Study to Evaluate Cinacalcet in Children With Chronic Kidney Disease

June 12, 2020 updated by: Amgen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany, 69120
        • Research Site
  • United Kingdom
      • 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
        • Research Site
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Research Site
      • San Francisco, California, United States, 94143
        • Research Site
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Research Site
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 weeks to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1 to day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose
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
Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose
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
Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose
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
Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose
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.
Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose
Percent Change From Baseline in Intact Parathyroid Hormone
Time Frame: Baseline (predose) and at 2, 8, 12 and 48 hours post-dose.
Baseline (predose) and at 2, 8, 12 and 48 hours post-dose.
Percent Change From Baseline in Total Calcium
Time Frame: Baseline (predose) and 2, 8, 12 and 48 hours post-dose.
Baseline (predose) and 2, 8, 12 and 48 hours post-dose.
Percent Change From Baseline in Albumin Corrected Calcium
Time Frame: Baseline (predose) and 2, 8, 12 and 48 hours post-dose.
Baseline (predose) and 2, 8, 12 and 48 hours post-dose.
Percent Change From Baseline in Ionized Calcium
Time Frame: Baseline (predose) and 2, 8, 12 and 48 hours post-dose.
Baseline (predose) and 2, 8, 12 and 48 hours post-dose.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2011

Primary Completion (Actual)

September 23, 2015

Study Completion (Actual)

September 23, 2015

Study Registration Dates

First Submitted

January 20, 2011

First Submitted That Met QC Criteria

February 3, 2011

First Posted (Estimate)

February 4, 2011

Study Record Updates

Last Update Posted (Actual)

June 17, 2020

Last Update Submitted That Met QC Criteria

June 12, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20090005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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