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Completed

NCT Number: NCT00234702

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

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.

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Key information

Conditions

Kidney Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

VA Greater Los Angeles Health Care System, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lanthanum carbonate

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.

Other names: FOSRENOL

Placebo

Drug

Placebo

Primary outcomes

  1. Serum phosphorus levels at 8 weeks.

    Time frame: 8 weeks

Secondary outcomes

  1. PTH levels, calcium-phosphorus product.

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Oct 7, 2005
Registry last updated
Jun 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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