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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00234702

Enrollment

Registered

2005-10-07

Start date

2006-01-11

Completion date

2007-06-01

Last updated

2021-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Diseases

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.

Interventions

DRUGLanthanum 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.

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Serum phosphorus levels at 8 weeks.	8 weeks

Secondary

Measure	Time frame
PTH levels, calcium-phosphorus product.	8 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026