Efficacy and Safety of Lanthanum Carbonate in Reducing Serum Phosphorus Levels in Subjects With Stage 3 and 4 Chronic Kidney Disease - Full Text View

Sponsor:	Shire Pharmaceutical Development
Information provided by:	Shire Pharmaceutical Development
ClinicalTrials.gov Identifier:	NCT00234702

Purpose

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.

Condition	Intervention	Phase
Kidney Diseases	Drug: Lanthanum carbonate Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Drug Information available for: Lanthanum Carbonate Phosphorus

U.S. FDA Resources

Further study details as provided by Shire Pharmaceutical Development:

Primary Outcome Measures:

Serum phosphorus levels at 8 weeks. [ Time Frame: 8 weeks ]

Secondary Outcome Measures:

PTH levels, calcium-phosphorus product. [ Time Frame: 8 weeks ]

Estimated Enrollment:	84
Study Start Date:	October 2005
Study Completion Date:	June 2007
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Lanthanum carbonate Lanthanum carbonate 750mg/day, T.I.D. for 2 weeks; titrated at the next 3 weekly visits in order to achieve target serum phosphorus levels, up to a maximum dose of 3000mg/day; 4-week maintenance period where subject receives the final titrated daily dose established during the titration period.
2: Placebo Comparator	Drug: Placebo Placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00234702

Locations

United States, California
Barnett Research & Communications Medical Corporation
Torrance, California, United States, 90503
VA Greater Los Angeles Health Care System
Los Angeles, California, United States, 90073
United States, Colorado
Western Nephrology & Metabolic Bone Disease, PC
Thornton, Colorado, United States, 80260
United States, Florida
Outcomes Research International, Inc.
Hudson, Florida, United States, 34667
United States, Minnesota
Twin Cities Clinical Research
Brooklyn Center, Minnesota, United States, 55430
United States, Missouri
St. Louis University/Nephrology
St. Louis, Missouri, United States, 63110
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Oregon
Northwest Renal Clinic
Portland, Oregon, United States, 97210
United States, Tennessee
Nephrology Associates
Nashville, Tennessee, United States
United States, Texas
Kidney Associates
Houston, Texas, United States, 77030

Sponsors and Collaborators

Shire Pharmaceutical Development

Investigators

Principal Investigator:

Dr. William F Finn

The University of North Carolina, Chapel Hill

More Information

Additional Information:

FDA Recall Information This link exits the ClinicalTrials.gov site

FDA Medical Product Safety Alerts This link exits the ClinicalTrials.gov site

FDA-approved Label This link exits the ClinicalTrials.gov site

Synopsis of Study Results This link exits the ClinicalTrials.gov site

Publications:

Sprague SM, Abboud H, Qiu P, Dauphin M, Zhang P, Finn W. Lanthanum carbonate reduces phosphorus burden in patients with CKD stages 3 and 4: a randomized trial. Clin J Am Soc Nephrol. 2009 Jan;4(1):178-85. Epub 2008 Dec 3.

Responsible Party:	Shire ( Timothy Whitaker, M.D. )
Study ID Numbers:	SPD405-206
Study First Received:	October 5, 2005
Last Updated:	January 20, 2009
ClinicalTrials.gov Identifier:	NCT00234702 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on November 25, 2009