Hemodialysis, Hyperphosphatemia
Conditions
Keywords
Hemodialysis, Hyperphosphatemia
Brief summary
The purpose of this study is to evaluate the efficacy and safety of PA21 in hemodialysis patients with hyperphosphatemia
Interventions
DRUGPA21
Sponsors
Kissei Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients age 20 or older, regardless of gender. * Receiving stable maintenance hemodialysis 3 times a week. * Patients not having changed their phosphate binder agent dose, for 4 weeks or more before their observation period start.
Exclusion criteria
* Patients having history of a pronounced brain / cardiovascular disorder. * Patients having severe gastrointestinal disorders. * Patients having severe hepatic disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adjusted Mean of Serum Phosphorus Concentrations at the End of Treatment | 12 weeks | Covariate: Serum phosphorus concentrations at baseline. |
Secondary
| Measure | Time frame |
|---|---|
| Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value) | 12 weeks |
| Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value) | 12 weeks |
| Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value) | 12 weeks |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PA21 PA21 | 100 |
| Sevelamer Hydrochloride Sevelamer hydrochloride | 92 |
| Total | 192 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 7 | 10 |
| Overall Study | Decrease in serum calcium | 2 | 3 |
| Overall Study | Increase in serum ferritin | 1 | 0 |
| Overall Study | Physician Decision | 2 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 4 |
Baseline characteristics
| Characteristic | PA21 | Sevelamer Hydrochloride | Total |
|---|---|---|---|
| Age, Continuous | 61.0 years STANDARD_DEVIATION 11.7 | 60.8 years STANDARD_DEVIATION 12 | 60.9 years STANDARD_DEVIATION 11.8 |
| Dialysis vintage | 104.9 months STANDARD_DEVIATION 79.7 | 102.4 months STANDARD_DEVIATION 90.6 | 103.7 months STANDARD_DEVIATION 84.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 100 Participants | 92 Participants | 192 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 28 Participants | 39 Participants | 67 Participants |
| Sex: Female, Male Male | 72 Participants | 53 Participants | 125 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 108 | 0 / 105 |
| other Total, other adverse events | 47 / 108 | 42 / 105 |
| serious Total, serious adverse events | 6 / 108 | 5 / 105 |
Outcome results
Primary
Adjusted Mean of Serum Phosphorus Concentrations at the End of Treatment
Covariate: Serum phosphorus concentrations at baseline.
Time frame: 12 weeks
Population: Per Protocol Set
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PA21 | Adjusted Mean of Serum Phosphorus Concentrations at the End of Treatment | 5.00 mg/dL |
| Sevelamer Hydrochloride | Adjusted Mean of Serum Phosphorus Concentrations at the End of Treatment | 5.34 mg/dL |
p-value: 0.0295% CI: [-0.63, -0.05]ANCOVA
Secondary
Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value)
Time frame: 12 weeks
Population: Per Protocol Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PA21 | Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value) | 9.14 mg/dL | Standard Deviation 0.68 |
| Sevelamer Hydrochloride | Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value) | 8.91 mg/dL | Standard Deviation 0.71 |
Secondary
Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value)
Time frame: 12 weeks
Population: Per Protocol Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PA21 | Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value) | 203.6 pg/mL | Standard Deviation 117.1 |
| Sevelamer Hydrochloride | Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value) | 253.1 pg/mL | Standard Deviation 168.6 |
Secondary
Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value)
Time frame: 12 weeks
Population: Per Protocol Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PA21 | Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value) | 5.01 mg/dL | Standard Deviation 1.01 |
| Sevelamer Hydrochloride | Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value) | 5.33 mg/dL | Standard Deviation 1.03 |