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
ClinicalTrials.gov Identifier:
NCT00234702
First received: October 5, 2005
Last updated: April 29, 2010
Last verified: April 2010
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Shire:

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
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
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
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, see Learn About Clinical Studies.

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

Locations
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
Shire
Investigators
Principal Investigator: Dr. William F Finn University of North Carolina, Chapel Hill
  More Information

Additional Information:
Publications:
Responsible Party: Timothy Whitaker, M.D., Shire
ClinicalTrials.gov Identifier: NCT00234702     History of Changes
Other Study ID Numbers: SPD405-206
Study First Received: October 5, 2005
Last Updated: April 29, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on September 11, 2014