Trial record 1 of 1 for:    NCT01277497
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Effect of Phosphate Binders on Markers of Vascular Health in Chronic Kidney Disease Stages 3 and 4

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Albany College of Pharmacy and Health Sciences
Sponsor:
Collaborators:
Albany Medical College
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Darius Mason, Albany College of Pharmacy and Health Sciences
ClinicalTrials.gov Identifier:
NCT01277497
First received: January 6, 2011
Last updated: November 21, 2013
Last verified: November 2013

January 6, 2011
November 21, 2013
January 2011
December 2014   (final data collection date for primary outcome measure)
The primary outcome measure will be the change in FGF-23 concentrations [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01277497 on ClinicalTrials.gov Archive Site
  • Change in vascular calcification biomarker levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in endothelial dysfunction biomarker levels. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Change in inflammatory biomarker levels [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Phosphate Binders on Markers of Vascular Health in Chronic Kidney Disease Stages 3 and 4
A Randomized Study on the Effects of Sevelamer Carbonate Versus Calcium Acetate on Biomarkers of Vascular Calcification, Inflammation, and Endothelial Dysfunction in Chronic Kidney Disease Stages 3 and 4

Chronic kidney disease (CKD) patients often have high levels of a substance called fibroblast growth factor-23 (FGF-23), a phosphorus excreting hormone, which has been related to heart disease. As kidney function declines, less phosphorus is removed by the kidneys and as a result phosphorus accumulates in the blood. In response to elevated phosphorus levels, more FGF-23 is released to help facilitate the excretion of extra phosphorus into the urine. In addition to effects on FGF-23, increased phosphorus levels can lead to calcification (hardening) of the blood vessels in the CKD population.

Phosphate binding medicines are used in CKD patients to lower the amount of phosphorus absorbed by the stomach and intestines after eating meals and snacks. In patients with CKD, studies have shown that phosphate binders can lower FGF-23 levels in the blood. Lowering FGF-23 levels in CKD patients may also lower substances in the blood that cause calcification of blood vessels in the CKD population.

This study is being done to determine if using phosphate binders, either sevelamer carbonate or calcium acetate, in the earlier stages kidney disease (before dialysis) can decrease FGF-23 and biomarkers (substances in the blood) associated with hardening of the blood vessels and heart disease.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Chronic Kidney Disease
  • Drug: Sevelamer carbonate
    Sevelamer carbonate 1,600 mg three times daily with meals
    Other Name: Renvela
  • Drug: Calcium acetate
    Calcium acetate 1,334 mg three times daily with meals for 12 weeks
    Other Name: Phoslo
  • Experimental: Sevelamer carbonate
    1,600 mg (2 x 800 mg) three times daily with meals for a total of 12 weeks
    Intervention: Drug: Sevelamer carbonate
  • Active Comparator: Calcium acetate
    1,334 mg (2 x 667 mg) three times daily with meals for a total of 12 weeks
    Intervention: Drug: Calcium acetate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males or females ≥ 18 years of age at start of screening
  • CKD stage 3 or 4 defined by an eGFR 15 - 60 mL/min/1.73m2
  • Not expected to start dialysis for 8 months
  • Serum intact PTH < 500 pg/mL during screening period
  • On a stable ACE inhibitor/ARB regimen for 30 days prior to screening

Exclusion Criteria:

  • History of any of the following diseases: congestive heart failure, MI within the last 6 months, cerebrovascular accident, significant valvular disease, malignancy
  • Currently receiving erythropoiesis stimulating agent or IV iron therapy
  • History of inflammatory/autoimmune disease
  • History of polycystic kidney disease
  • HIV positive or AIDS
  • Pregnant or breastfeeding
  • Receiving activated Vitamin D analogs, nutritional vitamin D agents > 2,000 IU/day, or calcimimetics with in the last 3 months
  • Significant GI disorder
  • Proteinuria >3.5 g/24 hours
Both
18 Years and older
No
Contact: Darius L Mason, Pharm.D. (518) 694-7188 darius.mason@acphs.edu
Contact: Daryl Nnani, BS (518) 694-7449 daryl.nnani@acphs.edu
United States
 
NCT01277497
2902
No
Darius Mason, Albany College of Pharmacy and Health Sciences
Albany College of Pharmacy and Health Sciences
  • Albany Medical College
  • Genzyme, a Sanofi Company
Principal Investigator: Darius L Mason, Pharm.D. Albany College of Pharmacy and Health Sciences
Albany College of Pharmacy and Health Sciences
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP