Conditions: Chronic Kidney Disease
Keywords: phosphate, phosphorus, FGF-23, PTH, 1,25D
Allocation: RANDOMIZED | Intervention model: FACTORIAL
Enrollment: 16
Healthy volunteers: no

Brief summary:
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.

Detailed description:
Phosphorus is a mineral found in dairy products, nuts, and meat that is essential for bone health and many other important functions inside the body's cells. The kidneys are responsible for keeping the blood levels of phosphorus normal. Healthy kidneys do this by spilling excess phosphorus into the urine. In patients with chronic kidney disease, the kidneys are unable to spill an adequate amount of phosphorus so that excess phosphorus can accumulate in the walls of blood vessels leading to heart disease, their leading cause of death. A recently discovered hormone called FGF-23 helps control the blood levels of phosphorus by "telling" the kidney how much phosphorus to spill in the urine. The purpose of this study is to learn more about how FGF-23 helps the kidneys control the blood levels of phosphorus. 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.

Arms:
arm 1: 25% of subjects will receive binders plus a phosphate restricted diet. arm 2: 25% binders + unrestricted phosphate diet. arm 3: 25% placebo + phosphate restricted diet. arm 4: 25% placebo + unrestricted phosphate diet.

Interventions: intervention 1: Lanthanum Carbonate intervention 2: Low Phosphorus Diet intervention 3: Unrestricted Phosphorus Diet intervention 4: Placebo
Intervention descriptions: intervention 1: Lanthanum carbonate 1000mg 3x/day intervention 2: Low phosphorus diet will consist of 800 mg of phosphorus per day. intervention 3: Unrestricted diet will contain 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg. intervention 4: Lanthanum Carbonate placebo given three times a day with meals.

Protocol document: