Status:
COMPLETED
Efficacy of Phosphate Binding in Healthy Volunteers: Chewed Versus Crushed Lanthanum Carbonate
Lead Sponsor:
University of Illinois at Chicago
Collaborating Sponsors:
Shire
Conditions:
Hyperphosphatemia in Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 b...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00458289
Start Date
January 1 2007
End Date
August 1 2008
Last Update
December 20 2019
Active Locations (1)
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1
University of Illinois at Chicago, Dept of Pharmacy Practice
Chicago, Illinois, United States, 60612