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

Study Overview
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Brief Summary
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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).

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

Conditions
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Dialysis, Cardiovascular Disease, Atherosclerosis, Inflammation, Hyperphosphatemia

Intervention / Treatment
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* Drug: Sevelamer Carbonate (Renvela)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sevelamer Carbonate (Renvela)<br>Sevelamer Carbonate (Renvela). Information including those from the scans and blood test will be compared before and after treatment with Renvela. | Drug: Sevelamer Carbonate (Renvela)<br>* Patients' will be given doses of Renvela equivalent to their prior dose of calcium based phosphate binders and the dose will be titrated as necessary to achieve phosphate levels recommended by KDOQI guidelines.<br>* Other names: Renvela;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET): FDG-PET/CT Dual Scan Score |  | Baseline and 6 months | 
| Changes in High Sensitivity C-Reactive Protein (Hs-CRP) Level |  | Baseline and 6 months | 
| Changes in Interleukin-6 (IL-6) Level |  | Baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Albumin Levels |  | Baseline and 6 months | 
| Erythropoiesis Stimulating Agent (ESA) Dose Requirement |  | Baseline and 6 months | 
| Hemoglobin Level |  | Baseline and 6 months | 
| Rate of Cardiovascular Events |  | Baseline and 6 months | 
| Hemodialysis Access Stenosis/Thrombosis |  | Baseline and 6 months |