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Completed

NCT Number: NCT01521494

PA21 Phase II Clinical Study in Hemodialysis Patients With Hyperphosphatemia

To investigate dose-response efficacy and safety in hemodialysis patients with hyperphosphatemia.

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Key information

Conditions

Chronic Kidney Disease Requiring Hemodialysis Hyperphosphatemia 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

Japan

Multiple Locations, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients age 20 or older, regardless of gender.
  • Receiving stable maintenance hemodialysis 3 times a week.
  • Patients not having changed their phosphate binder agent dose, for 4 weeks or more before their observation period start.

Exclusion criteria

  • Patients having history of a pronounced brain / cardiovascular disorder.
  • Patients having severe gastrointestinal disorders.
  • Patients having severe hepatic disorders.

Treatment and study plan

PA21

Drug

Placebo

Drug

Primary outcomes

  1. Change From Baseline in Serum Phosphorus Concentrations at the End of Treatment.

    Time frame: 6 weeks

    Changes in serum phosphorus concentrations from baseline to the end of treatment were adjusted by serum phosphorus concentration at baseline.

Secondary outcomes

  1. Change From Baseline in Serum Calcium Concentrations.

    Time frame: 6 weeks

  2. Change From Baseline in Serum Intact-PTH Concentrations.

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Kissei Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 30, 2012
Registry last updated
Aug 23, 2018

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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