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NCT01277497 · ClinicalTrials.gov registry record · Phase 4
Effect of Phosphate Binders on Markers of Vascular Health in Chronic Kidney Disease Stages 3 and 4
A Phase 4 study, sponsored by Albany College of Pharmacy and Health Sciences.
- Terminated
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
NCT01277497 is a Phase 4 study that was terminated before completion, run by Albany College of Pharmacy and Health Sciences. The registered enrollment target is 30 participants.
The verdict
NCT01277497, a Phase 4 study, was terminated before completion, sponsored by Albany College of Pharmacy and Health Sciences.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
Study Summary
Chronic kidney disease (CKD) patients often have high levels of a substance called fibroblast growth factor-23 (FGF-23), a phosphorus excreting hormone, which has been related to heart disease. As kidney function declines, less phosphorus is removed by the kidneys and as a result phosphorus accumulates in the blood. In response to elevated phosphorus levels, more FGF-23 is released to help facilitate the excretion of extra phosphorus into the urine. In addition to effects on FGF-23, increased phosphorus levels can lead to calcification (hardening) of the blood vessels in the CKD population. Phosphate binding medicines are used in CKD patients to lower the amount of phosphorus absorbed by the stomach and intestines after eating meals and snacks. In patients with CKD, studies have shown that phosphate binders can lower FGF-23 levels in the blood. Lowering FGF-23 levels in CKD patients may also lower substances in the blood that cause calcification of blood vessels in the CKD population. This study is being done to determine if using phosphate binders, either sevelamer carbonate or calcium acetate, in the earlier stages kidney disease (before dialysis) can decrease FGF-23 and biomarkers (substances in the blood) associated with hardening of the blood vessels and heart disease.
Interventions
- DRUG Sevelamer carbonate
- DRUG Calcium acetate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2011-01 |
| Est. Completion | 2016-03 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01277497
The ClinicalTrials.gov registry entry for NCT01277497 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Albany College of Pharmacy and Health Sciences, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sevelamer carbonate is the first listed.
NCT01277497 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01277497 about?
NCT01277497 is a clinical study titled "Effect of Phosphate Binders on Markers of Vascular Health in Chronic Kidney Disease Stages 3 and 4". Chronic kidney disease (CKD) patients often have high levels of a substance called fibroblast growth factor-23 (FGF-23), a phosphorus excreting hormone, which has been related to heart disease. As kidney function declines, less phosphorus is removed by the kidneys and as a result phosphorus accumula...
What is the current status of trial NCT01277497?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2011-01. Estimated completion is 2016-03.
What interventions are being tested in trial NCT01277497?
The interventions under investigation include: Sevelamer carbonate (DRUG), Calcium acetate (DRUG).
Who is sponsoring clinical trial NCT01277497?
This trial is sponsored by Albany College of Pharmacy and Health Sciences, which has 4 total clinical trials registered on ClinicalTrials.gov.
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