Status:
COMPLETED
Fibroblast Growth Factor-23 (FGF23) Reduction in Predialysis Chronic Kidney Disease (CKD)
Lead Sponsor:
Myles Wolf
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The investigators would like to study the role of phosphorus metabolism in the development of certain hormonal problems in people with chronic kidney disease (CKD). More specifically, the goals of the...
Detailed Description
The purposes of this proposal are to (1) develop pilot data of a treatment strategy that manipulates phosphate loading in an effort to ameliorate the development of secondary hyperparathyroidism by in...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00843349
Start Date
July 1 2009
End Date
March 1 2012
Last Update
June 7 2013
Active Locations (1)
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1
University of Miami Hospital
Miami, Florida, United States, 33136