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Sponsors and Collaborators: |
University of Illinois Shire Pharmaceutical Development |
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Information provided by: | University of Illinois |
ClinicalTrials.gov Identifier: | NCT00458289 |
Patients with end-stage renal disease (ESRD) commonly have high concentrations of phosphorous, a mineral, in the blood (hyperphosphatemia). This is a result of their inability to excrete phosphorous by the kidneys. This in turn may result in the development of a condition known as secondary hyperparathyroidism and renal osteodystrophy or bone disease. As such, these patients often receive medications known as phosphate binders such as calcium carbonate or acetate, sevelamer, aluminum hydroxide and lanthanum carbonate to manage and treat hyperphosphatemia.
Lanthanum carbonate is a newly available phosphate binding agent that is effective in the management of hyperphosphatemia and preventing secondary hyperparathyroidism. It works in the gastrointestinal tract by binding to the phosphorus in the diet. ESRD patients taking lanthanum carbonate are counseled to chew the tablets completely before swallowing, with or immediately after meals. However, patients who are intubated or receiving nutrition via feeding tubes are unable to chew the tablets. For these patients, medications are commonly crushed and administered via the tube. Moreover, some patients prefer to crush the tablets and mix it with food instead of chewing. To date, it is not known if crushing the lanthanum carbonate tablets prior to administration and taking it with food would be as effective as chewing them.
The purpose of this study is to compare the efficacy of phosphate binding between chewed and crushed lanthanum carbonate tablets.
Condition | Intervention | Phase |
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Hyperphosphatemia in Chronic Kidney Disease |
Drug: Lanthanum carbonate (chewed vs. crushed) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study |
Enrollment: | 12 |
Study Start Date: | January 2007 |
Study Completion Date: | August 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: No Intervention
P-containing meal alone
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2: Active Comparator
P-containing meal AND single 1 g oral dose of chewed lanthanum carbonate
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Drug: Lanthanum carbonate (chewed vs. crushed)
single 1 g oral dose of lanthanum carbonate either chewed or crushed into a fine powder
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3: Active Comparator
P-containing meal and single 1 g oral dose of lanthanum carbonate crushed into a fine powder
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Drug: Lanthanum carbonate (chewed vs. crushed)
single 1 g oral dose of lanthanum carbonate either chewed or crushed into a fine powder
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Illinois | |
University of Illinois at Chicago, Dept of Pharmacy Practice | |
Chicago, Illinois, United States, 60612 |
Principal Investigator: | Alan H Lau, Pharm.D. | University of Illinois |
Study ID Numbers: | 2006-0530 |
Study First Received: | April 6, 2007 |
Last Updated: | March 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00458289 History of Changes |
Health Authority: | United States: Institutional Review Board |
Renal Insufficiency Metabolic Diseases Urologic Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic |
Hyperphosphatemia Healthy Kidney Diseases Metabolic Disorder Kidney Failure |
Phosphorus Metabolism Disorders Renal Insufficiency Metabolic Diseases Urologic Diseases Renal Insufficiency, Chronic |
Kidney Failure, Chronic Hyperphosphatemia Kidney Diseases Kidney Failure |