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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00234702
Recruitment Status : Completed
First Posted : October 7, 2005
Last Update Posted : April 30, 2010
Information provided by:

Brief 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.

Condition or disease Intervention/treatment Phase
Kidney Diseases Drug: Lanthanum carbonate Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : October 2005
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: 1 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.
Other Name: FOSRENOL

Placebo Comparator: 2 Drug: Placebo

Primary Outcome Measures :
  1. Serum phosphorus levels at 8 weeks. [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. PTH levels, calcium-phosphorus product. [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00234702

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United States, California
VA Greater Los Angeles Health Care System
Los Angeles, California, United States, 90073
Barnett Research & Communications Medical Corporation
Torrance, California, United States, 90503
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
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Principal Investigator: Dr. William F Finn University of North Carolina, Chapel Hill

Additional Information:
Publications of Results:
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Responsible Party: Timothy Whitaker, M.D., Shire Identifier: NCT00234702    
Other Study ID Numbers: SPD405-206
First Posted: October 7, 2005    Key Record Dates
Last Update Posted: April 30, 2010
Last Verified: April 2010
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency