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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zeria Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01237288
First received: November 7, 2010
Last updated: September 30, 2013
Last verified: September 2013
  Purpose

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

  Eligibility

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

Inclusion Criteria:

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

Exclusion Criteria:

  • A hyperparathyroidism
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01237288

Locations
Japan
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
Investigators
Study Chair: Keiichi Ozono, M.D., Ph.D. Osaka University Hospital
  More Information

No publications provided

Responsible Party: Zeria Pharmaceutical
ClinicalTrials.gov 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:
Rickets
Rickets, Hypophosphatemic
Familial Hypophosphatemic Rickets
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Hypophosphatemia
Phosphorus Metabolism Disorders
Hypophosphatemia, Familial
Renal Tubular Transport, Inborn Errors
Kidney Diseases
Urologic Diseases
Metal Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on August 21, 2014