Trial Outcomes & Findings for Pharmacokinetic Assessment of Sodium Sulfide in Subjects With Impaired Renal Function (NCT NCT00879645)
NCT ID: NCT00879645
Last Updated: 2019-12-17
Results Overview
Total concentration of thiosulfate in plasma was measured through pharmacokinetic blood sampling.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
28 participants
Primary outcome timeframe
8 hours after treatment
Results posted on
2019-12-17
Participant Flow
Participant milestones
| Measure |
Sodium Sulfide - Mild Cohort
Mild renal impairment (RI) Cohort administered 1.5 mg/kg/hr infusion of Sodium sulfide intravenously for 3 hours.
|
Sodium Sulfide - Healthy Cohort
Healthy subjects received soduim sufide intravenously at 1.5 mg/kg/hr for 3 hours
|
Sodium Sulfide - Moderate Cohort
Moderate RI cohort received sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours
|
Sodium Sulfide - Severe Cohort
Severe RI cohort received sodium sulfide intravenously at 1.0 mg/kg/hr for 3 hours
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
6
|
6
|
7
|
|
Overall Study
COMPLETED
|
8
|
6
|
6
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sodium Sulfide - Mild Cohort
Mild renal impairment (RI) Cohort administered 1.5 mg/kg/hr infusion of Sodium sulfide intravenously for 3 hours.
|
Sodium Sulfide - Healthy Cohort
Healthy subjects received soduim sufide intravenously at 1.5 mg/kg/hr for 3 hours
|
Sodium Sulfide - Moderate Cohort
Moderate RI cohort received sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours
|
Sodium Sulfide - Severe Cohort
Severe RI cohort received sodium sulfide intravenously at 1.0 mg/kg/hr for 3 hours
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Pharmacokinetic Assessment of Sodium Sulfide in Subjects With Impaired Renal Function
Baseline characteristics by cohort
| Measure |
Sodium Sulfide - Mild Cohort
n=9 Participants
Mild renal impairment (RI) Cohort administered 1.5 mg/kg/hr infusion of Sodium sulfide intravenously for 3 hours.
|
Sodium Sulfide - Healthy Cohort
n=6 Participants
Healthy subjects received soduim sufide intravenously at 1.5 mg/kg/hr for 3 hours
|
Sodium Sulfide - Moderate Cohort
n=6 Participants
Moderate RI cohort received sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours
|
Sodium Sulfide - Severe Cohort
n=7 Participants
Severe RI cohort received sodium sulfide intravenously at 1.0 mg/kg/hr for 3 hours
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
28 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Continuous
|
56.3 years
STANDARD_DEVIATION 7.41 • n=93 Participants
|
56.1 years
STANDARD_DEVIATION 14.69 • n=4 Participants
|
60.6 years
STANDARD_DEVIATION 7.91 • n=27 Participants
|
48.9 years
STANDARD_DEVIATION 11.96 • n=483 Participants
|
55.3 years
STANDARD_DEVIATION 10.82 • n=36 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
14 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
14 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=93 Participants
|
6 participants
n=4 Participants
|
6 participants
n=27 Participants
|
7 participants
n=483 Participants
|
28 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 8 hours after treatmentTotal concentration of thiosulfate in plasma was measured through pharmacokinetic blood sampling.
Outcome measures
| Measure |
Sodium Sulfide - Mild Cohort
n=9 Participants
Mild renal impairment (RI) Cohort administered 1.5 mg/kg/hr infusion of Sodium sulfide intravenously for 3 hours.
|
Sodium Sulfide - Healthy Cohort
n=6 Participants
Healthy subjects received soduim sufide intravenously at 1.5 mg/kg/hr for 3 hours
|
Sodium Sulfide - Moderate Cohort
n=6 Participants
Moderate RI cohort received sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours
|
Sodium Sulfide - Severe Cohort
n=7 Participants
Severe RI cohort received sodium sulfide intravenously at 1.0 mg/kg/hr for 3 hours
|
|---|---|---|---|---|
|
Thiosulfate in Plasma
|
120.4 ng/mL
Standard Deviation 57.83
|
199.6 ng/mL
Standard Deviation 100.74
|
199.1 ng/mL
Standard Deviation 60.32
|
190.1 ng/mL
Standard Deviation 36.41
|
PRIMARY outcome
Timeframe: 48 hours after treatmentTotal concentration of thiosulfate in urine was measure through pharmacokinetic urine collection
Outcome measures
| Measure |
Sodium Sulfide - Mild Cohort
n=9 Participants
Mild renal impairment (RI) Cohort administered 1.5 mg/kg/hr infusion of Sodium sulfide intravenously for 3 hours.
|
Sodium Sulfide - Healthy Cohort
n=6 Participants
Healthy subjects received soduim sufide intravenously at 1.5 mg/kg/hr for 3 hours
|
Sodium Sulfide - Moderate Cohort
n=6 Participants
Moderate RI cohort received sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours
|
Sodium Sulfide - Severe Cohort
n=7 Participants
Severe RI cohort received sodium sulfide intravenously at 1.0 mg/kg/hr for 3 hours
|
|---|---|---|---|---|
|
Thiosulfate in Urine
|
1805.5 ng/mL
Standard Deviation 552.00
|
2137.7 ng/mL
Standard Deviation 688.83
|
1114.3 ng/mL
Standard Deviation 720.79
|
603.8 ng/mL
Standard Deviation 433.44
|
PRIMARY outcome
Timeframe: 8 hours after treatmentTotal concentration of sodium sulfide in blood was measured through pharmacokinetic blood sampling.
Outcome measures
| Measure |
Sodium Sulfide - Mild Cohort
n=9 Participants
Mild renal impairment (RI) Cohort administered 1.5 mg/kg/hr infusion of Sodium sulfide intravenously for 3 hours.
|
Sodium Sulfide - Healthy Cohort
n=6 Participants
Healthy subjects received soduim sufide intravenously at 1.5 mg/kg/hr for 3 hours
|
Sodium Sulfide - Moderate Cohort
n=6 Participants
Moderate RI cohort received sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours
|
Sodium Sulfide - Severe Cohort
n=7 Participants
Severe RI cohort received sodium sulfide intravenously at 1.0 mg/kg/hr for 3 hours
|
|---|---|---|---|---|
|
Sodium Sulfide in Blood
|
51.2 ng/mL
Standard Deviation 12.23
|
49.6 ng/mL
Standard Deviation 14.58
|
49.8 ng/mL
Standard Deviation 17.23
|
42.9 ng/mL
Standard Deviation 5.55
|
Adverse Events
Sodium Sulfide - Mild Cohort
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Sodium Sulfide - Healthy Cohort
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Sodium Sulfide - Moderate Cohort
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Sodium Sulfide - Severe Cohort
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sodium Sulfide - Mild Cohort
n=9 participants at risk
Mild renal impairment (RI) Cohort administered 1.5 mg/kg/hr infusion of Sodium sulfide intravenously for 3 hours.
|
Sodium Sulfide - Healthy Cohort
n=6 participants at risk
Healthy subjects received soduim sufide intravenously at 1.5 mg/kg/hr for 3 hours
|
Sodium Sulfide - Moderate Cohort
n=6 participants at risk
Moderate RI cohort received sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours
|
Sodium Sulfide - Severe Cohort
n=7 participants at risk
Severe RI cohort received sodium sulfide intravenously at 1.0 mg/kg/hr for 3 hours
|
|---|---|---|---|---|
|
General disorders
Application Site Rash
|
0.00%
0/9 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
0.00%
0/6 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/9 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
0.00%
0/6 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
0.00%
0/6 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
|
General disorders
Infusion Site Irritation
|
0.00%
0/9 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
0.00%
0/6 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
0.00%
0/6 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
0.00%
0/6 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
0.00%
0/6 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
11.1%
1/9 • Number of events 1 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
0.00%
0/6 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
0.00%
0/7 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
|
Injury, poisoning and procedural complications
Excoriation
|
11.1%
1/9 • Number of events 1 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
0.00%
0/6 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
0.00%
0/6 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
0.00%
0/7 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
|
General disorders
Infusion Site Erythema
|
11.1%
1/9 • Number of events 1 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
0.00%
0/6 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
0.00%
0/6 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
0.00%
0/7 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
|
General disorders
Infusion Site Paraesthesia
|
11.1%
1/9 • Number of events 1 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
0.00%
0/6 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
0.00%
0/7 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
1/9 • Number of events 1 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
0.00%
0/6 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
0.00%
0/6 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
0.00%
0/7 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
|
General disorders
Infusion Site Phlebitis
|
11.1%
1/9 • Number of events 1 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
0.00%
0/6 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
0.00%
0/6 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
0.00%
0/7 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/9 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
0.00%
0/6 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
0.00%
0/7 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
|
General disorders
Infusion Site Anaesthesia
|
0.00%
0/9 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
0.00%
0/6 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
0.00%
0/7 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
|
General disorders
Application Site Irritation
|
0.00%
0/9 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
0.00%
0/6 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
0.00%
0/7 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/9 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
0.00%
0/6 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
0.00%
0/7 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
11.1%
1/9 • Number of events 1 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
0.00%
0/6 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
0.00%
0/6 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
0.00%
0/7 • Adverse events were collected for the 6-month duration of the trial.
Clinically significant changes in vital signs and laboratory values are recorded as adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER