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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: | NCT00660530 |
Patients with end-stage renal disease (ESRD) commonly develop hyperphosphatemia due to the loss of excretory function of the kidney. This in turn may lead to the development of secondary hyperparathyroidism (SHPT) and renal osteodystrophy. Lanthanum carbonate, a phosphate binding agent, works by releasing lanthanum ions in the gastrointestinal tract to bind dietary phosphate and is effective in the management of hyperphosphatemia and in preventing secondary hyperparathyroidism.
Patients taking lanthanum carbonate as part of their phosphate binder therapy are counseled to chew the tablets completely before swallowing, with or immediately after meals. However, ESRD patients who are intubated or are receiving enteral tube feedings are unable to chew the lanthanum carbonate tablets. For such patients, medications are commonly crushed and administered through a gastrostomy tube (G-tube). Some patients may also prefer to crush the lanthanum carbonate 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 will be as efficacious as chewing it.
The objective of this study is to compare the efficacy of phosphate binding between chewed and crushed lanthanum carbonate in patients undergoing hemodialysis.
Condition | Intervention | Phase |
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Hyperphosphatemia Kidney Disease |
Drug: Lanthanum carbonate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study |
Official Title: | An Evaluation of Chewed vs. Crushed Lanthanum Carbonate in the Efficacy of Phosphate Binding in Hemodialysis Patients |
Estimated Enrollment: | 20 |
Study Start Date: | January 2008 |
Arms | Assigned Interventions |
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1: Active Comparator
Lanthanum 1 g to be chewed, three times daily with meals
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Drug: Lanthanum carbonate
Lanthanum carbonate 1 g to be chewed, three times daily with meals
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2: Experimental
Lanthanum carbonate 1 g crushed into a fine powder, three times daily with meal
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Drug: Lanthanum carbonate
Lanthanum carbonate 1 g crushed into a fine powder, three times daily with meal
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Priscilla P How, Pharm.D., BCPS | 312-413-3720 | phow1@uic.edu |
Contact: Alan H Lau, Pharm.D. | 312-996-0894 | alanlau@uic.edu |
United States, Illinois | |
University of Illinois at Chicago | Recruiting |
Chicago, Illinois, United States, 60612 | |
Contact: Priscilla P How, Pharm.D. 312-413-3720 phow1@uic.edu | |
Contact: Alan H Lau, Pharm.D. 312-996-0894 alanlau@uic.edu |
Principal Investigator: | Alan H Lau, Pharm.D. | Univsersity of Illinois at Chicago |
Responsible Party: | University of Illinois at Chicago ( Alan Lau, Pharm.D. ) |
Study ID Numbers: | 2006-0588 |
Study First Received: | April 9, 2008 |
Last Updated: | April 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00660530 |
Health Authority: | United States: Institutional Review Board |
stage 5 chronic hemodialysis |
Metabolic Diseases Urologic Diseases Hyperphosphatemia Kidney Diseases Metabolic disorder |
Phosphorus Metabolism Disorders |