Trial Outcomes & Findings for PA21 Phase II Clinical Study in Hemodialysis Patients With Hyperphosphatemia (NCT NCT01521494)
NCT ID: NCT01521494
Last Updated: 2018-08-23
Results Overview
Changes in serum phosphorus concentrations from baseline to the end of treatment were adjusted by serum phosphorus concentration at baseline.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
183 participants
Primary outcome timeframe
6 weeks
Results posted on
2018-08-23
Participant Flow
Participant milestones
| Measure |
PA21 750 mg/Day
PA21
|
PA21 1500 mg/Day
PA21
|
PA21 2250 mg/Day
PA21
|
PA21 3000 mg/Day
PA21
|
Placebo
Placebo
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
39
|
36
|
35
|
36
|
37
|
|
Overall Study
COMPLETED
|
37
|
31
|
23
|
15
|
30
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
12
|
21
|
7
|
Reasons for withdrawal
| Measure |
PA21 750 mg/Day
PA21
|
PA21 1500 mg/Day
PA21
|
PA21 2250 mg/Day
PA21
|
PA21 3000 mg/Day
PA21
|
Placebo
Placebo
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
9
|
6
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
2
|
0
|
|
Overall Study
Decrease in serum phosphate
|
0
|
2
|
3
|
12
|
0
|
|
Overall Study
Decrease in serum calcium
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
2
|
Baseline Characteristics
PA21 Phase II Clinical Study in Hemodialysis Patients With Hyperphosphatemia
Baseline characteristics by cohort
| Measure |
PA21 750 mg/Day
n=39 Participants
PA21
|
PA21 1500 mg/Day
n=35 Participants
PA21
|
PA21 2250 mg/Day
n=33 Participants
PA21
|
PA21 3000 mg/Day
n=34 Participants
PA21
|
Placebo
n=37 Participants
Placebo
|
Total
n=178 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
59.4 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
63.8 years
STANDARD_DEVIATION 12.0 • n=7 Participants
|
61.9 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
61.4 years
STANDARD_DEVIATION 11.2 • n=4 Participants
|
60.8 years
STANDARD_DEVIATION 10.2 • n=21 Participants
|
61.4 years
STANDARD_DEVIATION 10.9 • n=10 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
63 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
115 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
39 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
178 Participants
n=10 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Dialysis vintage
|
77.6 months
STANDARD_DEVIATION 67.5 • n=5 Participants
|
85.1 months
STANDARD_DEVIATION 60.7 • n=7 Participants
|
95.8 months
STANDARD_DEVIATION 81.9 • n=5 Participants
|
91.5 months
STANDARD_DEVIATION 58.6 • n=4 Participants
|
71.0 months
STANDARD_DEVIATION 45.0 • n=21 Participants
|
83.7 months
STANDARD_DEVIATION 63.5 • n=10 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Total of 5 patients were excluded from analysis because they failed to have primary endpoint.
Changes in serum phosphorus concentrations from baseline to the end of treatment were adjusted by serum phosphorus concentration at baseline.
Outcome measures
| Measure |
PA21 750 mg/Day
n=39 Participants
PA21
|
PA21 1500 mg/Day
n=35 Participants
PA21
|
PA21 2250 mg/Day
n=33 Participants
PA21
|
PA21 3000 mg/Day
n=34 Participants
PA21
|
Placebo
n=37 Participants
Placebo
|
|---|---|---|---|---|---|
|
Change From Baseline in Serum Phosphorus Concentrations at the End of Treatment.
|
-1.84 mg/dL
Interval -2.23 to -1.44
|
-2.59 mg/dL
Interval -3.01 to -2.17
|
-3.17 mg/dL
Interval -3.6 to -2.74
|
-3.78 mg/dL
Interval -4.2 to -3.36
|
0.14 mg/dL
Interval -0.26 to 0.55
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Total of 5 patients were excluded from analysis because they failed to have primary endpoint.
Outcome measures
| Measure |
PA21 750 mg/Day
n=39 Participants
PA21
|
PA21 1500 mg/Day
n=35 Participants
PA21
|
PA21 2250 mg/Day
n=33 Participants
PA21
|
PA21 3000 mg/Day
n=34 Participants
PA21
|
Placebo
n=37 Participants
Placebo
|
|---|---|---|---|---|---|
|
Change From Baseline in Serum Calcium Concentrations.
|
0.20 mg/dL
Standard Deviation 0.34
|
0.16 mg/dL
Standard Deviation 0.33
|
0.38 mg/dL
Standard Deviation 0.44
|
0.38 mg/dL
Standard Deviation 0.39
|
-0.09 mg/dL
Standard Deviation 0.31
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Some patients were excluded from analysis because they failed to have primary endpoint or missed to measure intact-PTH at the end of treatment.
Outcome measures
| Measure |
PA21 750 mg/Day
n=39 Participants
PA21
|
PA21 1500 mg/Day
n=34 Participants
PA21
|
PA21 2250 mg/Day
n=31 Participants
PA21
|
PA21 3000 mg/Day
n=31 Participants
PA21
|
Placebo
n=37 Participants
Placebo
|
|---|---|---|---|---|---|
|
Change From Baseline in Serum Intact-PTH Concentrations.
|
-35.2 pg/mL
Standard Deviation 89.8
|
-45.6 pg/mL
Standard Deviation 79.2
|
-97.0 pg/mL
Standard Deviation 92.7
|
-86.5 pg/mL
Standard Deviation 104.0
|
21.5 pg/mL
Standard Deviation 82.5
|
Adverse Events
PA21 750 mg/Day
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
PA21 1500 mg/Day
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
PA21 2250 mg/Day
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
PA21 3000 mg/Day
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PA21 750 mg/Day
n=39 participants at risk
PA21
|
PA21 1500 mg/Day
n=36 participants at risk
PA21
|
PA21 2250 mg/Day
n=35 participants at risk
PA21
|
PA21 3000 mg/Day
n=36 participants at risk
PA21
|
Placebo
n=37 participants at risk
Placebo
|
|---|---|---|---|---|---|
|
Infections and infestations
Liver abscess
|
0.00%
0/39 • 6 weeks
|
2.8%
1/36 • 6 weeks
|
0.00%
0/35 • 6 weeks
|
0.00%
0/36 • 6 weeks
|
0.00%
0/37 • 6 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/39 • 6 weeks
|
2.8%
1/36 • 6 weeks
|
0.00%
0/35 • 6 weeks
|
0.00%
0/36 • 6 weeks
|
0.00%
0/37 • 6 weeks
|
|
Nervous system disorders
Brain stem infarction
|
0.00%
0/39 • 6 weeks
|
0.00%
0/36 • 6 weeks
|
2.9%
1/35 • 6 weeks
|
0.00%
0/36 • 6 weeks
|
0.00%
0/37 • 6 weeks
|
|
Nervous system disorders
Cerebral infarction
|
2.6%
1/39 • 6 weeks
|
0.00%
0/36 • 6 weeks
|
0.00%
0/35 • 6 weeks
|
0.00%
0/36 • 6 weeks
|
0.00%
0/37 • 6 weeks
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/39 • 6 weeks
|
0.00%
0/36 • 6 weeks
|
2.9%
1/35 • 6 weeks
|
0.00%
0/36 • 6 weeks
|
0.00%
0/37 • 6 weeks
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/39 • 6 weeks
|
0.00%
0/36 • 6 weeks
|
0.00%
0/35 • 6 weeks
|
2.8%
1/36 • 6 weeks
|
0.00%
0/37 • 6 weeks
|
|
Cardiac disorders
Cardiac failure congestive
|
2.6%
1/39 • 6 weeks
|
0.00%
0/36 • 6 weeks
|
0.00%
0/35 • 6 weeks
|
0.00%
0/36 • 6 weeks
|
0.00%
0/37 • 6 weeks
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/39 • 6 weeks
|
0.00%
0/36 • 6 weeks
|
0.00%
0/35 • 6 weeks
|
0.00%
0/36 • 6 weeks
|
2.7%
1/37 • 6 weeks
|
Other adverse events
| Measure |
PA21 750 mg/Day
n=39 participants at risk
PA21
|
PA21 1500 mg/Day
n=36 participants at risk
PA21
|
PA21 2250 mg/Day
n=35 participants at risk
PA21
|
PA21 3000 mg/Day
n=36 participants at risk
PA21
|
Placebo
n=37 participants at risk
Placebo
|
|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
12.8%
5/39 • 6 weeks
|
13.9%
5/36 • 6 weeks
|
8.6%
3/35 • 6 weeks
|
8.3%
3/36 • 6 weeks
|
10.8%
4/37 • 6 weeks
|
|
Psychiatric disorders
Insomnia
|
5.1%
2/39 • 6 weeks
|
0.00%
0/36 • 6 weeks
|
0.00%
0/35 • 6 weeks
|
0.00%
0/36 • 6 weeks
|
0.00%
0/37 • 6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
5.1%
2/39 • 6 weeks
|
0.00%
0/36 • 6 weeks
|
0.00%
0/35 • 6 weeks
|
0.00%
0/36 • 6 weeks
|
0.00%
0/37 • 6 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/39 • 6 weeks
|
0.00%
0/36 • 6 weeks
|
0.00%
0/35 • 6 weeks
|
5.6%
2/36 • 6 weeks
|
0.00%
0/37 • 6 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/39 • 6 weeks
|
2.8%
1/36 • 6 weeks
|
5.7%
2/35 • 6 weeks
|
5.6%
2/36 • 6 weeks
|
2.7%
1/37 • 6 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
15.4%
6/39 • 6 weeks
|
16.7%
6/36 • 6 weeks
|
37.1%
13/35 • 6 weeks
|
41.7%
15/36 • 6 weeks
|
18.9%
7/37 • 6 weeks
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/39 • 6 weeks
|
0.00%
0/36 • 6 weeks
|
0.00%
0/35 • 6 weeks
|
2.8%
1/36 • 6 weeks
|
5.4%
2/37 • 6 weeks
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/39 • 6 weeks
|
0.00%
0/36 • 6 weeks
|
5.7%
2/35 • 6 weeks
|
0.00%
0/36 • 6 weeks
|
0.00%
0/37 • 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/39 • 6 weeks
|
2.8%
1/36 • 6 weeks
|
5.7%
2/35 • 6 weeks
|
0.00%
0/36 • 6 weeks
|
0.00%
0/37 • 6 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/39 • 6 weeks
|
0.00%
0/36 • 6 weeks
|
0.00%
0/35 • 6 weeks
|
11.1%
4/36 • 6 weeks
|
0.00%
0/37 • 6 weeks
|
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