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

NCT01277497 | Terminated Phase 4

• 1 other identifier: 2902
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Keywords

Chronic kidney disease; Phosphate binder; Sevelamer carbonate; Calcium acetate; Vascular calcification; Endothelial Dysfunction

Outcome Measures

Primary Outcomes (1)

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

  12 weeks

Secondary Outcomes (3)

• Change in vascular calcification biomarker levels

  12 weeks

• Change in endothelial dysfunction biomarker levels.

  12 Weeks

• Change in inflammatory biomarker levels

  12 Weeks

Study Arms (2)

Sevelamer carbonate

EXPERIMENTAL

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

Drug: Sevelamer carbonate

Calcium acetate

ACTIVE COMPARATOR

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

Drug: Calcium acetate

Interventions

Sevelamer carbonate DRUG

Sevelamer carbonate 1,600 mg three times daily with meals

Also known as: Renvela

Sevelamer carbonate

Calcium acetate DRUG

Calcium acetate 1,334 mg three times daily with meals for 12 weeks

Also known as: Phoslo

Calcium acetate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Albany College of Pharmacy and Health Sciences: lead
• Albany Medical College: collaborator
• Genzyme, a Sanofi Company: collaborator

Study Sites (1)

Albany Medical Center South Clinical Campus

Albany, New York, 12208, United States

Location

Related Publications (1)

• 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.

  PMID: 34599865 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Vascular Calcification

Interventions

Sevelamer; calcium acetate

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Calcinosis; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Polyamines; Amines; Organic Chemicals

Study Officials

• Darius L Mason, Pharm.D.

  Albany College of Pharmacy and Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: January 6, 2011
• First Posted: January 17, 2011
• Study Start: January 1, 2011
• Primary Completion: January 1, 2016
• Study Completion: March 1, 2016
• Last Updated: January 14, 2016

Record last verified: 2016-01

Locations

US (1)