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

• Status: Terminated
• Trial end date: 2016-04-08
• Target enrollment: 0
• Participant gender: All

Summary

The hypothesis is that switching calcium based phosphate binders to sevelamer carbonate will be associated with less inflammation including less atherosclerotic plaque inflammation (inflammation of the vessel walls).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Treatments: Sevelamer

Criteria

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.