Effect of Phosphate Binders on Markers of Vascular Health in Chronic Kidney Disease Stages 3 and 4
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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 |
- The primary outcome measure will be the change in FGF-23 concentrations [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- 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: | April 2013 |
| Estimated Primary Completion Date: | January 2013 (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 |
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| Contact: Darius L Mason, Pharm.D. | (518) 694-7188 | darius.mason@acphs.edu |
| Contact: Magdalene M Assimon, Pharm.D. | (518) 694-7289 | magdalene.assimon@acphs.edu |
| United States, New York | |
| Albany Medical Center South Clinical Campus | Recruiting |
| Albany, New York, United States, 12208 | |
| 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: | December 29, 2011 |
| 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:
|
Kidney Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic Urologic Diseases Renal Insufficiency Calcium, Dietary Sevelamer |
Calcium acetate Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Chelating Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 17, 2013