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OpenTrials
Completed

NCT Number: NCT00767637

Long-term Treatment on BAY77-1931 (Lanthanum Carbonate) to Measure Lanthanum Concentrations in Bone

To measure lanthanum concentrations in bone in patients with hyperphosphatemia receiving dialysis

Completed

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Key information

Conditions

Hyperphosphatemia Dialysis Metabolic Diseases Nutritional and Metabolic Diseases Phosphorus Metabolism Disorders

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Isesaki, Gunma, Japan

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing dialysis or plan to start dialysis before the initial administration of the study medication

Exclusion criteria

  • Patients with severe hypocalcemia (adjusted serum calcium level of <7.5 mg/dL)

Treatment and study plan

Lanthanum Carbonate (BAY77-1931)

Drug

BAY77-1931 750mg, in the morning, day and evening

Primary outcomes

  1. Changes in pre-dialysis serum phosphate levels

    Time frame: Every 2 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 2 weeks

  2. Changes in corrected serum calcium level

    Time frame: Every 2 weeks

  3. Changes in the product of serum calcium and phosphate

    Time frame: Every 2 weeks

  4. Changes in serum intact-PHT levels

    Time frame: Every 2 weeks

  5. Changes in bone metabolism markers

    Time frame: Every 2 weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Open Label, Non-controlled Long-term Treatment on BAY77-1931 (Lanthanum Carbonate) to Measure Lanthanum Concentrations in Bone in Patients With Hyperphosphatemia Receiving Dialysis

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Oct 7, 2008
Registry last updated
Jun 20, 2014

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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