Hyperphosphatemia in Chronic Kidney Disease Clinical Trial
| NCT number | NCT00458289 |
| Other study ID # | 2006-0530 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 1 |
| First received | |
| Last updated | |
| Start date | January 2007 |
| Est. completion date | August 2008 |
| Verified date | December 2019 |
| Source | University of Illinois at Chicago |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 12 |
| Est. completion date | August 2008 |
| Est. primary completion date | June 2008 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Illinois at Chicago, Dept of Pharmacy Practice | Chicago | Illinois |
| Lead Sponsor | Collaborator |
|---|---|
| University of Illinois at Chicago | Shire |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Serum phosphorous concentration | Hourly from time=0-8 h after administration of meal and drug |