Hemodialysis, Hyperphosphatemia
Conditions
Keywords
Hemodialysis, Hyperphosphatemia
Brief summary
The purpose of this study is to investigate the safety and efficacy when administering PA21 with calcium carbonate in hemodialysis patients with hyperphosphatemia for 12 weeks.
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 | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Serum Ferritin Concentrations at End of Treatment (Actual Measured Value) | 12 weeks |
| Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value) | 12 weeks |
| Hb Concentrations at End of Treatment (Actual Measured Value) | 12 weeks |
| Constipation Condition | 12 weeks |
| Satisfaction With Bowel Movement | 12 weeks |
| TSAT at End of Treatment (Actual Measured Value) | 12 weeks |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PA21 PA21 | 35 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Decrease in serum calcium | 2 |
| Overall Study | Decrease in serum phosphorus | 1 |
| Overall Study | Increase in serum ferritin | 1 |
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | PA21 |
|---|---|
| Age, Continuous | 63.7 years STANDARD_DEVIATION 8 |
| Dialysis vintage | 111.1 months STANDARD_DEVIATION 87.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 35 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 | 14 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 35 |
| other Total, other adverse events | 23 / 35 |
| serious Total, serious adverse events | 1 / 35 |
Outcome results
Primary
Incidence of Adverse Events
Time frame: 12 weeks
Population: Safety Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PA21 | Incidence of Adverse Events | 28 Participants |
Secondary
Constipation Condition
Time frame: 12 weeks
Population: Safety Set
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| PA21 | Constipation Condition | Week 0 | Not at all bothersome | 15 Participants |
| PA21 | Constipation Condition | Week 0 | Bothers me very little | 14 Participants |
| PA21 | Constipation Condition | Week 0 | Somewhat bothersome | 2 Participants |
| PA21 | Constipation Condition | Week 0 | Bothers me quite a lot | 4 Participants |
| PA21 | Constipation Condition | Week 0 | Could not tolerate | 0 Participants |
| PA21 | Constipation Condition | End of treatment | Not at all bothersome | 26 Participants |
| PA21 | Constipation Condition | End of treatment | Bothers me very little | 5 Participants |
| PA21 | Constipation Condition | End of treatment | Somewhat bothersome | 2 Participants |
| PA21 | Constipation Condition | End of treatment | Bothers me quite a lot | 2 Participants |
| PA21 | Constipation Condition | End of treatment | Could not tolerate | 0 Participants |
Secondary
Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value)
Time frame: 12 weeks
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PA21 | Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value) | 9.52 mg/dL | Standard Deviation 0.88 |
Secondary
Hb Concentrations at End of Treatment (Actual Measured Value)
Time frame: 12 weeks
Population: Safety Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PA21 | Hb Concentrations at End of Treatment (Actual Measured Value) | 11.22 g/dL | Standard Deviation 1.19 |
Secondary
Satisfaction With Bowel Movement
Time frame: 12 weeks
Population: Safety Set
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| PA21 | Satisfaction With Bowel Movement | Week 0 | Very much satisfied/Satisfied | 21 Participants |
| PA21 | Satisfaction With Bowel Movement | Week 0 | Can say neither | 8 Participants |
| PA21 | Satisfaction With Bowel Movement | Week 0 | Very much dissatisfied/Dissatisfied | 6 Participants |
| PA21 | Satisfaction With Bowel Movement | End of treatment | Very much satisfied/Satisfied | 28 Participants |
| PA21 | Satisfaction With Bowel Movement | End of treatment | Can say neither | 5 Participants |
| PA21 | Satisfaction With Bowel Movement | End of treatment | Very much dissatisfied/Dissatisfied | 2 Participants |
Secondary
Serum Ferritin Concentrations at End of Treatment (Actual Measured Value)
Time frame: 12 weeks
Population: Safety Set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PA21 | Serum Ferritin Concentrations at End of Treatment (Actual Measured Value) | 73.8 ng/mL |
Secondary
Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value)
Time frame: 12 weeks
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PA21 | Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value) | 177.9 pg/mL | Standard Deviation 146.4 |
Secondary
Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value)
Time frame: 12 weeks
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PA21 | Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value) | 4.89 mg/dL | Standard Deviation 1.14 |
Secondary
TSAT at End of Treatment (Actual Measured Value)
Time frame: 12 weeks
Population: Safety Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PA21 | TSAT at End of Treatment (Actual Measured Value) | 27.72 percentage of TSAT | Standard Deviation 8.27 |