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The purpose of this study is to investigate the safety and efficacy for 52-week dosing in hemodialysis patients with hyperphosphatemia.
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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 | 52 weeks |
| Measure | Description | 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| JAPAN | 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 | 52 weeks |
|
|
52 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 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyelonephritis | Infections and infestations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | 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) |
| 52 weeks |
| Decrease in serum phosphorus |
|
| Decrease in serum calcium |
|
| 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 | 52 weeks |
|
|
|
| Secondary | Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value) | Full Analysis Set | Posted | Mean | Standard Deviation | mg/dL | 52 weeks |
|
|
|
| Secondary | Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value) | Full Analysis Set | Posted | Mean | Standard Deviation | pg/mL | 52 weeks |
|
|
|
| 161 |
| 29 |
| 161 |
| 133 |
| 161 |
| Renal cyst infection | Infections and infestations | Non-systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | Non-systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | Non-systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | Non-systematic Assessment |
|
| VIIth nerve paralysis | Nervous system disorders | Non-systematic Assessment |
|
| Cataract | Eye disorders | Non-systematic Assessment |
|
| Retinal haemorrhage | Eye disorders | Non-systematic Assessment |
|
| Vitreous haemorrhage | Eye disorders | Non-systematic Assessment |
|
| Macular fibrosis | Eye disorders | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | Non-systematic Assessment |
|
| Arteriosclerosis coronary artery | Cardiac disorders | Non-systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | Non-systematic Assessment |
|
| Ventricular fibrillation | Cardiac disorders | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | Non-systematic Assessment |
|
| Venous stenosis | Vascular disorders | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
|
| Ileus | Gastrointestinal disorders | Non-systematic Assessment |
|
| Jaw cyst | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Renal cyst haemorrhage | Renal and urinary disorders | Non-systematic Assessment |
|
| Pyrexia | General disorders | Non-systematic Assessment |
|
| Shunt occlusion | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Shunt stenosis | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Shunt malfunction | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Shunt aneurysm | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Procedural hypotension | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
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