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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

This study has been completed.
Sponsor:
Information provided by:
Shire Development LLC
ClinicalTrials.gov Identifier:
NCT00234702
First received: October 5, 2005
Last updated: April 29, 2010
Last verified: April 2010
History of Changes

October 5, 2005
April 29, 2010
October 2005
June 2007   (final data collection date for primary outcome measure)
Serum phosphorus levels at 8 weeks. [ Time Frame: 8 weeks ]
Serum phosphorus levels at 8 weeks.
Complete list of historical versions of study NCT00234702 on ClinicalTrials.gov Archive Site
PTH levels, calcium-phosphorus product. [ Time Frame: 8 weeks ]
PTH levels, calcium-phosphorus product.
Not Provided
Not Provided
 
Efficacy and Safety of Lanthanum Carbonate in Reducing Serum Phosphorus Levels in Subjects With Stage 3 and 4 Chronic Kidney Disease
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

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Kidney Diseases
  • 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
  • Drug: Placebo
    Placebo
  • Experimental: 1
    Intervention: Drug: Lanthanum carbonate
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
84
June 2007
June 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00234702
SPD405-206
Not Provided
Timothy Whitaker, M.D., Shire
Shire Development LLC
Not Provided
Principal Investigator: Dr. William F Finn University of North Carolina, Chapel Hill
Shire Development LLC
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP