Clinical trial NCT00458289: Efficacy of Phosphate Binding in Healthy Volunteers: Chewed Versus Crushed Lanthanum Carbonate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hyperphosphatemia in Chronic Kidney Disease
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Shire
First posted: 2007-04-10
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Serum phosphorous concentration
timeFrame: Hourly from time=0-8 h after administration of meal and drug
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago, Dept of Pharmacy Practice
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Alan H Lau, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References: