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Safety, Tolerability, and Clinical Effects of Twice-daily Doses of Cinacalcet (AMG 073) in Adults With Primary Hyperparathyroidism (HPT)

Primary Purpose

Primary Hyperparathyroidism

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Cinacalcet
Placebo
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Hyperparathyroidism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men or women ≥ 18 years old before beginning of screening
  • Use, in the opinion of the principal investigator, effective contraceptive measures throughout the study
  • Negative serum pregnancy test within 15 days before day 0
  • Plasma iPTH concentration > 45 pg/mL on at least 2 occasions (during the screening phase) at least 7 days apart
  • Serum calcium concentration ≥ 11 mg/dL on 2 occasions (during the screening phase) at least 7 days apart
  • Acceptable renal function, with an estimated creatinine clearance > 50 mL/min as determined by the Cockroft and Gault equation
  • Acceptable hepatic function, defined as serum aspartate transaminase (AST), alanine transaminase (ALT), and total bilirubin ≤ 2 times the upper limit of normal (central laboratory's range)
  • Laboratory test results within the central laboratory's normal range for hematology, coagulation, urinalysis, and clinical chemistry parameters not mentioned specifically in other inclusion/exclusion criteria
  • Chest x-ray within the past 12 months, with no evidence of an active infectious, inflammatory, or malignant process
  • Informed consent for participation in the study

Exclusion Criteria:

  • Any unstable medical condition requiring hospitalization within 30 days before day 0, or otherwise unstable condition in the judgment of the investigator
  • Awaiting or scheduled for parathyroidectomy within 2 months after study day 0
  • Pregnant or nursing
  • Received, within 21 days before day 0, therapy with systemic glucocorticoids (> 5 mg/day prednisone or equivalent), lithium, tricyclic antidepressants (with the exception of amitriptyline and nortriptyline), thioridazine, haloperidol, flecainide, drugs with a narrow therapeutic index that are primarily metabolized by hepatic cytochrome P450 CYP 2D6, drugs that affect renal tubular calcium handling (ie, thiazide or loop diuretics), or calcitonin
  • Dose changes in bisphosphonates, thyroid replacement therapy, selective estrogen receptor modulators (SERMs), or changes in daily doses of estrogen (greater than 0.75 mg) within 90 days before day 0
  • Subjects who discontinued estrogen or SERM therapy must have been off treatment for at least 90 days before day 0.
  • Alcohol or illicit drug abuse within 12 months before day 0 based on self-report
  • Myocardial infarction within 6 months before day 0
  • Ventricular rhythm disturbance requiring current treatment
  • Seizure within 12 months before day 0
  • History (within 5 years) of malignancy of any type, other than nonmelanomatous skin cancers or in situ cervical cancer
  • Evidence (within 5 years) of treatment for and/or active sarcoidosis, tuberculosis, or diseases other than primary HPT known to cause hypercalcemia
  • History of familial hypocalciuric hypercalcemia (FHH)
  • Uncontrolled diabetes, as defined by hemoglobin A1c (HbA1c) ≥ 8.0
  • Gastrointestinal disorder that may be associated with impaired absorption of orally administered medications
  • Inability to swallow tablets similar in size to an aspirin tablet
  • Known sensitivity to products administered during the study
  • Previous participation as a subject in this study (ie, withdrawn early) or a prior study involving AMG 073 administration
  • Enrolled in, or not yet completed at least 28 days since ending other investigational device or drug trial(s)
  • Psychiatric disorder that would interfere with understanding and giving informed consent or compliance with protocol requirements
  • Any other condition that might reduce the chance of obtaining data (ie, known poor compliance) required by the protocol or that might compromise the ability to give truly informed consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Cinacalcet

    Placebo

    Arm Description

    Participants received 65 mg cinacalcet orally twice a day for 4 weeks.

    Participants received placebo to cinacalcet orally twice a day for 4 weeks.

    Outcomes

    Primary Outcome Measures

    Number of Participants with Adverse Events
    Number of Participants with Clinically Significant Laboratory Tests, Vital Signs or Electrocardiogram Assessments

    Secondary Outcome Measures

    Percent Change from Baseline in Serum Calcium
    Percent Change from Baseline in Plasma Intact Parathyroid Hormone (iPTH)
    Percent Change from Baseline in Bone-specific Alkaline Phosphatase (BALP)
    Percent Change from Baseline in 1,25 dihydroxy Vitamin D3
    Percent Change from Baseline in Serum Phosphorus
    Percent Change from Baseline in N-telopeptide (NTx)
    Percent Change from Baseline in Urine Osmolality
    Percent Change from Baseline in Calcium/Creatinine Ratio
    Percent Change from Baseline in Phosphorus/Creatinine Ratio
    Percent Change from Baseline in N-telopeptide/Creatinine Ratio

    Full Information

    First Posted
    December 13, 2018
    Last Updated
    December 13, 2018
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03776058
    Brief Title
    Safety, Tolerability, and Clinical Effects of Twice-daily Doses of Cinacalcet (AMG 073) in Adults With Primary Hyperparathyroidism (HPT)
    Official Title
    A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Safety, Tolerability, and Clinical Effects of Twice-daily Doses of an Oral Calcimimetic Agent (AMG 073) in Subjects With Primary Hyperparathyroidism (HPT)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    June 15, 2000 (Actual)
    Primary Completion Date
    December 26, 2000 (Actual)
    Study Completion Date
    December 26, 2000 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Amgen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The primary objectives were to assess the safety and tolerability of twice daily (BID) doses of 65 mg cinacalcet administered orally to adults with primary HPT.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Primary Hyperparathyroidism

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cinacalcet
    Arm Type
    Experimental
    Arm Description
    Participants received 65 mg cinacalcet orally twice a day for 4 weeks.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Participants received placebo to cinacalcet orally twice a day for 4 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Cinacalcet
    Other Intervention Name(s)
    AMG 073, Sensipar®, Mimpara®
    Intervention Description
    Tablets for oral administration
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Tablets for oral administration
    Primary Outcome Measure Information:
    Title
    Number of Participants with Adverse Events
    Time Frame
    4 weeks
    Title
    Number of Participants with Clinically Significant Laboratory Tests, Vital Signs or Electrocardiogram Assessments
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Percent Change from Baseline in Serum Calcium
    Time Frame
    Baseline and week 4
    Title
    Percent Change from Baseline in Plasma Intact Parathyroid Hormone (iPTH)
    Time Frame
    Baseline and week 4
    Title
    Percent Change from Baseline in Bone-specific Alkaline Phosphatase (BALP)
    Time Frame
    Baseline and week 4
    Title
    Percent Change from Baseline in 1,25 dihydroxy Vitamin D3
    Time Frame
    Baseline and week 4
    Title
    Percent Change from Baseline in Serum Phosphorus
    Time Frame
    Baseline and week 4
    Title
    Percent Change from Baseline in N-telopeptide (NTx)
    Time Frame
    Baseline and week 4
    Title
    Percent Change from Baseline in Urine Osmolality
    Time Frame
    Baseline and week 4
    Title
    Percent Change from Baseline in Calcium/Creatinine Ratio
    Time Frame
    Baseline and week 4
    Title
    Percent Change from Baseline in Phosphorus/Creatinine Ratio
    Time Frame
    Baseline and week 4
    Title
    Percent Change from Baseline in N-telopeptide/Creatinine Ratio
    Time Frame
    Baseline and week 4

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Men or women ≥ 18 years old before beginning of screening Use, in the opinion of the principal investigator, effective contraceptive measures throughout the study Negative serum pregnancy test within 15 days before day 0 Plasma iPTH concentration > 45 pg/mL on at least 2 occasions (during the screening phase) at least 7 days apart Serum calcium concentration ≥ 11 mg/dL on 2 occasions (during the screening phase) at least 7 days apart Acceptable renal function, with an estimated creatinine clearance > 50 mL/min as determined by the Cockroft and Gault equation Acceptable hepatic function, defined as serum aspartate transaminase (AST), alanine transaminase (ALT), and total bilirubin ≤ 2 times the upper limit of normal (central laboratory's range) Laboratory test results within the central laboratory's normal range for hematology, coagulation, urinalysis, and clinical chemistry parameters not mentioned specifically in other inclusion/exclusion criteria Chest x-ray within the past 12 months, with no evidence of an active infectious, inflammatory, or malignant process Informed consent for participation in the study Exclusion Criteria: Any unstable medical condition requiring hospitalization within 30 days before day 0, or otherwise unstable condition in the judgment of the investigator Awaiting or scheduled for parathyroidectomy within 2 months after study day 0 Pregnant or nursing Received, within 21 days before day 0, therapy with systemic glucocorticoids (> 5 mg/day prednisone or equivalent), lithium, tricyclic antidepressants (with the exception of amitriptyline and nortriptyline), thioridazine, haloperidol, flecainide, drugs with a narrow therapeutic index that are primarily metabolized by hepatic cytochrome P450 CYP 2D6, drugs that affect renal tubular calcium handling (ie, thiazide or loop diuretics), or calcitonin Dose changes in bisphosphonates, thyroid replacement therapy, selective estrogen receptor modulators (SERMs), or changes in daily doses of estrogen (greater than 0.75 mg) within 90 days before day 0 Subjects who discontinued estrogen or SERM therapy must have been off treatment for at least 90 days before day 0. Alcohol or illicit drug abuse within 12 months before day 0 based on self-report Myocardial infarction within 6 months before day 0 Ventricular rhythm disturbance requiring current treatment Seizure within 12 months before day 0 History (within 5 years) of malignancy of any type, other than nonmelanomatous skin cancers or in situ cervical cancer Evidence (within 5 years) of treatment for and/or active sarcoidosis, tuberculosis, or diseases other than primary HPT known to cause hypercalcemia History of familial hypocalciuric hypercalcemia (FHH) Uncontrolled diabetes, as defined by hemoglobin A1c (HbA1c) ≥ 8.0 Gastrointestinal disorder that may be associated with impaired absorption of orally administered medications Inability to swallow tablets similar in size to an aspirin tablet Known sensitivity to products administered during the study Previous participation as a subject in this study (ie, withdrawn early) or a prior study involving AMG 073 administration Enrolled in, or not yet completed at least 28 days since ending other investigational device or drug trial(s) Psychiatric disorder that would interfere with understanding and giving informed consent or compliance with protocol requirements Any other condition that might reduce the chance of obtaining data (ie, known poor compliance) required by the protocol or that might compromise the ability to give truly informed consent

    12. IPD Sharing Statement

    Learn more about this trial

    Safety, Tolerability, and Clinical Effects of Twice-daily Doses of Cinacalcet (AMG 073) in Adults With Primary Hyperparathyroidism (HPT)

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