Phase 3
Completed N=51
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)
Source: ClinicalTrials.gov NCT01297309 ↗Enrolled (actual)
51
Serious AEs
26.5%
Results posted
Aug 2019
Primary outcomePrimary: Number of Participants With Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE) — 13; 48 Participants
◆ Published Evidence
Established
66citations · ~9 / year
Safety and Efficacy of 5 Years of Treatment With Recombinant Human Parathyroid Hormone in Adults With Hypoparathyroidism.
Summary
This study is a long-term, open-label study using NPSP558 for the treatment of adult patients with Hypoparathyroidism.
Linked Publications (5)
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Safety and Efficacy of 5 Years of Treatment With Recombinant Human Parathyroid Hormone in Adults With Hypoparathyroidism.
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Five-year Estimated Glomerular Filtration Rate in Patients With Hypoparathyroidism Treated With and Without rhPTH(1-84).
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The risk of chronic kidney disease development in adult patients with chronic hypoparathyroidism treated with rhPTH(1-84): A retrospective cohort study.
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Five-Year Estimated Glomerular Filtration Rate in Adults with Chronic Hypoparathyroidism Treated with rhPTH(1-84): A Retrospective Cohort Study.
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Lower Risk of Cardiovascular Events in Adult Patients with Chronic Hypoparathyroidism Treated with rhPTH(1-84): A Retrospective Cohort Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE) |
13; 48 | — |
| PRIMARY Number of Responders With Calcium Source at Week 52 |
7; 21 | — |
| PRIMARY Number of Responders With Calcium Source at End Of Treatment (EOT) (Up to 82 Months) |
7; 20 | — |
| SECONDARY Percent Change From Baseline in Oral Calcium Supplementation at Week 52 and EOT (Up to 82 Months) |
-68.7; -39.4 | — |
| SECONDARY Percent Change From Baseline in Oral Calcitriol Supplementation at Week 52 and EOT (Up to 82 Months) |
-72.024; -73.737 | — |
| SECONDARY Percent Change From Baseline in Albumin Corrected Total Serum Calcium (ACSC) at EOT (Up to 82 Months) |
-0.03 | — |
| SECONDARY Change From Baseline in 24-Hour Urine Calcium Excretion Through EOT (Up to 82 Months) |
8.92; -2.37 | — |
| SECONDARY Change From Baseline in 24-hour Urine Calcium Excretion in Participants Who Used Calcium-Sparing Diuretics Through EOT (Up to 82 Months) |
-4.07; -1.79 | — |
| SECONDARY Change From Baseline in Serum Calcium Concentration in Participants Who Used and Calcium Sparing Diuretics at EOT (Upto 82 Months) |
-0.21; -0.04 | — |
| SECONDARY Change From Baseline in Serum Phosphate at Month 72 and EOT (Upto 82 Months) |
-0.309; -0.254 | — |
| SECONDARY Number of Participants Who Maintained a Calcium Phosphate Product in A Normal Range at EOT (Up to 82 Months) |
49 | — |
| SECONDARY Change From Baseline in Bone Turnover Markers at EOT (Up to 82 Months) |
5.27; 91.85; 10.06 | — |
| SECONDARY Change From Baseline in Serum Carboxy Terminal Telopeptide of Type I Collagen (s-CTx) Bone Turnover Marker at EOT (Up to 82 Months) |
224.21 | — |
| SECONDARY Change From Baseline in Bone Mineral Density (BMD) at Week 52 and EOT (Up to 82 Months) |
-0.0156; -0.0272; -0.0189; -0.0329; -0.0278; -0.0364 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01297309) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.