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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PA21 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PA21 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | 12 weeks |
| Measure | Description | 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Japan |
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| ID | Title | Description |
|---|---|---|
| FG000 | PA21 | PA21 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Full Analysis Set
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| ID | Title | Description |
|---|---|---|
| BG000 | PA21 | PA21 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Adverse Events | Safety Set | Posted | Count of Participants | Participants | 12 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PA21 | PA21 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatitis acute | Hepatobiliary disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development Division | Kissei Pharmaceutical Co., Ltd | Email only | rinsyousiken@pharm.kissei.co.jp |
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| ID | Term |
|---|---|
| D054559 | Hyperphosphatemia |
| ID | Term |
|---|---|
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 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 |
| TSAT 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 |
| Increase in serum ferritin |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Dialysis vintage | Mean | Standard Deviation | months |
|
|
| Secondary | Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value) | Full Analysis Set | Posted | Mean | Standard Deviation | mg/dL | 12 weeks |
|
|
|
| Secondary | Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value) | Full Analysis Set | Posted | Mean | Standard Deviation | mg/dL | 12 weeks |
|
|
|
| Secondary | Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value) | Full Analysis Set | Posted | Mean | Standard Deviation | pg/mL | 12 weeks |
|
|
|
| Secondary | Serum Ferritin Concentrations at End of Treatment (Actual Measured Value) | Safety Set | Posted | Median | Inter-Quartile Range | ng/mL | 12 weeks |
|
|
|
| Secondary | TSAT at End of Treatment (Actual Measured Value) | Safety Set | Posted | Mean | Standard Deviation | percentage of TSAT | 12 weeks |
|
|
|
| Secondary | Hb Concentrations at End of Treatment (Actual Measured Value) | Safety Set | Posted | Mean | Standard Deviation | g/dL | 12 weeks |
|
|
|
| Secondary | Constipation Condition | Safety Set | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Secondary | Satisfaction With Bowel Movement | Safety Set | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| 35 |
| 1 |
| 35 |
| 23 |
| 35 |
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Wound | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
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| Could not tolerate |
|
| Bothers me quite a lot |
|
| Could not tolerate |
|