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
  Purpose

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 Intervention Phase
Chronic Kidney Disease
Drug: Sevelamer carbonate
Drug: Calcium acetate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Albany College of Pharmacy and Health Sciences:

Primary Outcome Measures:
  • The primary outcome measure will be the change in FGF-23 concentrations [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: January 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01277497

Contacts
Contact: Darius L Mason, Pharm.D. (518) 694-7188 darius.mason@acphs.edu
Contact: Daryl Nnani, BS (518) 694-7449 daryl.nnani@acphs.edu

Locations
United States, New York
Albany Medical Center South Clinical Campus Recruiting
Albany, New York, United States, 12208
Sponsors and Collaborators
Albany College of Pharmacy and Health Sciences
Albany Medical College
Genzyme, a Sanofi Company
Investigators
Principal Investigator: Darius L Mason, Pharm.D. Albany College of Pharmacy and Health Sciences
  More Information

No publications provided

Responsible Party: Darius Mason, PI, Albany College of Pharmacy and Health Sciences
ClinicalTrials.gov Identifier: NCT01277497     History of Changes
Other Study ID Numbers: 2902
Study First Received: January 6, 2011
Last Updated: November 21, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Calcium, Dietary
Calcium acetate
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
Sevelamer
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014