ClinicalTrials.gg
Sign In
CompletedNCT02204579Updated Aug 9, 2021Results posted

A Study to Determine the Effects of NPSP795 on the Calcium-sensing Receptor in Subjects With Autosomal Dominant Hypocalcemia as Measured by PTH Levels and Blood Calcium Concentrations

A Phase 2 interventional study of NPSP795 in Autosomal Dominant Hypocalcemia (ADH), sponsored by Shire. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-09.

Sponsored by Shire (part of Takeda) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This is an open-label study looking at the effects of NPSP795 (a selective calcium receptor antagonist) on activating mutations of the Calcium-sensing receptor in patients with Autosomal Dominant Hypocalcemia. Patients with ADH have low blood calcium levels and an inappropriately increased renal calcium excretion, decreased renal phosphate excretion, and hyperphosphatemia. PTH and blood calcium levels will be tested during and after the IV infusion of NPSP795. Concentrations of NPSP795 and length of time of IV infusion will vary depending on measured levels of ionized calcium.

02

Conditions studied

  • Autosomal Dominant Hypocalcemia (ADH)

Keywords

  • Autosomal Dominant Hypocalcemia
  • Hypocalcemia
  • ADH
  • Hypoparathyroidism
03

In context

Hypocalcemia

98 studies on the registry are indexed under Hypocalcemia; 16 are open to participants now.

This study's enrollment of 7 is below the median of 84 across 66 interventional studies indexed under Hypocalcemia.

Browse Hypocalcemia studies →

Lead sponsor

Shire is the lead sponsor of 351 studies on the registry; 2 are open to participants now.

Of its 48 completed or terminated interventional studies of FDA-regulated products, 48 (100%) have results posted.

First submitted before Shire became part of Takeda.

Browse Shire studies →All Takeda studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subjects with a heterozygous activating mutation of the CaSR gene (ADH); if not previously confirmed, genetic testing will be performed at the screening visit
  • At least 18 years of age
  • (BMI) ≥ 18.5 to \< 39 kg/m2

Exclusion criteria

Exclusion Criteria:

  • Diseases or conditions that might compromise any major body system or interfere with the pharmacokinetics of NPSP795
  • History of treatment with PTH 1-84 or 1-34 within the previous 6 months
  • History of hypocalcemia requiring frequent IV calcium infusions
  • History of hypocalcemic seizure within the past 3 months
  • Blood 25-hydroxy vitamin D level \< 25 ng/mL. If subjects have a blood 25-hydroxy vitamin D level \< 25 ng/mL at the outpatient screening visit, they will be prescribed vitamin D replacement. Once the 25-hydroxy vitamin D level is > 25 ng/mL, the subject will be eligible to continue on to the treatment phase of the study
  • Estimated (GFR) \< 25 mL/minute, and/or abnormal hepatic, hematologic, and/or clotting function
  • 12 lead resting (ECG) with abnormalities
  • Concomitant medications with the potential to interfere with NPSP795 metabolism
  • History of thyroid or parathyroid surgery
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    NPSP795

    intravenous

    Drug: NPSP795

Interventions

  • DrugNPSP795
06

What researchers measure

Primary outcomes

  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

    Time frame: From Day 1 up to safety follow-up assessment (upto Day 17 after discharge)

  2. Number of Participants With Clinically Significant Vital Signs and Electrocardiogram (ECG) Abnormalities

    Time frame: From Day 1 up to safety follow-up assessment (upto Day 17 after discharge)

  3. Number of Participants With Potentially Clinically Important Laboratory Abnormalities

    Time frame: From Day 1 up to safety follow-up assessment (upto Day 17 after discharge)

  4. Number of Participants With Clinically Significant Abnormalities Related to Physical Examination

    Time frame: From Day 1 up to safety follow-up assessment (upto Day 17 after discharge)

  5. Change From Baseline in Ionised Calcium

    Time frame: 10 Minute (min) Infusion Time: within 5 min pre-dose; & post-dose 15, 30, 45, 60, 75, 90, 105 min, and 2, 2.5, 3, 3.5, & 4 hour (hr) 3.5 hr Infusion Time: within 5 min pre-dose; & post-dose 15, 30, 45, 60, 75, 90, 105 min, & 2, 2.5, 3, 3.5, 4, 5, and 8 hr

  6. Change From Baseline in Serum Calcium

    Time frame: 10 Minutes (min) Infusion Time: within 5 min pre-dose; & post-dose 1, 2, 3, 4, 8 12 hours (hr). 3.5 hr Infusion Time: within 5 min pre-dose; & post-dose 1, 2, 3, 4, 8 12 hr.

  7. Change From Baseline in Urinary Calcium

    Time frame: 10 Minutes (min) Infusion Time: within 5 min pre-dose; & post-dose 1, 2, 3, 4, 8 12 hours (hr). 3.5 hr Infusion Time: within 5 min pre-dose; & post-dose 1, 2, 3, 4, 8 12 hr.

  8. Change From Baseline in Serum Parathyroid Hormone (PTH)

    Time frame: 10 Minutes (min) Infusion Time: within 5 min pre-dose; & post-dose 5, 10, 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 8 hours (hr). 3.5 hr Infusion Time: within 5 min pre-dose; & post-dose 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 hr

Secondary outcomes

  1. Area Under the Plasma Concentration Versus Time Curve (AUC[0-t]) of NPSP795

    Time frame: 10 Minutes (min) Infusion Time: within 5 min pre-dose; & post-dose 5, 10, 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 8 hours (hr). 3.5 hr Infusion Time: within 5 min pre-dose; & post-dose 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 hr

  2. Area Under the Concentration Time Curve Extrapolated to Infinity (AUC0-infinity) of NPSP795

    Time frame: 10 Minutes (min) Infusion Time: within 5 min pre-dose; & post-dose 5, 10, 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 8 hours (hr). 3.5 hr Infusion Time: within 5 min pre-dose; & post-dose 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 hr

  3. Maximum Observed Drug Concentration (Cmax) of NPSP795 in Plasma

    Time frame: 10 Minutes (min) Infusion Time: within 5 min pre-dose; & post-dose 5, 10, 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 8 hours (hr). 3.5 hr Infusion Time: within 5 min pre-dose; & post-dose 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 hr

  4. Elimination Half-life (t1/2) of NPSP795 in Plasma

    Time frame: 10 Minutes (min) Infusion Time: within 5 min pre-dose; & post-dose 5, 10, 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 8 hours (hr). 3.5 hr Infusion Time: within 5 min pre-dose; & post-dose 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 hr

  5. Change From Baseline in Fractional Excretion of Calcium (FECa)

    Time frame: 10 Minutes (min) Infusion Time: within 5 min pre-dose; & post-dose 1, 2, 3, 4, 8, 12 hours (hr). 3.5 hr Infusion Time: within 5 min pre-dose; & post-dose 1, 2, 3, 4, 8, 12 hr.

07

Results

Posted Dec 21, 2016

Participant flow

Participant flow — Overall Study
MilestoneNPSP795
Started7
Participants started in pre-amendment2
Participants started in post-amendment5
Treated5
Completed5
Not completed2
Withdrew: Screen failures2

Outcome measures

PrimaryNumber of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Time frame:
From Day 1 up to safety follow-up assessment (upto Day 17 after discharge)
Reported as:
Number · participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
participantsNPSP795
Participants with TEAEs3
Participants with TESAEs1
PrimaryNumber of Participants With Clinically Significant Vital Signs and Electrocardiogram (ECG) Abnormalities
Time frame:
From Day 1 up to safety follow-up assessment (upto Day 17 after discharge)
Reported as:
Number · participants
Number of Participants With Clinically Significant Vital Signs and Electrocardiogram (ECG) Abnormalities
participantsNPSP795
Number of Participants With Clinically Significant Vital Signs and Electrocardiogram (ECG) Abnormalities0
PrimaryNumber of Participants With Potentially Clinically Important Laboratory Abnormalities
Time frame:
From Day 1 up to safety follow-up assessment (upto Day 17 after discharge)
Reported as:
Number · participants
Number of Participants With Potentially Clinically Important Laboratory Abnormalities
participantsNPSP795
Number of Participants With Potentially Clinically Important Laboratory Abnormalities1
PrimaryNumber of Participants With Clinically Significant Abnormalities Related to Physical Examination
Time frame:
From Day 1 up to safety follow-up assessment (upto Day 17 after discharge)
Reported as:
Number · participants
Number of Participants With Clinically Significant Abnormalities Related to Physical Examination
participantsNPSP795
Number of Participants With Clinically Significant Abnormalities Related to Physical Examination1
PrimaryChange From Baseline in Ionised Calcium
Time frame:
10 Minute (min) Infusion Time: within 5 min pre-dose; & post-dose 15, 30, 45, 60, 75, 90, 105 min, and 2, 2.5, 3, 3.5, & 4 hour (hr) 3.5 hr Infusion Time: within 5 min pre-dose; & post-dose 15, 30, 45, 60, 75, 90, 105 min, & 2, 2.5, 3, 3.5, 4, 5, and 8 hr
Reported as:
Mean · millimole/liter (mmol/L)
Change From Baseline in Ionised Calcium
millimole/liter (mmol/L)NPSP795 on Day 1 (5 mg/10 Minutes)NPSP795 on Day 2 (15 mg/3.5 Hours)NPSP795 on Day 3 (30 mg/3.5 Hours)NPSP795 on Day 4 (30 mg/3.5 Hours)NPSP795 on Day 4 (50 mg/3.5 Hours)
Baseline0.972 ± 0.0580.950 ± 0.0540.986 ± 0.0450.933 ± 0.0551.025 ± 0.078
Change at 4 Hours Post dose-0.016 ± 0.0270.010 ± 0.026-0.014 ± 0.023-0.030 ± 0.046-0.015 ± 0.035
Change at 8 Hours Post doseNA ± NA-0.034 ± 0.044-0.040 ± 0.060-0.033 ± 0.046-0.060 ± 0.028
PrimaryChange From Baseline in Serum Calcium
Time frame:
10 Minutes (min) Infusion Time: within 5 min pre-dose; & post-dose 1, 2, 3, 4, 8 12 hours (hr). 3.5 hr Infusion Time: within 5 min pre-dose; & post-dose 1, 2, 3, 4, 8 12 hr.
Reported as:
Mean · millimole/liter (mmol/L)
Change From Baseline in Serum Calcium
millimole/liter (mmol/L)NPSP795 on Day 1 (5 mg/10 Minutes)NPSP795 on Day 2 (15 mg/3.5 Hours)NPSP795 on Day 3 (30 mg/3.5 Hours)NPSP795 on Day 4 (30 mg/3.5 Hours)NPSP795 on Day 4 (50 mg/3.5 Hours)
Baseline1.914 ± 0.1571.790 ± 0.1251.852 ± 0.1321.677 ± 0.1351.980 ± 0.184
Change at 12 Hours Postdose-0.114 ± 0.141-0.042 ± 0.054-0.106 ± 0.079-0.040 ± 0.053-0.270 ± 0.057
PrimaryChange From Baseline in Urinary Calcium
Time frame:
10 Minutes (min) Infusion Time: within 5 min pre-dose; & post-dose 1, 2, 3, 4, 8 12 hours (hr). 3.5 hr Infusion Time: within 5 min pre-dose; & post-dose 1, 2, 3, 4, 8 12 hr.
Reported as:
Mean · millimole/liter (mmol/L)
Change From Baseline in Urinary Calcium
millimole/liter (mmol/L)NPSP795 on Day 1 (5 mg/10 Minutes)NPSP795 on Day 2 (15 mg/3.5 Hours)NPSP795 on Day 3 (30 mg/3.5 Hours)NPSP795 on Day 4 (30 mg/3.5 Hours)NPSP795 on Day 4 (50 mg/3.5 Hours)
Baseline3.302 ± 2.2833.912 ± 3.2992.936 ± 1.7502.537 ± 1.9682.065 ± 1.916
Change at 12 Hours Postdose-0.590 ± 0.861-2.162 ± 2.027-1.188 ± 1.634-1.190 ± 1.460-0.755 ± 1.082
PrimaryChange From Baseline in Serum Parathyroid Hormone (PTH)
Time frame:
10 Minutes (min) Infusion Time: within 5 min pre-dose; & post-dose 5, 10, 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 8 hours (hr). 3.5 hr Infusion Time: within 5 min pre-dose; & post-dose 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 hr
Reported as:
Mean · nanogram/liter (ng/L)
Change From Baseline in Serum Parathyroid Hormone (PTH)
nanogram/liter (ng/L)NPSP795 on Day 1 (5 mg/10 Minutes)NPSP795 on Day 2 (15 mg/3.5 Hours)NPSP795 on Day 3 (30 mg/3.5 Hours)NPSP795 on Day 4 (30 mg/3.5 Hours)NPSP795 on Day 4 (50 mg/3.5 Hours)
Baseline7.32 ± 2.939.14 ± 3.299.58 ± 5.3212.80 ± 8.687.40 ± 3.54
Change at 5.5 Hours PostdoseNA ± NA0.84 ± 0.861.92 ± 1.530.13 ± 1.501.75 ± 0.64
Change at 8 Hours Postdose0.60 ± 1.56NA ± NANA ± NANA ± NANA ± NA
SecondaryArea Under the Plasma Concentration Versus Time Curve (AUC[0-t]) of NPSP795
Time frame:
10 Minutes (min) Infusion Time: within 5 min pre-dose; & post-dose 5, 10, 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 8 hours (hr). 3.5 hr Infusion Time: within 5 min pre-dose; & post-dose 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 hr
Reported as:
Mean · nanogram*hour per millilitre (ng·h/mL)
Area Under the Plasma Concentration Versus Time Curve (AUC[0-t]) of NPSP795
nanogram*hour per millilitre (ng·h/mL)NPSP795 on Day 1 (5 mg/10 Minutes)NPSP795 on Day 2 (15 mg/3.5 Hours)NPSP795 on Day 3 (30 mg/3.5 Hours)NPSP795 on Day 4 (30 mg/3.5 Hours)NPSP795 on Day 4 (50 mg/3.5 Hours)
Area Under the Plasma Concentration Versus Time Curve (AUC[0-t]) of NPSP795309.512 ± 122.601795.766 ± 294.3451561.746 ± 546.4791657.057 ± 650.1562251.818 ± 568.782
SecondaryArea Under the Concentration Time Curve Extrapolated to Infinity (AUC0-infinity) of NPSP795
Time frame:
10 Minutes (min) Infusion Time: within 5 min pre-dose; & post-dose 5, 10, 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 8 hours (hr). 3.5 hr Infusion Time: within 5 min pre-dose; & post-dose 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 hr
Reported as:
Mean · nanogram*hour per milliliter(ng·h/mL)
Area Under the Concentration Time Curve Extrapolated to Infinity (AUC0-infinity) of NPSP795
nanogram*hour per milliliter(ng·h/mL)NPSP795 on Day 1 (5 mg/10 Minutes)NPSP795 on Day 2 (15 mg/3.5 Hours)NPSP795 on Day 3 (30 mg/3.5 Hours)NPSP795 on Day 4 (30 mg/3.5 Hours)NPSP795 on Day 4 (50 mg/3.5 Hours)
Area Under the Concentration Time Curve Extrapolated to Infinity (AUC0-infinity) of NPSP7952.672 ± 1.7755.572 ± 2.7245.437 ± 2.5877.648 ± 3.6074.521 ± 2.991
SecondaryMaximum Observed Drug Concentration (Cmax) of NPSP795 in Plasma
Time frame:
10 Minutes (min) Infusion Time: within 5 min pre-dose; & post-dose 5, 10, 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 8 hours (hr). 3.5 hr Infusion Time: within 5 min pre-dose; & post-dose 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 hr
Reported as:
Mean · nanogram/milliliter (ng/mL)
Maximum Observed Drug Concentration (Cmax) of NPSP795 in Plasma
nanogram/milliliter (ng/mL)NPSP795 on Day 1 (5 mg/10 Minutes)NPSP795 on Day 2 (15 mg/3.5 Hours)NPSP795 on Day 3 (30 mg/3.5 Hours)NPSP795 on Day 4 (30 mg/3.5 Hours)NPSP795 on Day 4 (50 mg/3.5 Hours)
Maximum Observed Drug Concentration (Cmax) of NPSP795 in Plasma301.900 ± 120.664745.335 ± 254.2051467.102 ± 475.3431515.086 ± 548.0562141.500 ± 475.706
SecondaryElimination Half-life (t1/2) of NPSP795 in Plasma
Time frame:
10 Minutes (min) Infusion Time: within 5 min pre-dose; & post-dose 5, 10, 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 8 hours (hr). 3.5 hr Infusion Time: within 5 min pre-dose; & post-dose 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 hr
Reported as:
Mean · hour
Elimination Half-life (t1/2) of NPSP795 in Plasma
hourNPSP795 on Day 1 (5 mg/10 Minutes)NPSP795 on Day 2 (15 mg/3.5 Hours)NPSP795 on Day 3 (30 mg/3.5 Hours)NPSP795 on Day 4 (30 mg/3.5 Hours)NPSP795 on Day 4 (50 mg/3.5 Hours)
Elimination Half-life (t1/2) of NPSP795 in Plasma3.013 ± 0.6123.913 ± 0.2224.213 ± 0.4493.839 ± 0.2944.000 ± 0.000
SecondaryChange From Baseline in Fractional Excretion of Calcium (FECa)
Time frame:
10 Minutes (min) Infusion Time: within 5 min pre-dose; & post-dose 1, 2, 3, 4, 8, 12 hours (hr). 3.5 hr Infusion Time: within 5 min pre-dose; & post-dose 1, 2, 3, 4, 8, 12 hr.
Reported as:
Mean · Fraction of excretion
Change From Baseline in Fractional Excretion of Calcium (FECa)
Fraction of excretionNPSP795 on Day 1 (5 mg/10 Minutes)NPSP795 on Day 2 (15 mg/3.5 Hours)NPSP795 on Day 3 (30 mg/3.5 Hours)NPSP795 on Day 4 (30 mg/3.5 Hours)NPSP795 on Day 4 (50 mg/3.5 Hours)
FECa: Baseline0.030 ± 0.0230.031 ± 0.0170.027 ± 0.0140.030 ± 0.0110.026 ± 0.032
FECa: Change at 12 Hours Postdose0.002 ± 0.0050.002 ± 0.0120.001 ± 0.011-0.009 ± 0.0180.002 ± 0.007

Adverse events

Collected over From the sign of informed consent form (Day -93) up to safety follow-up assessment (upto Day 17 after discharge). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
NPSP795—1/5 (20%)3/5 (60%)
Most frequent serious events
Most frequent serious events
EventNPSP795
CholelithiasisHepatobiliary disorders1/5
Most frequent other events
Most frequent other events
EventNPSP795
CholelithiasisHepatobiliary disorders1/5
Hypersensitivity reactionImmune system disorders1/5
Nipple painReproductive system and breast disorders1/5

Baseline characteristics

Age, Continuous
Age, Continuous(Years)NPSP795
Mean39.8 ± 15.2
Sex: Female, Male
Sex: Female, Male(Participants)NPSP795
Female2
Male3
08

Study locations

1 site
  • National Institute of Health (NIH)
    Bethesda, Maryland 20892-1103, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02204579
Lead sponsor
Shire
Collaborators
National Institutes of Health (NIH)
Responsible party
Sponsor
First posted
Jul 30, 2014
Start date
Jul 18, 2014
Primary completion
May 4, 2015
Completion
May 4, 2015
Results posted
Dec 21, 2016
Last update
Aug 9, 2021

Study contacts

Study Director
study director · Takeda

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hypocalcemia →

Other studies from this sponsor

Shire →

Start the discussion