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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01238588
Other study ID # 2010P002213
Secondary ID
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


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
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