Clinical trial NCT00234702: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kidney Diseases
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2005-10-07
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Serum phosphorus levels at 8 weeks.
timeFrame: 8 weeks
Secondary outcomes:
measure: PTH levels, calcium-phosphorus product.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: VA Greater Los Angeles Health Care System
state: California
city: Torrance
country: United States
facility: Barnett Research & Communications Medical Corporation
state: California
city: Thornton
country: United States
facility: Western Nephrology & Metabolic Bone Disease, PC
state: Colorado
city: Hudson
country: United States
facility: Outcomes Research International, Inc.
state: Florida
city: Brooklyn Center
country: United States
facility: Twin Cities Clinical Research
state: Minnesota
city: Saint Louis
country: United States
facility: St. Louis University/Nephrology
state: Missouri
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Portland
country: United States
facility: Northwest Renal Clinic
state: Oregon
city: Nashville
country: United States
facility: Nephrology Associates
state: Tennessee
city: Houston
country: United States
facility: Kidney Associates
state: Texas
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
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.