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A Open-label Study Investigating the Safety and Tolerability of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH [1-84]), for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study (RACE)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Shire Identifier:
First received: February 11, 2011
Last updated: February 1, 2017
Last verified: February 2017
This study is a long-term, open-label study using NPSP558 for the treatment of adult patients with Hypoparathyroidism.

Condition Intervention Phase
Drug: NPSP558
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Long-term Open-label Study Investigating the Safety and Tolerability of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH[1-84]), for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study (RACE)

Resource links provided by NLM:

Further study details as provided by Shire:

Primary Outcome Measures:
  • Demonstrate the long-term safety of subcutaneous (SC) NPSP558 (rhPTH[1-84]) [ Time Frame: Up to 80 months of treatment, 4 weeks of follow-up ]
  • Demonstrate the long-term tolerability of subcutaneous (SC) NPSP558 (rhPTH[1-84]) [ Time Frame: up to 80 months of treatment, 4 weeks of follow-up ]

Secondary Outcome Measures:
  • Evaluate the impact of different preparations of calcium on the response to rhPTH[1-84] replacement therapy [ Time Frame: Up to 80 months of treatment, 4 weeks of follow-up ]
  • Demonstrate that dosing with rhPTH[1-84] across a dose range of 25 to 100 μg SC can be implemented in a safe and effective manner and can be maintained throughout long-term treatment [ Time Frame: Up to 80 months of treatment, 4 weeks of follow-up ]
  • Evaluate the impact of calcium-sparing diuretics on serum and urinary calcium [ Time Frame: 52 weeks of treatment, 4 weeks of follow-up ]

Estimated Enrollment: 50
Study Start Date: April 2011
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NPSP558
titration of 25, 50, 75 or 100 μg
Drug: NPSP558
All patients will inject NPSP558 individual titration of 25, 50, 75 or 100 μg SC QD into alternating thighs in the morning via a multidose injection pen device.
Other Name: RACE

Detailed Description:
Patients with a history of Hypoparathyroidism will be enrolled to receive study drug for up to 80 months, which will be injected daily in either thigh. During that time they will be monitored for safety (specifically calcium levels in blood or urine). In addition, the patients' intake of Vitamin D and Calcium will be measured.

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Previously completed the rhPTH[1-84] RELAY study (8 weeks of active therapy) and/or previously completed the rhPTH[1-84] REPLACE study (Visit 18).
  • Able to perform daily SC self-injections of study medication (or have a designee perform injection).
  • Women who are (1) postmenopausal; (2) surgically sterilized; or, (3) of childbearing potential with a negative pregnancy test and who consent to use two acceptable methods of contraception for the duration of the study.
  • Males who have female partners of childbearing potential must use two acceptable forms of contraception for the duration of the study.
  • Serum creatinine <1.5 mg/dL at enrollment.
  • Total serum calcium less than or equal to upper limit of normal (ULN) based on local laboratory result prior to enrollment.
  • Serum 25 hydroxy (OH) vitamin D less than or equal to 1.5 times the ULN within approximately 16 weeks prior to enrollment.

Exclusion Criteria:

  • Any condition that, in the investigator's opinion after consultation with the sponsor, would preclude the safe use of parathyroid hormone (PTH).
  • Pregnant or lactating women.
  • Any disease or condition which has a high probability of precluding the subject from completing the study or where the subject cannot or will not appropriately comply with study requirements.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01297309

United States, California
Advance Medical Research LLC
Lakewood, California, United States, 90712
United States, Florida
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
Michigan Bone & Mineral Clinic PC
Detroit, Michigan, United States, 48236
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
University Physicians Group
Staten Island, New York, United States, 10301
United States, North Carolina
Physician East PA
Greenville, North Carolina, United States, 27834
United States, Ohio
University of Cincinnati Bone Health and Osteoporosis Center
Cincinnati, Ohio, United States, 45219
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Cetero Research DGD Research Inc.
San Antonio, Texas, United States, 78229
United States, Washington
The Vancouver Clinic
Vancouver, Washington, United States, 98664
Sponsors and Collaborators
Study Director: Shire Physician Shire
  More Information

Responsible Party: Shire Identifier: NCT01297309     History of Changes
Other Study ID Numbers: PAR-C10-008
Study First Received: February 11, 2011
Last Updated: February 1, 2017

Keywords provided by Shire:
PTH 1-84
Parathyroid Hormone 1-84

Additional relevant MeSH terms:
Parathyroid Diseases
Endocrine System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on April 27, 2017