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

Mass General Brigham

Status: Terminated

Conditions: Inflammation; Dialysis; Hyperphosphatemia; Atherosclerosis; Cardiovascular Disease

Treatments: Drug: Sevelamer Carbonate (Renvela)

Study type: Interventional

Funder types: Other

Identifiers

NCT01238588

2010P002213

Details and patient eligibility

About

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).

Enrollment: 24 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Sevelamer Carbonate (Renvela)

Other group

Description:

Sevelamer Carbonate (Renvela). Information including those from the scans and blood test will be compared before and after treatment with Renvela.

Treatment:

Drug: Sevelamer Carbonate (Renvela)