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NCT01340482 · ClinicalTrials.gov registry record · Phase 1
A Repeated Study of KRN23 in Adults With X-Linked Hypophosphatemia
A Phase 1 study, sponsored by Kyowa Kirin Co..
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
NCT01340482: Completed Phase 1 study, sponsored by Kyowa Kirin Co..
NCT01340482 is a Phase 1 study that has completed, run by Kyowa Kirin Co.. The registered enrollment target is 29 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01340482, a Phase 1 study, has completed, sponsored by Kyowa Kirin Co..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
Study 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.
Primary Outcome
Safety and efficacy of repeated SC injections of KRN23 from baseline as assessed by serum phosphorus levels,immunogenicity, adverse events and clinically significant changes in vital signs and laboratory testing.
Interventions
- DRUG KRN23
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2011-04 |
| Est. Completion | 2013-10 |
| Phase | Phase 1 |
What the finished NCT01340482 record still lists
NCT01340482 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 1 intervention - of which KRN23 is the first listed.
NCT01340482 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01340482 about?
NCT01340482 is a clinical study titled "A Repeated Study of KRN23 in Adults With X-Linked Hypophosphatemia". 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.
What is the current status of trial NCT01340482?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2011-04. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01340482?
The interventions under investigation include: KRN23 (DRUG).
Who is sponsoring clinical trial NCT01340482?
This trial is sponsored by Kyowa Kirin Co., which has 25 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01340482's enrollment target sits among peer trials
29 1440th of 2000 higher than 554 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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