Efficacy and Safety of Lanthanum Carbonate in Reducing Serum Phosphorus Levels in Subjects With Stage 3 and 4 Chronic Kidney Disease
Information source: Shire Pharmaceutical Development
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Kidney Diseases
Intervention: Lanthanum carbonate (Drug); Placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Shire Pharmaceutical Development Official(s) and/or principal investigator(s):
Dr. William F Finn, Principal Investigator, Affiliation: University of North Carolina
Summary
Chronic kidney disease (CKD) can result in a loss of ability to filter and excrete phosphate.
The body's attempt to adjust to an increased level of phosphate in the blood can result in
elevated levels of hormones and minerals resulting in serious clinical consequences. This
study is being conducted to evaluate the safety and efficacy of lanthanum carbonate in
lowering high levels of phosphorus in the blood in subjects with CKD Stages 3 and 4 compared
to placebo.
Clinical Details
Official title: A Phase II, Double-Blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of Lanthanum Carbonate for the Reduction of Serum Phosphorus in Subjects With Stage 3 and 4 Chronic Kidney Disease Who Have Elevated Serum Phosphorus Levels
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Serum phosphorus levels at 8 weeks.
Secondary outcome: PTH levels, calcium-phosphorus product.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Under a physician's care for CKD for > 2 months and are not expected to begin dialysis
for 4 months
- Screening estimated GFR of 15-59 mL/1. 73 m2
- Serum phosphorus >= 4. 7 mg/d following washout
Exclusion Criteria:
- Requiring treatment with cinacalcet HCI or compounds containing phosphate, aluminum,
calcium or magnesium
- Rapidly progressing glomerulonephritis
- Cirrhosis or other clinically significant liver diseases
- Past or present uncontrolled peptic ulcer, Crohn's disease, malignancy or recent GI
bleed
Locations and Contacts
Barnett Research & Communications Medical Corporation, Torrance, California 90503, United States
VA Greater Los Angeles Health Care System, Los Angeles, California 90073, United States
Western Nephrology & Metabolic Bone Disease, PC, Thornton, Colorado 80260, United States
Outcomes Research International, Inc., Hudson, Florida 34667, United States
Twin Cities Clinical Research, Brooklyn Center, Minnesota 55430, United States
St. Louis University/Nephrology, St. Louis, Missouri 63110, United States
University of North Carolina, Chapel Hill, North Carolina 27599, United States
Northwest Renal Clinic, Portland, Oregon 97210, United States
Nephrology Associates, Nashville, Tennessee, United States
Kidney Associates, Houston, Texas 77030, United States
Additional Information
Starting date: October 2005
Ending date: June 2007
Last updated: May 14, 2008
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