drugset / Trial / NCT01340482
A Repeated Study of KRN23 in Adults With X-Linked Hypophosphatemia
NaSingle-groupOpen-labelTreatment
Summary
The primary purpose of this study is to assess the safety and efficacy of repeated subcutaneous (SC) injections of KRN23 in adult subjects with X-Linked Hypophosphatemia (XLH). A Bone Substudy will evaluate the effects of single-blind KRN23 versus Placebo on bone mineral density and bone quality.
Timeline
- Start
- 2011-04
- Primary completion
- 2013-05
- Completion
- 2013-10
Publications
- Zhang X, Imel EA, Ruppe MD, Weber TJ, Klausner MA, Ito T, Vergeire M, Humphrey J, Glorieux FH, Portale AA, Insogna K, Carpenter TO, Peacock M. Pharmacokinetics and pharmacodynamics of a human monoclonal anti-FGF23 antibody (KRN23) in the first multiple ascending-dose trial treating adults with X-linked hypophosphatemia. J Clin Pharmacol. 2016 Feb;56(2):176-85. doi: 10.1002/jcph.570. Epub 2015 Aug 11.
- Imel EA, Zhang X, Ruppe MD, Weber TJ, Klausner MA, Ito T, Vergeire M, Humphrey JS, Glorieux FH, Portale AA, Insogna K, Peacock M, Carpenter TO. Prolonged Correction of Serum Phosphorus in Adults With X-Linked Hypophosphatemia Using Monthly Doses of KRN23. J Clin Endocrinol Metab. 2015 Jul;100(7):2565-73. doi: 10.1210/jc.2015-1551. Epub 2015 Apr 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Burosumab | Monoclonal antibody | 0.05 mg/kg | Subcutaneous |
| Subject | Burosumab | Monoclonal antibody | 0.1 mg/kg | Subcutaneous |
| Subject | Burosumab | Monoclonal antibody | 0.3 mg/kg | Subcutaneous |
| Subject | Burosumab | Monoclonal antibody | 0.6 mg/kg | Subcutaneous |