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Completed

NCT Number: NCT01833494

A Long-term Study of PA21 in Hemodialysis Patients With Hyperphosphatemia

The purpose of this study is to investigate the safety and efficacy for 52-week dosing in hemodialysis patients with hyperphosphatemia.

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Key information

Conditions

Hemodialysis Patients With Hyperphosphatemia 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

JAPAN

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: 52 weeks

Secondary outcomes

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

    Time frame: 52 weeks

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

    Time frame: 52 weeks

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

    Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

Kissei Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 17, 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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