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NCT Number: NCT01514851

Phase III Double-blind Comparative Study of BAY77-1931 (Lanthanum Carbonate) With Calcium Carbonate

To assess the effect on reduction of serum phosphate and the safety of BAY77-1931 (Lanthanum Carbonate) in patients with hyperphosphatemia undergoing hemodialysis in a randomized, double-blind, parallel group study in comparison with Calcium carbonate.

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Key information

Conditions

Hyperphosphatemia Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Phosphorus Metabolism Disorders Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Toyohashi, Aichi-ken, 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

  • Pre-dialysis serum phosphate levels: ≧5.6 mg/dL and <11.0 mg/dL at 1 week after the initiation of the washout period.
  • Out-patient
  • Undergoing hemodialysis three times per week for at least previous 3 consecutive months

Exclusion criteria

  • Pre-dialysis serum phosphate levels of ≧10.0 mg/dL at the start of the washout period or ≧11.0 mg/dL at 1 week after
  • Corrected serum calcium level of <7.0 mg/dL or ≧11.0 mg/dL at the start of the washout period and/or 1 week after
  • Serum intact PTH (Parathyroid) of ≧1000 pg/mL at the start of the washout period
  • Pregnant woman, or lactating mother
  • Significant gastrointestinal disorders including known acute peptic ulcer
  • Liver dysfunction
  • History of cardiovascular or cerebrovascular diseases
  • Requiring treatment for hypothyroidism

Treatment and study plan

Lanthanum Carbonate (BAY77-1931)

Drug

Calcium Carbonate

Drug

Primary outcomes

  1. Change from baseline in pre-dialysis serum phosphate levels (PSPL) at the end of the double-blind period

    Time frame: baseline to week 8

  2. Presence/absence of incidence of hypercalcemia up to 8 weeks

    Time frame: up to 8 weeks

Secondary outcomes

  1. Number of participants achieving target PSPL and time to achievement

    Time frame: up to 8 weeks

  2. Serum calcium x phosphate product at the end of the double-blind treatment period

    Time frame: Week 8

  3. Serum intact-PTH (Parathyroid) levels

    Time frame: Week 8

  4. Serum calcium level corrected by serum albumin level at the end of the double-blind treatment period

    Time frame: Week 8

  5. Number of participants achieving the target serum calcium levels

    Time frame: Week 8

  6. Safety variables will be summarized using descriptive statistics based on adverse events collection

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Phase III Double-blind Comparative Study of BAY 77 1931 (Lanthanum Carbonate) With a Calcium Carbonate in Patients With Hyperphosphatemia Undergoing Hemodialysis

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Jan 23, 2012
Registry last updated
Jun 8, 2012

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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