The Effect(s) of Sevelamer Carbonate (Renvela) on Atherosclerotic Plaque Inflammation Judged by FDG-PET Scan

Inclusion Criteria:

- A signed consent form;

- Male or Female, 50 years or older;

- Diagnosed with end stage renal disease (ESRD), on maintenance hemodialysis for at
least three (3) months;

- On calcium-based phosphate binders;

- Subject must be able to understand and provide informed consent;

- No known contraindications to therapy with sevelamer carbonate.

Exclusion Criteria:

- Any patient with a medical condition or taking any medications that would be
contraindicated with the use of sevelamer carbonate, such as history of bowel
obstruction;

- History of severe allergic reactions to the study medication;

- History of active infection (other than a simple respiratory tract infection) or
acute gouty attack within 2 weeks prior to enrollment;

- Known serological positivity for Human Immunodeficiency Virus (HIV), Hepatitis B
surface Antigen (HBsAg), or Hepatitis C Virus Antibody (HCV Ab) except dose with
normal liver function tests (AST, ALT, Bilirubin, and Alkaline Phophatase) and no
history of cirrhosis;

- Elevation of liver function tests at time of entry (Aspartate Aminotransferase (AST)
and/or Alanine Aminotransferase (ALT) > 2 times the upper limit of normal);

- History of drug, alcohol, or chemical abuse within 6 months prior to enrollment;

- History of malignancy except those adequately treated, has completed treatment and
clinically in remission for more than 6 month; adequately treated in-situ cervical
carcinoma, or adequately treated basal or squamous cell carcinoma of the skin;

- History of an inflammatory disease such as systemic lupus erythematosus (SLE),
rheumatoid arthritis or ulcerative colitis except those in remission for more than 6
months;

- Patients currently on sevelamer carbonate or sevelamer chloride or history of taking
them for more than a week in the past three months;

- Patients receiving chronic anti-inflammatory therapy;

- Patients in whom FDG-PET/CT dual scans are contraindicated.