Trial Outcomes & Findings for Equivalence of Calcium Acetate Oral Solution and Sevelamer Carbonate Tablets in Hemodialysis Patients (NCT NCT01427907)
NCT ID: NCT01427907
Last Updated: 2016-01-14
Results Overview
The average phosphorus level of non-missing laboratory assessments from the last two weeks of each treatment period for each subject
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
38 participants
Primary outcome timeframe
2 weeks
Results posted on
2016-01-14
Participant Flow
A total of 44 subjects signed the informed consent form (ICF), 5 subjects were not eligible, and 1 eligible subject withdrew the ICF prior to randomization.
Participant milestones
| Measure |
Sequence I: COS (4 Weeks) Then Sevelamar (4 Weeks)
Patient receive Calcium Acetate Oral Solution (COS) for 4 weeks then cross over to Sevelamer tablets for 4 weeks.
|
Sequence II: Sevelamer (4 Weeks) Then COS (4 Weeks)
Patient receive Sevelamer tablets for 4 weeks, then cross over to take COS for 4 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
18
|
|
Overall Study
COMPLETED
|
17
|
14
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
Sequence I: COS (4 Weeks) Then Sevelamar (4 Weeks)
Patient receive Calcium Acetate Oral Solution (COS) for 4 weeks then cross over to Sevelamer tablets for 4 weeks.
|
Sequence II: Sevelamer (4 Weeks) Then COS (4 Weeks)
Patient receive Sevelamer tablets for 4 weeks, then cross over to take COS for 4 weeks.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
Baseline Characteristics
Equivalence of Calcium Acetate Oral Solution and Sevelamer Carbonate Tablets in Hemodialysis Patients
Baseline characteristics by cohort
| Measure |
Sequence I: COS Then Sevelamer
n=20 Participants
Sequence I: Calcium Acetate Oral Solution for 4 weeks then Sevelamer Carbonate for 4 weeks
|
Sequence II: Sevelamer Then COS
n=18 Participants
Sevelamer Carbonate for 4 weeks then Calcium Acetate Oral Solution for 4 weeks
|
Total
n=38 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
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Continuous
|
60 years
STANDARD_DEVIATION 16.3 • n=5 Participants
|
57 years
STANDARD_DEVIATION 20.2 • n=7 Participants
|
59 years
STANDARD_DEVIATION 18.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
18 participants
n=7 Participants
|
38 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: Modified intent-to-treat: subjects who were randomized, received at least one prescribed dose of the study medication and provided at least one of the last 4 laboratory assessments of each treatment period
The average phosphorus level of non-missing laboratory assessments from the last two weeks of each treatment period for each subject
Outcome measures
| Measure |
Calcium Acetate Oral Solution
n=32 Participants
Calcium Acetate Oral Solution for periods 1 and 2
|
Sevelamer Carbonate
n=32 Participants
Sevelamer Carbonate for periods 1 and 2
|
|---|---|---|
|
Serum Phosphorus Levels
|
4.6 mg/dL
Standard Deviation 1.20
|
4.6 mg/dL
Standard Deviation 0.93
|
Adverse Events
Calcium Acetate Oral Solution
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Sevelamer Carbonate
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Calcium Acetate Oral Solution
n=38 participants at risk
Sequence I: Calcium Acetate Oral Solution for periods 1 and 2
|
Sevelamer Carbonate
n=38 participants at risk
Sevelamer Carbonate for periods 1 and 2
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute Bronchitis
|
2.6%
1/38 • Number of events 1 • 6 months
|
0.00%
0/38 • 6 months
|
|
Skin and subcutaneous tissue disorders
hospitalization
|
2.6%
1/38 • Number of events 1 • 6 months
|
0.00%
0/38 • 6 months
|
|
Infections and infestations
Bacteremia; cellulitis, fever
|
0.00%
0/38 • 6 months
|
2.6%
1/38 • Number of events 3 • 6 months
|
Other adverse events
| Measure |
Calcium Acetate Oral Solution
n=38 participants at risk
Sequence I: Calcium Acetate Oral Solution for periods 1 and 2
|
Sevelamer Carbonate
n=38 participants at risk
Sevelamer Carbonate for periods 1 and 2
|
|---|---|---|
|
Renal and urinary disorders
hematemesis
|
2.6%
1/38 • Number of events 1 • 6 months
|
0.00%
0/38 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
squamous cell carcinoma removed
|
2.6%
1/38 • Number of events 1 • 6 months
|
0.00%
0/38 • 6 months
|
|
Metabolism and nutrition disorders
hypercalcimia
|
7.9%
3/38 • Number of events 3 • 6 months
|
0.00%
0/38 • 6 months
|
|
Metabolism and nutrition disorders
hyperphosphatemia
|
2.6%
1/38 • Number of events 1 • 6 months
|
0.00%
0/38 • 6 months
|
|
Musculoskeletal and connective tissue disorders
left uper quadrant discomfort
|
2.6%
1/38 • Number of events 1 • 6 months
|
0.00%
0/38 • 6 months
|
|
Gastrointestinal disorders
nausea
|
2.6%
1/38 • Number of events 1 • 6 months
|
2.6%
1/38 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
diarrhea
|
5.3%
2/38 • Number of events 2 • 6 months
|
2.6%
1/38 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
flatulence
|
2.6%
1/38 • Number of events 1 • 6 months
|
0.00%
0/38 • 6 months
|
|
Gastrointestinal disorders
emesis
|
2.6%
1/38 • Number of events 1 • 6 months
|
0.00%
0/38 • 6 months
|
|
General disorders
arm pain
|
0.00%
0/38 • 6 months
|
2.6%
1/38 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
sharp stomach pain
|
2.6%
1/38 • Number of events 1 • 6 months
|
0.00%
0/38 • 6 months
|
|
Gastrointestinal disorders
strong acid reflux
|
0.00%
0/38 • 6 months
|
2.6%
1/38 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
chest pain
|
0.00%
0/38 • 6 months
|
2.6%
1/38 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
cramping
|
2.6%
1/38 • Number of events 1 • 6 months
|
0.00%
0/38 • 6 months
|
|
Vascular disorders
hypertension
|
0.00%
0/38 • 6 months
|
2.6%
1/38 • Number of events 1 • 6 months
|
Additional Information
Mayuri Thakuria MD (MBBS), MPH
Fresenius Medical Care, North America
Phone: 781-699-4645
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place