/41 (0%) 0 1/44 (2.3%) 1 1/44 (2.3%) 1
    Vitreous detachment 2/41 (4.9%) 2 0/44 (0%) 0 0/44 (0%) 0
    Conjunctival follicles 0/41 (0%) 0 0/44 (0%) 0 1/44 (2.3%) 1
    Conjunctival haemorrhage 0/41 (0%) 0 0/44 (0%) 0 1/44 (2.3%) 1
    Detachment of macular retinal pigment 0/41 (0%) 0 1/44 (2.3%) 1 0/44 (0%) 0
    Diplopia 1/41 (2.4%) 1 0/44 (0%) 0 0/44 (0%) 0
    Dry eye 1/41 (2.4%) 1 0/44 (0%) 0 0/44 (0%) 0
    Eye pruritus 0/41 (0%) 0 0/44 (0%) 0 1/44 (2.3%) 1
    Foreign body sensation in eyes 0/41 (0%) 0 1/44 (2.3%) 2 0/44 (0%) 0
    Lacrimation increased 1/41 (2.4%) 1 0/44 (0%) 0 0/44 (0%) 0
    Posterior capsule opacification 0/41 (0%) 0 0/44 (0%) 0 1/44 (2.3%) 1
    Retinal neovascularisation 1/41 (2.4%) 1 0/44 (0%) 0 0/44 (0%) 0
    Retinal vessel avulsion 0/41 (0%) 0 1/44 (2.3%) 1 0/44 (0%) 0
    Gastrointestinal disorders
    Vomiting 0/41 (0%) 0 0/44 (0%) 0 1/44 (2.3%) 1
    Abdominal discomfort 0/41 (0%) 0 0/44 (0%) 0 1/44 (2.3%) 1
    Abdominal distension 0/41 (0%) 0 0/44 (0%) 0 1/44 (2.3%) 1
    Diarrhoea 0/41 (0%) 0 0/44 (0%) 0 1/44 (2.3%) 1
    Haematemesis 1/41 (2.4%) 1 0/44 (0%) 0 0/44 (0%) 0
    Large intestine polyp 0/41 (0%) 0 0/44 (0%) 0 1/44 (2.3%) 1
    Tooth disorder 0/41 (0%) 0 0/44 (0%) 0 1/44 (2.3%) 1
    General disorders
    Oedema peripheral 1/41 (2.4%) 1 0/44 (0%) 0 2/44 (4.5%) 2
    Pyrexia 0/41 (0%) 0 1/44 (2.3%) 1 1/44 (2.3%) 1
    Asthenia 0/41 (0%) 0 1/44 (2.3%) 1 0/44 (0%) 0
    Facial pain 0/41 (0%) 0 0/44 (0%) 0 1/44 (2.3%) 1
    Fatigue 0/41 (0%) 0 1/44 (2.3%) 1 0/44 (0%) 0
    Injection site erythema 0/41 (0%) 0 1/44 (2.3%) 4 0/44 (0%) 0
    Injection site haemorrhage 0/41 (0%) 0 0/44 (0%) 0 1/44 (2.3%) 2
    Non-cardiac chest pain 1/41 (2.4%) 2 0/44 (0%) 0 0/44 (0%) 0
    Hepatobiliary disorders
    Chronic hepatic failure 1/41 (2.4%) 1 0/44 (0%) 0 0/44 (0%) 0
    Hepatic steatosis 0/41 (0%) 0 1/44 (2.3%) 1 0/44 (0%) 0
    Immune system disorders
    Allergy to arthropod bite 0/41 (0%) 0 0/44 (0%) 0 1/44 (2.3%) 1
    Drug hypersensitivity 0/41 (0%) 0 1/44 (2.3%) 1 0/44 (0%) 0
    Seasonal allergy 0/41 (0%) 0 1/44 (2.3%) 1 0/44 (0%) 0
    Infections and infestations
    Urinary tract infection 3/41 (7.3%) 3 2/44 (4.5%) 2 4/44 (9.1%) 4
    Bronchitis 1/41 (2.4%) 1 0/44 (0%) 0 1/44 (2.3%) 1
    Nasopharyngitis 1/41 (2.4%) 1 1/44 (2.3%) 1 1/44 (2.3%) 1
    Cellulitis staphylococcal 1/41 (2.4%) 1 1/44 (2.3%) 1 0/44 (0%) 0
    Abscess limb 0/41 (0%) 0 1/44 (2.3%) 1 0/44 (0%) 0
    Appendicitis 0/41 (0%) 0 1/44 (2.3%) 1 0/44 (0%) 0
    Cellulitis 0/41 (0%) 0 1/44 (2.3%) 1 0/44 (0%) 0
    Fungal skin infection 0/41 (0%) 0 1/44 (2.3%) 1 0/44 (0%) 0
    Influenza 1/41 (2.4%) 1 0/44 (0%) 0 0/44 (0%) 0
    Localised infection 0/41 (0%) 0 1/44 (2.3%) 2 0/44 (0%) 0
    Osteomyelitis 0/41 (0%) 0 1/44 (2.3%) 1 0/44 (0%) 0
    Pharyngitis 1/41 (2.4%) 1 0/44 (0%) 0 0/44 (0%) 0
    Pneumonia 0/41 (0%) 0 0/44 (0%) 0 1/44 (2.3%) 1
    Sepsis 1/41 (2.4%) 1 0/44 (0%) 0 0/44 (0%) 0
    Staphylococcal abscess 1/41 (2.4%) 1 0/44 (0%) 0 0/44 (0%) 0
    Staphylococcal infection 1/41 (2.4%) 1 0/44 (0%) 0 0/44 (0%) 0
    Tooth infection 0/41 (0%) 0 0/44 (0%) 0 1/44 (2.3%) 1
    Upper respiratory tract infection 0/41 (0%) 0 1/44 (2.3%) 1 0/44 (0%) 0
    Injury, poisoning and procedural complications
    Fall 1/41 (2.4%) 1 1/44 (2.3%) 1 0/44 (0%) 0
    Corneal abrasion 0/41 (0%) 0 1/44 (2.3%) 1 0/44 (0%) 0
    Eyelid injury 0/41 (0%) 0 1/44 (2.3%) 1 0/44 (0%) 0
    Spinal fracture 0/41 (0%) 0 1/44 (2.3%) 1 0/44 (0%) 0
    Investigations
    Blood glucose fluctuations 0/41 (0%) 0 1/44 (2.3%) 1 0/44 (0%) 0
    Blood urea increased 0/41 (0%) 0 1/44 (2.3%) 1 0/44 (0%) 0
    Blood uric acid increased 0/41 (0%) 0 1/44 (2.3%) 1 0/44 (0%) 0
    Medication residue present 0/41 (0%) 0 0/44 (0%) 0 1/44 (2.3%) 1
    Blood pressure increased 0/41 (0%) 0 2/44 (4.5%) 2 1/44 (2.3%) 1
    Blood creatinine increased 0/41 (0%) 0 1/44 (2.3%) 1 1/44 (2.3%) 1
    Blood potassium increased 0/41 (0%) 0 2/44 (4.5%) 2 0/44 (0%) 0
    Blood triglycerides increased 1/41 (2.4%) 1 0/44 (0%) 0 1/44 (2.3%) 1
    Intraocular pressure increased 1/41 (2.4%) 1 1/44 (2.3%) 1 0/44 (0%) 0
    Optic nerve cup/disc ratio increased 0/41 (0%) 0 1/44 (2.3%) 1 0/44 (0%) 0
    Urine albumin/creatinine ratio increased 1/41 (2.4%) 1 0/44 (0%) 0 0/44 (0%) 0
    Metabolism and nutrition disorders
    Hypoglycaemia 2/41 (4.9%) 2 0/44 (0%) 0 0/44 (0%) 0
    Diabetes mellitus inadequate control 0/41 (0%) 0 0/44 (0%) 0 1/44 (2.3%) 1
    Hypercholesterolaemia 1/41 (2.4%) 1 0/44 (0%) 0 0/44 (0%) 0
    Hyperglycaemia 0/41 (0%) 0 1/44 (2.3%) 1 0/44 (0%) 0
    Hyperkalaemia 1/41 (2.4%) 1 0/44 (0%) 0 0/44 (0%) 0
    Musculoskeletal and connective tissue disorders
    Pain in extremity 0/41 (0%) 0 1/44 (2.3%) 1 0/44 (0%) 0
    Tendonitis 0/41 (0%) 0 0/44 (0%) 0 1/44 (2.3%) 1
    Neck pain 1/41 (2.4%) 1 1/44 (2.3%) 1 0/44 (0%) 0
    Arthralgia 1/41 (2.4%) 1 0/44 (0%) 0 0/44 (0%) 0
    Arthritis 0/41 (0%) 0 0/44 (0%) 0 1/44 (2.3%) 1
    Joint swelling 1/41 (2.4%) 1 0/44 (0%) 0 0/44 (0%) 0
    Muscle twitching 1/41 (2.4%) 2 0/44 (0%) 0 0/44 (0%) 0
    Nervous system disorders
    Headache 1/41 (2.4%) 1 0/44 (0%) 0 1/44 (2.3%) 1
    Cerebrovascular accident 1/41 (2.4%) 1 0/44 (0%) 0 0/44 (0%) 0
    Dizziness 1/41 (2.4%) 1 0/44 (0%) 0 0/44 (0%) 0
    Disarthria 1/41 (2.4%) 1 0/44 (0%) 0 0/44 (0%) 0
    Psychiatric disorders
    Insomnia 0/41 (0%) 0 1/44 (2.3%) 1 0/44 (0%) 0
    Mental status change 0/41 (0%) 0 0/44 (0%) 0 1/44 (2.3%) 1
    Renal and urinary disorders
    Acute kidney injury 0/41 (0%) 0 1/44 (2.3%) 1 0/44 (0%) 0
    Chronic kidney disease 0/41 (0%) 0 0/44 (0%) 0 1/44 (2.3%) 1
    Diabetic nephropathy 0/41 (0%) 0 0/44 (0%) 0 1/44 (2.3%) 1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea 1/41 (2.4%) 1 1/44 (2.3%) 1 0/44 (0%) 0
    Cough 1/41 (2.4%) 1 0/44 (0%) 0 0/44 (0%) 0
    Oropharyngeal pain 0/41 (0%) 0 0/44 (0%) 0 1/44 (2.3%) 1
    Pneumonia aspiration 1/41 (2.4%) 1 0/44 (0%) 0 0/44 (0%) 0
    Sinus pain 0/41 (0%) 0 0/44 (0%) 0 1/44 (2.3%) 1
    Skin and subcutaneous tissue disorders
    Diabetic foot 0/41 (0%) 0 0/44 (0%) 0 1/44 (2.3%) 1
    Erythema 0/41 (0%) 0 1/44 (2.3%) 1 0/44 (0%) 0
    Skin ulcer 0/41 (0%) 0 1/44 (2.3%) 2 0/44 (0%) 0
    Vascular disorders
    Hypertension 3/41 (7.3%) 4 4/44 (9.1%) 5 3/44 (6.8%) 3

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Director Clinical
    Organization KalVista Pharmaceuticals
    Phone 857-999-0075
    Email clinicalinfo@kalvista.com
    Responsible Party:
    KalVista Pharmaceuticals, Ltd.
    ClinicalTrials.gov Identifier:
    NCT03466099
    Other Study ID Numbers:
    • KVD001-201
    First Posted:
    Mar 15, 2018
    Last Update Posted:
    Jan 28, 2021
    Last Verified:
    Jan 1, 2021