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

This study has been terminated.
(The study stopped due to lack of funding.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01238588
First Posted: November 10, 2010
Last Update Posted: July 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kambiz Zandi-Nejad, MD, Brigham and Women's Hospital
  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: Intervention Model: Single Group Assignment
Masking: None (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 Kambiz Zandi-Nejad, MD, 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 ]
  • Changes in High Sensitivity C-Reactive Protein (Hs-CRP) Level [ Time Frame: Baseline and 6 months ]
  • Changes in Interleukin-6 (IL-6) Level [ Time Frame: Baseline and 6 months ]

Secondary Outcome Measures:
  • Albumin Levels [ Time Frame: Baseline and 6 months ]
  • Erythropoiesis Stimulating Agent (ESA) Dose Requirement [ Time Frame: Baseline and 6 months ]
  • Hemoglobin Level [ Time Frame: Baseline and 6 months ]
  • Rate of Cardiovascular Events [ Time Frame: Baseline and 6 months ]
  • Hemodialysis Access Stenosis/Thrombosis [ Time Frame: Baseline and 6 months ]

Enrollment: 24
Actual Study Start Date: June 10, 2011
Study Completion Date: April 8, 2016
Primary Completion Date: April 8, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sevelamer Carbonate (Renvela)
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)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01238588


Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Fresenius Boston-TKC
Boston, Massachusetts, United States, 02215
BWH/FH/DCI Outpatient Dialysis Unit
Boston, Massachusetts, United States
Fresenius Framingham (#1109)
Framingham, Massachusetts, United States, 01701
Fresenius Marlborough (#3448)
Marlborough, Massachusetts, United States, 01752
Fresenius Medford Dialysis (#1246)
Medford, Massachusetts, United States, 02155
Fresenius Quincy (#1610)
Quincy, Massachusetts, United States, 02169
Fresenius Roxbury (#1630)
Roxbury, Massachusetts, United States, 02119
DCI Dialysis Unit-Somerville
Somerville, Massachusetts, United States, 02145
Fresenius QCDC-Weymouth (#9144)
Weymouth, Massachusetts, United States, 02190
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Kambiz Zandi-Nejad, MD Brigham and Women's Hospital
  More Information

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
First Submitted: November 9, 2010
First Posted: November 10, 2010
Results First Submitted: May 26, 2017
Results First Posted: June 21, 2017
Last Update Posted: July 31, 2017
Last Verified: July 2017

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