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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Brigham and Women's Hospital
Sponsor:
Information provided by (Responsible Party):
Kambiz Zandi-Nejad, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01238588
First received: November 9, 2010
Last updated: October 8, 2014
Last verified: October 2014
  Purpose

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
Dialysis
Cardiovascular Disease
Atherosclerosis
Inflammation
Hyperphosphatemia
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: December 2015
Estimated Primary Completion Date: December 2015 (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

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01238588

Contacts
Contact: Kambiz Zandi- Nejad, MD 617-732-5700 ext 34769 kzandinejad@partners.org

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Kambiz ZANDI-NEJAD, MD    617-732-5700 ext 34769    kzandinejad@partners.org   
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    617-732-5700 ext 34769    kzandinejad@partners.org   
Contact: Joseph P Curran, RN    617-983-4480      
Principal Investigator: Kambiz ZANDI-NEJAD, MD         
Fresenius Boston-TKC Recruiting
Bostone, Massachusetts, United States, 02215
Contact: Kambiz Zandi-Nejad, MD    617-732-5700 ext 34769    kzandinejad@partners.org   
Fresenius Framingham (#1109) Recruiting
Framingham, Massachusetts, United States, 01701
Contact: Kambiz Zandi-Nejad, MD    617-732-5700 ext 34769    kzandinejad@partners.org   
Fresenius Marlborough (#3448) Recruiting
Marlborough, Massachusetts, United States, 01752
Contact: Kambiz Zandi-Nejad, MD    617-732-5700 ext 34769    kzandinejad@partners.org   
Fresenius Medford Dialysis (#1246) Recruiting
Medford, Massachusetts, United States, 02155
Contact: Kambiz Zandi-Nejad, MD    617-732-5700 ext 34769    kzandinejad@partners.org   
Fresenius Quincy (#1610) Recruiting
Quincy, Massachusetts, United States, 02169
Contact: Kambiz Zandi-Nejad, MD    617-732-5700 ext 34769    kzandinejad@partners.org   
Fresenius Roxbury (#1630) Recruiting
Roxbury, Massachusetts, United States, 02119
Contact: Kambiz Zandi-Nejad, MD    617-732-5700 ext 34769    kzandinejad@partners.org   
DCI Dialysis Unit-Somerville Recruiting
Somerville, Massachusetts, United States, 02145
Contact: Kambiz Zandi-Nejad, MD    617-732-5700 ext 34769    kzandinejad@partners.org   
Contact: Joseph P Curran, RN    617-983-4480    jpcurran@partners.org   
Fresenius QCDC-Weymouth (#9144) Recruiting
Weymouth, Massachusetts, United States, 02190
Contact: Kambiz Zandi-Nejad, MD    617-732-5700 ext 34769    kzandinejad@partners.org   
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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
ClinicalTrials.gov Identifier: NCT01238588     History of Changes
Other Study ID Numbers: 2010P002213
Study First Received: November 9, 2010
Last Updated: October 8, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Hyperphosphatemia
Inflammation
Plaque, Atherosclerotic
Arterial Occlusive Diseases
Metabolic Diseases
Pathologic Processes
Pathological Conditions, Anatomical
Phosphorus Metabolism Disorders
Vascular Diseases
Sevelamer
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Sequestering Agents

ClinicalTrials.gov processed this record on October 23, 2014