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

NCT ID: NCT01238588

Last Updated: 2017-07-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-10
• Study Completion Date: 2016-04-08

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).

Conditions

Dialysis; Cardiovascular Disease; Atherosclerosis; Inflammation; Hyperphosphatemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sevelamer Carbonate (Renvela)

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

Group Type: OTHER

Sevelamer Carbonate (Renvela)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Sevelamer carbonate; Renvela

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kambiz Zandi-Nejad, MD

Instructor in Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kambiz Zandi-Nejad, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Fresenius Boston-TKC

Boston, Massachusetts, United States

BWH/FH/DCI Outpatient Dialysis Unit

Boston, 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, United States

Countries

United States

Other Identifiers

2010P002213

Identifier Type: -

Identifier Source: org_study_id