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The purpose of this study is to evaluate the efficacy and safety of PA21 in hemodialysis patients with hyperphosphatemia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PA21 | Experimental |
| |
| Sevelamer hydrochloride | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PA21 | Drug |
| ||
| Sevelamer hydrochloride |
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Mean of Serum Phosphorus Concentrations at the End of Treatment | Covariate: Serum phosphorus concentrations at baseline. | 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 |
| 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 | PA21 |
| FG001 | Sevelamer Hydrochloride | Sevelamer hydrochloride |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Per Protocol Set
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| ID | Title | Description |
|---|---|---|
| BG000 | PA21 | PA21 |
| BG001 | Sevelamer Hydrochloride | Sevelamer hydrochloride |
| 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 | Adjusted Mean of Serum Phosphorus Concentrations at the End of Treatment | Covariate: Serum phosphorus concentrations at baseline. | Per Protocol Set | Posted | Mean | 95% Confidence Interval | mg/dL | 12 weeks |
|
|
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 |
|---|---|---|---|---|---|
| Diverticulitis | 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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| ID | Term |
|---|---|
| D000069603 | Sevelamer |
| ID | Term |
|---|---|
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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|
| Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value) |
| 12 weeks |
| Withdrawal by Subject |
|
| Decrease in serum calcium |
|
| Increase in serum ferritin |
|
| 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 |
|
| Participants |
|
|
|
| Secondary | Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value) | Per Protocol Set | Posted | Mean | Standard Deviation | mg/dL | 12 weeks |
|
|
|
| Secondary | Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value) | Per Protocol Set | Posted | Mean | Standard Deviation | mg/dL | 12 weeks |
|
|
|
| Secondary | Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value) | Per Protocol Set | Posted | Mean | Standard Deviation | pg/mL | 12 weeks |
|
|
|
| 108 |
| 6 |
| 108 |
| 47 |
| 108 |
| EG001 | Sevelamer Hydrochloride | Sevelamer hydrochloride | 0 | 105 | 5 | 105 | 42 | 105 |
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | Non-systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | Non-systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Renal cyst ruptured | Renal and urinary disorders | Non-systematic Assessment |
|
| Shunt stenosis | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
|
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