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

Primary Purpose

Chronic Kidney Disease

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sevelamer carbonate
Calcium acetate
Sponsored by
Albany College of Pharmacy and Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Kidney Disease focused on measuring Chronic kidney disease, Phosphate binder, Sevelamer carbonate, Calcium acetate, Vascular calcification, Endothelial Dysfunction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Albany Medical Center South Clinical Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sevelamer carbonate

Calcium acetate

Arm Description

1,600 mg (2 x 800 mg) three times daily with meals for a total of 12 weeks

1,334 mg (2 x 667 mg) three times daily with meals for a total of 12 weeks

Outcomes

Primary Outcome Measures

The primary outcome measure will be the change in FGF-23 concentrations

Secondary Outcome Measures

Change in vascular calcification biomarker levels
Change in endothelial dysfunction biomarker levels.
Change in inflammatory biomarker levels

Full Information

First Posted
January 6, 2011
Last Updated
January 13, 2016
Sponsor
Albany College of Pharmacy and Health Sciences
Collaborators
Albany Medical College, Genzyme, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT01277497
Brief Title
Effect of Phosphate Binders on Markers of Vascular Health in Chronic Kidney Disease Stages 3 and 4
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 Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Why Stopped
low enrollment
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
March 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albany College of Pharmacy and Health Sciences
Collaborators
Albany Medical College, Genzyme, a Sanofi Company

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Chronic kidney disease, Phosphate binder, Sevelamer carbonate, Calcium acetate, Vascular calcification, Endothelial Dysfunction

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sevelamer carbonate
Arm Type
Experimental
Arm Description
1,600 mg (2 x 800 mg) three times daily with meals for a total of 12 weeks
Arm Title
Calcium acetate
Arm Type
Active Comparator
Arm Description
1,334 mg (2 x 667 mg) three times daily with meals for a total of 12 weeks
Intervention Type
Drug
Intervention Name(s)
Sevelamer carbonate
Other Intervention Name(s)
Renvela
Intervention Description
Sevelamer carbonate 1,600 mg three times daily with meals
Intervention Type
Drug
Intervention Name(s)
Calcium acetate
Other Intervention Name(s)
Phoslo
Intervention Description
Calcium acetate 1,334 mg three times daily with meals for 12 weeks
Primary Outcome Measure Information:
Title
The primary outcome measure will be the change in FGF-23 concentrations
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in vascular calcification biomarker levels
Time Frame
12 weeks
Title
Change in endothelial dysfunction biomarker levels.
Time Frame
12 Weeks
Title
Change in inflammatory biomarker levels
Time Frame
12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darius L Mason, Pharm.D.
Organizational Affiliation
Albany College of Pharmacy and Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albany Medical Center South Clinical Campus
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34599865
Citation
Mason DL, Godugu K, Nnani D, Mousa SA. Effects of sevelamer carbonate versus calcium acetate on vascular calcification, inflammation, and endothelial dysfunction in chronic kidney disease. Clin Transl Sci. 2022 Feb;15(2):353-360. doi: 10.1111/cts.13151. Epub 2021 Oct 2.
Results Reference
derived

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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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