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NCT01748812 · ClinicalTrials.gov registry record · Phase 1
Cinacalcet for Fibroblast Growth Factor 23 (FGF23)-Mediated Hypophosphatemia (Hypophosphatemic Rickets)
A Phase 1 study, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT01748812 is a Phase 1 study that was terminated before completion, run by National Institute of Dental and Craniofacial Research (NIDCR). The registered enrollment target is 1 participants.
The verdict
NCT01748812, a Phase 1 study, was terminated before completion, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
Background: * Hypophosphatemia is a condition where a person has low levels of phosphorus in the blood. Low blood phosphorus can cause muscle and bone weakness (such as rickets) and teeth problems. One cause of the condition is having too much fibroblast growth factor 23 (FGF23). FGF23 is a hormone that causes the kidney to get rid of phosphorus in the urine. It can also prevent the body from making vitamin D, which helps the body absorb phosphorus in food. * Many people with low blood phosphorus take high doses of phosphorus and calcium medications. However, one side effect of these drugs is increased blood levels of parathyroid hormone (PTH). The drug cinacalcet can help lower PTH levels, which may decrease the amount of phosphorus lost in the urine and increase the phosphorus levels in the blood. Researchers want to see if cinacalcet can help blood phosphorus and decrease the amount of phosphorus supplements that people need to take. Objectives: \- To see if cinacalcet can be a safe and effective treatment for people with low phosphorus conditions due to high FGF23. Eligibility: \- Individuals between 18 and 70 years of age who have different forms of hypophosphatemic rickets and tumor-induced hypophosphatemia Design: * Participants will have up to 25 study visits over about 28 weeks. * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. * Up to three more lab visits for blood and urine tests will be required before treatment. Imaging studies of the bones, spine, and kidneys will be performed. * Participants will have a 3-night hospital stay to start treatment. They will take cinacalcet once a day. Treatment will be monitored with frequent blood tests and imaging studies. * Participants will continue to take cinacalcet once a day for 3 weeks. They will have regular study visits to monitor the treatment. * There will be up to two other overnight hospital stays (1 to 3 nights) to adjust cinacalce
Interventions
- DRUG Osteomalacia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2012-11-16 |
| Est. Completion | 2016-12-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01748812
The ClinicalTrials.gov registry entry for NCT01748812 describes a study currently listed as terminated, categorized as Phase 1. 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 National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Osteomalacia is the first listed.
NCT01748812 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01748812 about?
NCT01748812 is a clinical study titled "Cinacalcet for Fibroblast Growth Factor 23 (FGF23)-Mediated Hypophosphatemia (Hypophosphatemic Rickets)". Background: * Hypophosphatemia is a condition where a person has low levels of phosphorus in the blood. Low blood phosphorus can cause muscle and bone weakness (such as rickets) and teeth problems. One cause of the condition is having too much fibroblast growth factor 23 (FGF23). FGF23 is a hormone...
What is the current status of trial NCT01748812?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2012-11-16. Estimated completion is 2016-12-31.
What interventions are being tested in trial NCT01748812?
The interventions under investigation include: Osteomalacia (DRUG).
Who is sponsoring clinical trial NCT01748812?
This trial is sponsored by National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total clinical trials registered on ClinicalTrials.gov.
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