Trial Outcomes & Findings for Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3/4 Chronic Kidney Disease (CKD) With Secondary Hyperparathyroidism (SHPT) (NCT NCT00823303)
NCT ID: NCT00823303
Last Updated: 2014-08-07
Results Overview
Serum Calcium 10.5 mg/dL or higher, confirmed by repeat measurement.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
110 participants
Primary outcome timeframe
24 week treatment period
Results posted on
2014-08-07
Participant Flow
Participant milestones
| Measure |
Paricalcitol
titrated to achieve 40-60% PTH suppression
Paricalcitol: 1 mcg daily, adjusted to achieve 40-60% PTH suppression
|
Calcitriol
titrated to achieve 40-60% PTH suppression
Calcitriol: 0.25 mcg daily, adjusted to achieve 40-60% PTH suppression
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
56
|
|
Overall Study
COMPLETED
|
45
|
45
|
|
Overall Study
NOT COMPLETED
|
9
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3/4 Chronic Kidney Disease (CKD) With Secondary Hyperparathyroidism (SHPT)
Baseline characteristics by cohort
| Measure |
Paricalcitol
n=54 Participants
titrated to achieve 40-60% PTH suppression
Paricalcitol: 1 mcg daily, adjusted to achieve 40-60% PTH suppression
|
Calcitriol
n=56 Participants
titrated to achieve 40-60% PTH suppression
Calcitriol: 0.25 mcg daily, adjusted to achieve 40-60% PTH suppression
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.6 years
STANDARD_DEVIATION 13.2 • n=99 Participants
|
64.7 years
STANDARD_DEVIATION 12.6 • n=107 Participants
|
65.6 years
STANDARD_DEVIATION 12.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
33 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 24 week treatment periodSerum Calcium 10.5 mg/dL or higher, confirmed by repeat measurement.
Outcome measures
| Measure |
Paricalcitol
n=53 Participants
titrated to achieve 40-60% PTH suppression
Paricalcitol: 1 mcg daily, adjusted to achieve 40-60% PTH suppression
|
Calcitriol
n=54 Participants
titrated to achieve 40-60% PTH suppression
Calcitriol: 0.25 mcg daily, adjusted to achieve 40-60% PTH suppression
|
|---|---|---|
|
Confirmed Hypercalcemia
|
3 participants
|
1 participants
|
Adverse Events
Paricalcitol
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Calcitriol
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Paricalcitol
n=53 participants at risk
titrated to achieve 40-60% PTH suppression
Paricalcitol: 1 mcg daily, adjusted to achieve 40-60% PTH suppression
|
Calcitriol
n=54 participants at risk
titrated to achieve 40-60% PTH suppression
Calcitriol: 0.25 mcg daily, adjusted to achieve 40-60% PTH suppression
|
|---|---|---|
|
Endocrine disorders
Hypercalcemia
|
0.00%
0/53
|
1.9%
1/54 • Number of events 1
|
Other adverse events
| Measure |
Paricalcitol
n=53 participants at risk
titrated to achieve 40-60% PTH suppression
Paricalcitol: 1 mcg daily, adjusted to achieve 40-60% PTH suppression
|
Calcitriol
n=54 participants at risk
titrated to achieve 40-60% PTH suppression
Calcitriol: 0.25 mcg daily, adjusted to achieve 40-60% PTH suppression
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
28.3%
15/53 • Number of events 15
|
22.2%
12/54 • Number of events 12
|
Additional Information
Dr. Daniel W. Coyne
Washington University School of Medicine
Phone: 3143627211
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place