Trial Outcomes & Findings for Effect of RBT-1 on Preconditioning Response Biomarkers in Subjects Undergoing CABG and/or Cardiac Valve Surgery (NCT NCT04564833)
NCT ID: NCT04564833
Last Updated: 2024-04-15
Results Overview
Composite of the geometric mean of the ratios of the maximum PreOp value over Baseline for plasma heme oxygenase-1 (HO-1), ferritin, and interleukin-10 (IL-10)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
152 participants
Primary outcome timeframe
Baseline through Pre-Surgery
Results posted on
2024-04-15
Participant Flow
17 participants were excluded after signing informed consent (11 did not meet eligibility criteria, 5 withdrew consent prior to treatment, 1 had surgery changed to another location)
Participant milestones
| Measure |
High Dose RBT-1
Single IV infusion of high dose RBT-1 within 1-2 days prior to scheduled cardiac surgery
|
Low Dose RBT-1
Single IV infusion of low dose RBT-1 within 1-2 days prior to scheduled cardiac surgery
|
Placebo
Single IV infusion of placebo within 1-2 days prior to scheduled cardiac surgery
|
|---|---|---|---|
|
Overall Study
STARTED
|
46
|
45
|
44
|
|
Overall Study
COMPLETED
|
46
|
45
|
44
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of RBT-1 on Preconditioning Response Biomarkers in Subjects Undergoing CABG and/or Cardiac Valve Surgery
Baseline characteristics by cohort
| Measure |
High Dose RBT-1
n=46 Participants
Single IV infusion of high dose RBT-1 within 1-2 days prior to scheduled cardiac surgery
|
Low Dose RBT-1
n=45 Participants
Single IV infusion of low dose RBT-1 within 1-2 days prior to scheduled cardiac surgery
|
Placebo
n=44 Participants
Single IV infusion of placebo within 1-2 days prior to scheduled cardiac surgery
|
Total
n=135 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66.04 years
n=5 Participants
|
63.87 years
n=7 Participants
|
65.70 years
n=5 Participants
|
65.21 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
102 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
129 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
41 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
120 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
10 participants
n=5 Participants
|
27 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
32 participants
n=7 Participants
|
31 participants
n=5 Participants
|
96 participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
3 participants
n=5 Participants
|
12 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline through Pre-SurgeryPopulation: Values were missing from 3 subjects in the low dose RBT-1 treatment group.
Composite of the geometric mean of the ratios of the maximum PreOp value over Baseline for plasma heme oxygenase-1 (HO-1), ferritin, and interleukin-10 (IL-10)
Outcome measures
| Measure |
High Dose RBT-1
n=46 Participants
Intention-To-Treat (ITT) Population - all subjects who had biomarker assessments at Baseline and prior to surgery
|
Low Dose RBT-1
n=42 Participants
Intention-To-Treat (ITT) Population - all subjects who had biomarker assessments at Baseline and prior to surgery
|
Placebo
n=44 Participants
Intention-To-Treat (ITT) Population - all subjects who had biomarker assessments at Baseline and prior to surgery
|
|---|---|---|---|
|
Evaluate the Efficacy of RBT-1 in Generating a Preconditioning Response as Measured by a Composite of Biomarkers
|
3.60 composite ratio
Interval 3.1 to 4.18
|
2.63 composite ratio
Interval 2.25 to 3.07
|
1.00 composite ratio
Interval 0.86 to 1.17
|
SECONDARY outcome
Timeframe: Baseline through Day 3 post-cardiac surgeryPopulation: Biomarker samples were missing from 2 subjects in the Low Dose RBT-1 group and 1 subject in the Placebo group.
Geometric mean of the ratios of the maximum PostOp value over Baseline for urine KIM-1, NGAL, and cystatin C.
Outcome measures
| Measure |
High Dose RBT-1
n=41 Participants
Intention-To-Treat (ITT) Population - all subjects who had biomarker assessments at Baseline and prior to surgery
|
Low Dose RBT-1
n=37 Participants
Intention-To-Treat (ITT) Population - all subjects who had biomarker assessments at Baseline and prior to surgery
|
Placebo
n=40 Participants
Intention-To-Treat (ITT) Population - all subjects who had biomarker assessments at Baseline and prior to surgery
|
|---|---|---|---|
|
Change in Renal Tubular Injury Biomarkers
|
7.89 Composite ratio
Interval 5.09 to 12.23
|
10.84 Composite ratio
Interval 6.92 to 16.98
|
6.10 Composite ratio
Interval 3.96 to 9.39
|
SECONDARY outcome
Timeframe: Baseline through post-cardiac surgery through Day 5Documented AE of sustained reduction in urine output, oliguria, or anuria post-cardiac surgery through Day 5
Outcome measures
| Measure |
High Dose RBT-1
n=41 Participants
Intention-To-Treat (ITT) Population - all subjects who had biomarker assessments at Baseline and prior to surgery
|
Low Dose RBT-1
n=39 Participants
Intention-To-Treat (ITT) Population - all subjects who had biomarker assessments at Baseline and prior to surgery
|
Placebo
n=41 Participants
Intention-To-Treat (ITT) Population - all subjects who had biomarker assessments at Baseline and prior to surgery
|
|---|---|---|---|
|
Number of Subjects With Reduction in Urine Output
|
2 Participants
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline through Day 5 post-cardiac surgeryAKI is defined using the KDIGO criteria (ie, an absolute increase in serum creatinine of ≥1.5 × Baseline; or documented AE of sustained reduction in urine output, oliguria, or anuria; or initiation of dialysis).
Outcome measures
| Measure |
High Dose RBT-1
n=41 Participants
Intention-To-Treat (ITT) Population - all subjects who had biomarker assessments at Baseline and prior to surgery
|
Low Dose RBT-1
n=39 Participants
Intention-To-Treat (ITT) Population - all subjects who had biomarker assessments at Baseline and prior to surgery
|
Placebo
n=41 Participants
Intention-To-Treat (ITT) Population - all subjects who had biomarker assessments at Baseline and prior to surgery
|
|---|---|---|---|
|
Number of Subjects With Acute Kidney Injury (AKI)
|
7 Participants
|
7 Participants
|
8 Participants
|
Adverse Events
High Dose RBT-1
Serious events: 22 serious events
Other events: 42 other events
Deaths: 2 deaths
Low Dose RBT-1
Serious events: 13 serious events
Other events: 40 other events
Deaths: 1 deaths
Placebo
Serious events: 18 serious events
Other events: 40 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
High Dose RBT-1
n=46 participants at risk
Single IV infusion of high dose RBT-1 within 1-2 days prior to scheduled cardiac surgery
|
Low Dose RBT-1
n=45 participants at risk
Single IV infusion of low dose RBT-1 within 1-2 days prior to scheduled cardiac surgery
|
Placebo
n=44 participants at risk
Single IV infusion of placebo within 1-2 days prior to scheduled cardiac surgery
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Blood loss anemia
|
2.2%
1/46 • An average of 90 days from the start of dosing
|
0.00%
0/45 • An average of 90 days from the start of dosing
|
0.00%
0/44 • An average of 90 days from the start of dosing
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/46 • An average of 90 days from the start of dosing
|
4.4%
2/45 • An average of 90 days from the start of dosing
|
2.3%
1/44 • An average of 90 days from the start of dosing
|
|
Cardiac disorders
Atrial flutter
|
2.2%
1/46 • An average of 90 days from the start of dosing
|
0.00%
0/45 • An average of 90 days from the start of dosing
|
0.00%
0/44 • An average of 90 days from the start of dosing
|
|
Cardiac disorders
Atrioventricular block complete
|
2.2%
1/46 • An average of 90 days from the start of dosing
|
0.00%
0/45 • An average of 90 days from the start of dosing
|
0.00%
0/44 • An average of 90 days from the start of dosing
|
|
Cardiac disorders
Bradycardia
|
2.2%
1/46 • An average of 90 days from the start of dosing
|
0.00%
0/45 • An average of 90 days from the start of dosing
|
0.00%
0/44 • An average of 90 days from the start of dosing
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/46 • An average of 90 days from the start of dosing
|
0.00%
0/45 • An average of 90 days from the start of dosing
|
4.5%
2/44 • An average of 90 days from the start of dosing
|
|
Cardiac disorders
Cardiac failure congestive
|
2.2%
1/46 • An average of 90 days from the start of dosing
|
0.00%
0/45 • An average of 90 days from the start of dosing
|
4.5%
2/44 • An average of 90 days from the start of dosing
|
|
Cardiac disorders
Cardiogenic shock
|
2.2%
1/46 • An average of 90 days from the start of dosing
|
4.4%
2/45 • An average of 90 days from the start of dosing
|
2.3%
1/44 • An average of 90 days from the start of dosing
|
|
Cardiac disorders
Low cardiac output
|
0.00%
0/46 • An average of 90 days from the start of dosing
|
0.00%
0/45 • An average of 90 days from the start of dosing
|
2.3%
1/44 • An average of 90 days from the start of dosing
|
|
Cardiac disorders
Pericardial effusion
|
2.2%
1/46 • An average of 90 days from the start of dosing
|
2.2%
1/45 • An average of 90 days from the start of dosing
|
2.3%
1/44 • An average of 90 days from the start of dosing
|
|
Cardiac disorders
Ventricular fibrillation
|
2.2%
1/46 • An average of 90 days from the start of dosing
|
0.00%
0/45 • An average of 90 days from the start of dosing
|
0.00%
0/44 • An average of 90 days from the start of dosing
|
|
Cardiac disorders
Ventricular hypokinesia
|
0.00%
0/46 • An average of 90 days from the start of dosing
|
2.2%
1/45 • An average of 90 days from the start of dosing
|
0.00%
0/44 • An average of 90 days from the start of dosing
|
|
Cardiac disorders
Ventricular tachycardia
|
2.2%
1/46 • An average of 90 days from the start of dosing
|
0.00%
0/45 • An average of 90 days from the start of dosing
|
0.00%
0/44 • An average of 90 days from the start of dosing
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/46 • An average of 90 days from the start of dosing
|
2.2%
1/45 • An average of 90 days from the start of dosing
|
0.00%
0/44 • An average of 90 days from the start of dosing
|
|
Gastrointestinal disorders
Duodenal ulcer hemorrhage
|
2.2%
1/46 • An average of 90 days from the start of dosing
|
0.00%
0/45 • An average of 90 days from the start of dosing
|
0.00%
0/44 • An average of 90 days from the start of dosing
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
2.2%
1/46 • An average of 90 days from the start of dosing
|
2.2%
1/45 • An average of 90 days from the start of dosing
|
0.00%
0/44 • An average of 90 days from the start of dosing
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/46 • An average of 90 days from the start of dosing
|
0.00%
0/45 • An average of 90 days from the start of dosing
|
2.3%
1/44 • An average of 90 days from the start of dosing
|
|
Gastrointestinal disorders
Intestinal ischemia
|
0.00%
0/46 • An average of 90 days from the start of dosing
|
2.2%
1/45 • An average of 90 days from the start of dosing
|
0.00%
0/44 • An average of 90 days from the start of dosing
|
|
General disorders
Non-cardiac chest pain
|
2.2%
1/46 • An average of 90 days from the start of dosing
|
0.00%
0/45 • An average of 90 days from the start of dosing
|
2.3%
1/44 • An average of 90 days from the start of dosing
|
|
Infections and infestations
COVID-19
|
0.00%
0/46 • An average of 90 days from the start of dosing
|
0.00%
0/45 • An average of 90 days from the start of dosing
|
2.3%
1/44 • An average of 90 days from the start of dosing
|
|
Infections and infestations
Cellulitis
|
0.00%
0/46 • An average of 90 days from the start of dosing
|
0.00%
0/45 • An average of 90 days from the start of dosing
|
2.3%
1/44 • An average of 90 days from the start of dosing
|
|
Infections and infestations
Pneumonia
|
2.2%
1/46 • An average of 90 days from the start of dosing
|
2.2%
1/45 • An average of 90 days from the start of dosing
|
2.3%
1/44 • An average of 90 days from the start of dosing
|
|
Infections and infestations
Pneumonia pseudomonas
|
0.00%
0/46 • An average of 90 days from the start of dosing
|
2.2%
1/45 • An average of 90 days from the start of dosing
|
0.00%
0/44 • An average of 90 days from the start of dosing
|
|
Infections and infestations
Sepsis
|
2.2%
1/46 • An average of 90 days from the start of dosing
|
0.00%
0/45 • An average of 90 days from the start of dosing
|
2.3%
1/44 • An average of 90 days from the start of dosing
|
|
Infections and infestations
Systemic candida
|
0.00%
0/46 • An average of 90 days from the start of dosing
|
0.00%
0/45 • An average of 90 days from the start of dosing
|
2.3%
1/44 • An average of 90 days from the start of dosing
|
|
Infections and infestations
Wound infection
|
2.2%
1/46 • An average of 90 days from the start of dosing
|
0.00%
0/45 • An average of 90 days from the start of dosing
|
0.00%
0/44 • An average of 90 days from the start of dosing
|
|
Injury, poisoning and procedural complications
Post procedural hemorrhage
|
0.00%
0/46 • An average of 90 days from the start of dosing
|
2.2%
1/45 • An average of 90 days from the start of dosing
|
0.00%
0/44 • An average of 90 days from the start of dosing
|
|
Injury, poisoning and procedural complications
Post pericardiotomy syndrome
|
0.00%
0/46 • An average of 90 days from the start of dosing
|
0.00%
0/45 • An average of 90 days from the start of dosing
|
2.3%
1/44 • An average of 90 days from the start of dosing
|
|
Investigations
Carbon dioxide increased
|
2.2%
1/46 • An average of 90 days from the start of dosing
|
0.00%
0/45 • An average of 90 days from the start of dosing
|
0.00%
0/44 • An average of 90 days from the start of dosing
|
|
Metabolism and nutrition disorders
Hypervolemia
|
0.00%
0/46 • An average of 90 days from the start of dosing
|
0.00%
0/45 • An average of 90 days from the start of dosing
|
2.3%
1/44 • An average of 90 days from the start of dosing
|
|
Nervous system disorders
Cerebral infarction
|
2.2%
1/46 • An average of 90 days from the start of dosing
|
0.00%
0/45 • An average of 90 days from the start of dosing
|
0.00%
0/44 • An average of 90 days from the start of dosing
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/46 • An average of 90 days from the start of dosing
|
0.00%
0/45 • An average of 90 days from the start of dosing
|
4.5%
2/44 • An average of 90 days from the start of dosing
|
|
Nervous system disorders
Dizziness
|
2.2%
1/46 • An average of 90 days from the start of dosing
|
0.00%
0/45 • An average of 90 days from the start of dosing
|
0.00%
0/44 • An average of 90 days from the start of dosing
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/46 • An average of 90 days from the start of dosing
|
0.00%
0/45 • An average of 90 days from the start of dosing
|
2.3%
1/44 • An average of 90 days from the start of dosing
|
|
Nervous system disorders
Hypoglycemic seizure
|
0.00%
0/46 • An average of 90 days from the start of dosing
|
2.2%
1/45 • An average of 90 days from the start of dosing
|
0.00%
0/44 • An average of 90 days from the start of dosing
|
|
Nervous system disorders
Transient global amnesia
|
2.2%
1/46 • An average of 90 days from the start of dosing
|
0.00%
0/45 • An average of 90 days from the start of dosing
|
0.00%
0/44 • An average of 90 days from the start of dosing
|
|
Product Issues
Device dislocation
|
2.2%
1/46 • An average of 90 days from the start of dosing
|
0.00%
0/45 • An average of 90 days from the start of dosing
|
0.00%
0/44 • An average of 90 days from the start of dosing
|
|
Psychiatric disorders
Agitation
|
0.00%
0/46 • An average of 90 days from the start of dosing
|
2.2%
1/45 • An average of 90 days from the start of dosing
|
0.00%
0/44 • An average of 90 days from the start of dosing
|
|
Psychiatric disorders
Delirium
|
2.2%
1/46 • An average of 90 days from the start of dosing
|
0.00%
0/45 • An average of 90 days from the start of dosing
|
0.00%
0/44 • An average of 90 days from the start of dosing
|
|
Renal and urinary disorders
Acute kidney injury
|
2.2%
1/46 • An average of 90 days from the start of dosing
|
2.2%
1/45 • An average of 90 days from the start of dosing
|
4.5%
2/44 • An average of 90 days from the start of dosing
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.2%
1/46 • An average of 90 days from the start of dosing
|
2.2%
1/45 • An average of 90 days from the start of dosing
|
4.5%
2/44 • An average of 90 days from the start of dosing
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/46 • An average of 90 days from the start of dosing
|
0.00%
0/45 • An average of 90 days from the start of dosing
|
2.3%
1/44 • An average of 90 days from the start of dosing
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal hemorrhage
|
0.00%
0/46 • An average of 90 days from the start of dosing
|
2.2%
1/45 • An average of 90 days from the start of dosing
|
0.00%
0/44 • An average of 90 days from the start of dosing
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.5%
3/46 • An average of 90 days from the start of dosing
|
4.4%
2/45 • An average of 90 days from the start of dosing
|
6.8%
3/44 • An average of 90 days from the start of dosing
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.2%
1/46 • An average of 90 days from the start of dosing
|
0.00%
0/45 • An average of 90 days from the start of dosing
|
2.3%
1/44 • An average of 90 days from the start of dosing
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/46 • An average of 90 days from the start of dosing
|
0.00%
0/45 • An average of 90 days from the start of dosing
|
2.3%
1/44 • An average of 90 days from the start of dosing
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/46 • An average of 90 days from the start of dosing
|
0.00%
0/45 • An average of 90 days from the start of dosing
|
2.3%
1/44 • An average of 90 days from the start of dosing
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/46 • An average of 90 days from the start of dosing
|
0.00%
0/45 • An average of 90 days from the start of dosing
|
2.3%
1/44 • An average of 90 days from the start of dosing
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.2%
1/46 • An average of 90 days from the start of dosing
|
2.2%
1/45 • An average of 90 days from the start of dosing
|
6.8%
3/44 • An average of 90 days from the start of dosing
|
|
Respiratory, thoracic and mediastinal disorders
Upper airway obstruction
|
2.2%
1/46 • An average of 90 days from the start of dosing
|
0.00%
0/45 • An average of 90 days from the start of dosing
|
0.00%
0/44 • An average of 90 days from the start of dosing
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
4.3%
2/46 • An average of 90 days from the start of dosing
|
0.00%
0/45 • An average of 90 days from the start of dosing
|
0.00%
0/44 • An average of 90 days from the start of dosing
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/46 • An average of 90 days from the start of dosing
|
0.00%
0/45 • An average of 90 days from the start of dosing
|
2.3%
1/44 • An average of 90 days from the start of dosing
|
|
Vascular disorders
Hematoma
|
0.00%
0/46 • An average of 90 days from the start of dosing
|
0.00%
0/45 • An average of 90 days from the start of dosing
|
2.3%
1/44 • An average of 90 days from the start of dosing
|
|
Vascular disorders
Hemorrhage
|
0.00%
0/46 • An average of 90 days from the start of dosing
|
2.2%
1/45 • An average of 90 days from the start of dosing
|
0.00%
0/44 • An average of 90 days from the start of dosing
|
|
Vascular disorders
Hypotension
|
4.3%
2/46 • An average of 90 days from the start of dosing
|
2.2%
1/45 • An average of 90 days from the start of dosing
|
0.00%
0/44 • An average of 90 days from the start of dosing
|
Other adverse events
| Measure |
High Dose RBT-1
n=46 participants at risk
Single IV infusion of high dose RBT-1 within 1-2 days prior to scheduled cardiac surgery
|
Low Dose RBT-1
n=45 participants at risk
Single IV infusion of low dose RBT-1 within 1-2 days prior to scheduled cardiac surgery
|
Placebo
n=44 participants at risk
Single IV infusion of placebo within 1-2 days prior to scheduled cardiac surgery
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
13.0%
6/46 • An average of 90 days from the start of dosing
|
17.8%
8/45 • An average of 90 days from the start of dosing
|
25.0%
11/44 • An average of 90 days from the start of dosing
|
|
Blood and lymphatic system disorders
Blood loss anemia
|
2.2%
1/46 • An average of 90 days from the start of dosing
|
8.9%
4/45 • An average of 90 days from the start of dosing
|
9.1%
4/44 • An average of 90 days from the start of dosing
|
|
Blood and lymphatic system disorders
Leukocytosis
|
8.7%
4/46 • An average of 90 days from the start of dosing
|
6.7%
3/45 • An average of 90 days from the start of dosing
|
13.6%
6/44 • An average of 90 days from the start of dosing
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.3%
2/46 • An average of 90 days from the start of dosing
|
8.9%
4/45 • An average of 90 days from the start of dosing
|
6.8%
3/44 • An average of 90 days from the start of dosing
|
|
Cardiac disorders
Atrial fibrillation
|
21.7%
10/46 • An average of 90 days from the start of dosing
|
22.2%
10/45 • An average of 90 days from the start of dosing
|
36.4%
16/44 • An average of 90 days from the start of dosing
|
|
Cardiac disorders
Cardiomegaly
|
4.3%
2/46 • An average of 90 days from the start of dosing
|
6.7%
3/45 • An average of 90 days from the start of dosing
|
4.5%
2/44 • An average of 90 days from the start of dosing
|
|
Gastrointestinal disorders
Abdominal distention
|
2.2%
1/46 • An average of 90 days from the start of dosing
|
0.00%
0/45 • An average of 90 days from the start of dosing
|
6.8%
3/44 • An average of 90 days from the start of dosing
|
|
Gastrointestinal disorders
Constipation
|
10.9%
5/46 • An average of 90 days from the start of dosing
|
8.9%
4/45 • An average of 90 days from the start of dosing
|
9.1%
4/44 • An average of 90 days from the start of dosing
|
|
Gastrointestinal disorders
Diarrhea
|
6.5%
3/46 • An average of 90 days from the start of dosing
|
2.2%
1/45 • An average of 90 days from the start of dosing
|
6.8%
3/44 • An average of 90 days from the start of dosing
|
|
Gastrointestinal disorders
Nausea
|
30.4%
14/46 • An average of 90 days from the start of dosing
|
20.0%
9/45 • An average of 90 days from the start of dosing
|
20.5%
9/44 • An average of 90 days from the start of dosing
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/46 • An average of 90 days from the start of dosing
|
4.4%
2/45 • An average of 90 days from the start of dosing
|
6.8%
3/44 • An average of 90 days from the start of dosing
|
|
General disorders
Chest pain
|
4.3%
2/46 • An average of 90 days from the start of dosing
|
2.2%
1/45 • An average of 90 days from the start of dosing
|
6.8%
3/44 • An average of 90 days from the start of dosing
|
|
General disorders
Generalized edema
|
6.5%
3/46 • An average of 90 days from the start of dosing
|
6.7%
3/45 • An average of 90 days from the start of dosing
|
11.4%
5/44 • An average of 90 days from the start of dosing
|
|
General disorders
Edema
|
4.3%
2/46 • An average of 90 days from the start of dosing
|
4.4%
2/45 • An average of 90 days from the start of dosing
|
9.1%
4/44 • An average of 90 days from the start of dosing
|
|
General disorders
Edema peripheral
|
6.5%
3/46 • An average of 90 days from the start of dosing
|
13.3%
6/45 • An average of 90 days from the start of dosing
|
4.5%
2/44 • An average of 90 days from the start of dosing
|
|
General disorders
Pain
|
2.2%
1/46 • An average of 90 days from the start of dosing
|
2.2%
1/45 • An average of 90 days from the start of dosing
|
11.4%
5/44 • An average of 90 days from the start of dosing
|
|
Infections and infestations
Urinary tract infection
|
10.9%
5/46 • An average of 90 days from the start of dosing
|
0.00%
0/45 • An average of 90 days from the start of dosing
|
2.3%
1/44 • An average of 90 days from the start of dosing
|
|
Injury, poisoning and procedural complications
Incision site pain
|
8.7%
4/46 • An average of 90 days from the start of dosing
|
13.3%
6/45 • An average of 90 days from the start of dosing
|
4.5%
2/44 • An average of 90 days from the start of dosing
|
|
Injury, poisoning and procedural complications
Procedural pain
|
19.6%
9/46 • An average of 90 days from the start of dosing
|
20.0%
9/45 • An average of 90 days from the start of dosing
|
25.0%
11/44 • An average of 90 days from the start of dosing
|
|
Investigations
Breath sounds abnormal
|
2.2%
1/46 • An average of 90 days from the start of dosing
|
6.7%
3/45 • An average of 90 days from the start of dosing
|
2.3%
1/44 • An average of 90 days from the start of dosing
|
|
Investigations
Urine output decreased
|
13.0%
6/46 • An average of 90 days from the start of dosing
|
8.9%
4/45 • An average of 90 days from the start of dosing
|
9.1%
4/44 • An average of 90 days from the start of dosing
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.9%
5/46 • An average of 90 days from the start of dosing
|
11.1%
5/45 • An average of 90 days from the start of dosing
|
11.4%
5/44 • An average of 90 days from the start of dosing
|
|
Metabolism and nutrition disorders
Hypervolemia
|
10.9%
5/46 • An average of 90 days from the start of dosing
|
8.9%
4/45 • An average of 90 days from the start of dosing
|
20.5%
9/44 • An average of 90 days from the start of dosing
|
|
Psychiatric disorders
Delirium
|
2.2%
1/46 • An average of 90 days from the start of dosing
|
6.7%
3/45 • An average of 90 days from the start of dosing
|
6.8%
3/44 • An average of 90 days from the start of dosing
|
|
Psychiatric disorders
Hallucination
|
2.2%
1/46 • An average of 90 days from the start of dosing
|
0.00%
0/45 • An average of 90 days from the start of dosing
|
6.8%
3/44 • An average of 90 days from the start of dosing
|
|
Psychiatric disorders
Insomnia
|
4.3%
2/46 • An average of 90 days from the start of dosing
|
11.1%
5/45 • An average of 90 days from the start of dosing
|
11.4%
5/44 • An average of 90 days from the start of dosing
|
|
Renal and urinary disorders
Acute kidney injury
|
6.5%
3/46 • An average of 90 days from the start of dosing
|
15.6%
7/45 • An average of 90 days from the start of dosing
|
9.1%
4/44 • An average of 90 days from the start of dosing
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
23.9%
11/46 • An average of 90 days from the start of dosing
|
24.4%
11/45 • An average of 90 days from the start of dosing
|
20.5%
9/44 • An average of 90 days from the start of dosing
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.5%
3/46 • An average of 90 days from the start of dosing
|
4.4%
2/45 • An average of 90 days from the start of dosing
|
9.1%
4/44 • An average of 90 days from the start of dosing
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/46 • An average of 90 days from the start of dosing
|
0.00%
0/45 • An average of 90 days from the start of dosing
|
6.8%
3/44 • An average of 90 days from the start of dosing
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/46 • An average of 90 days from the start of dosing
|
6.7%
3/45 • An average of 90 days from the start of dosing
|
4.5%
2/44 • An average of 90 days from the start of dosing
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
19.6%
9/46 • An average of 90 days from the start of dosing
|
20.0%
9/45 • An average of 90 days from the start of dosing
|
18.2%
8/44 • An average of 90 days from the start of dosing
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
6.5%
3/46 • An average of 90 days from the start of dosing
|
2.2%
1/45 • An average of 90 days from the start of dosing
|
4.5%
2/44 • An average of 90 days from the start of dosing
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
21.7%
10/46 • An average of 90 days from the start of dosing
|
13.3%
6/45 • An average of 90 days from the start of dosing
|
0.00%
0/44 • An average of 90 days from the start of dosing
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
6.5%
3/46 • An average of 90 days from the start of dosing
|
4.4%
2/45 • An average of 90 days from the start of dosing
|
0.00%
0/44 • An average of 90 days from the start of dosing
|
|
Vascular disorders
Hypotension
|
26.1%
12/46 • An average of 90 days from the start of dosing
|
24.4%
11/45 • An average of 90 days from the start of dosing
|
27.3%
12/44 • An average of 90 days from the start of dosing
|
Additional Information
Stacey Ruiz, PhD / VP, Drug Development
Renibus Therapeutics
Phone: 424-209-2734
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Study Center and Investigator shall not publish or present the Study results until after the first publication or presentation regarding the overall study is completed, such publication or presentation to be at the sole discretion of Sponsor, or eighteen (18) months from the completion date of the Study (as defined in 42 U.S.C. 282(j)(1)(A)(v)), whichever occurs first.
- Publication restrictions are in place
Restriction type: OTHER