Trial Outcomes & Findings for A Phase III Study of PA21 With Calcium Carbonate in Hemodialysis Patients With Hyperphosphatemia (NCT NCT01850641)
NCT ID: NCT01850641
Last Updated: 2018-10-09
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
35 participants
Primary outcome timeframe
12 weeks
Results posted on
2018-10-09
Participant Flow
Participant milestones
| Measure |
PA21
PA21
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
PA21
PA21
|
|---|---|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Decrease in serum phosphorus
|
1
|
|
Overall Study
Decrease in serum calcium
|
2
|
|
Overall Study
Increase in serum ferritin
|
1
|
Baseline Characteristics
A Phase III Study of PA21 With Calcium Carbonate in Hemodialysis Patients With Hyperphosphatemia
Baseline characteristics by cohort
| Measure |
PA21
n=35 Participants
PA21
|
|---|---|
|
Age, Continuous
|
63.7 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Dialysis vintage
|
111.1 months
STANDARD_DEVIATION 87.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Safety Set
Outcome measures
| Measure |
PA21
n=35 Participants
PA21
|
|---|---|
|
Incidence of Adverse Events
|
28 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Full Analysis Set
Outcome measures
| Measure |
PA21
n=35 Participants
PA21
|
|---|---|
|
Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value)
|
4.89 mg/dL
Standard Deviation 1.14
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Full Analysis Set
Outcome measures
| Measure |
PA21
n=35 Participants
PA21
|
|---|---|
|
Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value)
|
9.52 mg/dL
Standard Deviation 0.88
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Full Analysis Set
Outcome measures
| Measure |
PA21
n=35 Participants
PA21
|
|---|---|
|
Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value)
|
177.9 pg/mL
Standard Deviation 146.4
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Safety Set
Outcome measures
| Measure |
PA21
n=35 Participants
PA21
|
|---|---|
|
Serum Ferritin Concentrations at End of Treatment (Actual Measured Value)
|
73.8 ng/mL
Interval 38.2 to 183.0
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Safety Set
Outcome measures
| Measure |
PA21
n=35 Participants
PA21
|
|---|---|
|
TSAT at End of Treatment (Actual Measured Value)
|
27.72 percentage of TSAT
Standard Deviation 8.27
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Safety Set
Outcome measures
| Measure |
PA21
n=35 Participants
PA21
|
|---|---|
|
Hb Concentrations at End of Treatment (Actual Measured Value)
|
11.22 g/dL
Standard Deviation 1.19
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Safety Set
Outcome measures
| Measure |
PA21
n=35 Participants
PA21
|
|---|---|
|
Constipation Condition
Week 0 · Not at all bothersome
|
15 Participants
|
|
Constipation Condition
Week 0 · Bothers me very little
|
14 Participants
|
|
Constipation Condition
Week 0 · Somewhat bothersome
|
2 Participants
|
|
Constipation Condition
Week 0 · Bothers me quite a lot
|
4 Participants
|
|
Constipation Condition
Week 0 · Could not tolerate
|
0 Participants
|
|
Constipation Condition
End of treatment · Not at all bothersome
|
26 Participants
|
|
Constipation Condition
End of treatment · Bothers me very little
|
5 Participants
|
|
Constipation Condition
End of treatment · Somewhat bothersome
|
2 Participants
|
|
Constipation Condition
End of treatment · Bothers me quite a lot
|
2 Participants
|
|
Constipation Condition
End of treatment · Could not tolerate
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Safety Set
Outcome measures
| Measure |
PA21
n=35 Participants
PA21
|
|---|---|
|
Satisfaction With Bowel Movement
Week 0 · Very much satisfied/Satisfied
|
21 Participants
|
|
Satisfaction With Bowel Movement
Week 0 · Can say neither
|
8 Participants
|
|
Satisfaction With Bowel Movement
Week 0 · Very much dissatisfied/Dissatisfied
|
6 Participants
|
|
Satisfaction With Bowel Movement
End of treatment · Very much satisfied/Satisfied
|
28 Participants
|
|
Satisfaction With Bowel Movement
End of treatment · Can say neither
|
5 Participants
|
|
Satisfaction With Bowel Movement
End of treatment · Very much dissatisfied/Dissatisfied
|
2 Participants
|
Adverse Events
PA21
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PA21
n=35 participants at risk
PA21
|
|---|---|
|
Hepatobiliary disorders
Hepatitis acute
|
2.9%
1/35
|
Other adverse events
| Measure |
PA21
n=35 participants at risk
PA21
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
28.6%
10/35
|
|
Gastrointestinal disorders
Diarrhoea
|
40.0%
14/35
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
5.7%
2/35
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
5.7%
2/35
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.7%
2/35
|
|
Injury, poisoning and procedural complications
Wound
|
5.7%
2/35
|
Additional Information
Clinical Development Division
Kissei Pharmaceutical Co., Ltd
Phone: Email only
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place