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Study to Evaluate Cinacalcet in Children With Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT01290029
Recruitment Status : Completed
First Posted : February 4, 2011
Results First Posted : December 19, 2016
Last Update Posted : June 17, 2020
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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Brief Summary:
The primary objective of the study was to evaluate the safety and tolerability of cinacalcet after a single oral dose in children aged 28 days to less than 6 years with chronic kidney disease receiving dialysis.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Hyperparathyroidism, Secondary Secondary Hyperparathyroidism Drug: Cinacalcet Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Cinacalcet HCl in Pediatric Subjects Aged 28 Days to Less Than 6 Years With Chronic Kidney Disease Receiving Dialysis
Actual Study Start Date : January 25, 2011
Actual Primary Completion Date : September 23, 2015
Actual Study Completion Date : September 23, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cinacalcet
Participants received a single, oral dose of 0.25 mg/kg cinacalcet.
 Drug: Cinacalcet
Single, oral dose of 0.25 mg/kg cinacalcet
Other Names:
  • Sensipar®
  • Mimpara®


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Adverse Events [ Time Frame: Day 1 to day 30 ]
    A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal • life threatening • requires in patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other medically important serious event. Treatment-related adverse events are those the investigator assessed as being possibly related to any study mandated activity (eg, administration of investigational product, protocol-required therapies, device(s) and/or procedure). Events of interest included acute pancreatitis, convulsions, drug related hepatic disorders, fractures, hypersensitivity, hypocalcemia, ischaemic heart disease, ventricular tachyarrhythmias, cardiac failure, and hypotension.


Secondary Outcome Measures :
  1. Area Under the Plasma Concentration Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) for Cinacalcet [ Time Frame: Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose ]
  2. Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUCinf) for Cinacalcet [ Time Frame: Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose ]
  3. Maximum Observed Plasma Concentration (Cmax) of Cinacalcet [ Time Frame: Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose ]
  4. Time to Reach Maximum Observed Plasma Concentration of Cinacalcet (Tmax) [ Time Frame: Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose ]
  5. Terminal Half-life of Cinacalcet [ Time Frame: Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose ]
    The terminal half-life (T1/2) of cinacalcet associated with the slope of the terminal phase.

  6. Percent Change From Baseline in Intact Parathyroid Hormone [ Time Frame: Baseline (predose) and at 2, 8, 12 and 48 hours post-dose. ]
  7. Percent Change From Baseline in Total Calcium [ Time Frame: Baseline (predose) and 2, 8, 12 and 48 hours post-dose. ]
  8. Percent Change From Baseline in Albumin Corrected Calcium [ Time Frame: Baseline (predose) and 2, 8, 12 and 48 hours post-dose. ]
  9. Percent Change From Baseline in Ionized Calcium [ Time Frame: Baseline (predose) and 2, 8, 12 and 48 hours post-dose. ]

Eligibility Criteria
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Ages Eligible for Study:   28 Days to 2190 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject's parent, or legally acceptable guardian, must sign an Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved Informed Consent Form.
  • Subjects 28 days to < 6 years of age with chronic kidney disease (CKD) and secondary hyperparathyroidism (sHPT) as diagnosed by principal investigators, undergoing hemodialysis or peritoneal dialysis at the time of screening (subjects 6 months or older should have been receiving dialysis for ≥ 1 months) and who have not received any cinacalcet HCl therapy for at least 2 weeks prior to dosing on Day 1
  • Free of any disease or condition (other than those diseases or conditions related to their renal disease that, in the opinion of the investigator, would impact the subject's safety or the integrity of the study data).
  • Must weigh ≥ 6 kg at screening and at Day-1.
  • Must be at least 30 weeks of gestational age.
  • Physical examination must be acceptable to the investigator at screening and at Day -1.
  • Hemoglobin ≥ 8 g/dL at screening and at Day -1.
  • Serum calcium within age-appropriate normal ranges per the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF KDOQI) guidelines at screening and at Day -1
  • Normal or clinically acceptable electrocardiogram (ECG) (12-lead reporting RR, PR, QRS, and QTc intervals) at screening and at Day -1.
  • Clinical laboratory tests that are acceptable to the investigator at screening and at Day -1.

Exclusion Criteria

  • Current or historic malignancy.
  • Cardiac ventricular arrhythmias within 28 days prior to screening.
  • A gastrointestinal disorder or surgery that could affect the absorption of drugs (eg, pyloric stenosis or any gut-shortening surgical procedure prior to screening).
  • A new onset of seizure or worsening of a pre-existing seizure disorder within 2 months prior to IP administration.
  • Major surgery (defined as any surgical procedure that involves general anesthesia or respiratory assistance) within 28 days prior to screening.
  • Hepatic impairment indicated by elevated levels of hepatic transaminase or bilirubin (aspartate aminotransferase (AST) ≥ 1.5 x upper limit of normal (ULN) OR alanine aminotransferase (ALT) ≥ 1.5 x ULN OR total bilirubin ≥ 1 x ULN per institutional laboratory range) at screening or Day-1.
  • History of prolongation of the QT interval (eg, congenital long QT interval, second or third degree heart block or other conditions which prolong the QT interval)
  • Corrected QT Interval (QTc) > 500 ms during screening, using Bazett's formula
  • QTc ≥ 450 and ≤ 500 ms during screening, using Bazett's formula, unless written permission to enroll is provided by the investigator after consultation with a pediatric cardiologist
  • Known hypersensitivity to cinacalcet HCl or any of the excipients in cinacalcet HCl.
  • Use of grapefruit juice, herbal medications or potent CYP 3A4 inhibitors (eg, erythromycin, clarithromycin, ketokonazole, itraconazole) within the 14 days prior to enrollment and during the study.
  • Concurrent or within 28 days prior to enrollment use of medications that are predominantly metabolized by the enzyme CYP2D6 and have a narrow therapeutic index (eg, flecainide, vinblastine, thioridazine, tricyclic antidepressants such as desipramine and imipramine, and beta-blockers such as metoprolol or carvedilol).
  • Concurrent or within 28 days prior to enrollment use of medications that prolong QT interval (eg, sotalol, amiodarone, erythromycin, or clarithromycin).
  • Currently receiving treatment in another investigational device or drug study, or less than 90 days since ending treatment on another investigational device or drug study(s).
  • Other investigational procedures while participating in this study are excluded.
Contacts and Locations
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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): NCT01290029


Locations
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United States, California
Research Site
Los Angeles, California, United States, 90095
Research Site
San Francisco, California, United States, 94143
United States, Kentucky
Research Site
Louisville, Kentucky, United States, 40202
United States, Missouri
Research Site
Kansas City, Missouri, United States, 64108
Germany
Research Site
Heidelberg, Germany, 69120
United Kingdom
Research Site
Bristol, United Kingdom, BS2 8BJ
Research Site
Glasgow, United Kingdom, G3 8SJ
Research Site
Leeds, United Kingdom, LS1 3EX
Research Site
Manchester, United Kingdom, M13 9WL
Research Site
Nottingham, United Kingdom, NG7 2UH
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
More Information
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Additional Information:

Publications:

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01290029    
Other Study ID Numbers: 20090005
First Posted: February 4, 2011    Key Record Dates
Results First Posted: December 19, 2016
Last Update Posted: June 17, 2020
Last Verified: June 2020
Keywords provided by Amgen:
pediatric
CKD
dialysis
paediatric
Additional relevant MeSH terms:
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Neoplasm Metastasis
Kidney Diseases
Renal Insufficiency, Chronic
Hyperparathyroidism
Hyperparathyroidism, Secondary
Urologic Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
 Renal Insufficiency
Parathyroid Diseases
Endocrine System Diseases
Cinacalcet
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Calcimimetic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists