NCT00234702

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 7, 2005

Completed
3 months until next milestone

Study Start

First participant enrolled

January 11, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

June 8, 2021

Status Verified

June 1, 2021

Enrollment Period

1.4 years

First QC Date

October 5, 2005

Last Update Submit

June 4, 2021

Conditions

Kidney Diseases

Outcome Measures

Primary Outcomes (1)

  • Serum phosphorus levels at 8 weeks.

    8 weeks

Secondary Outcomes (1)

  • PTH levels, calcium-phosphorus product.

    8 weeks

Study Arms (2)

1

EXPERIMENTAL
Drug: Lanthanum carbonate

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Lanthanum carbonateDRUG

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.

Also known as: FOSRENOL
1
PlaceboDRUG

Placebo

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

VA Greater Los Angeles Health Care System

Los Angeles, California, 90073, United States

Location

Barnett Research & Communications Medical Corporation

Torrance, California, 90503, United States

Location

Western Nephrology & Metabolic Bone Disease, PC

Thornton, Colorado, 80260, United States

Location

Outcomes Research International, Inc.

Hudson, Florida, 34667, United States

Location

Twin Cities Clinical Research

Brooklyn Center, Minnesota, 55430, United States

Location

St. Louis University/Nephrology

St Louis, Missouri, 63110, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Northwest Renal Clinic

Portland, Oregon, 97210, United States

Location

Nephrology Associates

Nashville, Tennessee, United States

Location

Kidney Associates

Houston, Texas, 77030, United States

Location

Related Publications (2)

  • 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.

    PMID: 19056618RESULT

  • 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.

    PMID: 40576086DERIVED

Related Links

MeSH Terms

Conditions

Kidney Diseases

Interventions

lanthanum carbonate

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Study Director

    Takeda

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2005

First Posted

October 7, 2005

Study Start

January 11, 2006

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

June 8, 2021

Record last verified: 2021-06

Locations

US(10)