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

NCT01238588 | Terminated Results

• 1 other identifier: 2010P002213
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 10

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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

Study Arms (1)

Sevelamer Carbonate (Renvela)

OTHER

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)

Interventions

Sevelamer Carbonate (Renvela) 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.

Also known as: Sevelamer carbonate, Renvela

Sevelamer Carbonate (Renvela)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (10)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Fresenius Boston-TKC

Boston, Massachusetts, 02215, United States

Location

BWH/FH/DCI Outpatient Dialysis Unit

Boston, Massachusetts, United States

Location

Fresenius Framingham (#1109)

Framingham, Massachusetts, 01701, United States

Location

Fresenius Marlborough (#3448)

Marlborough, Massachusetts, 01752, United States

Location

Fresenius Medford Dialysis (#1246)

Medford, Massachusetts, 02155, United States

Location

Fresenius Quincy (#1610)

Quincy, Massachusetts, 02169, United States

Location

Fresenius Roxbury (#1630)

Roxbury, Massachusetts, 02119, United States

Location

DCI Dialysis Unit-Somerville

Somerville, Massachusetts, 02145, United States

Location

Fresenius QCDC-Weymouth (#9144)

Weymouth, Massachusetts, 02190, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Atherosclerosis; Inflammation; Hyperphosphatemia

Interventions

Sevelamer

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Polyamines; Amines; Organic Chemicals

Limitations and Caveats

Enrollment was much slower than anticipated due to logistical reasons, study at the direction of funding source terminated early and therefore none of the collected samples were analyzed.

Results Point of Contact

• Title: Kambiz Zandi-Nejad
• Organization: Brigham and Women's Hospital

kzandinejad@partners.org

617-732-5500

Study Officials

• Kambiz Zandi-Nejad, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Medicine

Study Record Dates

• First Submitted: November 9, 2010
• First Posted: November 10, 2010
• Study Start: June 10, 2011
• Primary Completion: April 8, 2016
• Study Completion: April 8, 2016
• Last Updated: July 31, 2017
• Results First Posted: June 21, 2017

Record last verified: 2017-07

Locations

US (10)