Trial Outcomes & Findings for Metabolic Effects of Paricalcitol (NCT NCT01003275)
NCT ID: NCT01003275
Last Updated: 2014-04-28
Results Overview
Glucose AUC during a 2-hour oral glucose tolerance test
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
8 weeks
Results posted on
2014-04-28
Participant Flow
Participants were recruited from 2010 through 2011 from Nephrology clinics associated with the University of Washington.
Participant milestones
| Measure |
Paricalcitol Followed by Placebo
Participants will receive paricalcitol for 8 weeks, then an 8-week wash-out, then placebo for 8 weeks.
|
Placebo Followed by Paricalcitol
Participants will receive placebo for 8 weeks, then an 8-week wash-out, then paricalcitol for 8 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Metabolic Effects of Paricalcitol
Baseline characteristics by cohort
| Measure |
Paricalcitol Followed by Placebo
n=11 Participants
Participants will receive paricalcitol for 8 weeks, then an 8-week wash-out, then placebo for 8 weeks.
|
Placebo Followed by Paricalcitol
n=11 Participants
Participants will receive placebo for 8 weeks, then an 8-week wash-out, then paricalcitol for 8 weeks.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 years
STANDARD_DEVIATION 10.4 • n=93 Participants
|
65.5 years
STANDARD_DEVIATION 13.1 • n=4 Participants
|
65.8 years
STANDARD_DEVIATION 11.6 • n=27 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=93 Participants
|
11 participants
n=4 Participants
|
22 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 8 weeksGlucose AUC during a 2-hour oral glucose tolerance test
Outcome measures
| Measure |
During Paricalcitol Treatment
n=22 Participants
|
During Placebo Treatment
n=22 Participants
|
|---|---|---|
|
Glucose Area Under the Curve (AUC)
|
20817 mg*min/dL
Geometric Coefficient of Variation 1.2
|
21139 mg*min/dL
Geometric Coefficient of Variation 1.2
|
Adverse Events
During/After Paricalcitol
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
During/After Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
During/After Paricalcitol
n=22 participants at risk
|
During/After Placebo
n=21 participants at risk
|
|---|---|---|
|
Endocrine disorders
Hypercalcemia
|
4.5%
1/22 • Number of events 1
|
0.00%
0/21
|
|
Metabolism and nutrition disorders
Elevated serum creatinine
|
4.5%
1/22 • Number of events 1
|
0.00%
0/21
|
|
Metabolism and nutrition disorders
Fistula placement
|
4.5%
1/22 • Number of events 1
|
0.00%
0/21
|
|
Metabolism and nutrition disorders
Renal artery stent
|
4.5%
1/22 • Number of events 1
|
0.00%
0/21
|
|
Cardiac disorders
Dyspnea with palpitations and lightheadedness
|
4.5%
1/22 • Number of events 1
|
0.00%
0/21
|
|
Cardiac disorders
Dyspnea
|
4.5%
1/22 • Number of events 1
|
0.00%
0/21
|
|
Cardiac disorders
Elevated blood pressure
|
4.5%
1/22 • Number of events 1
|
4.8%
1/21 • Number of events 1
|
|
Cardiac disorders
Bradycardia
|
4.5%
1/22 • Number of events 1
|
4.8%
1/21 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Low back pain
|
4.5%
1/22 • Number of events 1
|
0.00%
0/21
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps
|
4.5%
1/22 • Number of events 1
|
0.00%
0/21
|
|
Musculoskeletal and connective tissue disorders
Paresthesias
|
0.00%
0/22
|
4.8%
1/21 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Gout flare
|
4.5%
1/22 • Number of events 1
|
0.00%
0/21
|
|
Infections and infestations
Fever
|
4.5%
1/22 • Number of events 1
|
0.00%
0/21
|
|
Infections and infestations
Common cold
|
4.5%
1/22 • Number of events 1
|
14.3%
3/21 • Number of events 3
|
|
Infections and infestations
Allergies
|
0.00%
0/22
|
9.5%
2/21 • Number of events 2
|
|
Nervous system disorders
Vertigo
|
4.5%
1/22 • Number of events 1
|
0.00%
0/21
|
|
Musculoskeletal and connective tissue disorders
Rash
|
4.5%
1/22 • Number of events 1
|
0.00%
0/21
|
|
Eye disorders
Cataract surgery
|
0.00%
0/22
|
4.8%
1/21 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer removal
|
0.00%
0/22
|
4.8%
1/21 • Number of events 1
|
Additional Information
Ian H. de Boer, MD, MS, Associate Professor of Medicine
University of Washington
Phone: 2066165403
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60