Status:

COMPLETED

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

Lead Sponsor:

Shire

Conditions:

Kidney Diseases

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 11 2006

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2007

Estimated Enrollment :

84 Patients enrolled

Trial Details

Trial ID

NCT00234702

Start Date

January 11 2006

End Date

June 1 2007

Last Update

June 8 2021

Active Locations (10)

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Page 1 of 3 (10 locations)

1

VA Greater Los Angeles Health Care System

Los Angeles, California, United States, 90073

2

Barnett Research & Communications Medical Corporation

Torrance, California, United States, 90503

3

Western Nephrology & Metabolic Bone Disease, PC

Thornton, Colorado, United States, 80260

4

Outcomes Research International, Inc.

Hudson, Florida, United States, 34667