A Phase III Study of PA21 in Peritoneal Dialysis Patients... | NCT01852682

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

NCT01852682

Sponsor

Kissei Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Nov 13, 2014Estimated

Enrollment

Not provided

Phase

Phase 3

Conditions

Peritoneal Dialysis
Hyperphosphatemia

Interventions

PA21

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Mar 2014Actual

Completion Date

Not provided

First Submitted Date

May 7, 2013

First Submission Date that Met QC Criteria

May 9, 2013

First Posted Date

May 14, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 11, 2014

Last Update Posted Date

Nov 13, 2014Estimated

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Label	Type	Description	Intervention Names
PA21	Experimental		Drug: PA21

Name	Type	Description	Arm Group Labels	Other Names
PA21	Drug		PA21

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serum phosphate concentrations		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Incidences of Adverse Events		12 weeks
Incidences of Adverse Events		28 weeks
Serum phosphate concentrations

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D054559	Hyperphosphatemia

Ancestor Terms

ID	Term
D010760	Phosphorus Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided