NCT01237288

Brief Summary

The purpose of this study is to investigate the efficacy and safety of oral phosphate (Z-521) in subjects with primary hypophosphatemic rickets.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2010

Typical duration for phase_3

Geographic Reach
1 country

4 active sites

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

September 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2010

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

October 1, 2013

Status Verified

September 1, 2013

Enrollment Period

2.6 years

First QC Date

November 7, 2010

Last Update Submit

September 30, 2013

Conditions

Primary Hypophosphatemic Rickets

Outcome Measures

Primary Outcomes (2)

  • Serum ALP level

    6 month

  • Serum phosphate level

    6 month

Study Arms (1)

Z-521

EXPERIMENTAL
Drug: Z-521

Interventions

Z-521DRUG
Z-521

Eligibility Criteria

Age1 Year - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosed as primary hypophosphatemic rickets based on familial history, genetic test or laboratory test results.

You may not qualify if:

  • A hyperparathyroidism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Chiba Children's Hospital

Chiba, Japan

Location

Kanagawa Children's Medical Center

Kanagawa, Japan

Location

Osaka University Hospital

Osaka, Japan

Location

Tokyo Metropolitan Children's Medical Center

Tokyo, Japan

Location

Related Publications (1)

  • Ozono K, Hasegawa Y, Minagawa M, Adachi M, Namba N, Kazukawa I, Kitaoka T, Asakura Y, Shimura A, Naito Y. Therapeutic use of oral sodium phosphate (phosribbon((R)) combination granules) in hereditary hypophosphatemic rickets. Clin Pediatr Endocrinol. 2014 Jan;23(1):9-15. doi: 10.1292/cpe.23.9. Epub 2014 Feb 3.

    PMID: 24532956DERIVED

Study Officials

  • Keiichi Ozono, M.D., Ph.D.

    Osaka University Hospital

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

November 7, 2010

First Posted

November 9, 2010

Study Start

September 1, 2010

Primary Completion

April 1, 2013

Study Completion

July 1, 2013

Last Updated

October 1, 2013

Record last verified: 2013-09

Locations

JP(4)