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OpenTrials
Completed

NCT Number: NCT01518387

Open Study of BAY77-1931 (Lanthanum Carbonate) in Continuous Ambulatory Peritoneal Dialysis Patients

The purpose of this study is to assess the effect on reduction of serum phosphate and the safety of BAY77-1931 (lanthanum carbonate) in patients with hyperphosphatemia undergoing continuous ambulatory peritoneal dialysis.

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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–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fukuoka, 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

  • Serum phosphate levels: >5.0 mg/dL and <11.0 mg/dL 2 weeks after the initiation of the washout period
  • Out-patient
  • Undergoing CAPD for at least previous 3 consecutive months

Exclusion criteria

  • Who may not enable to continue CAPD
  • Serum phosphate levels of >=10.0 mg/dL at the start of the washout period or >=11.0 mg/dL 2 week after
  • Corrected serum calcium level of <7.0 mg/dL at the start of the washout period or >=11.0 mg/dL 2 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

Treatment and study plan

Lanthanum Carbonate (BAY77-1931)

Drug

Primary outcomes

  1. Change from baseline in serum phosphate levels at the end of the treatment period

    Time frame: Baseline to Week 8

Secondary outcomes

  1. Number of participants achieving the target PSPL (Pre-dialysis serum phosphate level) and time to achievement

    Time frame: Week 8

  2. Serum calcium level corrected by serum albumin level at the end of the treatment period

    Time frame: Week 8

  3. Serum calcium x phosphate product at the end of the treatment period

    Time frame: Week 8

  4. Serum intact-PTH (Parathyroid) levels at the end of the treatment period

    Time frame: Week 8

  5. 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 Open Study of BAY 77 1931 (Lanthanum Carbonate) in Patients With Hyperphosphatemia Undergoing Continuous Ambulatory Peritoneal Dialysis (CAPD)

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Jan 26, 2012
Registry last updated
Mar 14, 2016

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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