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| Name | Class |
|---|---|
| Kyowa Hakko Kirin Pharma, Inc. | INDUSTRY |
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The primary objective of this study is to assess the safety and tolerability of KRN23 after a single intravenous (IV) and subcutaneous (SC) administration in XLH patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KRN23 | Experimental | Single IV or SC administration on day 1 |
|
| Placebo | Placebo Comparator | Single IV or SC administration on day 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | single dose IV or SC administration |
| |
| KRN23 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability | AEs, etc | Up to 7 weeks after dosing (maximally 11 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Effect to pharmacodynamic parameter | Change in Serum Phosphate | Up to 7 weeks after dosing (maximally 11 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas O. Carpenter, M.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine | New Haven | Connecticut | 06510 | United States | ||
| General Clinical Research Center, Indiana University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24569459 | Derived | Carpenter TO, Imel EA, Ruppe MD, Weber TJ, Klausner MA, Wooddell MM, Kawakami T, Ito T, Zhang X, Humphrey J, Insogna KL, Peacock M. Randomized trial of the anti-FGF23 antibody KRN23 in X-linked hypophosphatemia. J Clin Invest. 2014 Apr;124(4):1587-97. doi: 10.1172/JCI72829. Epub 2014 Feb 24. |
| Label | URL |
|---|---|
| KRN23-INT-002 An Extension Study of KRN23 in Adults With X-Linked Hypophosphatemia | View source |
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| ID | Term |
|---|---|
| D053098 | Familial Hypophosphatemic Rickets |
| ID | Term |
|---|---|
| D063730 | Rickets, Hypophosphatemic |
| D012279 | Rickets |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
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| ID | Term |
|---|---|
| C000601956 | burosumab |
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| Drug |
Single IV administration on day 1: 0.003, 0.01, 0.03, 0.1 and 0.3 mg/kg and Single SC administration on day 1: 0.1, 0.3, 0.6 and 1.0 mg/kg |
|
| Indianapolis |
| Indiana |
| 46202-5250 |
| United States |
| Duke Clinical Research Unit | Durham | North Carolina | 27710 | United States |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| D009140 |
| Musculoskeletal Diseases |
| D007015 | Hypophosphatemia, Familial |
| D015499 | Renal Tubular Transport, Inborn Errors |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008664 | Metal Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D002128 | Calcium Metabolism Disorders |
| D017674 | Hypophosphatemia |
| D010760 | Phosphorus Metabolism Disorders |
| D014808 | Vitamin D Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |