Low Phosphate Diets in Patients With Early Stages of Chronic Kidney Disease

Completed · Not applicable · Has a placebo group

Conditions studied: Chronic Kidney Disease

In brief

The purpose of this study is to learn more about how the kidneys control the blood levels of phosphorus in patients with early chronic kidney disease. The ultimate goal is to use this information to design improved treatment strategies for phosphorus-related problems for the millions of patients with chronic kidney disease.

Key facts

Study ID

NCT00438932

Run by

Massachusetts General Hospital

People needed

16

Starts

2007-01-01

Expected to finish

2010-01-01

Last updated by the study team

2011-09-27

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• subjects with stage 3a, 3b and 4 CKD
• subjects have to be aged 18 years or older
• subjects have to have normal serum phosphate levels (< 4.6 mg/dl)
• subjects have to have sufficient 25-OH Vit0amin D levels (≥ 20 ng/ml)

You may not qualify if…

• subjects with rapidly advancing renal failure who thus might develop hyperphosphatemia or end stage renal disease requiring initiation of dialysis during the study period
• subjects expected to require dialysis initiation within the follow up period
• subjects with hyperphosphatemia > 4.6 mg/dL
• subjects with any previous or current treatment with phosphate binders or active vitamin D (doxercalciferol or calcitriol)
• subjects with malnutrition, defined as a serum albumin < 3.0 mg/dl, in order to avoid worsening protein-malnutrition status during the restricted study period since phosphate restricted diets are also low in protein
• subjects with chronic gastrointestinal diseases that could impede their absorptive ability such as Crohn's disease, ulcerative colitis and sprue
• subjects 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
• subjects with anemia, defined as a hematocrit <27% at the screening visit
• subjects wht have been hospitalization within the previous 4 weeks
• subjects who are pregnant
• subjects who are breastfeeding mothers
• subjects with primary hypoparathyroidism
• subjects with primary hyperparathyroidism
• subjects with previous subtotal parathyroidectomy
• subjects with previous outpatient counseling by a renal nutritionist
• subjects who are unable to independently provide written informed consent - prisoners, mentally incompetent, minors

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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