Trial Outcomes & Findings for Safety & Efficacy of BCT197 in Patients Undergoing Cardiac Surgery (NCT NCT01336959)
NCT ID: NCT01336959
Last Updated: 2020-11-06
Results Overview
Median percent change from baseline in estimated Glomerular Filtration Rate (eGFR) at 48 hours postdose.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
91 participants
Primary outcome timeframe
48 hours
Results posted on
2020-11-06
Participant Flow
Participant milestones
| Measure |
BCT197 Part A
10 mg BCT197 dosed 2 hours prior to surgery
|
BCT197 Part B
BCT197 Part B: Randomized Double-blind BCT197. Single dose 50mg capsule given 2 hours prior to surgery
|
Placebo Part B
Double-blind randomized Placebo: Placebo capsules matching 50mg BCT197 capsules. Single dose given 2 hours prior to surgery
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
42
|
41
|
|
Overall Study
COMPLETED
|
8
|
37
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
5
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety & Efficacy of BCT197 in Patients Undergoing Cardiac Surgery
Baseline characteristics by cohort
| Measure |
Open Label - BCT197
n=8 Participants
BCT197 Part A
|
Randomized Double-blind BCT197
n=42 Participants
BCT197 Part B: Randomized Double-blind BCT197
|
Randomized Double-blind BCT 197 Placebo
n=41 Participants
Placebo: Placebo capsules
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
8 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
89 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 48 hoursPopulation: Full Analysis Set
Median percent change from baseline in estimated Glomerular Filtration Rate (eGFR) at 48 hours postdose.
Outcome measures
| Measure |
Open Label - BCT197
n=8 Participants
BCT197 Part A
|
Randomized Double-blind BCT197
n=42 Participants
BCT197 Part B: Randomized Double-blind BCT197
|
Randomized Double-blind BCT 197 Placebo
n=41 Participants
Placebo: Placebo capsules
|
|---|---|---|---|
|
Renal Function Measured at 48 Hours Post Cardiac Surgery With Cardiopulmonary Bypass Pump.
|
8.68 Median percentage change
Interval -45.2 to 30.06
|
77 Median percentage change
Interval 32.52 to 142.36
|
85.81 Median percentage change
Interval 55.08 to 132.44
|
SECONDARY outcome
Timeframe: 4 daysPopulation: PK Analysis Set
Max serum concentration reached (ng/mL)
Outcome measures
| Measure |
Open Label - BCT197
n=8 Participants
BCT197 Part A
|
Randomized Double-blind BCT197
n=32 Participants
BCT197 Part B: Randomized Double-blind BCT197
|
Randomized Double-blind BCT 197 Placebo
Placebo: Placebo capsules
|
|---|---|---|---|
|
Pharmacokinetic Measurements of Drug in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass Pump. Pharmacokinetics Will be Measured Using Cmax
|
64.5 ng/mL
Standard Deviation 33.1
|
206 ng/mL
Standard Deviation 64.4
|
—
|
Adverse Events
Open Label - BCT197
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Randomized Double-blind BCT197
Serious events: 13 serious events
Other events: 37 other events
Deaths: 0 deaths
Randomized Double-blind BCT 197 Placebo
Serious events: 7 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Open Label - BCT197
n=8 participants at risk
BCT197 Part A
|
Randomized Double-blind BCT197
n=42 participants at risk
BCT197 Part B: Randomized Double-blind BCT197
|
Randomized Double-blind BCT 197 Placebo
n=41 participants at risk
Placebo: Placebo capsules
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.5%
1/8 • Number of events 1
|
0.00%
0/42
|
0.00%
0/41
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/8
|
2.4%
1/42 • Number of events 1
|
4.9%
2/41 • Number of events 2
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/8
|
4.8%
2/42 • Number of events 2
|
0.00%
0/41
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/8
|
4.8%
2/42 • Number of events 2
|
0.00%
0/41
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/8
|
0.00%
0/42
|
2.4%
1/41 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/8
|
7.1%
3/42 • Number of events 3
|
0.00%
0/41
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
12.5%
1/8 • Number of events 1
|
0.00%
0/42
|
0.00%
0/41
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/8
|
2.4%
1/42 • Number of events 1
|
0.00%
0/41
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/8
|
0.00%
0/42
|
2.4%
1/41 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/8
|
0.00%
0/42
|
2.4%
1/41 • Number of events 1
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/8
|
4.8%
2/42 • Number of events 2
|
0.00%
0/41
|
|
Infections and infestations
Wound infection
|
0.00%
0/8
|
2.4%
1/42 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.00%
0/8
|
0.00%
0/42
|
2.4%
1/41 • Number of events 1
|
|
Infections and infestations
Sepsis
|
0.00%
0/8
|
2.4%
1/42 • Number of events 1
|
0.00%
0/41
|
|
General disorders
Chest pain
|
0.00%
0/8
|
2.4%
1/42 • Number of events 1
|
0.00%
0/41
|
|
General disorders
Multi-organ failure
|
0.00%
0/8
|
2.4%
1/42 • Number of events 1
|
0.00%
0/41
|
|
General disorders
Oedema peripheral
|
0.00%
0/8
|
0.00%
0/42
|
2.4%
1/41 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/8
|
4.8%
2/42 • Number of events 2
|
2.4%
1/41 • Number of events 1
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/8
|
2.4%
1/42 • Number of events 1
|
0.00%
0/41
|
|
Investigations
Enterobacter test positive
|
0.00%
0/8
|
0.00%
0/42
|
2.4%
1/41 • Number of events 1
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.00%
0/8
|
2.4%
1/42 • Number of events 1
|
0.00%
0/41
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/8
|
2.4%
1/42 • Number of events 1
|
0.00%
0/41
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
12.5%
1/8 • Number of events 1
|
0.00%
0/42
|
0.00%
0/41
|
|
Vascular disorders
Ischaemia
|
12.5%
1/8 • Number of events 1
|
0.00%
0/42
|
0.00%
0/41
|
Other adverse events
| Measure |
Open Label - BCT197
n=8 participants at risk
BCT197 Part A
|
Randomized Double-blind BCT197
n=42 participants at risk
BCT197 Part B: Randomized Double-blind BCT197
|
Randomized Double-blind BCT 197 Placebo
n=41 participants at risk
Placebo: Placebo capsules
|
|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/8
|
38.1%
16/42 • Number of events 16
|
26.8%
11/41 • Number of events 11
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/8
|
4.8%
2/42 • Number of events 2
|
4.9%
2/41 • Number of events 2
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/8
|
9.5%
4/42 • Number of events 4
|
0.00%
0/41
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/8
|
2.4%
1/42 • Number of events 1
|
7.3%
3/41 • Number of events 3
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/8
|
7.1%
3/42 • Number of events 3
|
0.00%
0/41
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/8
|
2.4%
1/42 • Number of events 1
|
4.9%
2/41 • Number of events 2
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/8
|
2.4%
1/42 • Number of events 1
|
4.9%
2/41 • Number of events 2
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/8
|
4.8%
2/42 • Number of events 2
|
2.4%
1/41 • Number of events 1
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/8
|
0.00%
0/42
|
4.9%
2/41 • Number of events 2
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/8
|
4.8%
2/42 • Number of events 2
|
0.00%
0/41
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/8
|
0.00%
0/42
|
4.9%
2/41 • Number of events 2
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/8
|
2.4%
1/42 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/8
|
2.4%
1/42 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/8
|
26.2%
11/42 • Number of events 11
|
19.5%
8/41 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/8
|
16.7%
7/42 • Number of events 7
|
9.8%
4/41 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/8
|
7.1%
3/42 • Number of events 3
|
9.8%
4/41 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/8
|
7.1%
3/42 • Number of events 3
|
2.4%
1/41 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8
|
2.4%
1/42 • Number of events 1
|
4.9%
2/41 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/8
|
2.4%
1/42 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/8
|
2.4%
1/42 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/8
|
0.00%
0/42
|
4.9%
2/41 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/8
|
0.00%
0/42
|
4.9%
2/41 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/8
|
0.00%
0/42
|
4.9%
2/41 • Number of events 2
|
|
General disorders
Oedema peripheral
|
0.00%
0/8
|
11.9%
5/42 • Number of events 5
|
14.6%
6/41 • Number of events 6
|
|
General disorders
Generalised oedema
|
0.00%
0/8
|
14.3%
6/42 • Number of events 6
|
2.4%
1/41 • Number of events 1
|
|
General disorders
Pyrexia
|
0.00%
0/8
|
4.8%
2/42 • Number of events 2
|
12.2%
5/41 • Number of events 5
|
|
General disorders
Pain
|
0.00%
0/8
|
7.1%
3/42 • Number of events 3
|
7.3%
3/41 • Number of events 3
|
|
General disorders
Secretion discharge
|
0.00%
0/8
|
4.8%
2/42 • Number of events 2
|
4.9%
2/41 • Number of events 2
|
|
General disorders
Asthenia
|
0.00%
0/8
|
4.8%
2/42 • Number of events 2
|
0.00%
0/41
|
|
General disorders
Oedema
|
0.00%
0/8
|
2.4%
1/42 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/8
|
14.3%
6/42 • Number of events 6
|
17.1%
7/41 • Number of events 7
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/8
|
9.5%
4/42 • Number of events 4
|
2.4%
1/41 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.00%
0/8
|
4.8%
2/42 • Number of events 2
|
7.3%
3/41 • Number of events 3
|
|
Injury, poisoning and procedural complications
Procedural hypertension
|
0.00%
0/8
|
2.4%
1/42 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/8
|
19.0%
8/42 • Number of events 8
|
9.8%
4/41 • Number of events 4
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/8
|
16.7%
7/42 • Number of events 7
|
4.9%
2/41 • Number of events 2
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/8
|
11.9%
5/42 • Number of events 5
|
7.3%
3/41 • Number of events 3
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/8
|
7.1%
3/42 • Number of events 3
|
4.9%
2/41 • Number of events 2
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/8
|
2.4%
1/42 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8
|
16.7%
7/42 • Number of events 7
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8
|
9.5%
4/42 • Number of events 4
|
7.3%
3/41 • Number of events 3
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.00%
0/8
|
11.9%
5/42 • Number of events 5
|
4.9%
2/41 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8
|
9.5%
4/42 • Number of events 4
|
7.3%
3/41 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8
|
9.5%
4/42 • Number of events 4
|
4.9%
2/41 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/8
|
21.4%
9/42 • Number of events 9
|
9.8%
4/41 • Number of events 4
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/8
|
9.5%
4/42 • Number of events 4
|
2.4%
1/41 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/8
|
9.5%
4/42 • Number of events 4
|
2.4%
1/41 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/8
|
9.5%
4/42 • Number of events 4
|
0.00%
0/41
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/8
|
7.1%
3/42 • Number of events 3
|
2.4%
1/41 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/8
|
4.8%
2/42 • Number of events 2
|
0.00%
0/41
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/8
|
4.8%
2/42 • Number of events 2
|
0.00%
0/41
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/8
|
4.8%
2/42 • Number of events 2
|
12.2%
5/41 • Number of events 5
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/8
|
11.9%
5/42 • Number of events 5
|
2.4%
1/41 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/8
|
0.00%
0/42
|
4.9%
2/41 • Number of events 2
|
|
Investigations
Calcium ionised decreased
|
0.00%
0/8
|
4.8%
2/42 • Number of events 2
|
0.00%
0/41
|
|
Investigations
Urine output decreased
|
0.00%
0/8
|
0.00%
0/42
|
4.9%
2/41 • Number of events 2
|
|
Vascular disorders
Hypotension
|
0.00%
0/8
|
14.3%
6/42 • Number of events 6
|
12.2%
5/41 • Number of events 5
|
|
Vascular disorders
Hypertension
|
0.00%
0/8
|
7.1%
3/42 • Number of events 3
|
2.4%
1/41 • Number of events 1
|
|
Vascular disorders
Labile blood pressure
|
0.00%
0/8
|
2.4%
1/42 • Number of events 1
|
7.3%
3/41 • Number of events 3
|
|
Vascular disorders
Pallor
|
0.00%
0/8
|
4.8%
2/42 • Number of events 2
|
0.00%
0/41
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/8
|
9.5%
4/42 • Number of events 4
|
9.8%
4/41 • Number of events 4
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/8
|
9.5%
4/42 • Number of events 4
|
2.4%
1/41 • Number of events 1
|
|
Psychiatric disorders
Agitation
|
0.00%
0/8
|
7.1%
3/42 • Number of events 3
|
0.00%
0/41
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/8
|
4.8%
2/42 • Number of events 2
|
2.4%
1/41 • Number of events 1
|
|
Psychiatric disorders
Delirium
|
0.00%
0/8
|
2.4%
1/42 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/8
|
4.8%
2/42 • Number of events 2
|
0.00%
0/41
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8
|
9.5%
4/42 • Number of events 4
|
2.4%
1/41 • Number of events 1
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/8
|
11.9%
5/42 • Number of events 5
|
0.00%
0/41
|
|
Nervous system disorders
Headache
|
0.00%
0/8
|
2.4%
1/42 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/8
|
7.1%
3/42 • Number of events 3
|
4.9%
2/41 • Number of events 2
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/8
|
2.4%
1/42 • Number of events 1
|
4.9%
2/41 • Number of events 2
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/8
|
4.8%
2/42 • Number of events 2
|
0.00%
0/41
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/8
|
2.4%
1/42 • Number of events 1
|
7.3%
3/41 • Number of events 3
|
|
Infections and infestations
Wound infection
|
0.00%
0/8
|
4.8%
2/42 • Number of events 2
|
2.4%
1/41 • Number of events 1
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/8
|
4.8%
2/42 • Number of events 2
|
0.00%
0/41
|
|
Infections and infestations
Pneumonia
|
0.00%
0/8
|
2.4%
1/42 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/8
|
0.00%
0/42
|
4.9%
2/41 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/8
|
4.8%
2/42 • Number of events 2
|
0.00%
0/41
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8
|
2.4%
1/42 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Scar pain
|
0.00%
0/8
|
0.00%
0/42
|
4.9%
2/41 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8
|
4.8%
2/42 • Number of events 2
|
7.3%
3/41 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All PIs must seek written permission from the sponsor prior to publication on any trial results.
- Publication restrictions are in place
Restriction type: OTHER