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CompletedNCT01852682Updated Nov 13, 2014

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

A Phase 3 interventional study of PA21 in Peritoneal Dialysis and Hyperphosphatemia, sponsored by Kissei Pharmaceutical Co., Ltd.. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2014-11-13.

Sponsored by Kissei Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Allocation
Not applicable
Ages
20 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Peritoneal Dialysis
  • Hyperphosphatemia

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Keywords

  • Peritoneal Dialysis
  • Hyperphosphatemia
03

In context

Hyperphosphatemia

148 studies on the registry are indexed under Hyperphosphatemia; 10 are open to participants now.

Browse Hyperphosphatemia studies →

Lead sponsor

Kissei Pharmaceutical Co., Ltd. is the lead sponsor of 61 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All

Inclusion criteria

  • Receiving stable maintenance peritoneal dialysis
  • Peritoneal dialysis patients with hyperphosphatemia

Exclusion criteria

Exclusion Criteria:

  • Patients having history of a pronounced brain / cardiovascular disorder
  • Patients having severe gastrointestinal disorders
  • Patients having severe hepatic disorders
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)

Study arms

  • Experimental
    PA21

    Drug: PA21

Interventions

  • DrugPA21
06

What researchers measure

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

07

Study locations

1 site
  • Tokyo and Other Japanese City, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01852682
Lead sponsor
Kissei Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
May 14, 2013
Primary completion
Mar 2014
Last update
Nov 13, 2014
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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