Trial Outcomes & Findings for Safety and Dose Finding Study of Xigris in Hemodialysis Patients (NCT NCT01227187)
NCT ID: NCT01227187
Last Updated: 2022-02-03
Results Overview
PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
PTT level at 15 minutes after start up of Xigris during the hemodialysis treatment.
Results posted on
2022-02-03
Participant Flow
The study was conducted on stable inpatient HD patients between October 2008 and September 2010. The study design was based on different possible dose levels of APC infusion: 12, 18, 24, 30 μg/kg/h. The initial starting dose of APC for the first patient was 12 μg/kg/h. When a study patient's PTT was \<60 s, the starting dose for the next study patient was increased by 6. There were no patient's in the 30 μg/kg/h group with a PTT of \<60 s
Participants were evaluated for inclusion and exclusion criteria and immediately enrolled in the study.
Participant milestones
| Measure |
APC Initiation Dose of 12 μg/kg/h
Activated protein C initiation dose of 12 μg/kg/h for the first patient
|
APC Initiation Dose of 18 μg/kg/h
Activated protein C initiation dose of 18 μg/kg/h
|
APC Initiation Dose of 24 μg/kg/h
Activated protein C initiation dose of 24 μg/kg/h
|
APC Initiation Dose of 30 μg/kg/h
Activated protein C initiation dose of 30 μg/kg/h
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
3
|
3
|
5
|
|
Overall Study
COMPLETED
|
1
|
3
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
APC Initiation Dose of 12 μg/kg/h
Activated protein C initiation dose of 12 μg/kg/h for the first patient
|
APC Initiation Dose of 18 μg/kg/h
Activated protein C initiation dose of 18 μg/kg/h
|
APC Initiation Dose of 24 μg/kg/h
Activated protein C initiation dose of 24 μg/kg/h
|
APC Initiation Dose of 30 μg/kg/h
Activated protein C initiation dose of 30 μg/kg/h
|
|---|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Safety and Dose Finding Study of Xigris in Hemodialysis Patients
Baseline characteristics by cohort
| Measure |
Infusion Rate of 12 mcg/kg/h
n=1 Participants
|
Infusion Rate of 18 mcg/kg/h
n=3 Participants
|
Infusion Rate of 24 mcg/kg/h
n=3 Participants
|
Infusion Rate of 30 mcg/kg/h
n=5 Participants
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
38 years
STANDARD_DEVIATION 0 • n=93 Participants
|
46 years
STANDARD_DEVIATION 21.3 • n=4 Participants
|
48.7 years
STANDARD_DEVIATION 13.1 • n=27 Participants
|
53.2 years
STANDARD_DEVIATION 7.9 • n=483 Participants
|
49 years
STANDARD_DEVIATION 12.6 • n=36 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
White
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
10 Participants
n=36 Participants
|
|
Height
|
66 inches
STANDARD_DEVIATION 0 • n=93 Participants
|
68.7 inches
STANDARD_DEVIATION 2.9 • n=4 Participants
|
73.3 inches
STANDARD_DEVIATION 5.1 • n=27 Participants
|
68.8 inches
STANDARD_DEVIATION 4.1 • n=483 Participants
|
69.7 inches
STANDARD_DEVIATION 4.2 • n=36 Participants
|
|
Weight
|
96 kilograms
STANDARD_DEVIATION 00 • n=93 Participants
|
69.6 kilograms
STANDARD_DEVIATION 17.6 • n=4 Participants
|
104.5 kilograms
STANDARD_DEVIATION 12.6 • n=27 Participants
|
79.4 kilograms
STANDARD_DEVIATION 29.8 • n=483 Participants
|
84.6 kilograms
STANDARD_DEVIATION 29.7 • n=36 Participants
|
|
Diabetes
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
|
Congestive heart failure
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
|
WBC
|
6.0 10^3/µL
STANDARD_DEVIATION 0 • n=93 Participants
|
5.9 10^3/µL
STANDARD_DEVIATION 1.8 • n=4 Participants
|
8.1 10^3/µL
STANDARD_DEVIATION 0.7 • n=27 Participants
|
6.4 10^3/µL
STANDARD_DEVIATION 1.2 • n=483 Participants
|
6.7 10^3/µL
STANDARD_DEVIATION 1.4 • n=36 Participants
|
|
Red blood cells
|
3.6 million/mm^3
STANDARD_DEVIATION 0 • n=93 Participants
|
2.7 million/mm^3
STANDARD_DEVIATION 0.4 • n=4 Participants
|
3.4 million/mm^3
STANDARD_DEVIATION 0.9 • n=27 Participants
|
3.2 million/mm^3
STANDARD_DEVIATION 0.5 • n=483 Participants
|
3.1 million/mm^3
STANDARD_DEVIATION 0.6 • n=36 Participants
|
|
Hemoglobin
|
9.9 g/dL
STANDARD_DEVIATION 0 • n=93 Participants
|
7.2 g/dL
STANDARD_DEVIATION 0.6 • n=4 Participants
|
9.9 g/dL
STANDARD_DEVIATION 1.4 • n=27 Participants
|
9.0 g/dL
STANDARD_DEVIATION 1.4 • n=483 Participants
|
9.0 g/dL
STANDARD_DEVIATION 1.0 • n=36 Participants
|
|
Hematocrit
|
31.2 Percentage of red blood cells in blood
STANDARD_DEVIATION 0 • n=93 Participants
|
23.2 Percentage of red blood cells in blood
STANDARD_DEVIATION 2.5 • n=4 Participants
|
30.9 Percentage of red blood cells in blood
STANDARD_DEVIATION 4.0 • n=27 Participants
|
27.9 Percentage of red blood cells in blood
STANDARD_DEVIATION 3.6 • n=483 Participants
|
27.8 Percentage of red blood cells in blood
STANDARD_DEVIATION 3.6 • n=36 Participants
|
|
Platelets
|
333 10^9 per liter
STANDARD_DEVIATION 0 • n=93 Participants
|
196.7 10^9 per liter
STANDARD_DEVIATION 113.7 • n=4 Participants
|
315 10^9 per liter
STANDARD_DEVIATION 82.3 • n=27 Participants
|
220.2 10^9 per liter
STANDARD_DEVIATION 84.5 • n=483 Participants
|
247.4 10^9 per liter
STANDARD_DEVIATION 95.5 • n=36 Participants
|
|
BUN
|
26 mg/dL
STANDARD_DEVIATION 0 • n=93 Participants
|
36.3 mg/dL
STANDARD_DEVIATION 9.5 • n=4 Participants
|
47 mg/dL
STANDARD_DEVIATION 17.4 • n=27 Participants
|
53.2 mg/dL
STANDARD_DEVIATION 17.1 • n=483 Participants
|
45.2 mg/dL
STANDARD_DEVIATION 17.1 • n=36 Participants
|
|
Creatinine
|
15 μmol/L
STANDARD_DEVIATION 0 • n=93 Participants
|
7.8 μmol/L
STANDARD_DEVIATION 1.1 • n=4 Participants
|
7.8 μmol/L
STANDARD_DEVIATION 0.5 • n=27 Participants
|
9.2 μmol/L
STANDARD_DEVIATION 3.6 • n=483 Participants
|
9.0 μmol/L
STANDARD_DEVIATION 3.0 • n=36 Participants
|
|
Prothrombin time
|
13.2 seconds
STANDARD_DEVIATION 0 • n=93 Participants
|
14.6 seconds
STANDARD_DEVIATION 0.2 • n=4 Participants
|
14.2 seconds
STANDARD_DEVIATION 1.0 • n=27 Participants
|
13.1 seconds
STANDARD_DEVIATION 1.0 • n=483 Participants
|
13.8 seconds
STANDARD_DEVIATION 1.0 • n=36 Participants
|
|
Partial thromboplastin time
|
38.1 Seconds
STANDARD_DEVIATION 0 • n=93 Participants
|
37.3 Seconds
STANDARD_DEVIATION 4.3 • n=4 Participants
|
37.6 Seconds
STANDARD_DEVIATION 1.3 • n=27 Participants
|
35.5 Seconds
STANDARD_DEVIATION 6.1 • n=483 Participants
|
36.7 Seconds
STANDARD_DEVIATION 4.3 • n=36 Participants
|
|
International Normalized Ratio
|
1.1 Ratio
STANDARD_DEVIATION 0 • n=93 Participants
|
1.2 Ratio
STANDARD_DEVIATION 0.1 • n=4 Participants
|
1.2 Ratio
STANDARD_DEVIATION 0.2 • n=27 Participants
|
1.0 Ratio
STANDARD_DEVIATION 0.1 • n=483 Participants
|
1.1 Ratio
STANDARD_DEVIATION 0.1 • n=36 Participants
|
PRIMARY outcome
Timeframe: PTT level at 15 minutes after start up of Xigris during the hemodialysis treatment.PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant.
Outcome measures
| Measure |
APC Initiation Dose 12 μg/kg/h
n=1 Participants
APC Initiation dose 12 μg/kg/h
|
APC Initiation Dose 18 μg/kg/h
n=3 Participants
APC Initiation dose 18 μg/kg/h
|
APC Initiation Dose 24 μg/kg/h
n=3 Participants
APC Initiation dose 24 μg/kg/h
|
APC Initiation Dose 30 μg/kg/h
n=5 Participants
APC Initiation dose 30 μg/kg/h
|
|---|---|---|---|---|
|
Mean Partial Thromboplastin Time (PTT) at 15 Minutes
|
38.4 Seconds
Standard Deviation NA
Only 1 subject in arm
|
38.4 Seconds
Standard Deviation 4.6
|
45.4 Seconds
Standard Deviation 5.1
|
49.7 Seconds
Standard Deviation 12.0
|
PRIMARY outcome
Timeframe: PTT level at 30 minutes after start up of Xigris during the hemodialysis treatment.PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant.
Outcome measures
| Measure |
APC Initiation Dose 12 μg/kg/h
n=1 Participants
APC Initiation dose 12 μg/kg/h
|
APC Initiation Dose 18 μg/kg/h
n=3 Participants
APC Initiation dose 18 μg/kg/h
|
APC Initiation Dose 24 μg/kg/h
n=3 Participants
APC Initiation dose 24 μg/kg/h
|
APC Initiation Dose 30 μg/kg/h
n=5 Participants
APC Initiation dose 30 μg/kg/h
|
|---|---|---|---|---|
|
Mean Partial Thromboplastin Time (PTT) at 30 Minutes
|
36.2 Seconds
Standard Deviation NA
Only 1 subject in arm
|
35.7 Seconds
Standard Deviation 3.4
|
48.2 Seconds
Standard Deviation 8.8
|
51.3 Seconds
Standard Deviation 12.0
|
PRIMARY outcome
Timeframe: PTT level at 60 minutes after start up of Xigris during the hemodialysis treatment.PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant.
Outcome measures
| Measure |
APC Initiation Dose 12 μg/kg/h
n=1 Participants
APC Initiation dose 12 μg/kg/h
|
APC Initiation Dose 18 μg/kg/h
n=3 Participants
APC Initiation dose 18 μg/kg/h
|
APC Initiation Dose 24 μg/kg/h
n=3 Participants
APC Initiation dose 24 μg/kg/h
|
APC Initiation Dose 30 μg/kg/h
n=5 Participants
APC Initiation dose 30 μg/kg/h
|
|---|---|---|---|---|
|
Mean Partial Thromboplastin Time (PTT) at 60 Minutes
|
39.8 Seconds
Standard Deviation NA
Only 1 subject in arm
|
36.4 Seconds
Standard Deviation 1.4
|
39.2 Seconds
Standard Deviation 8.0
|
52.6 Seconds
Standard Deviation 16.1
|
PRIMARY outcome
Timeframe: PTT level at 120 minutes after start up of Xigris during the hemodialysis treatment.PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant.
Outcome measures
| Measure |
APC Initiation Dose 12 μg/kg/h
n=1 Participants
APC Initiation dose 12 μg/kg/h
|
APC Initiation Dose 18 μg/kg/h
n=3 Participants
APC Initiation dose 18 μg/kg/h
|
APC Initiation Dose 24 μg/kg/h
n=3 Participants
APC Initiation dose 24 μg/kg/h
|
APC Initiation Dose 30 μg/kg/h
n=4 Participants
APC Initiation dose 30 μg/kg/h
|
|---|---|---|---|---|
|
Mean Partial Thromboplastin Time (PTT) at 120 Minutes
|
39.4 Seconds
Standard Deviation NA
Only one subject in arm.
|
42.8 Seconds
Standard Deviation 4.6
|
51.2 Seconds
Standard Deviation 7.8
|
54.1 Seconds
Standard Deviation 14.2
|
PRIMARY outcome
Timeframe: PTT level at 180 minutes after start up of Xigris during the hemodialysis treatment.PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant.
Outcome measures
| Measure |
APC Initiation Dose 12 μg/kg/h
n=1 Participants
APC Initiation dose 12 μg/kg/h
|
APC Initiation Dose 18 μg/kg/h
n=3 Participants
APC Initiation dose 18 μg/kg/h
|
APC Initiation Dose 24 μg/kg/h
n=3 Participants
APC Initiation dose 24 μg/kg/h
|
APC Initiation Dose 30 μg/kg/h
n=4 Participants
APC Initiation dose 30 μg/kg/h
|
|---|---|---|---|---|
|
Mean Partial Thromboplastin Time (PTT) at 180 Minutes
|
35.6 Seconds
Standard Deviation NA
Only 1 subject in arm
|
40.9 Seconds
Standard Deviation 1.8
|
44.5 Seconds
Standard Deviation 11.1
|
52.4 Seconds
Standard Deviation 13.3
|
Adverse Events
APC Initiation Dose 12 μg/kg/h
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
APC Initiation Dose 18 μg/kg/h
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
APC Initiation Dose 24 μg/kg/h
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
APC Initiation Dose 30 μg/kg/h
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
APC Initiation Dose 12 μg/kg/h
n=1 participants at risk
APC initiation dose 12 μg/kg/h
|
APC Initiation Dose 18 μg/kg/h
n=3 participants at risk
APC initiation dose 18 μg/kg/h
|
APC Initiation Dose 24 μg/kg/h
n=3 participants at risk
APC initiation dose 24 μg/kg/h
|
APC Initiation Dose 30 μg/kg/h
n=5 participants at risk
APC initiation dose 30 μg/kg/h
|
|---|---|---|---|---|
|
Cardiac disorders
Severe intradialytic hypertension
|
0.00%
0/1 • Enrollment until post-treatment day 14
|
0.00%
0/3 • Enrollment until post-treatment day 14
|
0.00%
0/3 • Enrollment until post-treatment day 14
|
20.0%
1/5 • Enrollment until post-treatment day 14
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place