Fibroblast Growth Factor-23 (FGF23) Reduction in Predialysis Chronic Kidney Disease (CKD)

Completed · Not applicable · Has a placebo group

Conditions studied: Kidney Disease

In brief

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 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.

Key facts

Study ID

NCT00843349

Run by

Myles Wolf

People needed

43

Starts

2009-07-01

Expected to finish

2012-03-01

Last updated by the study team

2013-06-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• We will include stage 3a, 3b and 4 CKD patients, aged 18 years or over with normal serum phosphate levels (≤ 4.6 mg/dl)

You may not qualify if…

• 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

Where it is running

• University of Miami Hospital — Miami, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.