At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 29 enrolled
Drug / intervention
KRN23drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I/II, Open-Label, Repeat-Dose, Dose-Escalation Study of KRN23 in Adult Subjects With X-Linked Hypophosphatemia
In Brief
A Phase 2 clinical trial evaluating KRN23 for X-linked Hypophosphatemia. Completed, enrolled 29 participants across 6 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsX-linked Hypophosphatemia
CountriesCanada, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2011
First PostedApr 2011
Primary CompletionMay 2013
Study CompletionOct 2013
TodayJul 2026
First PostedApr 22, 2011
Enrollment StartApr 1, 2011
Primary CompletionMay 1, 2013
Study CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 15.2 years ago
Interventions
KRN23drug
Subjects will receive escalating doses of KRN23 administered by SC injections every 28-days (up to 4 doses) based on a dosing algorithm and discretion of the investigator and sponsor.