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Effect of Phosphate Binders on Markers of Vascular Health in Chronic Kidney Disease Stages 3 and 4

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ClinicalTrials.gov Identifier: NCT01277497
Recruitment Status : Terminated (low enrollment)
First Posted : January 17, 2011
Last Update Posted : January 14, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: Sevelamer carbonate Drug: Calcium acetate Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : January 2011
Primary Completion Date : January 2016
Estimated Study Completion Date : March 2016

Arms and Interventions

Arm Intervention/treatment
Experimental: Sevelamer carbonate
1,600 mg (2 x 800 mg) three times daily with meals for a total of 12 weeks
Drug: Sevelamer carbonate
Sevelamer carbonate 1,600 mg three times daily with meals
Other Name: Renvela
Active Comparator: Calcium acetate
1,334 mg (2 x 667 mg) three times daily with meals for a total of 12 weeks
Drug: Calcium acetate
Calcium acetate 1,334 mg three times daily with meals for 12 weeks
Other Name: Phoslo

Outcome Measures

Primary Outcome Measures :
  1. The primary outcome measure will be the change in FGF-23 concentrations [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Change in vascular calcification biomarker levels [ Time Frame: 12 weeks ]
  2. Change in endothelial dysfunction biomarker levels. [ Time Frame: 12 Weeks ]
  3. Change in inflammatory biomarker levels [ Time Frame: 12 Weeks ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01277497

United States, New York
Albany Medical Center South Clinical Campus
Albany, New York, United States, 12208
Sponsors and Collaborators
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
More Information

Responsible Party: Darius Mason, PI, Albany College of Pharmacy and Health Sciences
ClinicalTrials.gov Identifier: NCT01277497     History of Changes
Other Study ID Numbers: 2902
First Posted: January 17, 2011    Key Record Dates
Last Update Posted: January 14, 2016
Last Verified: January 2016

Keywords provided by Darius Mason, Albany College of Pharmacy and Health Sciences:
Chronic kidney disease
Phosphate binder
Sevelamer carbonate
Calcium acetate
Vascular calcification
Endothelial Dysfunction

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Vascular Calcification
Urologic Diseases
Renal Insufficiency
Calcium Metabolism Disorders
Metabolic Diseases
Calcium, Dietary
Calcium acetate
Bone Density Conservation Agents
Physiological Effects of Drugs
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action