Clinical trial NCT01238588: The Effect(s) of Sevelamer Carbonate (Renvela) on Atherosclerotic Plaque Inflammation Judged by FDG-PET Scan
Official title: The Effect(s) of Sevelamer Carbonate (Renvela) on Atherosclerotic Plaque Inflammation Judged by FDG-PET Scan
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dialysis
Cardiovascular Disease
Atherosclerosis
Inflammation
Hyperphosphatemia
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2010-11-10
Enrollment: 24
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility 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.

Primary outcomes:
measure: Changes in Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET): FDG-PET/CT Dual Scan Score
timeFrame: Baseline and 6 months
measure: Changes in High Sensitivity C-Reactive Protein (Hs-CRP) Level
timeFrame: Baseline and 6 months
measure: Changes in Interleukin-6 (IL-6) Level
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Albumin Levels
timeFrame: Baseline and 6 months
measure: Erythropoiesis Stimulating Agent (ESA) Dose Requirement
timeFrame: Baseline and 6 months
measure: Hemoglobin Level
timeFrame: Baseline and 6 months
measure: Rate of Cardiovascular Events
timeFrame: Baseline and 6 months
measure: Hemodialysis Access Stenosis/Thrombosis
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Fresenius Boston-TKC
state: Massachusetts
city: Boston
country: United States
facility: BWH/FH/DCI Outpatient Dialysis Unit
state: Massachusetts
city: Framingham
country: United States
facility: Fresenius Framingham (#1109)
state: Massachusetts
city: Marlborough
country: United States
facility: Fresenius Marlborough (#3448)
state: Massachusetts
city: Medford
country: United States
facility: Fresenius Medford Dialysis (#1246)
state: Massachusetts
city: Quincy
country: United States
facility: Fresenius Quincy (#1610)
state: Massachusetts
city: Roxbury
country: United States
facility: Fresenius Roxbury (#1630)
state: Massachusetts
city: Somerville
country: United States
facility: DCI Dialysis Unit-Somerville
state: Massachusetts
city: Weymouth
country: United States
facility: Fresenius QCDC-Weymouth (#9144)
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Kambiz Zandi-Nejad, MD
role: PRINCIPAL_INVESTIGATOR
References: