Chronic Kidney Disease Requiring Hemodialysis
Conditions
Keywords
Hemodialysis, Hyperphosphatemia
Brief summary
To investigate dose-response efficacy and safety in hemodialysis patients with hyperphosphatemia.
Interventions
DRUGPA21
DRUGPlacebo
Sponsors
Kissei Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
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 |
|---|---|---|
| Change From Baseline in Serum Phosphorus Concentrations at the End of Treatment. | 6 weeks | Changes in serum phosphorus concentrations from baseline to the end of treatment were adjusted by serum phosphorus concentration at baseline. |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline in Serum Calcium Concentrations. | 6 weeks |
| Change From Baseline in Serum Intact-PTH Concentrations. | 6 weeks |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PA21 750 mg/Day PA21 | 39 |
| PA21 1500 mg/Day PA21 | 35 |
| PA21 2250 mg/Day PA21 | 33 |
| PA21 3000 mg/Day PA21 | 34 |
| Placebo Placebo | 37 |
| Total | 178 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 | 9 | 6 | 2 |
| Overall Study | Decrease in serum calcium | 0 | 0 | 0 | 1 | 1 |
| Overall Study | Decrease in serum phosphate | 0 | 2 | 3 | 12 | 0 |
| Overall Study | Lack of Efficacy | 0 | 0 | 0 | 0 | 2 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | PA21 750 mg/Day | Total | Placebo | PA21 3000 mg/Day | PA21 2250 mg/Day | PA21 1500 mg/Day |
|---|---|---|---|---|---|---|
| Age, Continuous | 59.4 years STANDARD_DEVIATION 10.4 | 61.4 years STANDARD_DEVIATION 10.9 | 60.8 years STANDARD_DEVIATION 10.2 | 61.4 years STANDARD_DEVIATION 11.2 | 61.9 years STANDARD_DEVIATION 10.5 | 63.8 years STANDARD_DEVIATION 12 |
| Dialysis vintage | 77.6 months STANDARD_DEVIATION 67.5 | 83.7 months STANDARD_DEVIATION 63.5 | 71.0 months STANDARD_DEVIATION 45 | 91.5 months STANDARD_DEVIATION 58.6 | 95.8 months STANDARD_DEVIATION 81.9 | 85.1 months STANDARD_DEVIATION 60.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 39 Participants | 178 Participants | 37 Participants | 34 Participants | 33 Participants | 35 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 12 Participants | 63 Participants | 14 Participants | 15 Participants | 10 Participants | 12 Participants |
| Sex: Female, Male Male | 27 Participants | 115 Participants | 23 Participants | 19 Participants | 23 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 36 | 0 / 35 | 0 / 36 | 0 / 37 |
| other Total, other adverse events | 13 / 39 | 11 / 36 | 19 / 35 | 20 / 36 | 11 / 37 |
| serious Total, serious adverse events | 1 / 39 | 2 / 36 | 2 / 35 | 1 / 36 | 1 / 37 |
Outcome results
Primary
Change From Baseline in Serum Phosphorus Concentrations at the End of Treatment.
Changes in serum phosphorus concentrations from baseline to the end of treatment were adjusted by serum phosphorus concentration at baseline.
Time frame: 6 weeks
Population: Total of 5 patients were excluded from analysis because they failed to have primary endpoint.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| PA21 750 mg/Day | Change From Baseline in Serum Phosphorus Concentrations at the End of Treatment. | -1.84 mg/dL |
| PA21 1500 mg/Day | Change From Baseline in Serum Phosphorus Concentrations at the End of Treatment. | -2.59 mg/dL |
| PA21 2250 mg/Day | Change From Baseline in Serum Phosphorus Concentrations at the End of Treatment. | -3.17 mg/dL |
| PA21 3000 mg/Day | Change From Baseline in Serum Phosphorus Concentrations at the End of Treatment. | -3.78 mg/dL |
| Placebo | Change From Baseline in Serum Phosphorus Concentrations at the End of Treatment. | 0.14 mg/dL |
Secondary
Change From Baseline in Serum Calcium Concentrations.
Time frame: 6 weeks
Population: Total of 5 patients were excluded from analysis because they failed to have primary endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PA21 750 mg/Day | Change From Baseline in Serum Calcium Concentrations. | 0.20 mg/dL | Standard Deviation 0.34 |
| PA21 1500 mg/Day | Change From Baseline in Serum Calcium Concentrations. | 0.16 mg/dL | Standard Deviation 0.33 |
| PA21 2250 mg/Day | Change From Baseline in Serum Calcium Concentrations. | 0.38 mg/dL | Standard Deviation 0.44 |
| PA21 3000 mg/Day | Change From Baseline in Serum Calcium Concentrations. | 0.38 mg/dL | Standard Deviation 0.39 |
| Placebo | Change From Baseline in Serum Calcium Concentrations. | -0.09 mg/dL | Standard Deviation 0.31 |
Secondary
Change From Baseline in Serum Intact-PTH Concentrations.
Time frame: 6 weeks
Population: Some patients were excluded from analysis because they failed to have primary endpoint or missed to measure intact-PTH at the end of treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PA21 750 mg/Day | Change From Baseline in Serum Intact-PTH Concentrations. | -35.2 pg/mL | Standard Deviation 89.8 |
| PA21 1500 mg/Day | Change From Baseline in Serum Intact-PTH Concentrations. | -45.6 pg/mL | Standard Deviation 79.2 |
| PA21 2250 mg/Day | Change From Baseline in Serum Intact-PTH Concentrations. | -97.0 pg/mL | Standard Deviation 92.7 |
| PA21 3000 mg/Day | Change From Baseline in Serum Intact-PTH Concentrations. | -86.5 pg/mL | Standard Deviation 104 |
| Placebo | Change From Baseline in Serum Intact-PTH Concentrations. | 21.5 pg/mL | Standard Deviation 82.5 |