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Trial record 18 of 97 for:    calcium cation

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

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ClinicalTrials.gov Identifier: NCT02204579
Recruitment Status : Completed
First Posted : July 30, 2014
Results First Posted : December 21, 2016
Last Update Posted : December 21, 2016
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Shire

Brief 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.

Condition or disease Intervention/treatment Phase
Autosomal Dominant Hypocalcemia (ADH) Drug: NPSP795 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Intravenous NPSP795 in Autosomal Dominant Hypocalcemia Due to Mutations in the Calcium-sensing Receptor Gene: A Drug Repurposing Study
Study Start Date : July 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

Arm Intervention/treatment
Experimental: NPSP795
intravenous
Drug: NPSP795



Primary Outcome Measures :
  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 at Specified Timepoint [ Time Frame: Baseline (Predose), 4 Hours and 8 Hours Postdose ]
  6. Change From Baseline in Serum Calcium at 12 Hours Postdose [ Time Frame: Baseline (Predose) to 12 Hours Postdose ]
  7. Change From Baseline in Urinary Calcium at 12 Hours Postdose [ Time Frame: Baseline (Predose) to 12 Hours Postdose ]
  8. Change From Baseline in Serum Parathyroid Hormone (PTH) at Specified Time Point [ Time Frame: Baseline (Predose), 5.5 Hours, 8 Hours Postdose ]

Secondary Outcome Measures :
  1. Area Under the Plasma Concentration Versus Time Curve (AUC[0-t]) of NPSP795 [ Time Frame: Baseline (Predose), and 15, 30 Minutes, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 and 8 Hours Postdose ]
  2. Area Under the Concentration Time Curve Extrapolated to Infinity (AUC0-infinity) of NPSP795 [ Time Frame: Baseline (Predose), and 15, 30 minutes, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 and 8 Hours Postdose ]
  3. Maximum Observed Drug Concentration (Cmax) of NPSP795 in Plasma [ Time Frame: Baseline (Predose), and 15, 30 minutes, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 and 8 Hours Postdose ]
  4. Elimination Half-life (t1/2) of NPSP795 in Plasma [ Time Frame: Baseline (Predose), and 15, 30 minutes, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 and 8 Hours Postdose ]
  5. Change From Baseline in Fractional Excretion of Calcium (FECa) at 12 Hours Postdose [ Time Frame: Baseline (Predose) to 12 Hours Postdose ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • Body mass index (BMI) ≥ 18.5 to < 39 kg/m2

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 glomerular filtration rate (GFR) < 25 mL/minute, and/or abnormal hepatic, hematologic, and/or clotting function
  • 12 lead resting electrocardiogram (ECG) with clinically significant abnormalities
  • Concomitant medications with the potential to interfere with NPSP795 metabolism
  • History of thyroid or parathyroid surgery

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): NCT02204579


Locations
United States, Maryland
National Institute of Health (NIH)
Bethesda, Maryland, United States, 20892-1103
Sponsors and Collaborators
Shire
National Institutes of Health (NIH)

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT02204579     History of Changes
Other Study ID Numbers: CAL-C13-001
First Posted: July 30, 2014    Key Record Dates
Results First Posted: December 21, 2016
Last Update Posted: December 21, 2016
Last Verified: October 2016

Keywords provided by Shire:
Autosomal Dominant Hypocalcemia
Hypocalcemia
ADH
Hypoparathyroidism

Additional relevant MeSH terms:
Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance