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Completed

NCT Number: NCT01850641

A Phase III Study of PA21 With Calcium Carbonate in Hemodialysis Patients With Hyperphosphatemia

The purpose of this study is to investigate the safety and efficacy when administering PA21 with calcium carbonate in hemodialysis patients with hyperphosphatemia for 12 weeks.

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Key information

Conditions

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 3

Primary location

Multiple Locations, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Receiving stable maintenance hemodialysis 3 times a week
  • Dialysis patients with hyperphosphatemia

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

Primary outcomes

  1. Incidence of Adverse Events

    Time frame: 12 weeks

Secondary outcomes

  1. Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value)

    Time frame: 12 weeks

  2. Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value)

    Time frame: 12 weeks

  3. Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value)

    Time frame: 12 weeks

  4. Serum Ferritin Concentrations at End of Treatment (Actual Measured Value)

    Time frame: 12 weeks

  5. TSAT at End of Treatment (Actual Measured Value)

    Time frame: 12 weeks

  6. Hb Concentrations at End of Treatment (Actual Measured Value)

    Time frame: 12 weeks

  7. Constipation Condition

    Time frame: 12 weeks

  8. Satisfaction With Bowel Movement

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Kissei Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 9, 2013
Registry last updated
Oct 9, 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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