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Primary HyperparathyroidismPhase 2NCT03776058

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

A Phase 2 study testing Cinacalcet in people with Primary Hyperparathyroidism, run by Amgen.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Primary Hyperparathyroidism
What is being tested?
Cinacalcet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
10 participants
Where
No sites listed yet
Study dates
15 Jun 2000to 26 Dec 2000
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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.
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  • 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

About this study

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)

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.

Being tested
Cinacalcet, Placebo
Medical subject headings
Hyperparathyroidism, Primary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CinacalcetDrug

    Also called AMG 073, Sensipar®, Mimpara®

    Tablets for oral administration

  • PlaceboDrug

    Tablets for oral administration

Study groups in NCT03776058
Study groupRoleWhat they receive
CinacalcetExperimentalParticipants received 65 mg cinacalcet orally twice a day for 4 weeks.
Receives: Drug: Cinacalcet
PlaceboPlacebo comparatorParticipants received placebo to cinacalcet orally twice a day for 4 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Adverse Events

    Measured: 4 weeks

  2. Number of Participants with Clinically Significant Laboratory Tests, Vital Signs or Electrocardiogram Assessments

    Measured: 4 weeks

Secondary outcomes (10)

  1. Percent Change from Baseline in Serum Calcium

    Measured: Baseline and week 4

  2. Percent Change from Baseline in Plasma Intact Parathyroid Hormone (iPTH)

    Measured: Baseline and week 4

  3. Percent Change from Baseline in Bone-specific Alkaline Phosphatase (BALP)

    Measured: Baseline and week 4

  4. Percent Change from Baseline in 1,25 dihydroxy Vitamin D3

    Measured: Baseline and week 4

  5. Percent Change from Baseline in Serum Phosphorus

    Measured: Baseline and week 4

  6. Percent Change from Baseline in N-telopeptide (NTx)

    Measured: Baseline and week 4

  7. Percent Change from Baseline in Urine Osmolality

    Measured: Baseline and week 4

  8. Percent Change from Baseline in Calcium/Creatinine Ratio

    Measured: Baseline and week 4

  9. Percent Change from Baseline in Phosphorus/Creatinine Ratio

    Measured: Baseline and week 4

  10. Percent Change from Baseline in N-telopeptide/Creatinine Ratio

    Measured: Baseline and week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2018
  2. Study start15 Jun 2000
  3. Primary completion26 Dec 2000
  4. Study completion26 Dec 2000

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03776058
Sponsor's protocol ID
00990160
Status last verified
Dec 2018
First submitted
13 Dec 2018
Last updated
14 Dec 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cinacalcet in people with Primary Hyperparathyroidism, run by Amgen.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Adverse Events (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03776058.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2018.

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