A Phase 3 interventional study of NPSP558 in Hypoparathyroidism, sponsored by Shire. Completed at 3 sites in Hungary. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-06-11.
Sponsored by Shire · Phase 3, Interventional, and Treatment
This study is designed to evaluate the effect of 6-months of treatment with NPSP558 in reducing requirements for supplemental oral calcium and active vitamin D, while maintaining stable total serum calcium levels in adult subjects with hypoparathyroidism.
Subjects either must have previously completed NPSP558 Study CL1-11-040 (REPLACE) including 24 weeks of active therapy and 4 weeks of follow-up to Week 28 prior to enrolling in this study or have enrolled in REPLACE and dropped out during optimization, but currently meet inclusion/exclusion criteria for REPLACE.
120 studies on the registry are indexed under Hypoparathyroidism; 29 are open to participants now.
This study's enrollment of 24 is below the median of 52 across 71 interventional studies indexed under Hypoparathyroidism.
Browse Hypoparathyroidism studies →Shire is the lead sponsor of 346 studies on the registry; 2 are open to participants now.
Of its 47 completed or terminated interventional studies of FDA-regulated products, 47 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients who meet all the following inclusion criteria can be enrolled into this study:
Exclusion Criteria:
Patients who meet any of the following exclusion criteria at baseline (Visit 1) are not eligible for enrollment in this study:
Drug: NPSP558
50, 75, 100 μg
Also known as: REPEAT
Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 24, Based on Investigator Prescribed Data.
A ≥ 50% reduction from baseline in dose of oral calcium or an oral calcium dose of ≤ 500 mg and a ≥ 50% reduction from baseline in dose of oral active vitamin D (calcitriol dose of ≤ 0.25 μg/day or alphacalcidol dose of ≤ 0.50 μg/day) and a total serum calcium concentration that was normalized or maintained compared to the baseline value and did not exceed the ULN of the central laboratory.
Time frame: 24 Weeks
Mean Percentage Changes From Baseline in Active Vitamin D Dosages at Each Visit
Time frame: 24 Weeks
Mean Percentage Changes From Baseline in Oral Calcium at Each Visit
Time frame: 24 Weeks
Proportion of Patients Achieving the Primary Endpoint at Each Visit
A ≥ 50% reduction from baseline in dose of oral calcium or an oral calcium dose of ≤ 500 mg and a ≥ 50% reduction from baseline in dose of oral active vitamin D (calcitriol dose of ≤ 0.25 μg/day or alphacalcidol dose of ≤ 0.50 μg/day) and a total serum calcium concentration that was normalized or maintained compared to the baseline value and did not exceed the ULN of the central laboratory.
Time frame: 24 Weeks
Mean Change From Baseline in 24-hour Urine Calcium Excretion
Time frame: 24 Weeks
24 Subjects were enrolled between 8/2011 to 5/2012 at 3 Clinical sites in Hungary.
| Milestone | NPSP558 |
|---|---|
| Started | 24 |
| Completed | 24 |
| Not completed | 0 |
A ≥ 50% reduction from baseline in dose of oral calcium or an oral calcium dose of ≤ 500 mg and a ≥ 50% reduction from baseline in dose of oral active vitamin D (calcitriol dose of ≤ 0.25 μg/day or alphacalcidol dose of ≤ 0.50 μg/day) and a total serum calcium concentration that was normalized or maintained compared to the baseline value and did not exceed the ULN of the central laboratory.
| percentage of participants | NPSP558 |
|---|---|
| Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 24, Based on Investigator Prescribed Data. | 75.0 (53.3 to 90.2) |
| percentage of change | NPSP558 |
|---|---|
| Week 2 | -47.08 ± 31.566 |
| Week 4 | -80.38 ± 16.688 |
| Week 8 | -96.70 ± 7.865 |
| Week 16 | -96.18 ± 11.521 |
| Week 24 | -97.92 ± 10.206 |
| percentage of change | NPSP558 |
|---|---|
| Week 2 | -8.3 ± 36.20 |
| Week 4 | -46.4 ± 35.57 |
| Week 8 | -71.5 ± 33.14 |
| Week 16 | -71.7 ± 38.60 |
| Week 24 | -76.0 ± 40.48 |
A ≥ 50% reduction from baseline in dose of oral calcium or an oral calcium dose of ≤ 500 mg and a ≥ 50% reduction from baseline in dose of oral active vitamin D (calcitriol dose of ≤ 0.25 μg/day or alphacalcidol dose of ≤ 0.50 μg/day) and a total serum calcium concentration that was normalized or maintained compared to the baseline value and did not exceed the ULN of the central laboratory.
| percentage of participants | NPSP558 |
|---|---|
| Week 2 | 20.8 |
| Week 4 | 50.0 |
| Week 8 | 70.8 |
| Week 16 | 83.3 |
| Week 24 | 83.3 |
| mg/24 hour | NPSP558 |
|---|---|
| Week 8 | -64.58 ± 188.42 |
| Week 24 | -51.53 ± 183.41 |
Collected over 24 Weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NPSP558 | — | 0/24 (0%) | 22/24 (91.7%) |
| Event | NPSP558 |
|---|---|
| HypoaesthesiaNervous system disorders | 12/24 |
| Muscle spasmsMusculoskeletal and connective tissue disorders | 6/24 |
| Vitamin D decreasedInvestigations | 6/24 |
| HypercalcaemiaMetabolism and nutrition disorders | 5/24 |
| HeadacheNervous system disorders | 4/24 |
| HypocalcaemiaMetabolism and nutrition disorders | 4/24 |
| FatigueGeneral disorders | 4/24 |
| TetanyMetabolism and nutrition disorders | 3/24 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 3/24 |
| Hypoaesthesia oralGastrointestinal disorders | 3/24 |
| Age, Customized(Participants) | NPSP558 |
|---|---|
| < 45 years | 6 |
| 45 to 64 years | 17 |
| ≥ 65 years | 1 |
| Sex: Female, Male(Participants) | NPSP558 |
|---|---|
| Female | 21 |
| Male | 3 |
| Ethnicity (NIH/OMB)(Participants) | NPSP558 |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 24 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | NPSP558 |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 24 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | NPSP558 |
|---|---|
| Hungary | 24 |
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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