NCT01850641

Brief Summary

The purpose of this study is to investigate the safety and efficacy when administering PA21 with calcium carbonate in hemodialysis patients with hyperphosphatemia for 12 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2013

Shorter than P25 for phase_3

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

Study Start

First participant enrolled

April 29, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 9, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2013

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

October 9, 2018

Completed
Last Updated

October 9, 2018

Status Verified

November 1, 2014

Enrollment Period

7 months

First QC Date

May 7, 2013

Results QC Date

March 2, 2018

Last Update Submit

March 2, 2018

Conditions

HemodialysisHyperphosphatemia

Keywords

HemodialysisHyperphosphatemia

Outcome Measures

Primary Outcomes (1)

  • Incidence of Adverse Events

    12 weeks

Secondary Outcomes (8)

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

    12 weeks

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

    12 weeks

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

    12 weeks

  • Serum Ferritin Concentrations at End of Treatment (Actual Measured Value)

    12 weeks

  • TSAT at End of Treatment (Actual Measured Value)

    12 weeks

  • +3 more secondary outcomes

Study Arms (1)

PA21

EXPERIMENTAL
Drug: PA21

Interventions

PA21DRUG
PA21

Eligibility Criteria

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

You may qualify if:

  • Receiving stable maintenance hemodialysis 3 times a week
  • 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

Multiple Locations, Japan

Location

MeSH Terms

Conditions

Hyperphosphatemia

Condition Hierarchy (Ancestors)

Phosphorus Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Results Point of Contact

Title
Clinical Development Division
Organization
Kissei Pharmaceutical Co., Ltd
rinsyousiken@pharm.kissei.co.jp
Email only

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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 9, 2013

Study Start

April 29, 2013

Primary Completion

December 1, 2013

Study Completion

December 3, 2013

Last Updated

October 9, 2018

Results First Posted

October 9, 2018

Record last verified: 2014-11

Locations

JP(1)