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

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ClinicalTrials.gov Identifier: NCT03466099
Recruitment Status : Completed
First Posted : March 15, 2018
Results First Posted : December 8, 2020
Last Update Posted : January 28, 2021
Sponsor:
Information provided by (Responsible Party):
KalVista Pharmaceuticals, Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Diabetic Macular Edema
Interventions Drug: KVD001 Injection
Other: Sham Procedure
Enrollment 129
Recruitment Details  
Pre-assignment Details 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
Hide 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 [1]
Treated 41 44 44
Completed 24 30 28
Not Completed 17 14 17
Reason Not Completed
Adverse Event             1             1             1
Withdrawal by Subject             2             3             1
Use of rescue medication             8             9             13
Rescued without meeting criteria             4             1             1
Subject compliance             2             0             0
Worsening disease             0             0             1
[1]
One study subject consented and was randomized, but withdrew prior to receiving any study treatments
Arm/Group Title KVD001 Injection (High Dose) KVD001 Injection (Low Dose) Sham Procedure Total
Hide 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 Number of Baseline Participants 41 44 44 129
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 44 participants 44 participants 129 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
21
  51.2%
27
  61.4%
23
  52.3%
71
  55.0%
>=65 years
20
  48.8%
17
  38.6%
21
  47.7%
58
  45.0%
[1]
Measure Description: Age category by treatment group
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants 44 participants 44 participants 129 participants
63.2  (9.58) 61.1  (10.67) 64.6  (8.62) 63.0  (9.70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 44 participants 44 participants 129 participants
Female
15
  36.6%
20
  45.5%
23
  52.3%
58
  45.0%
Male
26
  63.4%
24
  54.5%
21
  47.7%
71
  55.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 44 participants 44 participants 129 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
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 44 participants 44 participants 129 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   2.3%
4
   9.1%
5
   3.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
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
  86.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   2.3%
0
   0.0%
1
   0.8%
Iris color  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 44 participants 44 participants 129 participants
Black
0
   0.0%
1
   2.3%
0
   0.0%
1
   0.8%
Blue
9
  22.0%
9
  20.5%
6
  13.6%
24
  18.6%
Brown
23
  56.1%
24
  54.5%
24
  54.5%
71
  55.0%
Hazel
7
  17.1%
7
  15.9%
11
  25.0%
25
  19.4%
Green
2
   4.9%
2
   4.5%
3
   6.8%
7
   5.4%
Gray
0
   0.0%
1
   2.3%
0
   0.0%
1
   0.8%
Baseline Height (cm)  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 41 participants 44 participants 44 participants 129 participants
167.98  (10.833) 169.21  (11.579) 164.78  (12.638) 167.31  (11.788)
Baseline Weight (kg)  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 41 participants 44 participants 44 participants 129 participants
88.88  (13.605) 94.94  (26.404) 85.34  (20.139) 89.74  (21.083)
Baseline BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/(m*m)
Number Analyzed 41 participants 44 participants 44 participants 129 participants
31.71  (5.367) 33.00  (7.728) 31.58  (6.999) 32.11  (6.778)
1.Primary Outcome
Title BCVA
Hide Description Change from Baseline in Best Corrected Visual Acuity (BCVA)
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title KVD001 Injection (High Dose) KVD001 Injection (Low Dose) Sham Procedure
Hide Arm/Group Description:
KVD001 Injection: Intravitreal KVD001 Injection 6ug
KVD001 Injection: Intravitreal KVD001 Injection 3ug
Sham Procedure: Sham Procedure
Overall Number of Participants Analyzed 40 44 44
Mean (Standard Deviation)
Unit of Measure: Letters
0.8  (6.65) -0.3  (8.36) -1.8  (12.27)
2.Secondary Outcome
Title DRSS
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS Population with observed data
Arm/Group Title KVD001 Injection (High Dose) KVD001 Injection (Low Dose) Sham Procedure
Hide Arm/Group Description:
KVD001 Injection: Intravitreal KVD001 Injection 6ug
KVD001 Injection: Intravitreal KVD001 Injection 3ug
Sham Procedure: Sham Procedure
Overall Number of Participants Analyzed 29 31 29
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0 to 0)
3.2
(0.1 to 16.7)
0
(0 to 0)
3.Secondary Outcome
Title CST
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS Population with LOCF
Arm/Group Title KVD001 Injection (High Dose) KVD001 Injection (Low Dose) Sham Procedure
Hide Arm/Group Description:
KVD001 Injection: Intravitreal KVD001 Injection 6ug
KVD001 Injection: Intravitreal KVD001 Injection 3ug
Sham Procedure: Sham Procedure
Overall Number of Participants Analyzed 40 44 44
Mean (Standard Deviation)
Unit of Measure: μm
10.9  (104.67) 2.3  (108.83) 8.2  (123.90)
Time Frame 28 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title KVD001 Injection (High Dose) KVD001 Injection (Low Dose) Sham Procedure
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/41 (0.00%)      0/44 (0.00%)      0/44 (0.00%)    
Hide 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 (7.32%)      3/44 (6.82%)      2/44 (4.55%)    
Cardiac disorders       
Angina pectoris † 1  0/41 (0.00%)  0 0/44 (0.00%)  0 2/44 (4.55%)  2
Gastrointestinal disorders       
Abdominal pain † 1  1/41 (2.44%)  1 0/44 (0.00%)  0 0/44 (0.00%)  0
Hepatobiliary disorders       
Chronic hepatic failure † 1  1/41 (2.44%)  1 0/44 (0.00%)  0 0/44 (0.00%)  0
Infections and infestations       
Appendicitis † 1  0/41 (0.00%)  0 1/44 (2.27%)  1 0/44 (0.00%)  0
Localized infection † 1  0/41 (0.00%)  0 1/44 (2.27%)  1 0/44 (0.00%)  0
Staphylococcal infection † 1  1/41 (2.44%)  1 0/44 (0.00%)  0 0/44 (0.00%)  0
Injury, poisoning and procedural complications       
Fall † 1  1/41 (2.44%)  1 0/44 (0.00%)  0 0/44 (0.00%)  0
Spinal fracture † 1  0/41 (0.00%)  0 1/44 (2.27%)  1 0/44 (0.00%)  0
Metabolism and nutrition disorders       
Hypoglycaemia † 1  1/41 (2.44%)  1 0/44 (0.00%)  0 0/44 (0.00%)  0
Nervous system disorders       
Cerebrovascular accident † 1  1/41 (2.44%)  1 0/44 (0.00%)  0 0/44 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Pneumonia aspiration † 1  1/41 (2.44%)  1 0/44 (0.00%)  0 0/44 (0.00%)  0
Vascular disorders       
Hypertension † 1  1/41 (2.44%)  1 0/44 (0.00%)  0 0/44 (0.00%)  0
1
Term from vocabulary, MedDRA version 20.1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
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 (53.66%)      26/44 (59.09%)      23/44 (52.27%)    
Blood and lymphatic system disorders       
Anaemia † 1  0/41 (0.00%)  0 1/44 (2.27%)  1 3/44 (6.82%)  3
Monocytosis † 1  0/41 (0.00%)  0 0/44 (0.00%)  0 1/44 (2.27%)  1
Cardiac disorders       
Angina pectoris † 1  0/41 (0.00%)  0 0/44 (0.00%)  0 1/44 (2.27%)  1
Eye disorders       
Diabetic retinal oedema † 1  0/41 (0.00%)  0 0/44 (0.00%)  0 1/44 (2.27%)  1
Diabetic retinopathy † 1  0/41 (0.00%)  0 1/44 (2.27%)  1 0/44 (0.00%)  0
Macular oedema † 1  1/41 (2.44%)  1 0/44 (0.00%)  0 0/44 (0.00%)  0
Eye Pain † 1  2/41 (4.88%)  2 3/44 (6.82%)  3 0/44 (0.00%)  0
Retinal aneurysm † 1  0/41 (0.00%)  0 1/44 (2.27%)  1 0/44 (0.00%)  0
Retinopathy † 1  0/41 (0.00%)  0 1/44 (2.27%)  1 0/44 (0.00%)  0
Vitreous floaters † 1  0/41 (0.00%)  0 0/44 (0.00%)  0 1/44 (2.27%)  1
Visual impairment † 1  0/41 (0.00%)  0 4/44 (9.09%)  4 1/44 (2.27%)  1
Vitreous haemorrhage † 1  1/41 (2.44%)  1 1/44 (2.27%)  1 1/44 (2.27%)  1
Catatact † 1  0/41 (0.00%)  0 0/44 (0.00%)  0 2/44 (4.55%)  3
Eye irritation † 1  2/41 (4.88%)  2 0/44 (0.00%)  0 0/44 (0.00%)  0
Ocular discomfort † 1  0/41 (0.00%)  0 1/44 (2.27%)  1 1/44 (2.27%)  1
Vision blurred † 1  1/41 (2.44%)  1 1/44 (2.27%)  1 0/44 (0.00%)  0
Visual acuity reduced † 1  0/41 (0.00%)  0 1/44 (2.27%)  1 1/44 (2.27%)  1
Vitreous detachment † 1  2/41 (4.88%)  2 0/44 (0.00%)  0 0/44 (0.00%)  0
Conjunctival follicles † 1  0/41 (0.00%)  0 0/44 (0.00%)  0 1/44 (2.27%)  1
Conjunctival haemorrhage † 1  0/41 (0.00%)  0 0/44 (0.00%)  0 1/44 (2.27%)  1
Detachment of macular retinal pigment † 1  0/41 (0.00%)  0 1/44 (2.27%)  1 0/44 (0.00%)  0
Diplopia † 1  1/41 (2.44%)  1 0/44 (0.00%)  0 0/44 (0.00%)  0
Dry eye † 1  1/41 (2.44%)  1 0/44 (0.00%)  0 0/44 (0.00%)  0
Eye pruritus † 1  0/41 (0.00%)  0 0/44 (0.00%)  0 1/44 (2.27%)  1
Foreign body sensation in eyes † 1  0/41 (0.00%)  0 1/44 (2.27%)  2 0/44 (0.00%)  0
Lacrimation increased † 1  1/41 (2.44%)  1 0/44 (0.00%)  0 0/44 (0.00%)  0
Posterior capsule opacification † 1  0/41 (0.00%)  0 0/44 (0.00%)  0 1/44 (2.27%)  1
Retinal neovascularisation † 1  1/41 (2.44%)  1 0/44 (0.00%)  0 0/44 (0.00%)  0
Retinal vessel avulsion † 1  0/41 (0.00%)  0 1/44 (2.27%)  1 0/44 (0.00%)  0
Gastrointestinal disorders       
Vomiting † 1  0/41 (0.00%)  0 0/44 (0.00%)  0 1/44 (2.27%)  1
Abdominal discomfort † 1  0/41 (0.00%)  0 0/44 (0.00%)  0 1/44 (2.27%)  1
Abdominal distension † 1  0/41 (0.00%)  0 0/44 (0.00%)  0 1/44 (2.27%)  1
Diarrhoea † 1  0/41 (0.00%)  0 0/44 (0.00%)  0 1/44 (2.27%)  1
Haematemesis † 1  1/41 (2.44%)  1 0/44 (0.00%)  0 0/44 (0.00%)  0
Large intestine polyp † 1  0/41 (0.00%)  0 0/44 (0.00%)  0 1/44 (2.27%)  1
Tooth disorder † 1  0/41 (0.00%)  0 0/44 (0.00%)  0 1/44 (2.27%)  1
General disorders       
Oedema peripheral † 1  1/41 (2.44%)  1 0/44 (0.00%)  0 2/44 (4.55%)  2
Pyrexia † 1  0/41 (0.00%)  0 1/44 (2.27%)  1 1/44 (2.27%)  1
Asthenia † 1  0/41 (0.00%)  0 1/44 (2.27%)  1 0/44 (0.00%)  0
Facial pain † 1  0/41 (0.00%)  0 0/44 (0.00%)  0 1/44 (2.27%)  1
Fatigue † 1  0/41 (0.00%)  0 1/44 (2.27%)  1 0/44 (0.00%)  0
Injection site erythema † 1  0/41 (0.00%)  0 1/44 (2.27%)  4 0/44 (0.00%)  0
Injection site haemorrhage † 1  0/41 (0.00%)  0 0/44 (0.00%)  0 1/44 (2.27%)  2
Non-cardiac chest pain † 1  1/41 (2.44%)  2 0/44 (0.00%)  0 0/44 (0.00%)  0
Hepatobiliary disorders       
Chronic hepatic failure † 1  1/41 (2.44%)  1 0/44 (0.00%)  0 0/44 (0.00%)  0
Hepatic steatosis † 1  0/41 (0.00%)  0 1/44 (2.27%)  1 0/44 (0.00%)  0
Immune system disorders       
Allergy to arthropod bite † 1  0/41 (0.00%)  0 0/44 (0.00%)  0 1/44 (2.27%)  1
Drug hypersensitivity † 1  0/41 (0.00%)  0 1/44 (2.27%)  1 0/44 (0.00%)  0
Seasonal allergy † 1  0/41 (0.00%)  0 1/44 (2.27%)  1 0/44 (0.00%)  0
Infections and infestations       
Urinary tract infection † 1  3/41 (7.32%)  3 2/44 (4.55%)  2 4/44 (9.09%)  4
Bronchitis † 1  1/41 (2.44%)  1 0/44 (0.00%)  0 1/44 (2.27%)  1
Nasopharyngitis † 1  1/41 (2.44%)  1 1/44 (2.27%)  1 1/44 (2.27%)  1
Cellulitis staphylococcal † 1  1/41 (2.44%)  1 1/44 (2.27%)  1 0/44 (0.00%)  0
Abscess limb † 1  0/41 (0.00%)  0 1/44 (2.27%)  1 0/44 (0.00%)  0
Appendicitis † 1  0/41 (0.00%)  0 1/44 (2.27%)  1 0/44 (0.00%)  0
Cellulitis † 1  0/41 (0.00%)  0 1/44 (2.27%)  1 0/44 (0.00%)  0
Fungal skin infection † 1  0/41 (0.00%)  0 1/44 (2.27%)  1 0/44 (0.00%)  0
Influenza † 1  1/41 (2.44%)  1 0/44 (0.00%)  0 0/44 (0.00%)  0
Localised infection † 1  0/41 (0.00%)  0 1/44 (2.27%)  2 0/44 (0.00%)  0
Osteomyelitis † 1  0/41 (0.00%)  0 1/44 (2.27%)  1 0/44 (0.00%)  0
Pharyngitis † 1  1/41 (2.44%)  1 0/44 (0.00%)  0 0/44 (0.00%)  0
Pneumonia † 1  0/41 (0.00%)  0 0/44 (0.00%)  0 1/44 (2.27%)  1
Sepsis † 1  1/41 (2.44%)  1 0/44 (0.00%)  0 0/44 (0.00%)  0
Staphylococcal abscess † 1  1/41 (2.44%)  1 0/44 (0.00%)  0 0/44 (0.00%)  0
Staphylococcal infection † 1  1/41 (2.44%)  1 0/44 (0.00%)  0 0/44 (0.00%)  0
Tooth infection † 1  0/41 (0.00%)  0 0/44 (0.00%)  0 1/44 (2.27%)  1
Upper respiratory tract infection † 1  0/41 (0.00%)  0 1/44 (2.27%)  1 0/44 (0.00%)  0
Injury, poisoning and procedural complications       
Fall † 1  1/41 (2.44%)  1 1/44 (2.27%)  1 0/44 (0.00%)  0
Corneal abrasion † 1  0/41 (0.00%)  0 1/44 (2.27%)  1 0/44 (0.00%)  0
Eyelid injury † 1  0/41 (0.00%)  0 1/44 (2.27%)  1 0/44 (0.00%)  0
Spinal fracture † 1  0/41 (0.00%)  0 1/44 (2.27%)  1 0/44 (0.00%)  0
Investigations       
Blood glucose fluctuations † 1  0/41 (0.00%)  0 1/44 (2.27%)  1 0/44 (0.00%)  0
Blood urea increased † 1  0/41 (0.00%)  0 1/44 (2.27%)  1 0/44 (0.00%)  0
Blood uric acid increased † 1  0/41 (0.00%)  0 1/44 (2.27%)  1 0/44 (0.00%)  0
Medication residue present † 1  0/41 (0.00%)  0 0/44 (0.00%)  0 1/44 (2.27%)  1
Blood pressure increased † 1  0/41 (0.00%)  0 2/44 (4.55%)  2 1/44 (2.27%)  1
Blood creatinine increased † 1  0/41 (0.00%)  0 1/44 (2.27%)  1 1/44 (2.27%)  1
Blood potassium increased † 1  0/41 (0.00%)  0 2/44 (4.55%)  2 0/44 (0.00%)  0
Blood triglycerides increased † 1  1/41 (2.44%)  1 0/44 (0.00%)  0 1/44 (2.27%)  1
Intraocular pressure increased † 1  1/41 (2.44%)  1 1/44 (2.27%)  1 0/44 (0.00%)  0
Optic nerve cup/disc ratio increased † 1  0/41 (0.00%)  0 1/44 (2.27%)  1 0/44 (0.00%)  0
Urine albumin/creatinine ratio increased † 1  1/41 (2.44%)  1 0/44 (0.00%)  0 0/44 (0.00%)  0
Metabolism and nutrition disorders       
Hypoglycaemia † 1  2/41 (4.88%)  2 0/44 (0.00%)  0 0/44 (0.00%)  0
Diabetes mellitus inadequate control † 1  0/41 (0.00%)  0 0/44 (0.00%)  0 1/44 (2.27%)  1
Hypercholesterolaemia † 1  1/41 (2.44%)  1 0/44 (0.00%)  0 0/44 (0.00%)  0
Hyperglycaemia † 1  0/41 (0.00%)  0 1/44 (2.27%)  1 0/44 (0.00%)  0
Hyperkalaemia † 1  1/41 (2.44%)  1 0/44 (0.00%)  0 0/44 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Pain in extremity † 1  0/41 (0.00%)  0 1/44 (2.27%)  1 0/44 (0.00%)  0
Tendonitis † 1  0/41 (0.00%)  0 0/44 (0.00%)  0 1/44 (2.27%)  1
Neck pain † 1  1/41 (2.44%)  1 1/44 (2.27%)  1 0/44 (0.00%)  0
Arthralgia † 1  1/41 (2.44%)  1 0/44 (0.00%)  0 0/44 (0.00%)  0
Arthritis † 1  0/41 (0.00%)  0 0/44 (0.00%)  0 1/44 (2.27%)  1
Joint swelling † 1  1/41 (2.44%)  1 0/44 (0.00%)  0 0/44 (0.00%)  0
Muscle twitching † 1  1/41 (2.44%)  2 0/44 (0.00%)  0 0/44 (0.00%)  0
Nervous system disorders       
Headache † 1  1/41 (2.44%)  1 0/44 (0.00%)  0 1/44 (2.27%)  1
Cerebrovascular accident † 1  1/41 (2.44%)  1 0/44 (0.00%)  0 0/44 (0.00%)  0
Dizziness † 1  1/41 (2.44%)  1 0/44 (0.00%)  0 0/44 (0.00%)  0
Disarthria † 1  1/41 (2.44%)  1 0/44 (0.00%)  0 0/44 (0.00%)  0
Psychiatric disorders       
Insomnia † 1  0/41 (0.00%)  0 1/44 (2.27%)  1 0/44 (0.00%)  0
Mental status change † 1  0/41 (0.00%)  0 0/44 (0.00%)  0 1/44 (2.27%)  1
Renal and urinary disorders       
Acute kidney injury † 1  0/41 (0.00%)  0 1/44 (2.27%)  1 0/44 (0.00%)  0
Chronic kidney disease † 1  0/41 (0.00%)  0 0/44 (0.00%)  0 1/44 (2.27%)  1
Diabetic nephropathy † 1  0/41 (0.00%)  0 0/44 (0.00%)  0 1/44 (2.27%)  1
Respiratory, thoracic and mediastinal disorders       
Dyspnoea † 1  1/41 (2.44%)  1 1/44 (2.27%)  1 0/44 (0.00%)  0
Cough † 1  1/41 (2.44%)  1 0/44 (0.00%)  0 0/44 (0.00%)  0
Oropharyngeal pain † 1  0/41 (0.00%)  0 0/44 (0.00%)  0 1/44 (2.27%)  1
Pneumonia aspiration † 1  1/41 (2.44%)  1 0/44 (0.00%)  0 0/44 (0.00%)  0
Sinus pain † 1  0/41 (0.00%)  0 0/44 (0.00%)  0 1/44 (2.27%)  1
Skin and subcutaneous tissue disorders       
Diabetic foot † 1  0/41 (0.00%)  0 0/44 (0.00%)  0 1/44 (2.27%)  1
Erythema † 1  0/41 (0.00%)  0 1/44 (2.27%)  1 0/44 (0.00%)  0
Skin ulcer † 1  0/41 (0.00%)  0 1/44 (2.27%)  2 0/44 (0.00%)  0
Vascular disorders       
Hypertension † 1  3/41 (7.32%)  4 4/44 (9.09%)  5 3/44 (6.82%)  3
1
Term from vocabulary, MedDRA version 20.1
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director Clinical
Organization: KalVista Pharmaceuticals
Phone: 857-999-0075
EMail: clinicalinfo@kalvista.com
Layout table for additonal information
Responsible Party: KalVista Pharmaceuticals, Ltd.
ClinicalTrials.gov Identifier: NCT03466099    
Other Study ID Numbers: KVD001-201
First Submitted: February 26, 2018
First Posted: March 15, 2018
Results First Submitted: October 8, 2020
Results First Posted: December 8, 2020
Last Update Posted: January 28, 2021