Trial Outcomes & Findings for Study of Protective Effects of Paricalcitol on Inner Layer of Vessels and Its Protective Effect on Inflammation (NCT NCT00428246)
NCT ID: NCT00428246
Last Updated: 2009-06-03
Results Overview
change in hsCRP level from baseline to 4 weeks
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
6 weeks
Results posted on
2009-06-03
Participant Flow
169 patients screened from renal speciality clinics from November 2006 to June 2007
Participant milestones
| Measure |
1
1 mcg paricalcitol
|
2
2 mcg paricalcitol
|
3
Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
7
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
1
1 mcg paricalcitol
|
2
2 mcg paricalcitol
|
3
Placebo
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
Baseline Characteristics
Study of Protective Effects of Paricalcitol on Inner Layer of Vessels and Its Protective Effect on Inflammation
Baseline characteristics by cohort
| Measure |
1
n=8 Participants
1 mcg paricalcitol
|
2
n=8 Participants
2 mcg paricalcitol
|
3
n=8 Participants
Placebo
|
Total
n=24 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
|
0.0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8.0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
16.0 Participants
n=4 Participants
|
|
Age Continuous
|
72.6 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
67.5 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
68.4 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
68.4 years
STANDARD_DEVIATION 10.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4.0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
20.0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
24.0 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 weekschange in hsCRP level from baseline to 4 weeks
Outcome measures
| Measure |
1
n=7 Participants
1 mcg paricalcitol
|
2
n=8 Participants
2 mcg paricalcitol
|
3
n=7 Participants
Placebo
|
|---|---|---|---|
|
Anti-Inflammatory Effects of Paricalcitol
|
.8 micrograms
Interval 0.3 to 1.9
|
.5 micrograms
Interval 0.3 to 0.9
|
1.5 micrograms
Interval 1.1 to 2.1
|
PRIMARY outcome
Timeframe: 6 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 weeksOutcome measures
Outcome data not reported
Adverse Events
1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place