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

Not Applicable

Terminated

• Conditions: Dialysis; Cardiovascular Disease; Atherosclerosis; Inflammation; Hyperphosphatemia
• Interventions: Drug: Sevelamer Carbonate (Renvela)

• Registration Number: NCT01238588
• Lead Sponsor: Brigham and Women's Hospital

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-09
• Study First Submitted QC: 2010-11-09
• Study First Posted: 2010-11-10
• Study Start: 2011-06-10
• Primary Completion: 2016-04-08
• Study Completion: 2016-04-08
• Results First Submitted: 2017-05-26
• Results First Submitted QC: 2017-05-26
• Results First Posted: 2017-06-21
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-03
• Last Update Posted: 2017-07-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sevelamer Carbonate (Renvela)	Sevelamer Carbonate (Renvela)	Sevelamer Carbonate (Renvela). Information including those from the scans and blood test will be compared before and after treatment with Renvela.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (10)

DCI Dialysis Unit-Somerville; 🇺🇸 Somerville, Massachusetts, United States

BWH/FH/DCI Outpatient Dialysis Unit; 🇺🇸 Boston, Massachusetts, United States

Fresenius Boston-TKC; 🇺🇸 Boston, Massachusetts, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Fresenius Framingham (#1109); 🇺🇸 Framingham, 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

Fresenius QCDC-Weymouth (#9144); 🇺🇸 Weymouth, Massachusetts, United States

Fresenius Marlborough (#3448); 🇺🇸 Marlborough, Massachusetts, United States