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Efficacy, Safety, and Tolerability of Selonsertib (GS-4997) in Participants With Diabetic Kidney Disease

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: NCT02177786
Recruitment Status : Completed
First Posted : June 30, 2014
Results First Posted : June 11, 2019
Last Update Posted : November 5, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Diabetic Kidney Disease
Interventions Drug: Selonsertib
Drug: Placebo to match selonsertib
Enrollment 334
Recruitment Details Participants were enrolled at study sites in United States and Canada. The first participant was screened on 30 June 2014. The last study visit occurred on 22 August 2016.
Pre-assignment Details 893 participants were screened.
Arm/Group Title Selonsertib 2 mg Selonsertib 6 mg Selonsertib 18 mg Placebo
Hide Arm/Group Description Selonsertib 2 mg tablet once daily for 48 weeks Selonsertib 6 mg tablet once daily for 48 weeks Selonsertib 18 mg tablet once daily for 48 weeks Placebo tablet once daily for 48 weeks
Period Title: Overall Study
Started 81 84 84 85
Randomized and Treated 81 84 83 85
Completed 75 70 66 72
Not Completed 6 14 18 13
Reason Not Completed
Withdrew Consent             2             6             9             5
Progression to End Stage Renal Disease             2             3             2             1
Adverse Event             1             1             2             3
Death             1             1             1             1
Lost to Follow-up             0             0             2             2
Non-Compliance with Study Drug             0             1             0             1
Protocol Violation             0             0             2             0
Progressive Disease             0             1             0             0
Missing study completion status             0             1             0             0
Arm/Group Title Selonsertib 2 mg Selonsertib 6 mg Selonsertib 18 mg Placebo Total
Hide Arm/Group Description Selonsertib 2 mg tablet once daily for 48 weeks Selonsertib 6 mg tablet once daily for 48 weeks Selonsertib 18 mg tablet once daily for 48 weeks Placebo tablet once daily for 48 weeks Total of all reporting groups
Overall Number of Baseline Participants 81 84 83 85 333
Hide Baseline Analysis Population Description
Full Analysis Set included all randomized participants who took at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 81 participants 84 participants 83 participants 85 participants 333 participants
63  (8.1) 62  (8.1) 63  (9.0) 62  (7.9) 63  (8.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 84 participants 83 participants 85 participants 333 participants
Female
28
  34.6%
20
  23.8%
27
  32.5%
32
  37.6%
107
  32.1%
Male
53
  65.4%
64
  76.2%
56
  67.5%
53
  62.4%
226
  67.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 84 participants 83 participants 85 participants 333 participants
Hispanic or Latino
25
  30.9%
31
  36.9%
33
  39.8%
30
  35.3%
119
  35.7%
Not Hispanic or Latino
56
  69.1%
53
  63.1%
50
  60.2%
55
  64.7%
214
  64.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 81 participants 84 participants 83 participants 85 participants 333 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.2%
1
   0.3%
Asian
3
   3.7%
4
   4.8%
2
   2.4%
3
   3.5%
12
   3.6%
Black
20
  24.7%
23
  27.4%
11
  13.3%
19
  22.4%
73
  21.9%
Native Hawaiian or Pacific Islander
1
   1.2%
0
   0.0%
1
   1.2%
0
   0.0%
2
   0.6%
White
53
  65.4%
57
  67.9%
68
  81.9%
61
  71.8%
239
  71.8%
Other
4
   4.9%
0
   0.0%
1
   1.2%
1
   1.2%
6
   1.8%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 84 participants 83 participants 85 participants 333 participants
Canada
2
   2.5%
3
   3.6%
3
   3.6%
4
   4.7%
12
   3.6%
United States
79
  97.5%
81
  96.4%
80
  96.4%
81
  95.3%
321
  96.4%
Estimated Glomerular Filtration Rate (eGFR)   [1] 
Mean (Standard Deviation)
Unit of measure:  mL/min/1.73 m^2
Number Analyzed 81 participants 84 participants 83 participants 85 participants 333 participants
31.6  (10.92) 31.9  (11.58) 31.1  (10.44) 31.4  (11.87) 31.5  (11.18)
[1]
Measure Description: The values of eGFR were calculated using the modification of diet in renal disease (MDRD) equation: eGFR = 175 x Serum Creatinine^-1.154 × age^-0.203 × 1.212 (if participant is black) × 0.742 (if female).
1.Primary Outcome
Title Change in eGFR From Baseline at Week 48
Hide Description The values of eGFR were calculated using the MDRD equation: eGFR = 175 x Serum Creatinine^-1.154 × age^-0.203 × 1.212 (if participant is black) × 0.742 (if female).
Time Frame Baseline; Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set included all randomized participants who took at least 1 dose of study drug.
Arm/Group Title Selonsertib 2 mg Selonsertib 6 mg Selonsertib 18 mg Placebo
Hide Arm/Group Description:
Selonsertib 2 mg tablet once daily for 48 weeks
Selonsertib 6 mg tablet once daily for 48 weeks
Selonsertib 18 mg tablet once daily for 48 weeks
Placebo tablet once daily for 48 weeks
Overall Number of Participants Analyzed 81 84 83 85
Mean (Standard Error)
Unit of Measure: mL/min/1.73 m^2
-2.83  (0.86) -2.37  (0.87) -4.07  (0.89) -3.20  (0.85)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Selonsertib 2 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.755
Comments Data was calculated using a mixed-effect model repeated measures (MMRM) model including terms for treatment group, baseline eGFR, visit and treatment by visit interaction for comparison of change from baseline in eGFR between selonsertib and placebo.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Means Difference
Estimated Value 0.38
Confidence Interval (2-Sided) 95%
-2.00 to 2.75
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.21
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Selonsertib 6 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.492
Comments Data was calculated using a MMRM model including terms for treatment group, baseline eGFR, visit and treatment by visit interaction for comparison of change from baseline in eGFR between selonsertib and placebo.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Means Difference
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
-1.55 to 3.23
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.22
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Selonsertib 18 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.481
Comments Data was calculated using a MMRM model including terms for treatment group, baseline eGFR, visit and treatment by visit interaction for comparison of change from baseline in eGFR between selonsertib and placebo.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Means Difference
Estimated Value -0.87
Confidence Interval (2-Sided) 95%
-3.29 to 1.56
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.23
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Achieving at Least a 30% Reduction From Baseline in Albuminuria (As Measured by Urine Albumin to Creatinine Ratio) at Week 48
Hide Description Baseline was the average of the last 2 values prior to randomization and the last value on or after the randomization date, but prior to or on the first dose date. Urine Albumin to Creatinine Ratio= urine albumin/urine creatinine.
Time Frame Baseline; Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Selonsertib 2 mg Selonsertib 6 mg Selonsertib 18 mg Placebo
Hide Arm/Group Description:
Selonsertib 2 mg tablet once daily for 48 weeks
Selonsertib 6 mg tablet once daily for 48 weeks
Selonsertib 18 mg tablet once daily for 48 weeks
Placebo tablet once daily for 48 weeks
Overall Number of Participants Analyzed 81 84 83 85
Measure Type: Number
Unit of Measure: percentage of participants
28.4 21.4 27.7 30.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Selonsertib 2 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.798
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value was based on a Cochran-Mantel-Haenszel (CMH) test stratified by stage of disease to compare the response rate between selonsertib and placebo.
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value -2.2
Confidence Interval (2-Sided) 95%
-16.1 to 11.7
Estimation Comments The 95% confidence interval (CI) in the difference in percentages between selonsertib and placebo was based on Wald Asymptotic test.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Selonsertib 6 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.175
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value was based on a CMH test stratified by stage of disease to compare the response rate between selonsertib and placebo.
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value -9.2
Confidence Interval (2-Sided) 95%
-22.3 to 4.0
Estimation Comments The 95% CI in the difference in percentages between selonsertib and placebo was based on Wald Asymptotic test.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Selonsertib 18 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.686
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value was based on a CMH test stratified by stage of disease to compare the response rate between selonsertib and placebo.
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value -2.9
Confidence Interval (2-Sided) 95%
-16.6 to 10.9
Estimation Comments The 95% CI in the difference in percentages between selonsertib and placebo was based on Wald Asymptotic test.
Time Frame First dose date up to Week 48 plus 30 days
Adverse Event Reporting Description Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.
 
Arm/Group Title Selonsertib 2 mg Selonsertib 6 mg Selonsertib 18 mg Placebo
Hide Arm/Group Description Selonsertib 2 mg tablet once daily for 48 weeks Selonsertib 6 mg tablet once daily for 48 weeks Selonsertib 18 mg tablet once daily for 48 weeks Placebo tablet once daily for 48 weeks
All-Cause Mortality
Selonsertib 2 mg Selonsertib 6 mg Selonsertib 18 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Selonsertib 2 mg Selonsertib 6 mg Selonsertib 18 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   24/81 (29.63%)   20/84 (23.81%)   20/83 (24.10%)   16/85 (18.82%) 
Blood and lymphatic system disorders         
Anaemia  1  1/81 (1.23%)  1/84 (1.19%)  0/83 (0.00%)  1/85 (1.18%) 
Cardiac disorders         
Acute coronary syndrome  1  0/81 (0.00%)  0/84 (0.00%)  1/83 (1.20%)  0/85 (0.00%) 
Acute myocardial infarction  1  1/81 (1.23%)  2/84 (2.38%)  0/83 (0.00%)  0/85 (0.00%) 
Angina pectoris  1  0/81 (0.00%)  0/84 (0.00%)  0/83 (0.00%)  1/85 (1.18%) 
Angina unstable  1  0/81 (0.00%)  0/84 (0.00%)  0/83 (0.00%)  1/85 (1.18%) 
Aortic valve stenosis  1  1/81 (1.23%)  0/84 (0.00%)  0/83 (0.00%)  0/85 (0.00%) 
Atrial fibrillation  1  0/81 (0.00%)  1/84 (1.19%)  1/83 (1.20%)  0/85 (0.00%) 
Atrioventricular block second degree  1  0/81 (0.00%)  0/84 (0.00%)  1/83 (1.20%)  0/85 (0.00%) 
Bradycardia  1  2/81 (2.47%)  0/84 (0.00%)  0/83 (0.00%)  1/85 (1.18%) 
Cardiac arrest  1  0/81 (0.00%)  0/84 (0.00%)  1/83 (1.20%)  0/85 (0.00%) 
Cardiac failure acute  1  2/81 (2.47%)  0/84 (0.00%)  0/83 (0.00%)  1/85 (1.18%) 
Cardiac failure congestive  1  2/81 (2.47%)  1/84 (1.19%)  4/83 (4.82%)  2/85 (2.35%) 
Myocardial infarction  1  0/81 (0.00%)  1/84 (1.19%)  1/83 (1.20%)  0/85 (0.00%) 
Sinus bradycardia  1  0/81 (0.00%)  0/84 (0.00%)  1/83 (1.20%)  0/85 (0.00%) 
Sinus node dysfunction  1  1/81 (1.23%)  0/84 (0.00%)  0/83 (0.00%)  0/85 (0.00%) 
Eye disorders         
Periorbital oedema  1  0/81 (0.00%)  0/84 (0.00%)  1/83 (1.20%)  0/85 (0.00%) 
Gastrointestinal disorders         
Constipation  1  0/81 (0.00%)  1/84 (1.19%)  0/83 (0.00%)  0/85 (0.00%) 
Diarrhoea  1  1/81 (1.23%)  0/84 (0.00%)  0/83 (0.00%)  0/85 (0.00%) 
Duodenal ulcer  1  0/81 (0.00%)  1/84 (1.19%)  0/83 (0.00%)  0/85 (0.00%) 
Faeces discoloured  1  0/81 (0.00%)  0/84 (0.00%)  1/83 (1.20%)  0/85 (0.00%) 
Gastritis erosive  1  0/81 (0.00%)  0/84 (0.00%)  0/83 (0.00%)  1/85 (1.18%) 
Gastrointestinal haemorrhage  1  0/81 (0.00%)  0/84 (0.00%)  1/83 (1.20%)  0/85 (0.00%) 
Impaired gastric emptying  1  0/81 (0.00%)  1/84 (1.19%)  0/83 (0.00%)  0/85 (0.00%) 
Intestinal mass  1  0/81 (0.00%)  1/84 (1.19%)  0/83 (0.00%)  0/85 (0.00%) 
Intestinal obstruction  1  0/81 (0.00%)  1/84 (1.19%)  0/83 (0.00%)  0/85 (0.00%) 
Nausea  1  0/81 (0.00%)  1/84 (1.19%)  0/83 (0.00%)  0/85 (0.00%) 
Oesophageal ulcer  1  0/81 (0.00%)  1/84 (1.19%)  0/83 (0.00%)  0/85 (0.00%) 
Peptic ulcer haemorrhage  1  1/81 (1.23%)  0/84 (0.00%)  0/83 (0.00%)  0/85 (0.00%) 
Vomiting  1  0/81 (0.00%)  1/84 (1.19%)  0/83 (0.00%)  0/85 (0.00%) 
General disorders         
Chest pain  1  1/81 (1.23%)  2/84 (2.38%)  1/83 (1.20%)  1/85 (1.18%) 
Oedema peripheral  1  0/81 (0.00%)  0/84 (0.00%)  0/83 (0.00%)  1/85 (1.18%) 
Infections and infestations         
Abdominal abscess  1  0/81 (0.00%)  1/84 (1.19%)  0/83 (0.00%)  0/85 (0.00%) 
Appendicitis  1  0/81 (0.00%)  1/84 (1.19%)  0/83 (0.00%)  0/85 (0.00%) 
Bronchitis viral  1  0/81 (0.00%)  0/84 (0.00%)  0/83 (0.00%)  1/85 (1.18%) 
Cellulitis  1  0/81 (0.00%)  1/84 (1.19%)  1/83 (1.20%)  1/85 (1.18%) 
Clostridium difficile colitis  1  1/81 (1.23%)  0/84 (0.00%)  0/83 (0.00%)  0/85 (0.00%) 
Gastroenteritis  1  1/81 (1.23%)  0/84 (0.00%)  0/83 (0.00%)  1/85 (1.18%) 
Influenza  1  1/81 (1.23%)  0/84 (0.00%)  0/83 (0.00%)  0/85 (0.00%) 
Pneumonia  1  3/81 (3.70%)  2/84 (2.38%)  1/83 (1.20%)  0/85 (0.00%) 
Sinusitis fungal  1  0/81 (0.00%)  0/84 (0.00%)  1/83 (1.20%)  0/85 (0.00%) 
Upper respiratory tract infection  1  0/81 (0.00%)  0/84 (0.00%)  0/83 (0.00%)  1/85 (1.18%) 
Urinary tract infection  1  1/81 (1.23%)  0/84 (0.00%)  0/83 (0.00%)  1/85 (1.18%) 
Injury, poisoning and procedural complications         
Contrast media reaction  1  0/81 (0.00%)  0/84 (0.00%)  0/83 (0.00%)  1/85 (1.18%) 
Femoral neck fracture  1  0/81 (0.00%)  0/84 (0.00%)  1/83 (1.20%)  0/85 (0.00%) 
Femur fracture  1  1/81 (1.23%)  0/84 (0.00%)  0/83 (0.00%)  0/85 (0.00%) 
Hip fracture  1  0/81 (0.00%)  0/84 (0.00%)  1/83 (1.20%)  0/85 (0.00%) 
Radius fracture  1  0/81 (0.00%)  0/84 (0.00%)  1/83 (1.20%)  0/85 (0.00%) 
Wound  1  0/81 (0.00%)  0/84 (0.00%)  0/83 (0.00%)  1/85 (1.18%) 
Investigations         
Electrocardiogram ST segment abnormal  1  0/81 (0.00%)  1/84 (1.19%)  0/83 (0.00%)  0/85 (0.00%) 
Metabolism and nutrition disorders         
Dehydration  1  0/81 (0.00%)  0/84 (0.00%)  1/83 (1.20%)  0/85 (0.00%) 
Fluid overload  1  2/81 (2.47%)  1/84 (1.19%)  1/83 (1.20%)  0/85 (0.00%) 
Folate deficiency  1  1/81 (1.23%)  0/84 (0.00%)  0/83 (0.00%)  0/85 (0.00%) 
Hyperglycaemia  1  1/81 (1.23%)  0/84 (0.00%)  0/83 (0.00%)  0/85 (0.00%) 
Hyperkalaemia  1  1/81 (1.23%)  1/84 (1.19%)  1/83 (1.20%)  0/85 (0.00%) 
Hypoglycaemia  1  1/81 (1.23%)  1/84 (1.19%)  0/83 (0.00%)  0/85 (0.00%) 
Hypokalaemia  1  1/81 (1.23%)  0/84 (0.00%)  0/83 (0.00%)  0/85 (0.00%) 
Hypovolaemia  1  2/81 (2.47%)  0/84 (0.00%)  0/83 (0.00%)  0/85 (0.00%) 
Musculoskeletal and connective tissue disorders         
Spinal column stenosis  1  0/81 (0.00%)  1/84 (1.19%)  0/83 (0.00%)  0/85 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Hepatocellular carcinoma  1  0/81 (0.00%)  0/84 (0.00%)  0/83 (0.00%)  1/85 (1.18%) 
Renal cell carcinoma stage III  1  0/81 (0.00%)  0/84 (0.00%)  1/83 (1.20%)  0/85 (0.00%) 
Nervous system disorders         
Brain stem stroke  1  1/81 (1.23%)  0/84 (0.00%)  0/83 (0.00%)  0/85 (0.00%) 
Carotid artery stenosis  1  1/81 (1.23%)  0/84 (0.00%)  0/83 (0.00%)  0/85 (0.00%) 
Cerebrovascular accident  1  0/81 (0.00%)  0/84 (0.00%)  0/83 (0.00%)  2/85 (2.35%) 
Encephalopathy  1  0/81 (0.00%)  0/84 (0.00%)  1/83 (1.20%)  0/85 (0.00%) 
Syncope  1  1/81 (1.23%)  0/84 (0.00%)  1/83 (1.20%)  0/85 (0.00%) 
Transient ischaemic attack  1  1/81 (1.23%)  1/84 (1.19%)  0/83 (0.00%)  0/85 (0.00%) 
Psychiatric disorders         
Mental status changes  1  1/81 (1.23%)  0/84 (0.00%)  0/83 (0.00%)  0/85 (0.00%) 
Renal and urinary disorders         
Acute kidney injury  1  3/81 (3.70%)  3/84 (3.57%)  1/83 (1.20%)  2/85 (2.35%) 
Bladder mass  1  0/81 (0.00%)  0/84 (0.00%)  0/83 (0.00%)  1/85 (1.18%) 
Chronic kidney disease  1  0/81 (0.00%)  0/84 (0.00%)  0/83 (0.00%)  1/85 (1.18%) 
End stage renal disease  1  0/81 (0.00%)  1/84 (1.19%)  0/83 (0.00%)  1/85 (1.18%) 
Haematuria  1  0/81 (0.00%)  1/84 (1.19%)  0/83 (0.00%)  0/85 (0.00%) 
Nephrolithiasis  1  0/81 (0.00%)  1/84 (1.19%)  0/83 (0.00%)  0/85 (0.00%) 
Nephropathy  1  0/81 (0.00%)  0/84 (0.00%)  0/83 (0.00%)  1/85 (1.18%) 
Renal failure  1  2/81 (2.47%)  0/84 (0.00%)  0/83 (0.00%)  0/85 (0.00%) 
Renal haematoma  1  0/81 (0.00%)  0/84 (0.00%)  0/83 (0.00%)  1/85 (1.18%) 
Renal impairment  1  0/81 (0.00%)  0/84 (0.00%)  1/83 (1.20%)  0/85 (0.00%) 
Ureterolithiasis  1  0/81 (0.00%)  0/84 (0.00%)  1/83 (1.20%)  0/85 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Acute respiratory failure  1  1/81 (1.23%)  1/84 (1.19%)  0/83 (0.00%)  0/85 (0.00%) 
Asthma  1  0/81 (0.00%)  0/84 (0.00%)  1/83 (1.20%)  0/85 (0.00%) 
Chronic obstructive pulmonary disease  1  3/81 (3.70%)  0/84 (0.00%)  0/83 (0.00%)  0/85 (0.00%) 
Dyspnoea  1  0/81 (0.00%)  2/84 (2.38%)  1/83 (1.20%)  0/85 (0.00%) 
Hypoxia  1  0/81 (0.00%)  0/84 (0.00%)  1/83 (1.20%)  0/85 (0.00%) 
Pneumonitis  1  0/81 (0.00%)  0/84 (0.00%)  0/83 (0.00%)  1/85 (1.18%) 
Pulmonary oedema  1  0/81 (0.00%)  1/84 (1.19%)  1/83 (1.20%)  1/85 (1.18%) 
Respiratory arrest  1  0/81 (0.00%)  0/84 (0.00%)  1/83 (1.20%)  0/85 (0.00%) 
Vascular disorders         
Deep vein thrombosis  1  0/81 (0.00%)  0/84 (0.00%)  0/83 (0.00%)  1/85 (1.18%) 
Hypertension  1  3/81 (3.70%)  0/84 (0.00%)  1/83 (1.20%)  0/85 (0.00%) 
Hypertensive crisis  1  0/81 (0.00%)  0/84 (0.00%)  1/83 (1.20%)  0/85 (0.00%) 
Hypotension  1  1/81 (1.23%)  0/84 (0.00%)  0/83 (0.00%)  0/85 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Selonsertib 2 mg Selonsertib 6 mg Selonsertib 18 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   51/81 (62.96%)   47/84 (55.95%)   55/83 (66.27%)   48/85 (56.47%) 
Blood and lymphatic system disorders         
Anaemia  1  3/81 (3.70%)  5/84 (5.95%)  5/83 (6.02%)  4/85 (4.71%) 
Gastrointestinal disorders         
Abdominal pain  1  0/81 (0.00%)  5/84 (5.95%)  1/83 (1.20%)  0/85 (0.00%) 
Constipation  1  6/81 (7.41%)  7/84 (8.33%)  3/83 (3.61%)  2/85 (2.35%) 
Diarrhoea  1  7/81 (8.64%)  2/84 (2.38%)  7/83 (8.43%)  4/85 (4.71%) 
Nausea  1  8/81 (9.88%)  4/84 (4.76%)  1/83 (1.20%)  4/85 (4.71%) 
General disorders         
Oedema peripheral  1  2/81 (2.47%)  5/84 (5.95%)  4/83 (4.82%)  7/85 (8.24%) 
Infections and infestations         
Bronchitis  1  1/81 (1.23%)  1/84 (1.19%)  3/83 (3.61%)  5/85 (5.88%) 
Cellulitis  1  1/81 (1.23%)  3/84 (3.57%)  6/83 (7.23%)  0/85 (0.00%) 
Upper respiratory tract infection  1  5/81 (6.17%)  5/84 (5.95%)  8/83 (9.64%)  8/85 (9.41%) 
Urinary tract infection  1  5/81 (6.17%)  1/84 (1.19%)  5/83 (6.02%)  4/85 (4.71%) 
Investigations         
Blood creatinine increased  1  6/81 (7.41%)  1/84 (1.19%)  3/83 (3.61%)  2/85 (2.35%) 
Metabolism and nutrition disorders         
Gout  1  3/81 (3.70%)  5/84 (5.95%)  0/83 (0.00%)  1/85 (1.18%) 
Hyperglycaemia  1  5/81 (6.17%)  1/84 (1.19%)  3/83 (3.61%)  1/85 (1.18%) 
Hyperkalaemia  1  6/81 (7.41%)  3/84 (3.57%)  7/83 (8.43%)  4/85 (4.71%) 
Hypoglycaemia  1  6/81 (7.41%)  4/84 (4.76%)  4/83 (4.82%)  1/85 (1.18%) 
Metabolic acidosis  1  3/81 (3.70%)  1/84 (1.19%)  5/83 (6.02%)  2/85 (2.35%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  6/81 (7.41%)  1/84 (1.19%)  1/83 (1.20%)  5/85 (5.88%) 
Back pain  1  3/81 (3.70%)  6/84 (7.14%)  6/83 (7.23%)  2/85 (2.35%) 
Nervous system disorders         
Dizziness  1  1/81 (1.23%)  1/84 (1.19%)  5/83 (6.02%)  4/85 (4.71%) 
Renal and urinary disorders         
Acute kidney injury  1  1/81 (1.23%)  4/84 (4.76%)  5/83 (6.02%)  0/85 (0.00%) 
Chronic kidney disease  1  2/81 (2.47%)  5/84 (5.95%)  3/83 (3.61%)  3/85 (3.53%) 
End stage renal disease  1  2/81 (2.47%)  3/84 (3.57%)  3/83 (3.61%)  5/85 (5.88%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  3/81 (3.70%)  2/84 (2.38%)  5/83 (6.02%)  0/85 (0.00%) 
Dyspnoea  1  1/81 (1.23%)  3/84 (3.57%)  6/83 (7.23%)  3/85 (3.53%) 
Vascular disorders         
Hypertension  1  7/81 (8.64%)  6/84 (7.14%)  2/83 (2.41%)  6/85 (7.06%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
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.

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

  • The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
  • The study has been completed at all study sites for at least 2 years
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gilead Clinical Study Information Center
Organization: Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
EMail: GileadClinicalTrials@gilead.com
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02177786    
Other Study ID Numbers: GS-US-223-1015
First Submitted: June 26, 2014
First Posted: June 30, 2014
Results First Submitted: May 23, 2019
Results First Posted: June 11, 2019
Last Update Posted: November 5, 2019