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)
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| ClinicalTrials.gov Identifier: NCT01297309 |
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Recruitment Status :
Completed
First Posted : February 16, 2011
Results First Posted : August 6, 2019
Last Update Posted : May 25, 2021
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Sponsor:
Shire
Information provided by (Responsible Party):
Takeda ( Shire )
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Brief Summary:
This study is a long-term, open-label study using NPSP558 for the treatment of adult patients with Hypoparathyroidism.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hypoparathyroidism | Drug: NPSP558 | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 51 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| 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) |
| Actual Study Start Date : | April 6, 2011 |
| Actual Primary Completion Date : | June 8, 2018 |
| Actual Study Completion Date : | June 8, 2018 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Hormones
Drug Information available for:
Parathyroid Hormone
| Arm | Intervention/treatment |
|---|---|
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Experimental: NPSP558
titration of 25, 50, 75 or 100 μg
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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 |
Primary Outcome Measures :
- Number of Participants With Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE) [ Time Frame: From start of study drug administration up to follow-up (82 months) ]SAE is an adverse event (AE) that results in death, life threatening, persistent or significant incapacity or substantial disruption of ability to conduct normal life functions, hospitalization or prolongation of existing hospitalization, congenital anomaly or birth defect, important medical events that may not result in death, be life threatening, or require hospitalization. An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical or medicinal product. Treatment emergent adverse events (TEAEs) were defined as AEs whose onset occurs, severity worsens or intensity increases after receiving the study medication of this study and <= 30 days after last dose of study drug.
- Number of Responders With Calcium Source at Week 52 [ Time Frame: Week 52 ]A responder was defined as a participant who met all of the following 3 criteria at each (1) a greater than (>) 50% reduction from baseline or less than (<) 500 milligram (mg) of daily calcium supplementation. (2) a >50% reduction from baseline or <0.25 microgram (mcg) of daily calcitriol supplementation. (3) an albumin-corrected total serum calcium concentration that was normalized or maintained compared to the baseline greater than or equal to (>=) 1.875 millimoles per liter (mmol/L) and not exceeding the Upper Limit of Normal (ULN) values (2.15 to 2.55 mmol/L). End of Treatment (EOT) was defined as the last determination of response or last available measurement during the treatment period. Number of responders with calcium source for citrate and carbonate at week 52 was reported here.
- Number of Responders With Calcium Source at End Of Treatment (EOT) (Up to 82 Months) [ Time Frame: EOT (up to 82 months) ]A responder was defined as a participant who met all of the following 3 criteria at each (1) a greater than (>) 50% reduction from baseline or less than (<) 500 milligram (mg) of daily calcium supplementation. (2) a >50% reduction from baseline or <0.25 microgram (mcg) of daily calcitriol supplementation. (3) an albumin-corrected total serum calcium concentration that was normalized or maintained compared to the baseline greater than or equal to (>=) 1.875 millimoles per liter (mmol/L) and not exceeding the Upper Limit of Normal (ULN) values (2.15 to 2.55 mmol/L). End of Treatment (EOT) was defined as the last determination of response or last available measurement during the treatment period. Number of responders with calcium source for citrate and carbonate at EOT was reported here.
Secondary Outcome Measures :
- Percent Change From Baseline in Oral Calcium Supplementation at Week 52 and EOT (Up to 82 Months) [ Time Frame: Baseline, Week 52 and EOT (up to 82 months) ]Percent change from baseline of oral calcium supplementation were reported. EOT was defined as the last determination of response or last available measurement during the treatment period.
- Percent Change From Baseline in Oral Calcitriol Supplementation at Week 52 and EOT (Up to 82 Months) [ Time Frame: Baseline, Week 52 and EOT (up to 82 months) ]Percent change from baseline of oral calcitriol supplementation were reported. EOT was defined as the last determination of response or last available measurement during the treatment period.
- Percent Change From Baseline in Albumin Corrected Total Serum Calcium (ACSC) at EOT (Up to 82 Months) [ Time Frame: Baseline, EOT (up to 82 months) ]Percent change in ACSC was reported. EOT was defined as the last determination of response or last available measurement during the treatment period.
- Change From Baseline in 24-Hour Urine Calcium Excretion Through EOT (Up to 82 Months) [ Time Frame: Baseline, EOT (up to 82 months) ]Change in 24 hour urine calcium excretion was reported. EOT was defined as the last determination of response or last available measurement during the treatment period.
- Change From Baseline in 24-hour Urine Calcium Excretion in Participants Who Used Calcium-Sparing Diuretics Through EOT (Up to 82 Months) [ Time Frame: Baseline, EOT (up to 82 months) ]Change from baseline in urinary calcium concentration in participants who used at least one calcium-sparing diuretics and participants who not used calcium-sparing diuretics were reported. EOT was defined as the last determination of response or last available measurement during the treatment period.
- Change From Baseline in Serum Calcium Concentration in Participants Who Used and Calcium Sparing Diuretics at EOT (Upto 82 Months) [ Time Frame: Baseline, EOT (upto 82 months) ]Change in serum calcium concentration of the number of participants who used at least one calcium-sparing diuretics and not used calcium sparing diuretics were reported. EOT was defined as the last determination of response or last available measurement during the treatment period.
- Change From Baseline in Serum Phosphate at Month 72 and EOT (Upto 82 Months) [ Time Frame: Baseline, Month 72, EOT (upto 82 months) ]Change of serum phosphate from baseline were reported. EOT was defined as the last determination of response or last available measurement during the treatment period.
- Number of Participants Who Maintained a Calcium Phosphate Product in A Normal Range at EOT (Up to 82 Months) [ Time Frame: EOT (up to 82 months) ]The normal range of calcium phosphate product is defined as <= 4.441 millimoles square per liter square (mmol^2/L^2).
- Change From Baseline in Bone Turnover Markers at EOT (Up to 82 Months) [ Time Frame: Baseline, EOT (up to 82 months) ]Bone Turnover Markers such as bone specific alkaline phosphatase (BSAP), serum procollagen type 1 amino-terminal propeptide (P1NP) , osteocalcin were reported in particpiants. EOT was defined as the last determination of response or last available measurement during the treatment period.
- Change From Baseline in Serum Carboxy Terminal Telopeptide of Type I Collagen (s-CTx) Bone Turnover Marker at EOT (Up to 82 Months) [ Time Frame: Baseline, EOT (up to 82 months) ]Change form baseline in bone turnover marker (s-CTx)was reported. EOT was defined as the last determination of response or last available measurement during the treatment period.
- Change From Baseline in Bone Mineral Density (BMD) at Week 52 and EOT (Up to 82 Months) [ Time Frame: Baseline, Week 52 and EOT (up to 82 months) ]Change from baseline in BMD of lumbar spine (L1-L4), hip-total, hip-trochanter, hip-intertrochanter, hip-ward's triangle, hip-femoral neck, distal one third radius at Week 52 then every 12 months until EOT were assessed by dual-energy X-ray absorptiometry [DXA] and Z-score. EOT was defined as the last determination of response or last available measurement during the treatment period.
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| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
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): NCT01297309
Locations
| 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
Shire
Investigators
| Study Director: | Study Director | Takeda |
Study Documents (Full-Text)
Documents provided by Takeda ( Shire ):
Documents provided by Takeda ( Shire ):
Study Protocol: Original Protocol [PDF] December 30, 2010
Study Protocol: Protocol Amendment 1 [PDF] June 29, 2011
Study Protocol: Protocol Amendment 2 [PDF] October 5, 2011
Study Protocol: Protocol Amendment 3 [PDF] March 15, 2012
Study Protocol: Protocol Amendment 5 [PDF] May 3, 2016
Study Protocol: Protocol Amendment 6 [PDF] October 24, 2016
Statistical Analysis Plan [PDF] March 22, 2018
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Shire |
| ClinicalTrials.gov Identifier: | NCT01297309 |
| Other Study ID Numbers: |
PAR-C10-008 |
| First Posted: | February 16, 2011 Key Record Dates |
| Results First Posted: | August 6, 2019 |
| Last Update Posted: | May 25, 2021 |
| Last Verified: | May 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) |
| Access Criteria: | IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement. |
| URL: | https://vivli.org/ourmember/takeda/ |
Keywords provided by Takeda ( Shire ):
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PTH 1-84 Hypoparathyroidism Parathyroid Hormone 1-84 NPSP558 |
Additional relevant MeSH terms:
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Hypoparathyroidism Parathyroid Diseases Endocrine System Diseases |