Trial Outcomes & Findings for Study of Safety and Efficacy of a rhPTH[1-84] of Fixed Doses of 25 and 50 mcg in Adults With Hypoparathyroidism (RELAY) (NCT NCT01268098)
NCT ID: NCT01268098
Last Updated: 2021-06-11
Results Overview
The triple efficacy endpoint criteria were defined as a reduction from baseline in oral calcium to ≤ 500 mg/day, a reduction from baseline in calcitriol dose to ≤ 0.25 µg/day, and an albumin-corrected total serum calcium level between 7.5 mg/dL and the upper limit of the laboratory normal range. The analysis of primary endpoint was based on investigator prescribed data.
COMPLETED
PHASE3
42 participants
8 Weeks
2021-06-11
Participant Flow
42 Subjects enrolled between 2/2011 and 9/2011 at 11 sites in the US.
Subjects who completed 24 wks of treatment and 4 wks follow-up in the REPLACE Study (NCT00732615) or received 2 single doses in Phase I Study C09-002 followed by a 4-wk washout, or enrolled in the REPLACE Study and entered into the optimization phase, but were not randomized due to the close of randomization; or were new to the NPSP558 program.
Participant milestones
| Measure |
NPSP558 - 25 µg Dose
NPSP558: Recombinant Human Parathyroid hormone (rhPTH\[1-84\]) 25 mcg subcutaneously daily.
|
NPSP558 - 50 µg Dose
NPSP558: Recombinant Human Parathyroid hormone (rhPTH\[1-84\]) 50 mcg subcutaneously daily.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
23
|
|
Overall Study
COMPLETED
|
18
|
23
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
NPSP558 - 25 µg Dose
NPSP558: Recombinant Human Parathyroid hormone (rhPTH\[1-84\]) 25 mcg subcutaneously daily.
|
NPSP558 - 50 µg Dose
NPSP558: Recombinant Human Parathyroid hormone (rhPTH\[1-84\]) 50 mcg subcutaneously daily.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Study of Safety and Efficacy of a rhPTH[1-84] of Fixed Doses of 25 and 50 mcg in Adults With Hypoparathyroidism (RELAY)
Baseline characteristics by cohort
| Measure |
NPSP558 - 25 µg Dose
n=19 Participants
NPSP558: Recombinant Human Parathyroid hormone (rhPTH\[1-84\]) 25 mcg subcutaneously daily
|
NPSP558 - 50 µg Dose
n=23 Participants
NPSP558: Recombinant Human Parathyroid hormone (rhPTH\[1-84\]) 50 mcg subcutaneously daily
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 45 years
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Customized
45 to 64 years
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Customized
>/= 65 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
17 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 WeeksPopulation: Intent to Treat (ITT) population, which includes all randomized subjects who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment.
The triple efficacy endpoint criteria were defined as a reduction from baseline in oral calcium to ≤ 500 mg/day, a reduction from baseline in calcitriol dose to ≤ 0.25 µg/day, and an albumin-corrected total serum calcium level between 7.5 mg/dL and the upper limit of the laboratory normal range. The analysis of primary endpoint was based on investigator prescribed data.
Outcome measures
| Measure |
NPSP558 - 25 µg Dose
n=19 Participants
NPSP558: Recombinant Human Parathyroid hormone (rhPTH\[1-84\]) 25 mcg subcutaneously daily
|
NPSP558 - 50 µg Dose
n=23 Participants
NPSP558: Recombinant Human Parathyroid hormone (rhPTH\[1-84\]) 50 mcg subcutaneously daily
|
|---|---|---|
|
Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 8, Based on Investigator Prescribed Data.
|
21.1 percentage of participants
Interval 6.1 to 45.6
|
26.1 percentage of participants
Interval 10.2 to 48.4
|
SECONDARY outcome
Timeframe: 8 WeeksPopulation: Intent to Treat (ITT) population, which includes all randomized subjects who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment.
The triple efficacy endpoint criteria were defined as at least a 50% reduction from the baseline in oral calcium dose and at least a 50% reduction from the baseline in active vitamin D dose and an albumin-corrected total serum calcium concentration that was maintained or normalized compared to the baseline value (≥ 7.5 mg/dL) and did not exceed the upper limit of the laboratory normal range. The analysis of primary efficacy endpoint was based on investigator prescribed data
Outcome measures
| Measure |
NPSP558 - 25 µg Dose
n=19 Participants
NPSP558: Recombinant Human Parathyroid hormone (rhPTH\[1-84\]) 25 mcg subcutaneously daily
|
NPSP558 - 50 µg Dose
n=23 Participants
NPSP558: Recombinant Human Parathyroid hormone (rhPTH\[1-84\]) 50 mcg subcutaneously daily
|
|---|---|---|
|
The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 8.
|
10.5 percentage of participants
Interval 1.3 to 33.1
|
26.1 percentage of participants
Interval 10.2 to 48.4
|
Adverse Events
NPSP558 - 25 µg Dose
NPSP558 - 50 µg Dose
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NPSP558 - 25 µg Dose
n=19 participants at risk
NPSP558: Recombinant Human Parathyroid hormone (rhPTH\[1-84\]) 25 mcg subcutaneously daily
|
NPSP558 - 50 µg Dose
n=23 participants at risk
NPSP558: Recombinant Human Parathyroid hormone (rhPTH\[1-84\]) 50 mcg subcutaneously daily
|
|---|---|---|
|
Nervous system disorders
Carotid artery stenosis
|
5.3%
1/19 • Number of events 1 • 8 weeks
8 weeks on treatment
|
0.00%
0/23 • 8 weeks
8 weeks on treatment
|
|
Nervous system disorders
Migraine
|
5.3%
1/19 • Number of events 1 • 8 weeks
8 weeks on treatment
|
0.00%
0/23 • 8 weeks
8 weeks on treatment
|
|
Gastrointestinal disorders
Nausea
|
10.5%
2/19 • Number of events 2 • 8 weeks
8 weeks on treatment
|
13.0%
3/23 • Number of events 4 • 8 weeks
8 weeks on treatment
|
|
General disorders
Fatigue
|
5.3%
1/19 • Number of events 1 • 8 weeks
8 weeks on treatment
|
8.7%
2/23 • Number of events 2 • 8 weeks
8 weeks on treatment
|
|
General disorders
Injection site pain
|
0.00%
0/19 • 8 weeks
8 weeks on treatment
|
8.7%
2/23 • Number of events 4 • 8 weeks
8 weeks on treatment
|
|
General disorders
Chest discomfort
|
5.3%
1/19 • Number of events 1 • 8 weeks
8 weeks on treatment
|
4.3%
1/23 • Number of events 1 • 8 weeks
8 weeks on treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
15.8%
3/19 • Number of events 5 • 8 weeks
8 weeks on treatment
|
13.0%
3/23 • Number of events 4 • 8 weeks
8 weeks on treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.5%
2/19 • Number of events 3 • 8 weeks
8 weeks on treatment
|
4.3%
1/23 • Number of events 1 • 8 weeks
8 weeks on treatment
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
5.3%
1/19 • Number of events 2 • 8 weeks
8 weeks on treatment
|
0.00%
0/23 • 8 weeks
8 weeks on treatment
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
5.3%
1/19 • Number of events 1 • 8 weeks
8 weeks on treatment
|
0.00%
0/23 • 8 weeks
8 weeks on treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
5.3%
1/19 • Number of events 1 • 8 weeks
8 weeks on treatment
|
0.00%
0/23 • 8 weeks
8 weeks on treatment
|
|
Cardiac disorders
Palpitations
|
5.3%
1/19 • Number of events 1 • 8 weeks
8 weeks on treatment
|
8.7%
2/23 • Number of events 2 • 8 weeks
8 weeks on treatment
|
|
Eye disorders
Blepharospasm
|
5.3%
1/19 • Number of events 1 • 8 weeks
8 weeks on treatment
|
0.00%
0/23 • 8 weeks
8 weeks on treatment
|
|
Infections and infestations
Sinusitis
|
0.00%
0/19 • 8 weeks
8 weeks on treatment
|
8.7%
2/23 • Number of events 2 • 8 weeks
8 weeks on treatment
|
|
Infections and infestations
Chronic sinusitis
|
5.3%
1/19 • Number of events 1 • 8 weeks
8 weeks on treatment
|
0.00%
0/23 • 8 weeks
8 weeks on treatment
|
|
Infections and infestations
Gastroenteritis
|
5.3%
1/19 • Number of events 1 • 8 weeks
8 weeks on treatment
|
0.00%
0/23 • 8 weeks
8 weeks on treatment
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
5.3%
1/19 • Number of events 1 • 8 weeks
8 weeks on treatment
|
0.00%
0/23 • 8 weeks
8 weeks on treatment
|
|
Investigations
Heart rate increased
|
5.3%
1/19 • Number of events 1 • 8 weeks
8 weeks on treatment
|
0.00%
0/23 • 8 weeks
8 weeks on treatment
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
10.5%
2/19 • Number of events 2 • 8 weeks
8 weeks on treatment
|
4.3%
1/23 • Number of events 1 • 8 weeks
8 weeks on treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.3%
1/19 • Number of events 1 • 8 weeks
8 weeks on treatment
|
4.3%
1/23 • Number of events 1 • 8 weeks
8 weeks on treatment
|
|
Psychiatric disorders
Nervousness
|
5.3%
1/19 • Number of events 1 • 8 weeks
8 weeks on treatment
|
0.00%
0/23 • 8 weeks
8 weeks on treatment
|
|
Renal and urinary disorders
Pollakiuria
|
10.5%
2/19 • Number of events 2 • 8 weeks
8 weeks on treatment
|
4.3%
1/23 • Number of events 1 • 8 weeks
8 weeks on treatment
|
|
Renal and urinary disorders
Nocturia
|
5.3%
1/19 • Number of events 1 • 8 weeks
8 weeks on treatment
|
0.00%
0/23 • 8 weeks
8 weeks on treatment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
5.3%
1/19 • Number of events 1 • 8 weeks
8 weeks on treatment
|
0.00%
0/23 • 8 weeks
8 weeks on treatment
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
5.3%
1/19 • Number of events 1 • 8 weeks
8 weeks on treatment
|
0.00%
0/23 • 8 weeks
8 weeks on treatment
|
|
Skin and subcutaneous tissue disorders
Hypoaesthesia facial
|
5.3%
1/19 • Number of events 1 • 8 weeks
8 weeks on treatment
|
0.00%
0/23 • 8 weeks
8 weeks on treatment
|
|
Nervous system disorders
Paresthesia
|
21.1%
4/19 • Number of events 8 • 8 weeks
8 weeks on treatment
|
21.7%
5/23 • Number of events 6 • 8 weeks
8 weeks on treatment
|
|
Nervous system disorders
Headache
|
5.3%
1/19 • Number of events 1 • 8 weeks
8 weeks on treatment
|
13.0%
3/23 • Number of events 3 • 8 weeks
8 weeks on treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER