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NCT04320316 · ClinicalTrials.gov registry record · Phase 4
A Trial to Assess the Safety and Efficacy of KRN23 in Epidermal Nevus Syndrome (ENS)
A Phase 4 study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 4
- Development phase
- 1
- Enrollment target
NCT04320316 is a Phase 4 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 1 participants.
The verdict
NCT04320316, a Phase 4 study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1 participants
- Enrollment target
Study Summary
KRN23 is a fully human immunoglobulin monoclonal antibody (mAb) that binds to and inhibits the activity of fibroblast growth factor 23 (FGF23), leading to an increase in serum phosphorus levels. There are multiple disorders that result in unusually high circulating levels of FGF23, which in turn result in renal phosphate wasting and reduced levels of 1,25-dihydroxy vitamin D (1,25\[OH\]2D). Across these disorders the clinical symptoms are similar and often include osteomalacia (and, in children, rickets), muscle weakness, fatigue, bone pain, and fractures. KRN23 has been studied in one of these disorders, X-linked hypophosphatemia (XLH). In single- and repeat-dose clinical studies in subjects with XLH, subcutaneous (SC) administration of KRN23 consistently increased and sustained serum phosphorus levels and tubular reabsorption of phosphate (TRP) without a major impact on urine calcium levels or vitamin D metabolism. Positive results were also observed in a nonclinical pharmacology model of XLH. It is hypothesized that KRN23 may provide clinical benefit in this patient due to the common underlying feature in this patient and in patients with XLH - abnormally elevated FGF23 in the context of low age -adjusted serum phosphorous levels. The primary objective is to study the effect of KRN23 treatment on normalizing age-adjusted fasting serum phosphorous levels in a single pediatric patient with Epidermal Nevus Syndrome associated hypophosphatemic rickets.
Interventions
- DRUG Crysvita (burosumab-twza) Treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2020-07-31 |
| Est. Completion | 2021-08-31 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04320316
The ClinicalTrials.gov registry entry for NCT04320316 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Crysvita (burosumab-twza) Treatment is the first listed.
NCT04320316 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04320316 about?
NCT04320316 is a clinical study titled "A Trial to Assess the Safety and Efficacy of KRN23 in Epidermal Nevus Syndrome (ENS)". KRN23 is a fully human immunoglobulin monoclonal antibody (mAb) that binds to and inhibits the activity of fibroblast growth factor 23 (FGF23), leading to an increase in serum phosphorus levels. There are multiple disorders that result in unusually high circulating levels of FGF23, which in turn res...
What is the current status of trial NCT04320316?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1 participants. The study started on 2020-07-31. Estimated completion is 2021-08-31.
What interventions are being tested in trial NCT04320316?
The interventions under investigation include: Crysvita (burosumab-twza) Treatment (DRUG).
Who is sponsoring clinical trial NCT04320316?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
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