Phase 2
N=29
A Repeated Study of KRN23 in Adults With X-Linked Hypophosphatemia
X-linked Hypophosphatemia
Bottom Line
View on ClinicalTrials.gov: NCT01340482 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Safety and Efficacy of Repeated SC Injections of KRN23 — 24; 1; 1; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- KRN23 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kyowa Kirin Co., Ltd.
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Efficacy of Repeated SC Injections of KRN23 |
24; 1; 1; 0; 0; 0 | — |
| SECONDARY Evaluation of Effect of Repeated SC Injections of KRN23 |
1.89; 2.18; 2.20; 2.14; 2.15; 1.96 | — |
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.
Eligibility Criteria
Main Inclusion Criteria:
- 18 years or older
- Clinical diagnosis of XLH
- TmP/GFR < 2.0 mg/dL
- GFR ≥60 mL/min
- Corrected Ca <10.8 mg/dL
- A willingness to utilize adequate contraception and not become pregnant[or to have their partner(s) become pregnant] during the study
- Additional inclusion criteria apply
Main Exclusion Criteria:
- Have any sign of active infectious disease or have had an infection requiring treatment with antibiotics within 3-weeks of Screening
- History of known immunodeficiency
- Pregnant or lactating females subjects or female planning to be become pregnant during the study
- Receipt of a live (attenuated) vaccine (except for influenza vaccines) within 3-months of Screening, and/or during the study
- Use of pharmacologic vitamin D metabolite or its analog, phosphate, calcimimetics, and ingestion of aluminum hydroxide antacids within 10-days prior to Screening and/or dosing
- Use of any supplement containing phosphate, calcium and/or vitamin D within 10-days prior to Screening and/or dosing
- Condition which could present a concern for either the subject's safety or difficulty with data interpretation
- Additional exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT01340482). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.