Effects of a Non-Calcium Based Phosphate Binder on FGF23 Levels in Chronic Kidney Disease
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 5/4/2018 |
| Start Date: | March 2011 |
| End Date: | February 27, 2014 |
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.
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.
Inclusion Criteria:
- Adults between ages 18-80 years old, with a GFR less than or equal to 50 ml/min/1.73
m2 as determined by the Modification of Diet in Renal Disease (MDRD) formula will be
included.
Exclusion Criteria:
- Patients will be excluded if they have a history of renal transplant or are pregnant.
In addition, patients with dysphagia, swallowing disorders, severe GI motility
disorders, severe constipation, history of major gastrointestinal surgery and patients
taking levothyroxine for hypothyroidism will be excluded.
We found this trial at
1
site
500 University Dr
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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