Trial Outcomes & Findings for A Phase III Study of PA21 in Hemodialysis Patients With Hyperphosphatemia (NCT NCT01850602)
NCT ID: NCT01850602
Last Updated: 2018-10-09
Results Overview
Covariate: Serum phosphorus concentrations at baseline.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
213 participants
Primary outcome timeframe
12 weeks
Results posted on
2018-10-09
Participant Flow
Participant milestones
| Measure |
PA21
PA21
|
Sevelamer Hydrochloride
Sevelamer hydrochloride
|
|---|---|---|
|
Overall Study
STARTED
|
108
|
105
|
|
Overall Study
COMPLETED
|
94
|
87
|
|
Overall Study
NOT COMPLETED
|
14
|
18
|
Reasons for withdrawal
| Measure |
PA21
PA21
|
Sevelamer Hydrochloride
Sevelamer hydrochloride
|
|---|---|---|
|
Overall Study
Adverse Event
|
7
|
10
|
|
Overall Study
Physician Decision
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
|
Overall Study
Decrease in serum calcium
|
2
|
3
|
|
Overall Study
Increase in serum ferritin
|
1
|
0
|
Baseline Characteristics
A Phase III Study of PA21 in Hemodialysis Patients With Hyperphosphatemia
Baseline characteristics by cohort
| Measure |
PA21
n=100 Participants
PA21
|
Sevelamer Hydrochloride
n=92 Participants
Sevelamer hydrochloride
|
Total
n=192 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.0 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
60.8 years
STANDARD_DEVIATION 12.0 • n=7 Participants
|
60.9 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
72 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
100 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
192 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
|
Dialysis vintage
|
104.9 months
STANDARD_DEVIATION 79.7 • n=5 Participants
|
102.4 months
STANDARD_DEVIATION 90.6 • n=7 Participants
|
103.7 months
STANDARD_DEVIATION 84.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Per Protocol Set
Covariate: Serum phosphorus concentrations at baseline.
Outcome measures
| Measure |
PA21
n=100 Participants
PA21
|
Sevelamer Hydrochloride
n=92 Participants
Sevelamer hydrochloride
|
|---|---|---|
|
Adjusted Mean of Serum Phosphorus Concentrations at the End of Treatment
|
5.00 mg/dL
Interval 4.8 to 5.19
|
5.34 mg/dL
Interval 5.13 to 5.55
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Per Protocol Set
Outcome measures
| Measure |
PA21
n=100 Participants
PA21
|
Sevelamer Hydrochloride
n=92 Participants
Sevelamer hydrochloride
|
|---|---|---|
|
Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value)
|
5.01 mg/dL
Standard Deviation 1.01
|
5.33 mg/dL
Standard Deviation 1.03
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Per Protocol Set
Outcome measures
| Measure |
PA21
n=100 Participants
PA21
|
Sevelamer Hydrochloride
n=92 Participants
Sevelamer hydrochloride
|
|---|---|---|
|
Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value)
|
9.14 mg/dL
Standard Deviation 0.68
|
8.91 mg/dL
Standard Deviation 0.71
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Per Protocol Set
Outcome measures
| Measure |
PA21
n=100 Participants
PA21
|
Sevelamer Hydrochloride
n=92 Participants
Sevelamer hydrochloride
|
|---|---|---|
|
Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value)
|
203.6 pg/mL
Standard Deviation 117.1
|
253.1 pg/mL
Standard Deviation 168.6
|
Adverse Events
PA21
Serious events: 6 serious events
Other events: 47 other events
Deaths: 0 deaths
Sevelamer Hydrochloride
Serious events: 5 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PA21
n=108 participants at risk
PA21
|
Sevelamer Hydrochloride
n=105 participants at risk
Sevelamer hydrochloride
|
|---|---|---|
|
Infections and infestations
Diverticulitis
|
0.00%
0/108 • 12 weeks
|
0.95%
1/105 • 12 weeks
|
|
Infections and infestations
Pneumonia
|
0.93%
1/108 • 12 weeks
|
0.00%
0/105 • 12 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.93%
1/108 • 12 weeks
|
0.00%
0/105 • 12 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/108 • 12 weeks
|
0.95%
1/105 • 12 weeks
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/108 • 12 weeks
|
0.95%
1/105 • 12 weeks
|
|
Cardiac disorders
Cardiac failure congestive
|
0.93%
1/108 • 12 weeks
|
0.00%
0/105 • 12 weeks
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.93%
1/108 • 12 weeks
|
0.00%
0/105 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.93%
1/108 • 12 weeks
|
0.00%
0/105 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.93%
1/108 • 12 weeks
|
0.00%
0/105 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/108 • 12 weeks
|
0.95%
1/105 • 12 weeks
|
|
Renal and urinary disorders
Renal cyst ruptured
|
0.93%
1/108 • 12 weeks
|
0.00%
0/105 • 12 weeks
|
|
Injury, poisoning and procedural complications
Shunt stenosis
|
0.00%
0/108 • 12 weeks
|
0.95%
1/105 • 12 weeks
|
Other adverse events
| Measure |
PA21
n=108 participants at risk
PA21
|
Sevelamer Hydrochloride
n=105 participants at risk
Sevelamer hydrochloride
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
22.2%
24/108 • 12 weeks
|
22.9%
24/105 • 12 weeks
|
|
Gastrointestinal disorders
Constipation
|
1.9%
2/108 • 12 weeks
|
18.1%
19/105 • 12 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
27/108 • 12 weeks
|
2.9%
3/105 • 12 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