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Completed

NCT Number: NCT01852682

A Phase III Study of PA21 in Peritoneal Dialysis Patients With Hyperphosphatemia

The purpose of this study is to investigate efficacy and safety, when administering PA21, in peritoneal dialysis patients having hyperphosphatemia.

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Key information

Conditions

Peritoneal Dialysis 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

Tokyo and Other Japanese City, Japan

Who can participate

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

Inclusion criteria

  • Receiving stable maintenance peritoneal dialysis
  • Peritoneal 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. Serum phosphate concentrations

    Time frame: 12 weeks

Secondary outcomes

  1. Incidences of Adverse Events

    Time frame: 12 weeks

  2. Incidences of Adverse Events

    Time frame: 28 weeks

  3. Serum phosphate concentrations

    Time frame: 28 weeks

Sponsors and collaborators

Lead sponsor

Kissei Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Primary completion
2014
First posted
May 14, 2013
Registry last updated
Nov 13, 2014

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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