Fibroblast Growth Factor-23 (FGF23) Reduction in Predialysis Chronic Kidney Disease (CKD)
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/27/2013 |
| Start Date: | February 2009 |
| End Date: | February 2012 |
| Contact: | Kelsey Smith, BA |
| Email: | ksmith3@med.miami.edu |
| Phone: | 305-243-4782 |
Fibroblast Growth Factor-23 Reduction in Predialysis Chronic Kidney Disease
The investigators would like to study the role of phosphorus metabolism in the development
of certain hormonal problems in people with chronic kidney disease. More specifically, the
goals of the research are (1) to understand the cause of hyperparathyroidism - a hormone
problem that often develops in patients who have kidney disease and (2) to test whether
decreasing phosphorus intake could help improve or prevent hyperparathyroidism.
Inclusion Criteria:
- We will include stage 3a, 3b and 4 CKD patients, aged 18 years or over with normal
serum phosphate levels (≤ 4.6 mg/dl)
Exclusion Criteria:
- Patients with rapidly advancing renal failure who thus might develop
hyperphosphatemia or end stage renal disease requiring initiation of dialysis during
the study period
- Patients expected to require dialysis initiation within the follow up period
- Patients with hyperphosphatemia > 4.6 mg/dl
- Patients with any previous or current treatment with phosphate binders or active
vitamin D (doxercalciferol or calcitriol)
- Malnutrition, defined as a serum albumin < 3.0 mg/dl
- Patients with liver disease (ALT or AST > 100 U/L) or cholestasis (direct bilirubin >
1.0 mg/dl) because this can limit their ability to absorb fat soluble vitamins such
as vitamin D
- Anemia, defined as a hematocrit < 27% at the screening visit
- Medical conditions impacting Pi metabolism—primary hyper- or hypoparathyroidism;
Patients with previous subtotal parathyroidectomy; gastrointestinal malabsorption
disorders such as Crohn's Disease, ulcerative colitis, celiac disease, or severe
liver dysfunction;
- Patients with outpatient counseling by a renal nutritionist within the previous 6
months
- Hospitalization within the previous 4 weeks
- Pregnancy or breastfeeding mothers
- Patients unable to independently provide written informed consent - prisoners,
mentally incompetent, minors
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