Efficacy of Phosphate Binding in Healthy Volunteers: Chewed Versus Crushed Lanthanum Carbonate
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Purpose
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 |
|---|---|---|
|
Hyperphosphatemia in Chronic Kidney Disease |
Drug: Lanthanum carbonate (chewed vs. crushed) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
- Serum phosphorous concentration [ Time Frame: Hourly from time=0-8 h after administration of meal and drug ] [ Designated as safety issue: No ]
| 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 |
|---|---|
|
No Intervention: 1
P-containing meal alone
|
|
|
Active Comparator: 2
P-containing meal AND single 1 g oral dose of chewed lanthanum carbonate
|
Drug: Lanthanum carbonate (chewed vs. crushed)
single 1 g oral dose of lanthanum carbonate either chewed or crushed into a fine powder
|
|
Active Comparator: 3
P-containing meal and single 1 g oral dose of lanthanum carbonate crushed into a fine powder
|
Drug: Lanthanum carbonate (chewed vs. crushed)
single 1 g oral dose of lanthanum carbonate either chewed or crushed into a fine powder
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Men and women at least 18 years of age
- No clinically significant abnormal findings on clinical laboratory evaluation and medical history
- Within 15% of ideal body weight for height and build according to the Metropolitan Life tables5
- Women of child-bearing potential (premenopausal and not surgically sterilized) who have a negative pregnancy test
- Women who are sexually active must be using effective means of contraception
Exclusion Criteria:
- History of dysphagia or swallowing disorders
- Clinically significant illness within 3 months of study enrollment
- Concomitant use of medication that might interact with lanthanum carbonate
- Pregnant or intends to become pregnant within 30 days of completing the study
- Breast feeding
- Alcohol or controlled substance abuse
- Use of an investigational agent within 30 days of study entry
Contacts and Locations| 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 |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00458289 History of Changes |
| Other Study ID Numbers: | 2006-0530 |
| Study First Received: | April 6, 2007 |
| Last Updated: | March 11, 2009 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Kidney Diseases Hyperphosphatemia Renal Insufficiency, Chronic Kidney Failure, Chronic |
Urologic Diseases Phosphorus Metabolism Disorders Metabolic Diseases Renal Insufficiency |
ClinicalTrials.gov processed this record on May 16, 2013