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Study With Oral Ferric Maltol for the Treatment of Iron Deficiency Anemia in Subjects With Chronic Kidney Disease (AEGIS-CKD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02968368
Recruitment Status : Completed
First Posted : November 18, 2016
Results First Posted : May 1, 2020
Last Update Posted : May 14, 2020
Sponsor:
Information provided by (Responsible Party):
Shield Therapeutics

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Renal Insufficiency, Chronic
Iron-Deficiency Anemia
Interventions Drug: Ferric maltol
Other: Placebo
Enrollment 167
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Oral Ferric Maltol Oral Placebo
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30mg capsules BID

Ferric maltol

Matching placebo capsules BID

Placebo

Period Title: Double Blind Phase
Started 111 56
Completed 90 39
Not Completed 21 17
Period Title: Open Label Phase
Started 86 39
Completed 67 25
Not Completed 19 14
Arm/Group Title Oral Ferric Maltol Oral Placebo Total
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30mg capsules BID

Ferric maltol

Matching placebo capsules BID

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 111 56 167
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants 56 participants 167 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
34
  30.6%
19
  33.9%
53
  31.7%
>=65 years
77
  69.4%
37
  66.1%
114
  68.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 111 participants 56 participants 167 participants
68.5  (12.43) 65.2  (12.79) 67.4  (12.61)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants 56 participants 167 participants
Female
78
  70.3%
39
  69.6%
117
  70.1%
Male
33
  29.7%
17
  30.4%
50
  29.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants 56 participants 167 participants
Hispanic or Latino
26
  23.4%
14
  25.0%
40
  24.0%
Not Hispanic or Latino
84
  75.7%
42
  75.0%
126
  75.4%
Unknown or Not Reported
1
   0.9%
0
   0.0%
1
   0.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants 56 participants 167 participants
American Indian or Alaska Native
1
   0.9%
0
   0.0%
1
   0.6%
Asian
2
   1.8%
0
   0.0%
2
   1.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
23
  20.7%
12
  21.4%
35
  21.0%
White
81
  73.0%
42
  75.0%
123
  73.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
   3.6%
2
   3.6%
6
   3.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 111 participants 56 participants 167 participants
111 56 167
1.Primary Outcome
Title Change in Hb Concentration From Baseline to Week 16
Hide Description Change in hemoglobin concentration from baseline to Week 16.
Time Frame 16 weeks
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ITT
Arm/Group Title Oral Ferric Maltol Oral Placebo
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30mg capsules BID

Ferric maltol

Matching placebo capsules BID

Placebo

Overall Number of Participants Analyzed 88 40
Least Squares Mean (Standard Deviation)
Unit of Measure: g/dl
0.50  (0.122) -0.02  (0.165)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oral Ferric Maltol, Oral Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0149
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.52
Confidence Interval (2-Sided) 95%
0.102 to 0.930
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.210
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Subjects That Achieve an Increase in Hb Concentration of ≥1 g/dL at Week 16
Hide Description Number of subjects that achieve an increase in Hemoglobin concentration of ≥1 g/dL at Week 16
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Oral Ferric Maltol Oral Placebo
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30mg capsules BID

Ferric maltol

Matching placebo capsules BID

Placebo

Overall Number of Participants Analyzed 111 56
Measure Type: Count of Participants
Unit of Measure: Participants
22
  19.8%
5
   8.9%
3.Secondary Outcome
Title Number of Subjects That Achieve a Hb Concentration of ≥11 g/dL at Week 16
Hide Description Number of subjects that achieve a Hemoglobin concentration of ≥11 g/dL at week 16
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Oral Ferric Maltol Oral Placebo
Hide Arm/Group Description:

30mg capsules BID

Ferric maltol

Matching placebo capsules BID

Placebo

Overall Number of Participants Analyzed 111 56
Measure Type: Count of Participants
Unit of Measure: Participants
30
  27.0%
7
  12.5%
4.Secondary Outcome
Title Change in Hb Concentration From Baseline to Week 8
Hide Description Change in Hemoglobin concentration from baseline to Week 8
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Where a subject had dropped from the study, we used a LOCF by MI methodology to impute values. Therefore the number of subjects and observations at a given time-point may differ.
Arm/Group Title Oral Ferric Maltol Oral Placebo
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30mg capsules BID

Ferric maltol

Matching placebo capsules BID

Placebo

Overall Number of Participants Analyzed 98 47
Mean (Standard Deviation)
Unit of Measure: g/dl
0.53  (0.901) 0.00  (0.909)
5.Secondary Outcome
Title Number of Subjects That Achieve an Increase in Hb Concentration of ≥2 g/dL at Week 16
Hide Description Number of subjects that achieve an increase in Hemoglobin concentration of ≥2 g/dL at Week 16
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Oral Ferric Maltol Oral Placebo
Hide Arm/Group Description:

30mg capsules BID

Ferric maltol

Matching placebo capsules BID

Placebo

Overall Number of Participants Analyzed 111 56
Measure Type: Count of Participants
Unit of Measure: Participants
7
   6.3%
0
   0.0%
6.Secondary Outcome
Title Changes in Ferritin From Baseline to Week 16
Hide Description Changes in iron parameter - ferritin - from baseline to week 16
Time Frame baseline to week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT OC
Arm/Group Title Oral Ferric Maltol Oral Placebo
Hide Arm/Group Description:

30mg capsules BID

Ferric maltol

Matching placebo capsules BID

Placebo

Overall Number of Participants Analyzed 111 56
Least Squares Mean (Standard Deviation)
Unit of Measure: ug/l
33.13  (6.166) -5.90  (9.137)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oral Ferric Maltol, Oral Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 39.03
Confidence Interval (2-Sided) 95%
17.070 to 60.992
Parameter Dispersion
Type: Standard Error of the Mean
Value: 11.097
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Number of Participants With (TEAEs)
Hide Description Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
safety population
Arm/Group Title Oral Ferric Maltol Oral Placebo
Hide Arm/Group Description:

30mg capsules BID

Ferric maltol

Matching placebo capsules BID

Placebo

Overall Number of Participants Analyzed 111 56
Measure Type: Count of Participants
Unit of Measure: Participants
75
  67.6%
42
  75.0%
8.Secondary Outcome
Title Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)
Hide Description Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs) during the double blind phase
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
safety population
Arm/Group Title Oral Ferric Maltol Oral Placebo
Hide Arm/Group Description:

30mg capsules BID

Ferric maltol

Matching placebo capsules BID

Placebo

Overall Number of Participants Analyzed 111 56
Measure Type: Count of Participants
Unit of Measure: Participants
23
  20.7%
12
  21.4%
9.Secondary Outcome
Title Changes in TSAT From Baseline to Week 16
Hide Description Changes in iron parameters - TSAT - from baseline to week 16
Time Frame baseline to week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT OC
Arm/Group Title Oral Ferric Maltol Oral Placebo
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30mg capsules BID

Ferric maltol

Matching placebo capsules BID

Placebo

Overall Number of Participants Analyzed 111 56
Least Squares Mean (Standard Deviation)
Unit of Measure: TSAT (%)
4.32  (0.719) -0.15  (1.060)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oral Ferric Maltol, Oral Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.46
Confidence Interval (2-Sided) 95%
1.928 to 7.001
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.282
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Changes in Iron Parameter From Baseline to Week 16
Hide Description Changes in iron parameters - serum iron - from baseline to week 16
Time Frame from baseline to week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT OC
Arm/Group Title Oral Ferric Maltol Oral Placebo
Hide Arm/Group Description:

30mg capsules BID

Ferric maltol

Matching placebo capsules BID

Placebo

Overall Number of Participants Analyzed 111 56
Least Squares Mean (Standard Deviation)
Unit of Measure: umol/l
1.87  (0.397) 0.01  (0.586)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oral Ferric Maltol, Oral Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0098
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.86
Confidence Interval (2-Sided) 95%
0.457 to 3.261
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.708
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Hide Description Number of Participants with Treatment-Emergent Adverse Events (TEAEs) during the open label phase
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
safety population
Arm/Group Title Oral Ferric Maltol Oral Placebo
Hide Arm/Group Description:

30mg capsules BID

Ferric maltol

Matching placebo capsules BID

Placebo

Overall Number of Participants Analyzed 86 39
Measure Type: Count of Participants
Unit of Measure: Participants
76
  88.4%
35
  89.7%
12.Secondary Outcome
Title Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)
Hide Description Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs) during the open label phase
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
safety population
Arm/Group Title Oral Ferric Maltol Oral Placebo
Hide Arm/Group Description:

30mg capsules BID

Ferric maltol

Matching placebo capsules BID

Placebo

Overall Number of Participants Analyzed 86 39
Measure Type: Count of Participants
Unit of Measure: Participants
27
  31.4%
9
  23.1%
Time Frame 16 week double blind phase
Adverse Event Reporting Description 167 subjects. Definitions of AEs and SAEs in line with clintrials.gov definitions
 
Arm/Group Title Oral Ferric Maltol DB Oral Placebo DB Oral Ferric Maltol OL Oral Placebo OL
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30mg capsules BID

Ferric maltol

double blind phase

Matching placebo capsules BID

Placebo

double blind phase

30mg capsules BID

Ferric maltol

open label phase

Matching placebo capsules BID

Placebo

open label phase

All-Cause Mortality
Oral Ferric Maltol DB Oral Placebo DB Oral Ferric Maltol OL Oral Placebo OL
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   75/111 (67.57%)   42/56 (75.00%)   76/86 (88.37%)   35/39 (89.74%) 
Hide Serious Adverse Events
Oral Ferric Maltol DB Oral Placebo DB Oral Ferric Maltol OL Oral Placebo OL
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   23/111 (20.72%)   12/56 (21.43%)   27/86 (31.40%)   9/39 (23.08%) 
Blood and lymphatic system disorders         
Anemia * 1  0/111 (0.00%)  2/56 (3.57%)  0/86 (0.00%)  0/39 (0.00%) 
Hemorrhagic anemia * 1  1/111 (0.90%)  1/56 (1.79%)  1/86 (1.16%)  0/39 (0.00%) 
Iron deficiency anemia * 1  0/111 (0.00%)  1/56 (1.79%)  0/86 (0.00%)  0/39 (0.00%) 
Coagulopathy * 1  0/111 (0.00%)  0/56 (0.00%)  1/86 (1.16%)  1/39 (2.56%) 
Normochromic normocytic anemia * 1  0/111 (0.00%)  0/56 (0.00%)  1/86 (1.16%)  0/39 (0.00%) 
Bradycardia * 1  0/111 (0.00%)  0/56 (0.00%)  1/86 (1.16%)  0/39 (0.00%) 
Cardiac disorders         
Angina pectoris * 1  0/111 (0.00%)  1/56 (1.79%)  0/86 (0.00%)  1/39 (2.56%) 
Atrioventricular block complete * 1  1/111 (0.90%)  0/56 (0.00%)  1/86 (1.16%)  0/39 (0.00%) 
Cardiac failure congestive * 1  1/111 (0.90%)  0/56 (0.00%)  1/86 (1.16%)  2/39 (5.13%) 
Coronary artery disease * 1  0/111 (0.00%)  1/56 (1.79%)  0/86 (0.00%)  0/39 (0.00%) 
Myocardial infarction * 1  0/111 (0.00%)  1/56 (1.79%)  0/86 (0.00%)  0/39 (0.00%) 
Acute myocardial infarction * 1  0/111 (0.00%)  0/56 (0.00%)  1/86 (1.16%)  1/39 (2.56%) 
Atrial fibrillation * 1  0/111 (0.00%)  0/56 (0.00%)  1/86 (1.16%)  0/39 (0.00%) 
Cardiac failure acute * 1  0/111 (0.00%)  0/56 (0.00%)  0/86 (0.00%)  1/39 (2.56%) 
Cardiomyopathy * 1  0/111 (0.00%)  0/56 (0.00%)  1/86 (1.16%)  0/39 (0.00%) 
Gastrointestinal disorders         
Diverticulum intestinal * 1  1/111 (0.90%)  0/56 (0.00%)  1/86 (1.16%)  0/39 (0.00%) 
Duodenal polyp * 1  1/111 (0.90%)  0/56 (0.00%)  0/86 (0.00%)  0/39 (0.00%) 
Gastritis erosive * 1  1/111 (0.90%)  0/56 (0.00%)  0/86 (0.00%)  0/39 (0.00%) 
Gastrointestinal hemorrhage * 1  1/111 (0.90%)  0/56 (0.00%)  1/86 (1.16%)  0/39 (0.00%) 
Enteritis * 1  0/111 (0.00%)  0/56 (0.00%)  1/86 (1.16%)  0/39 (0.00%) 
Gastrointestinal wall thickening * 1  0/111 (0.00%)  0/56 (0.00%)  1/86 (1.16%)  0/39 (0.00%) 
Gastroesophageal reflux disease * 1  0/111 (0.00%)  0/56 (0.00%)  0/86 (0.00%)  1/39 (2.56%) 
Oesophageal ulcer * 1  0/111 (0.00%)  0/56 (0.00%)  1/86 (1.16%)  0/39 (0.00%) 
Pancreatitis acute * 1  0/111 (0.00%)  0/56 (0.00%)  0/86 (0.00%)  1/39 (2.56%) 
Small intestinal obstruction * 1  0/111 (0.00%)  0/56 (0.00%)  1/86 (1.16%)  0/39 (0.00%) 
General disorders         
Sudden death * 1  1/111 (0.90%)  0/56 (0.00%)  0/86 (0.00%)  0/39 (0.00%) 
Infections and infestations         
Diverticulitis * 1  0/111 (0.00%)  1/56 (1.79%)  0/86 (0.00%)  0/39 (0.00%) 
Pneumonia * 1  1/111 (0.90%)  0/56 (0.00%)  2/86 (2.33%)  0/39 (0.00%) 
Pyelonephritis * 1  1/111 (0.90%)  0/56 (0.00%)  0/86 (0.00%)  0/39 (0.00%) 
Sepsis * 1  1/111 (0.90%)  0/56 (0.00%)  1/86 (1.16%)  0/39 (0.00%) 
Septic shock * 1  1/111 (0.90%)  0/56 (0.00%)  0/86 (0.00%)  0/39 (0.00%) 
Urinary tract infection * 1  0/111 (0.00%)  1/56 (1.79%)  2/86 (2.33%)  0/39 (0.00%) 
Urinary tract infection * 1  0/111 (0.00%)  1/56 (1.79%)  0/86 (0.00%)  0/39 (0.00%) 
Abscess limb * 1  0/111 (0.00%)  0/56 (0.00%)  1/86 (1.16%)  0/39 (0.00%) 
Cellulitis * 1  0/111 (0.00%)  0/56 (0.00%)  1/86 (1.16%)  1/39 (2.56%) 
Necrotizing fasciitis * 1  0/111 (0.00%)  0/56 (0.00%)  1/86 (1.16%)  0/39 (0.00%) 
Streptococcal bacteremia * 1  0/111 (0.00%)  0/56 (0.00%)  1/86 (1.16%)  0/39 (0.00%) 
Injury, poisoning and procedural complications         
Toxicity to various agents * 1  1/111 (0.90%)  0/56 (0.00%)  1/86 (1.16%)  0/39 (0.00%) 
Wound dehiscence * 1  0/111 (0.00%)  0/56 (0.00%)  1/86 (1.16%)  0/39 (0.00%) 
Investigations         
Hemoglobin decreased * 1  0/111 (0.00%)  0/56 (0.00%)  0/86 (0.00%)  1/39 (2.56%) 
Metabolism and nutrition disorders         
Dehydration * 1  0/111 (0.00%)  1/56 (1.79%)  0/86 (0.00%)  0/39 (0.00%) 
Failure to thrive * 1  1/111 (0.90%)  0/56 (0.00%)  0/86 (0.00%)  0/39 (0.00%) 
Fluid overload * 1  1/111 (0.90%)  0/56 (0.00%)  0/86 (0.00%)  0/39 (0.00%) 
Hyperglycemia * 1  1/111 (0.90%)  0/56 (0.00%)  0/86 (0.00%)  1/39 (2.56%) 
Hyperkalemia * 1  0/111 (0.00%)  1/56 (1.79%)  1/86 (1.16%)  1/39 (2.56%) 
Diabetes mellitus inadequate control * 1  0/111 (0.00%)  0/56 (0.00%)  1/86 (1.16%)  0/39 (0.00%) 
Diabetic ketoacidosis * 1  0/111 (0.00%)  0/56 (0.00%)  1/86 (1.16%)  0/39 (0.00%) 
Musculoskeletal and connective tissue disorders         
Joint contracture * 1  1/111 (0.90%)  0/56 (0.00%)  1/86 (1.16%)  0/39 (0.00%) 
Pathological fracture * 1  1/111 (0.90%)  0/56 (0.00%)  0/86 (0.00%)  0/39 (0.00%) 
Arthritis * 1  0/111 (0.00%)  0/56 (0.00%)  1/86 (1.16%)  0/39 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Metastatic squamous cell carcinoma * 1  1/111 (0.90%)  0/56 (0.00%)  0/86 (0.00%)  0/39 (0.00%) 
Rectosigmoid cancer * 1  0/111 (0.00%)  0/56 (0.00%)  1/86 (1.16%)  0/39 (0.00%) 
Nervous system disorders         
Cerebellar infarction * 1  1/111 (0.90%)  0/56 (0.00%)  0/86 (0.00%)  0/39 (0.00%) 
Cerebrovascular accident * 1  1/111 (0.90%)  0/56 (0.00%)  0/86 (0.00%)  0/39 (0.00%) 
Lacunar stroke * 1  0/111 (0.00%)  0/56 (0.00%)  1/86 (1.16%)  0/39 (0.00%) 
Syncope * 1  0/111 (0.00%)  0/56 (0.00%)  1/86 (1.16%)  0/39 (0.00%) 
Psychiatric disorders         
Mental status changes * 1  0/111 (0.00%)  1/56 (1.79%)  0/86 (0.00%)  1/39 (2.56%) 
Renal and urinary disorders         
Acute kidney injury * 1  1/111 (0.90%)  1/56 (1.79%)  1/86 (1.16%)  2/39 (5.13%) 
Chronic kidney disease * 1  0/111 (0.00%)  0/56 (0.00%)  1/86 (1.16%)  0/39 (0.00%) 
Renal impairment * 1  0/111 (0.00%)  0/56 (0.00%)  0/86 (0.00%)  1/39 (2.56%) 
Renal tubular necrosis * 1  0/111 (0.00%)  0/56 (0.00%)  1/86 (1.16%)  0/39 (0.00%) 
Reproductive system and breast disorders         
Vaginal hemorrhage * 1  0/111 (0.00%)  1/56 (1.79%)  0/86 (0.00%)  0/39 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Dyspnea * 1  1/111 (0.90%)  0/56 (0.00%)  0/86 (0.00%)  0/39 (0.00%) 
Skin and subcutaneous tissue disorders         
Skin ulcer * 1  1/111 (0.90%)  0/56 (0.00%)  1/86 (1.16%)  0/39 (0.00%) 
Vascular disorders         
Hypertensive emergency * 1  1/111 (0.90%)  1/56 (1.79%)  1/86 (1.16%)  1/39 (2.56%) 
Hypertension * 1  0/111 (0.00%)  0/56 (0.00%)  0/86 (0.00%)  1/39 (2.56%) 
Hypotension * 1  0/111 (0.00%)  0/56 (0.00%)  0/86 (0.00%)  1/39 (2.56%) 
Hypovolemic shock * 1  0/111 (0.00%)  0/56 (0.00%)  1/86 (1.16%)  0/39 (0.00%) 
Malignant hypertension * 1  0/111 (0.00%)  0/56 (0.00%)  1/86 (1.16%)  0/39 (0.00%) 
1
Term from vocabulary, MedDRA 18.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Oral Ferric Maltol DB Oral Placebo DB Oral Ferric Maltol OL Oral Placebo OL
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   75/111 (67.57%)   42/56 (75.00%)   76/86 (88.37%)   35/39 (89.74%) 
Blood and lymphatic system disorders         
Blood and lymphatic system disorders * 1 [1]  5/111 (4.50%)  9/56 (16.07%)  0/86 (0.00%)  0/39 (0.00%) 
Anemia * 1  4/111 (3.60%)  6/56 (10.71%)  0/86 (0.00%)  0/39 (0.00%) 
Gastrointestinal disorders         
Diarrhea * 1  10/111 (9.01%)  5/56 (8.93%)  7/86 (8.14%)  5/39 (12.82%) 
Nausea * 1  9/111 (8.11%)  5/56 (8.93%)  10/86 (11.63%)  5/39 (12.82%) 
Constipation * 1  9/111 (8.11%)  2/56 (3.57%)  14/86 (16.28%)  5/39 (12.82%) 
Feces discolored * 1  8/111 (7.21%)  1/56 (1.79%)  7/86 (8.14%)  1/39 (2.56%) 
Gastrointestinal disorders * 1  45/111 (40.54%)  17/56 (30.36%)  48/86 (55.81%)  18/39 (46.15%) 
Vomiting * 1  0/111 (0.00%)  0/56 (0.00%)  7/86 (8.14%)  0/39 (0.00%) 
General disorders         
General disorders and administration site conditions * 1  0/111 (0.00%)  0/56 (0.00%)  16/86 (18.60%)  5/39 (12.82%) 
Fatigue * 1  0/111 (0.00%)  0/56 (0.00%)  6/86 (6.98%)  1/39 (2.56%) 
Edema peripheral * 1  0/111 (0.00%)  0/56 (0.00%)  7/86 (8.14%)  2/39 (5.13%) 
Infections and infestations         
Infections and infestations * 1 [1]  17/111 (15.32%)  13/56 (23.21%)  39/86 (45.35%)  19/39 (48.72%) 
Urinary tract infection * 1  7/111 (6.31%)  5/56 (8.93%)  7/86 (8.14%)  4/39 (10.26%) 
Bronchitis * 1  0/111 (0.00%)  0/56 (0.00%)  5/86 (5.81%)  4/39 (10.26%) 
Nasopharyngitis * 1  0/111 (0.00%)  0/56 (0.00%)  9/86 (10.47%)  3/39 (7.69%) 
Pneumonia * 1  0/111 (0.00%)  0/56 (0.00%)  7/86 (8.14%)  2/39 (5.13%) 
Upper respiratory tract infection * 1  0/111 (0.00%)  0/56 (0.00%)  8/86 (9.30%)  4/39 (10.26%) 
Injury, poisoning and procedural complications         
Injury, poisoning, and procedural complications * 1  0/111 (0.00%)  0/56 (0.00%)  17/86 (19.77%)  4/39 (10.26%) 
Fall * 1  0/111 (0.00%)  0/56 (0.00%)  7/86 (8.14%)  1/39 (2.56%) 
Metabolism and nutrition disorders         
Metabolism and nutrition disorders * 1 [1]  21/111 (18.92%)  13/56 (23.21%)  25/86 (29.07%)  13/39 (33.33%) 
Hyperkalemia * 1  4/111 (3.60%)  7/56 (12.50%)  5/86 (5.81%)  6/39 (15.38%) 
Renal and urinary disorders         
Renal and urinary disorders * 1 [1]  10/111 (9.01%)  6/56 (10.71%)  0/86 (0.00%)  0/39 (0.00%) 
Acute kidney injury * 1  5/111 (4.50%)  4/56 (7.14%)  0/86 (0.00%)  0/39 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Respiratory, thoracic, and mediastinal disorders * 1  0/111 (0.00%)  0/56 (0.00%)  19/86 (22.09%)  7/39 (17.95%) 
Dyspnea * 1  0/111 (0.00%)  0/56 (0.00%)  5/86 (5.81%)  2/39 (5.13%) 
Vascular disorders         
Vascular disorders * 1  0/111 (0.00%)  0/56 (0.00%)  16/86 (18.60%)  5/39 (12.82%) 
Hypertension * 1  0/111 (0.00%)  0/56 (0.00%)  5/86 (5.81%)  3/39 (7.69%) 
1
Term from vocabulary, MedDRA 18.1
*
Indicates events were collected by non-systematic assessment
[1]
TEAEs in <5% of Subjects Overall by SOC
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: Dr Mark Sampson
Organization: Shield Therapeutics
Phone: 02071868513
EMail: msampson@shieldtx.com
Layout table for additonal information
Responsible Party: Shield Therapeutics
ClinicalTrials.gov Identifier: NCT02968368    
Other Study ID Numbers: ST10-01-303
First Submitted: August 30, 2016
First Posted: November 18, 2016
Results First Submitted: November 19, 2019
Results First Posted: May 1, 2020
Last Update Posted: May 14, 2020