Trial Outcomes & Findings for A Study of Zemplar® Injection and Hectorol® Injection on Intestinal Absorption of Calcium in Chronic Kidney Disease (NCT NCT00257920)
NCT ID: NCT00257920
Last Updated: 2009-12-24
Results Overview
Calcium Absorption Fraction obtained at the end of Period 1 \& Period 2
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
41 participants
Primary outcome timeframe
42 Days
Results posted on
2009-12-24
Participant Flow
Subjects assigned randomly in a 1:1 manner to Sequence Group I or II. Group I received Drug A (6 mcg Zemplar Injection QOD for 6 doses) in Period 1 and Drug B (3.6 mcg Hectorol Injection QOD for 6 doses) in Period 2. Each treatment period was 14 days and a 14 day washout separated the treatment periods.
Participant milestones
| Measure |
Zemplar First
6 mcg Zemplar Injection every other day (QOD) for 6 doses in Period 1 and 3.6 mcg Hectorol Injection for 6 doses in Period 2
|
Hectorol First
3.6 mcg Hectorol Injection QOD for 6 doses in Period 1 and 6 mcg Zemplar Injection QOD for 6 doses in Period 2
|
|---|---|---|
|
Period: First Intervention
STARTED
|
21
|
20
|
|
Period: First Intervention
COMPLETED
|
21
|
20
|
|
Period: First Intervention
NOT COMPLETED
|
0
|
0
|
|
Period: Washout Period of Two Weeks
STARTED
|
21
|
20
|
|
Period: Washout Period of Two Weeks
COMPLETED
|
21
|
19
|
|
Period: Washout Period of Two Weeks
NOT COMPLETED
|
0
|
1
|
|
Period: Second Intervention
STARTED
|
21
|
19
|
|
Period: Second Intervention
COMPLETED
|
19
|
18
|
|
Period: Second Intervention
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Zemplar First
6 mcg Zemplar Injection every other day (QOD) for 6 doses in Period 1 and 3.6 mcg Hectorol Injection for 6 doses in Period 2
|
Hectorol First
3.6 mcg Hectorol Injection QOD for 6 doses in Period 1 and 6 mcg Zemplar Injection QOD for 6 doses in Period 2
|
|---|---|---|
|
Period: Washout Period of Two Weeks
Lost to Follow-up
|
0
|
1
|
|
Period: Second Intervention
Other
|
2
|
1
|
Baseline Characteristics
A Study of Zemplar® Injection and Hectorol® Injection on Intestinal Absorption of Calcium in Chronic Kidney Disease
Baseline characteristics by cohort
| Measure |
Zemplar First
n=21 Participants
6 mcg Zemplar Injection QOD for 6 doses in Period 1 and 3.6 mcg Hectorol Injection QOD for 6 doses in Period 2
|
Hectorol First
n=20 Participants
3.6 mcg Hectorol Injection QOD for 6 doses in Period 1 and 6 mcg Zemplar Injection QOD for 6 doses in Period 2
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
54.3 years
STANDARD_DEVIATION 11.03 • n=5 Participants
|
55.6 years
STANDARD_DEVIATION 9.81 • n=7 Participants
|
55.0 years
STANDARD_DEVIATION 10.34 • n=5 Participants
|
|
Age, Customized
<40 years
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Age, Customized
40 - <60 years
|
13 participants
n=5 Participants
|
12 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Age, Customized
>=60 years
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
No ethnicity
|
21 participants
n=5 Participants
|
20 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
20 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
Calcium Absorption Fraction
|
0.085 Fractions
STANDARD_DEVIATION 0.0086 • n=5 Participants
|
0.130 Fractions
STANDARD_DEVIATION 0.0132 • n=7 Participants
|
0.107 Fractions
STANDARD_DEVIATION 0.0085 • n=5 Participants
|
PRIMARY outcome
Timeframe: 42 DaysPopulation: Per-Protocol Population - all subjects who completed both Period 1 and 2 and did not have major protocol violations.
Calcium Absorption Fraction obtained at the end of Period 1 \& Period 2
Outcome measures
| Measure |
Zemplar
n=33 Participants
6 mcg Zemplar Injection QOD for 6 doses in Period 1 or Period 2
|
Hectorol
n=33 Participants
3.6 mcg Hectorol Injection QOD for 6 doses in Period 1 or Period 2.
|
|---|---|---|
|
Calcium Absorption Fractions Analyzed by Analysis of Variance (ANOVA)
|
0.103 Fractions
Standard Error 0.007
|
0.108 Fractions
Standard Error 0.007
|
SECONDARY outcome
Timeframe: 42 DaysPopulation: ITT Population -all randomized subjects who received at least one dose of study drug and were analyzed by the randomized treatment sequence assigned to each subject.
Calcium Absorption Fraction obtained at the end of Period 1 \& Period 2
Outcome measures
| Measure |
Zemplar
n=36 Participants
6 mcg Zemplar Injection QOD for 6 doses in Period 1 or Period 2
|
Hectorol
n=37 Participants
3.6 mcg Hectorol Injection QOD for 6 doses in Period 1 or Period 2.
|
|---|---|---|
|
Calcium Absorption Fractions Analyzed by Mixed Model
|
0.106 Fractions
Standard Error 0.011
|
0.110 Fractions
Standard Error 0.011
|
Adverse Events
Zemplar
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
Hectorol
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Zemplar
6mcg Zemplar Injection QOD for 6 doses in Period 1 or Period 2.
|
Hectorol
3.6 mcg Hectorol Injection QOD for 6 doses in Period 1 or Period 2
|
|---|---|---|
|
Nervous system disorders
Hypoaesthesia
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
|
Nervous system disorders
Dizziness
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
|
Vascular disorders
Arterial Stenosis
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
|
Vascular disorders
Thrombosis
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
|
Cardiac disorders
Palpitations
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/40
|
7.3%
3/41 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/40
|
4.9%
2/41 • Number of events 2
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
|
General disorders
Asthenia
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
|
General disorders
Chest Pain
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
|
General disorders
Fatigue
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
|
General disorders
Oedema Peripheral
|
2.5%
1/40 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
|
General disorders
Suprapubic pain
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
Other adverse events
| Measure |
Zemplar
6mcg Zemplar Injection QOD for 6 doses in Period 1 or Period 2.
|
Hectorol
3.6 mcg Hectorol Injection QOD for 6 doses in Period 1 or Period 2
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
2.5%
1/40 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
|
Infections and infestations
Eye infection
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
|
Infections and infestations
Nasopharyngitis
|
2.5%
1/40 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
2.5%
1/40 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
|
Ear and labyrinth disorders
Hypoacusis
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
|
Eye disorders
Diabetic retinal oedema
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
|
General disorders
Chest pain
|
5.0%
2/40 • Number of events 2
|
0.00%
0/41
|
|
General disorders
Chills
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
|
General disorders
Local swelling
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
|
General disorders
Malaise
|
2.5%
1/40 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
|
General disorders
Oedema Peripheral
|
5.0%
2/40 • Number of events 2
|
0.00%
0/41
|
|
General disorders
Pain
|
2.5%
1/40 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
|
General disorders
Pyrexia
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
|
Investigations
Bleeding time prolonged
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
|
Investigations
Blood glucose decreased
|
2.5%
1/40 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
|
Investigations
Blood potassium decreased
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
|
Investigations
Blood pressure increased
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
|
Investigations
Body temperature increased
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
|
Investigations
Cardiac murmur
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
|
Investigations
Culture urine positive
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
|
Investigations
Heart rate irregular
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
|
Investigations
Urine output decreased
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
|
Investigations
Weight decreased
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.5%
1/40 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
2/40 • Number of events 2
|
0.00%
0/41
|
|
Nervous system disorders
Paraesthesia
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
|
Nervous system disorders
Hypoaesthesia
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
|
Psychiatric disorders
Insomnia
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.5%
1/40 • Number of events 1
|
4.9%
2/41 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
2/40 • Number of events 2
|
0.00%
0/41
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/40
|
4.9%
2/41 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/40
|
2.4%
1/41 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
2.5%
1/40 • Number of events 1
|
0.00%
0/41
|
Additional Information
Medical Information Specialist
Abbott
Phone: 1-800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60