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

Description

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).

Study Start Date

November 2010

Estimated Completion Date

December 2016

Interventions

  • Drug: Sevelamer Carbonate (Renvela)

Specialties

  • Cardiology: Atherosclerosis/Lipids
  • Family Medicine: Preventive/Nutrition
  • Radiology: CT/SPECT/PET,Nuclear Medicine
  • Physician Assistant: Cardiology

MeSH Terms

  • Atherosclerosis
  • Sevelamer Carbonate

Study ID

Brigham and Women's Hospital -- 2010P002213

Status

Unknown

Trial ID

NCT01238588

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

35

Sponsor

Brigham and Women's Hospital

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 six (6) 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)
  • 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 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
  • 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.

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (9)

Study Location Distance Name Phone Email
Fresenius BostonTKC - Bostone, Massachusetts 2.4 miles Kambiz ZandiNejad MD 617-732-5700 kzandinejad@partners.org
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Kambiz ZANDINEJAD MD 617-732-5700 kzandinejad@partners.org
Fresenius Quincy 1610 - Quincy, Massachusetts 4.5 miles Kambiz ZandiNejad MD 617-732-5700 kzandinejad@partners.org
Fresenius QCDCWeymouth 9144 - Weymouth, Massachusetts 4.5 miles Kambiz ZandiNejad MD 617-732-5700 kzandinejad@partners.org
DCI Dialysis UnitSomerville - Somerville, Massachusetts 4.5 miles Kambiz ZandiNejad MD 617-732-5700 kzandinejad@partners.org
Fresenius Medford Dialysis 1246 - Medford, Massachusetts 4.5 miles Kambiz ZandiNejad MD 617-732-5700 kzandinejad@partners.org
Fresenius Roxbury 1630 - Roxbury, Massachusetts 6.4 miles Kambiz ZandiNejad MD 617-732-5700 kzandinejad@partners.org
Fresenius Framingham 1109 - Framingham, Massachusetts 17.3 miles Kambiz ZandiNejad MD 617-732-5700 kzandinejad@partners.org
Fresenius Marlborough 3448 - Marlborough, Massachusetts 22.9 miles Kambiz ZandiNejad MD 617-732-5700 kzandinejad@partners.org

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