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

NCT ID: NCT00234702

Last Updated: 2021-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-11

Study Completion Date

2007-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Kidney Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

Lanthanum carbonate

Intervention Type DRUG

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.

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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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.

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Other Intervention Names

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FOSRENOL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shire

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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VA Greater Los Angeles Health Care System

Los Angeles, California, United States

Site Status

Barnett Research & Communications Medical Corporation

Torrance, California, United States

Site Status

Western Nephrology & Metabolic Bone Disease, PC

Thornton, Colorado, United States

Site Status

Outcomes Research International, Inc.

Hudson, Florida, United States

Site Status

Twin Cities Clinical Research

Brooklyn Center, Minnesota, United States

Site Status

St. Louis University/Nephrology

St Louis, Missouri, United States

Site Status

University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

Northwest Renal Clinic

Portland, Oregon, United States

Site Status

Nephrology Associates

Nashville, Tennessee, United States

Site Status

Kidney Associates

Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 19056618 (View on PubMed)

Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.

Reference Type DERIVED
PMID: 40576086 (View on PubMed)

Related Links

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Other Identifiers

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SPD405-206

Identifier Type: -

Identifier Source: org_study_id

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