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

This study has been completed.
Information provided by (Responsible Party):
Zeria Pharmaceutical Identifier:
First received: November 7, 2010
Last updated: September 30, 2013
Last verified: September 2013
The purpose of this study is to investigate the efficacy and safety of oral phosphate (Z-521) in subjects with primary hypophosphatemic rickets.

Condition Intervention Phase
Primary Hypophosphatemic Rickets
Drug: Z-521
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Therapeutic Use of Oral Sodium Phosphate (Z-521) in Primary Hypophosphatemic Rickets

Resource links provided by NLM:

Further study details as provided by Zeria Pharmaceutical:

Primary Outcome Measures:
  • Serum ALP level [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
  • Serum phosphate level [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: September 2010
Study Completion Date: July 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Z-521 Drug: Z-521


Ages Eligible for Study:   1 Year to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • A hyperparathyroidism
  Contacts and Locations
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Please refer to this study by its identifier: NCT01237288

Chiba Children's Hospital
Chiba, Japan
Kanagawa Children's Medical Center
Kanagawa, Japan
Osaka University Hospital
Osaka, Japan
Tokyo Metropolitan Children's Medical Center
Tokyo, Japan
Sponsors and Collaborators
Zeria Pharmaceutical
Study Chair: Keiichi Ozono, M.D., Ph.D. Osaka University Hospital
  More Information

No publications provided

Responsible Party: Zeria Pharmaceutical Identifier: NCT01237288     History of Changes
Other Study ID Numbers: 10010301
Study First Received: November 7, 2010
Last Updated: September 30, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Familial Hypophosphatemic Rickets
Rickets, Hypophosphatemic
Bone Diseases
Bone Diseases, Metabolic
Calcium Metabolism Disorders
Deficiency Diseases
Genetic Diseases, Inborn
Hypophosphatemia, Familial
Kidney Diseases
Metabolic Diseases
Metabolism, Inborn Errors
Metal Metabolism, Inborn Errors
Musculoskeletal Diseases
Nutrition Disorders
Phosphorus Metabolism Disorders
Renal Tubular Transport, Inborn Errors
Urologic Diseases
Vitamin D Deficiency
Therapeutic Uses
Pharmacologic Actions processed this record on November 27, 2015