Efficacy and Safety of Lanthanum Carbonate in Reducing Serum Phosphorus Levels in Subjects With Stage 3 and 4 Chronic Kidney Disease
Primary Purpose
Kidney Diseases
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lanthanum carbonate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Diseases
Eligibility 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
Sites / Locations
- VA Greater Los Angeles Health Care System
- Barnett Research & Communications Medical Corporation
- Western Nephrology & Metabolic Bone Disease, PC
- Outcomes Research International, Inc.
- Twin Cities Clinical Research
- St. Louis University/Nephrology
- University of North Carolina
- Northwest Renal Clinic
- Nephrology Associates
- Kidney Associates
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Serum phosphorus levels at 8 weeks.
Secondary Outcome Measures
PTH levels, calcium-phosphorus product.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00234702
Brief Title
Efficacy and Safety of Lanthanum Carbonate in Reducing Serum Phosphorus Levels in Subjects With Stage 3 and 4 Chronic Kidney Disease
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 Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 11, 2006 (Actual)
Primary Completion Date
June 1, 2007 (Actual)
Study Completion Date
June 1, 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Lanthanum carbonate
Other Intervention Name(s)
FOSRENOL
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Serum phosphorus levels at 8 weeks.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
PTH levels, calcium-phosphorus product.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
VA Greater Los Angeles Health Care System
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
Barnett Research & Communications Medical Corporation
City
Torrance
State/Province
California
ZIP/Postal Code
90503
Country
United States
Facility Name
Western Nephrology & Metabolic Bone Disease, PC
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80260
Country
United States
Facility Name
Outcomes Research International, Inc.
City
Hudson
State/Province
Florida
ZIP/Postal Code
34667
Country
United States
Facility Name
Twin Cities Clinical Research
City
Brooklyn Center
State/Province
Minnesota
ZIP/Postal Code
55430
Country
United States
Facility Name
St. Louis University/Nephrology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Northwest Renal Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Nephrology Associates
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Kidney Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19056618
Citation
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. doi: 10.2215/CJN.02830608. Epub 2008 Dec 3.
Results Reference
result
Links:
URL
http://www.fda.gov/opacom/7alerts.html
Description
FDA Recall Information
Learn more about this trial
Efficacy and Safety of Lanthanum Carbonate in Reducing Serum Phosphorus Levels in Subjects With Stage 3 and 4 Chronic Kidney Disease
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