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NCT01308242 · ClinicalTrials.gov registry record · Early Phase 1
Effects of a Non-Calcium Based Phosphate Binder on FGF23 Levels in Chronic Kidney Disease
A Early Phase 1 study, sponsored by Milton S. Hershey Medical Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 40
- Enrollment target
NCT01308242: Completed Early Phase 1 study, sponsored by Milton S. Hershey Medical Center.
NCT01308242 is a Early Phase 1 study that has completed, run by Milton S. Hershey Medical Center. The registered enrollment target is 40 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01308242, a Early Phase 1 study, has completed, sponsored by Milton S. Hershey Medical Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
Fibroblast Growth Factor 23 (FGF23) is a molecule that has been implicated in the homeostasis of phosphorus. Elevated FGF23 levels are well-documented in patients with Chronic Kidney Disease (CKD) and are inversely correlated with Glomerular Filtration Rate (GFR). FGF23 levels are also predictive of progression of CKD and predict mortality in CKD. Although studies in normal individuals suggest that phosphorus intake is related to FGF23 levels, the effect of dietary and pharmacologic phosphate restriction on FGF23 levels in patients with CKD has never been reported. Our objectives are to determine if phosphate reduction through the use of non-calcium based phosphate binder will decrease serum FGF23 levels. The investigators will also be investigating associations of elevation in FGF 23 levels with commonly encountered co-morbidities in CKD patients such as Coronary Artery Disease, Diabetes Mellitus, and Hypertension.
Primary Outcome
Determine if phosphate reduction through the use of non-calcium based phosphate binders will decrease serum FGF23 levels
Interventions
- DRUG Sevelamer Carbonate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2011-03 |
| Est. Completion | 2014-02-27 |
| Phase | Early Phase 1 |
What the finished NCT01308242 record still lists
NCT01308242 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 1 intervention - of which Sevelamer Carbonate is the first listed.
NCT01308242 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01308242 about?
NCT01308242 is a clinical study titled "Effects of a Non-Calcium Based Phosphate Binder on FGF23 Levels in Chronic Kidney Disease". Fibroblast Growth Factor 23 (FGF23) is a molecule that has been implicated in the homeostasis of phosphorus. Elevated FGF23 levels are well-documented in patients with Chronic Kidney Disease (CKD) and are inversely correlated with Glomerular Filtration Rate (GFR). FGF23 levels are also predictive of...
What is the current status of trial NCT01308242?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 40 participants. The study started on 2011-03. Estimated completion is 2014-02-27.
What interventions are being tested in trial NCT01308242?
The interventions under investigation include: Sevelamer Carbonate (DRUG).
Who is sponsoring clinical trial NCT01308242?
This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01308242's enrollment target sits among peer trials
40 629th of 2000 higher than 1,312 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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