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OpenTrials
Completed

NCT Number: NCT00150566

Efficacy and Safety of Lanthanum in Controlling Serum Phosphate Levels in Subjects With End Stage Renal Disease Who Require Treatment for High Levels of Phosphate in Their Blood

The purpose of this study is to test how well higher doses of lanthanum carbonate reduce the pre-dialysis level of serum phosphorus in subjects undergoing dialysis due to end stage renal disease.

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Key information

Conditions

Kidney Failure, Chronic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects with ESRD who currently require treatment for hyperphosphatemia
  • Women of childbearing potential must have a negative serum beta HCG pregnancy test and must agree to abstain from sexual activity or to use acceptable contraceptives from the time of informed consent throughout the study

Exclusion criteria

  • Treatment with compounds containing calcium, aluminum or magnesium for use as a phosphate binder
  • Hypocalcaemia
  • Treatment-naive to any phosphate binder with a serum phosphorus < 5.5 mg/dL
  • Any significant gastrointestinal surgery or gastrointestinal disorders

Treatment and study plan

Lanthanum carbonate

Drug

Primary outcomes

  1. Pre-dialysis serum phosphate levels after 4 and 8 weeks of treatment

    Time frame: 4 & 8 weeks

Secondary outcomes

  1. Tolerability

    Time frame: 8 weeks

  2. Quality of Life

    Time frame: 8 weeks

  3. Subject/physician satisfaction and preference questionnaires

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study title

A Phase IIIb, Multi-center, Two-Cohort, Randomized Study, With an Open-Label Run-In and a Long-Term Extensions Phase, Assessing an Extended Dose Range of Lanthanum Carbonate in End Stage Renal Disease Subjects Receiving Hemodialysis

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Sep 8, 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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