Hemodialysis Patients With Hyperphosphatemia
Conditions
Keywords
Hemodialysis, Hyperphosphatemia
Brief summary
The purpose of this study is to investigate the safety and efficacy for 52-week dosing in hemodialysis patients with hyperphosphatemia.
Interventions
DRUGPA21
Sponsors
Kissei Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Receiving stable maintenance hemodialysis 3 times a week. * Dialysis patients with hyperphosphatemia
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 |
|---|---|
| Incidence of Adverse Events | 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value) | 52 weeks |
| Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value) | 52 weeks |
| Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value) | 52 weeks |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PA21 PA21 | 160 |
| Total | 160 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 24 |
| Overall Study | Decrease in serum calcium | 4 |
| Overall Study | Decrease in serum phosphorus | 4 |
| Overall Study | Increase in serum ferritin | 1 |
| Overall Study | Physician Decision | 6 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | PA21 |
|---|---|
| Age, Continuous | 58.5 years STANDARD_DEVIATION 11.1 |
| Dialysis vintage | 85.3 months STANDARD_DEVIATION 63.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 160 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 47 Participants |
| Sex: Female, Male Male | 113 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 161 |
| other Total, other adverse events | 133 / 161 |
| serious Total, serious adverse events | 29 / 161 |
Outcome results
Primary
Incidence of Adverse Events
Time frame: 52 weeks
Population: Safety Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PA21 | Incidence of Adverse Events | 152 Participants |
Secondary
Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value)
Time frame: 52 weeks
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PA21 | Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value) | 9.05 mg/dL | Standard Deviation 0.7 |
Secondary
Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value)
Time frame: 52 weeks
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PA21 | Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value) | 251.6 pg/mL | Standard Deviation 151.4 |
Secondary
Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value)
Time frame: 52 weeks
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PA21 | Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value) | 5.00 mg/dL | Standard Deviation 1.17 |