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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Brigham and Women's Hospital.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Kambiz Zandi-Nejad, MD, Brigham and Women's Hospital Identifier:
First received: November 9, 2010
Last updated: September 14, 2013
Last verified: June 2011

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).

Condition Intervention
Cardiovascular Disease
Drug: Sevelamer Carbonate (Renvela)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect(s) of Sevelamer Carbonate (Renvela) on Atherosclerotic Plaque Inflammation Judged by FDG-PET Scan

Resource links provided by NLM:

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Changes in fluorodeoxyglucose (FDG)-positron emission tomography (PET): FDG-PET/CT dual scan score [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
  • Changes in high sensitivity C-Reactive Protein (hs-CRP) level [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
  • Changes in interleukin-6 (IL-6) level [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Albumin levels [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
  • Erythropoiesis Stimulating Agent (ESA) dose requirement [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
  • Hemoglobin Level [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
  • Rate of cardiovascular events [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
  • hemodialysis access stenosis/thrombosis [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: November 2010
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sevelamer Carbonate (Renvela)
Sevelamer Carbonate (Renvela)
Drug: Sevelamer Carbonate (Renvela)
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.
Other Names:
  • Sevelamer carbonate
  • Renvela


Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01238588

Contact: Kambiz Zandi- Nejad, MD 617-640-6261

United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Kambiz ZANDI-NEJAD, MD    617-983-7590   
Contact: Joseph P Curran, RN    617-983-4480      
Principal Investigator: Kambiz ZANDI-NEJAD, MD         
BWH/FH/DCI Outpatient Dialysis Unit Recruiting
Boston, Massachusetts, United States
Contact: Kambiz ZANDI-NEJAD, MD    617-983-7590   
Contact: Joseph P Curran, RN    617-983-4480      
Principal Investigator: Kambiz ZANDI-NEJAD, MD         
DCI Dialysis Unit-Somerville Recruiting
Somerville, Massachusetts, United States
Contact: Kambiz Zandi-Nejad, MD    617-983-7590   
Contact: Joseph P Curran, RN    617-983-4480   
Sponsors and Collaborators
Brigham and Women's Hospital
Principal Investigator: Kambiz Zandi-Nejad, MD Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Kambiz Zandi-Nejad, MD, Instructor in Medicine, Brigham and Women's Hospital Identifier: NCT01238588     History of Changes
Other Study ID Numbers: 2010P002213
Study First Received: November 9, 2010
Last Updated: September 14, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cardiovascular Diseases
Plaque, Atherosclerotic
Pathologic Processes
Arterial Occlusive Diseases
Vascular Diseases
Phosphorus Metabolism Disorders
Metabolic Diseases
Pathological Conditions, Anatomical
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions processed this record on September 30, 2014