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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01237288
First Posted: November 9, 2010
Last Update Posted: October 1, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zeria Pharmaceutical
  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
Intervention Model: Single Group Assignment
Masking: None (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 ]
  • Serum phosphate level [ Time Frame: 6 month ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 14 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Zeria Pharmaceutical
ClinicalTrials.gov Identifier: NCT01237288     History of Changes
Other Study ID Numbers: 10010301
First Submitted: November 7, 2010
First Posted: November 9, 2010
Last Update Posted: October 1, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
Rickets
Rickets, Hypophosphatemic
Familial Hypophosphatemic Rickets
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium Metabolism Disorders
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