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Completed

NCT Number: NCT00769496

BAY 77-1931 Long-term Extension From Phase II Study

A long-term study of BAY77-1931 (lanthanum carbonate) for hyperphosphatemia in patients undergoing hemodialysis

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Key information

Conditions

Hyperphosphatemia Metabolic Diseases Nutritional and Metabolic Diseases Phosphorus Metabolism Disorders

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Toyohashi, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Undergoing hemodialysis 3 times per week for chronic renal failure for the previous 3 consecutive months at least

Exclusion criteria

  • Pre-dialysis serum phosphate levels of 10.0mg/dL during the washout period

Treatment and study plan

BAY 77-1931

Drug

Lanthanum Carbonate (BAY 77-1931)

Primary outcomes

  1. Changes in pre-dialysis serum phosphate levels

    Time frame: Every 4 weeks

Secondary outcomes

  1. Achievement rate of the target predialysis serum phosphate levels (3.5 mg/dL and 5.5 mg/dL)

    Time frame: Every 4 weeks

  2. Changes in corrected serum calcium level

    Time frame: Every 4 weeks

  3. Changes in the product of serum calcium and phosphate

    Time frame: Every 4 weeks

  4. Changes in serum intact-PHT levels

    Time frame: Every 4 weeks

  5. Changes in bone metabolism markers

    Time frame: Every 4 weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Long-term, Open Label Extension, Non-controlled Study to Assess the Efficacy and Safety of BAY 77-1931 (Lanthanum Carbonate) for Hyperphosphatemia in Patients Undergoing Hemodialysis

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Oct 9, 2008
Registry last updated
Jan 23, 2013

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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