Therapeutic Use of Oral Sodium Phosphate (Z-521) in Primary Hypophosphatemic Rickets

Phase 3

Completed

• Conditions: Primary Hypophosphatemic Rickets
• Interventions: Drug: Z-521

• Registration Number: NCT01237288
• Lead Sponsor: Zeria Pharmaceutical

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-11-07
• Study First Submitted QC: 2010-11-08
• Study First Posted: 2010-11-09
• Primary Completion: 2013-04
• Study Completion: 2013-07
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-30
• Last Update Posted: 2013-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

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

Exclusion Criteria

• A hyperparathyroidism

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Z-521	Z-521	-

Primary Outcome Measures

Name	Time	Method
Serum ALP level	6 month
Serum phosphate level	6 month

Trial Locations

Locations (4)

Kanagawa Children's Medical Center; 🇯🇵 Kanagawa, Japan

Tokyo Metropolitan Children's Medical Center; 🇯🇵 Tokyo, Japan

Osaka University Hospital; 🇯🇵 Osaka, Japan

Chiba Children's Hospital; 🇯🇵 Chiba, Japan