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

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 Overview

• Status: Terminated
• Conditions: Inflammation; Cardiovascular Disease; Atherosclerosis; Hyperphosphatemia; Dialysis
• Intervention / Treatment: Drug: Sevelamer Carbonate (Renvela)

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02215
      • Fresenius Boston-TKC
    • Boston, Massachusetts, United States
      • BWH/FH/DCI Outpatient Dialysis Unit
    • Framingham, Massachusetts, United States, 01701
      • Fresenius Framingham (#1109)
    • Marlborough, Massachusetts, United States, 01752
      • Fresenius Marlborough (#3448)
    • Medford, Massachusetts, United States, 02155
      • Fresenius Medford Dialysis (#1246)
    • Quincy, Massachusetts, United States, 02169
      • Fresenius Quincy (#1610)
    • Roxbury, Massachusetts, United States, 02119
      • Fresenius Roxbury (#1630)
    • Somerville, Massachusetts, United States, 02145
      • DCI Dialysis Unit-Somerville
    • Weymouth, Massachusetts, United States, 02190
      • Fresenius QCDC-Weymouth (#9144)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET): FDG-PET/CT Dual Scan Score	Baseline and 6 months
Changes in High Sensitivity C-Reactive Protein (Hs-CRP) Level	Baseline and 6 months
Changes in Interleukin-6 (IL-6) Level	Baseline and 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Investigators: Principal Investigator: Kambiz Zandi-Nejad, MD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 10, 2011
• Primary Completion (ACTUAL): April 8, 2016
• Study Completion (ACTUAL): April 8, 2016

Study Registration Dates

• First Submitted: November 9, 2010
• First Submitted That Met QC Criteria: November 9, 2010
• First Posted (ESTIMATE): November 10, 2010

Study Record Updates

• Last Update Posted (ACTUAL): July 31, 2017
• Last Update Submitted That Met QC Criteria: July 3, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Vascular Diseases; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Phosphorus Metabolism Disorders; Cardiovascular Diseases; Inflammation; Atherosclerosis; Hyperphosphatemia; Plaque, Atherosclerotic; Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Sevelamer
• Other Study ID Numbers: 2010P002213