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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01238588
• Other study ID #: 2010P002213
• Status: Recruiting
• Phase: N/A
• First received: November 9, 2010
• Last updated: October 5, 2015
• Start date: November 2010
• Est. completion date: December 2016

Study information

• Verified date: October 2015
• Source: Brigham and Women's Hospital
• Contact: Kambiz Zandi- Nejad, MD
• Phone: 617-732-5700
• Email: kzandinejad[@]partners.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Cardiovascular Disease
• Cardiovascular Diseases
• Dialysis
• Hyperphosphatemia
• Inflammation
• Plaque, Atherosclerotic

Intervention

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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	BWH/FH/DCI Outpatient Dialysis Unit	Boston	Massachusetts
United States	Fresenius Boston-TKC	Bostone	Massachusetts
United States	Fresenius Framingham (#1109)	Framingham	Massachusetts
United States	Fresenius Marlborough (#3448)	Marlborough	Massachusetts
United States	Fresenius Medford Dialysis (#1246)	Medford	Massachusetts
United States	Fresenius Quincy (#1610)	Quincy	Massachusetts
United States	Fresenius Roxbury (#1630)	Roxbury	Massachusetts
United States	DCI Dialysis Unit-Somerville	Somerville	Massachusetts
United States	Fresenius QCDC-Weymouth (#9144)	Weymouth	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in fluorodeoxyglucose (FDG)-positron emission tomography (PET): FDG-PET/CT dual scan score		Baseline and 6 months	No
Primary	Changes in high sensitivity C-Reactive Protein (hs-CRP) level		Baseline and 6 months	No
Primary	Changes in interleukin-6 (IL-6) level		Baseline and 6 months	No
Secondary	Albumin levels		Baseline and 6 months	No
Secondary	Erythropoiesis Stimulating Agent (ESA) dose requirement		Baseline and 6 months	No
Secondary	Hemoglobin Level		Baseline and 6 months	No
Secondary	Rate of cardiovascular events		Baseline and 6 months	No
Secondary	hemodialysis access stenosis/thrombosis		Baseline and 6 months	No