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)
NCT ID: NCT01297309
Last Updated: 2021-05-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
51 participants
INTERVENTIONAL
2011-04-06
2018-06-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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NPSP558
titration of 25, 50, 75 or 100 μg
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
85 Years
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Advance Medical Research LLC
Lakewood, California, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Michigan Bone & Mineral Clinic PC
Detroit, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Columbia University Medical Center
New York, New York, United States
University Physicians Group
Staten Island, New York, United States
Physician East PA
Greenville, North Carolina, United States
University of Cincinnati Bone Health and Osteoporosis Center
Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Cetero Research DGD Research Inc.
San Antonio, Texas, United States
The Vancouver Clinic
Vancouver, Washington, United States
Countries
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References
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Ayodele O, Rejnmark L, Mu F, Lax A, Berman R, Swallow E, Gosmanova EO. Five-Year Estimated Glomerular Filtration Rate in Adults with Chronic Hypoparathyroidism Treated with rhPTH(1-84): A Retrospective Cohort Study. Adv Ther. 2022 Nov;39(11):5013-5024. doi: 10.1007/s12325-022-02292-1. Epub 2022 Aug 26.
Rejnmark L, Ayodele O, Lax A, Mu F, Swallow E, Gosmanova EO. The risk of chronic kidney disease development in adult patients with chronic hypoparathyroidism treated with rhPTH(1-84): A retrospective cohort study. Clin Endocrinol (Oxf). 2023 Apr;98(4):496-504. doi: 10.1111/cen.14813. Epub 2022 Aug 28.
Ayodele O, Mu F, Berman R, Swallow E, Rejnmark L, Gosmanova EO, Kaul S. Lower Risk of Cardiovascular Events in Adult Patients with Chronic Hypoparathyroidism Treated with rhPTH(1-84): A Retrospective Cohort Study. Adv Ther. 2022 Aug;39(8):3845-3856. doi: 10.1007/s12325-022-02198-y. Epub 2022 Jun 11.
Chen KS, Gosmanova EO, Curhan GC, Ketteler M, Rubin M, Swallow E, Zhao J, Wang J, Sherry N, Krasner A, Bilezikian JP. Five-year Estimated Glomerular Filtration Rate in Patients With Hypoparathyroidism Treated With and Without rhPTH(1-84). J Clin Endocrinol Metab. 2020 Oct 1;105(10):e3557-65. doi: 10.1210/clinem/dgaa490.
Mannstadt M, Clarke BL, Bilezikian JP, Bone H, Denham D, Levine MA, Peacock M, Rothman J, Shoback DM, Warren ML, Watts NB, Lee HM, Sherry N, Vokes TJ. Safety and Efficacy of 5 Years of Treatment With Recombinant Human Parathyroid Hormone in Adults With Hypoparathyroidism. J Clin Endocrinol Metab. 2019 Nov 1;104(11):5136-5147. doi: 10.1210/jc.2019-01010.
Provided Documents
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Document Type: Study Protocol: Original Protocol
Document Type: Study Protocol: Protocol Amendment 1
Document Type: Study Protocol: Protocol Amendment 2
Document Type: Study Protocol: Protocol Amendment 3
Document Type: Study Protocol: Protocol Amendment 5
Document Type: Study Protocol: Protocol Amendment 6
Document Type: Statistical Analysis Plan
Other Identifiers
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PAR-C10-008
Identifier Type: -
Identifier Source: org_study_id
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