NCT01852682

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 14, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Last Updated

November 13, 2014

Status Verified

November 1, 2014

First QC Date

May 7, 2013

Last Update Submit

November 11, 2014

Conditions

Peritoneal DialysisHyperphosphatemia

Keywords

Peritoneal DialysisHyperphosphatemia

Outcome Measures

Primary Outcomes (1)

  • Serum phosphate concentrations

    12 weeks

Secondary Outcomes (3)

  • Incidences of Adverse Events

    12 weeks

  • Incidences of Adverse Events

    28 weeks

  • Serum phosphate concentrations

    28 weeks

Study Arms (1)

PA21

EXPERIMENTAL
Drug: PA21

Interventions

PA21DRUG
PA21

Eligibility Criteria

Age20 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Tokyo and Other Japanese City, Japan

Location

MeSH Terms

Conditions

Hyperphosphatemia

Condition Hierarchy (Ancestors)

Phosphorus Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2013

First Posted

May 14, 2013

Primary Completion

March 1, 2014

Last Updated

November 13, 2014

Record last verified: 2014-11

Locations

JP(1)