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NCT04146935 · ClinicalTrials.gov registry record · Phase 4
Examining the Effect of Burosumab on Muscle Function
A Phase 4 study of X-linked Hypophosphatemia, sponsored by Yale University.
- Completed
- Registry status
- Phase 4
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT04146935: Completed Phase 4 study of X-linked Hypophosphatemia, sponsored by Yale University.
NCT04146935 is a Phase 4 study of X-linked Hypophosphatemia that has completed, run by Yale University. The registered enrollment target is 10 participants, below the 172-participant average among 5 other X-linked Hypophosphatemia trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04146935, a Phase 4 study of X-linked Hypophosphatemia, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
Patients with X-linked hypophosphatemia (XLH) often report symptoms of fatigue and weakness particularly after exertion, in addition to their skeletal complaints. In previous trials using KRN23 (same drug as burosumab/Crysvita®), patients report these symptoms improve. The investigators wish to test this hypothesis directly by measuring muscle energy when patients begin treatment with Crysvita® for the first time.
Primary Outcome
Rates of mitochondrial phosphorylation activity were assessed in the soleus/gastrocnemius muscle complex of the right calf by 31P magnetic resonance spectroscopy saturation transfer technique (micro-mol/g/min)
Conditions Studied
Interventions
- DRUG Burosumab Injection [Crysvita]
Study Locations (1)
Connecticut
- Yale University School of Medicine - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2019-11-13 |
| Est. Completion | 2022-08-25 |
| Phase | Phase 4 |
What the finished NCT04146935 record still lists
NCT04146935 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 172-participant average among 5 other X-linked Hypophosphatemia trials with a reported enrollment target (94% lower).
The record links to 1 condition, with X-linked Hypophosphatemia appearing as the primary indexed condition, and to 1 intervention - of which Burosumab Injection [Crysvita] is the first listed.
NCT04146935 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT04146935 about?
NCT04146935 is a clinical study titled "Examining the Effect of Burosumab on Muscle Function". Patients with X-linked hypophosphatemia (XLH) often report symptoms of fatigue and weakness particularly after exertion, in addition to their skeletal complaints. In previous trials using KRN23 (same drug as burosumab/Crysvita®), patients report these symptoms improve. The investigators wish to test...
What is the current status of trial NCT04146935?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2019-11-13. Estimated completion is 2022-08-25.
What conditions does trial NCT04146935 study?
This clinical trial studies the following conditions: X-linked Hypophosphatemia.
What interventions are being tested in trial NCT04146935?
The interventions under investigation include: Burosumab Injection [Crysvita] (DRUG).
Who is sponsoring clinical trial NCT04146935?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04146935 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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