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



Status:Recruiting
Conditions:Peripheral Vascular Disease, Renal Impairment / Chronic Kidney Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases, Nephrology / Urology
Healthy:No
Age Range:50 - Any
Updated:4/21/2016
Start Date:November 2010
End Date:December 2016
Contact:Kambiz Zandi- Nejad, MD
Email:kzandinejad@partners.org
Phone:617-732-5700

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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).


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.
We found this trial at
10
sites
75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Kambiz ZANDI-NEJAD, MD
Phone: 617-732-5700
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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