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To investigate dose-response efficacy and safety in hemodialysis patients with hyperphosphatemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PA21 750 mg/day | Experimental |
| |
| PA21 1500 mg/day | Experimental |
| |
| PA21 2250 mg/day | Experimental |
| |
| PA21 3000 mg/day | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PA21 | Drug |
| ||
| PA21 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Serum Calcium Concentrations. | 6 weeks | |
| Change From Baseline in Serum Intact-PTH Concentrations. | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tatsuro Takei | Clinical Development Department, Kissei pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Japan | Multiple Locations | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40576086 | Derived | Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | PA21 750 mg/Day | PA21 |
| FG001 | PA21 1500 mg/Day | PA21 |
| FG002 | PA21 2250 mg/Day | PA21 |
| FG003 | PA21 3000 mg/Day | PA21 |
| FG004 | Placebo | Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Total of 5 patients were excluded from analysis because they failed to have primary endpoint.
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| ID | Title | Description |
|---|---|---|
| BG000 | PA21 750 mg/Day | PA21 |
| BG001 | PA21 1500 mg/Day | PA21 |
| BG002 |
| 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 | 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. | Total of 5 patients were excluded from analysis because they failed to have primary endpoint. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | 6 weeks |
|
6 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 750 mg/Day | PA21 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Liver abscess | Infections and infestations | 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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|
| PA21 | Drug |
|
| PA21 | Drug |
|
| Placebo | Drug |
|
| Lack of Efficacy |
|
| Withdrawal by Subject |
|
| Decrease in serum phosphate |
|
| Decrease in serum calcium |
|
| Physician Decision |
|
| PA21 2250 mg/Day |
PA21 |
| BG003 | PA21 3000 mg/Day | PA21 |
| BG004 | Placebo | Placebo |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Dialysis vintage | Mean | Standard Deviation | months |
|
PA21 |
| OG003 | PA21 3000 mg/Day | PA21 |
| OG004 | Placebo | Placebo |
|
|
| Secondary | Change From Baseline in Serum Calcium Concentrations. | Total of 5 patients were excluded from analysis because they failed to have primary endpoint. | Posted | Mean | Standard Deviation | mg/dL | 6 weeks |
|
|
|
| Secondary | Change From Baseline in Serum Intact-PTH Concentrations. | Some patients were excluded from analysis because they failed to have primary endpoint or missed to measure intact-PTH at the end of treatment. | Posted | Mean | Standard Deviation | pg/mL | 6 weeks |
|
|
|
| 39 |
| 1 |
| 39 |
| 13 |
| 39 |
| EG001 | PA21 1500 mg/Day | PA21 | 0 | 36 | 2 | 36 | 11 | 36 |
| EG002 | PA21 2250 mg/Day | PA21 | 0 | 35 | 2 | 35 | 19 | 35 |
| EG003 | PA21 3000 mg/Day | PA21 | 0 | 36 | 1 | 36 | 20 | 36 |
| EG004 | Placebo | Placebo | 0 | 37 | 1 | 37 | 11 | 37 |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Brain stem infarction | Nervous system disorders | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | Non-systematic Assessment |
|
| Intracranial aneurysm | Nervous system disorders | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | Non-systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | Non-systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
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