Efficacy and Safety of Cinacalcet in Pediatric Patients With Secondary Hyperparathyroidism (SHPT) and Chronic Kidney Disease (CKD) on Dialysis

June 12, 2020 updated by: Amgen

A Randomized, Open-label, Controlled Study to Assess the Efficacy and Safety of Cinacalcet HCl in Pediatric Subjects With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Dialysis

The primary objective was to evaluate the efficacy of cinacalcet for reducing the plasma intact parathyroid hormone (iPTH) level by ≥ 30%.

Study Overview

Detailed Description

This was a 24-week, randomized, multicenter, open-label, controlled study. Participants were randomized into one of two treatment arms; oral administration of cinacalcet daily in addition to standard of care treatment, or standard of care alone. Randomization was stratified by age group (6 to < 12 and 12 to < 18 years of age). All participants received standard of care which could include therapy with Vitamin D sterols, calcium supplementation, and phosphate binders.

Participants in both treatment groups who completed the 20-week treatment period and those who ended the study due to study closure were eligible to enroll in an open-label extension study (20140159; NCT02341417) for further safety follow-up.

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 3

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

      • Bruxelles, Belgium, 1020
        • Research Site
      • Gent, Belgium, 9000
        • Research Site
      • Leuven, Belgium, 3000
        • Research Site
      • Praha 5, Czechia, 150 06
        • Research Site
      • Bron cedex, France, 69677
        • Research Site
      • Lille, France, 59800
        • Research Site
      • Marseille cedex 05, France, 13385
        • Research Site
      • Nice cedex 3, France, 06202
        • Research Site
      • Paris, France, 75012
        • Research Site
      • Paris, France, 75015
        • Research Site
      • Paris, France, 75019
        • Research Site
      • Hannover, Germany, 30625
        • Research Site
      • Heidelberg, Germany, 69120
        • Research Site
      • Marburg, Germany, 35043
        • Research Site
      • Athens, Greece, 11527
        • Research Site
      • Thessaloniki, Greece, 54642
        • Research Site
      • Budapest, Hungary, 1083
        • Research Site
      • Szeged, Hungary, 6720
        • Research Site
      • Genova, Italy, 16147
        • Research Site
      • Napoli, Italy, 80129
        • Research Site
      • Torino, Italy, 10126
        • Research Site
      • Vilinus, Lithuania, 08406
        • Research Site
      • Grafton, Auckland, New Zealand, 1023
        • Research Site
      • Krakow, Poland, 30-663
        • Research Site
      • Lodz, Poland, 93-338
        • Research Site
      • Warszawa, Poland, 00-576
        • Research Site
      • Porto, Portugal, 4050 371
        • Research Site
      • Moscow, Russian Federation, 107014
        • Research Site
      • Saint Petersburg, Russian Federation, 198205
        • Research Site
      • Samara, Russian Federation, 443095
        • Research Site
      • Kosice, Slovakia, 040 11
        • Research Site
    • Cataluña
      • Barcelona, Cataluña, Spain, 08035
        • Research Site
      • Espluques De LLobregat, Cataluña, Spain, 08950
        • Research Site
      • Kyiv, Ukraine, 01135
        • Research Site
    • California
      • Los Angeles, California, United States, 90027
        • Research Site
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Research Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Research Site
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Research Site
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • Research Site
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Research Site
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Research Site
      • Saint Louis, Missouri, United States, 63110
        • Research Site
      • Saint Louis, Missouri, United States, 63104
        • Research Site
    • New Jersey
      • West Orange, New Jersey, United States, 07052
        • Research Site
    • New York
      • Bronx, New York, United States, 10467
        • Research Site
      • New York, New York, United States, 10029
        • Research Site
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Research Site
      • Cleveland, Ohio, United States, 44106
        • Research Site
      • Columbus, Ohio, United States, 43205
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75235
        • Research Site
      • Houston, Texas, United States, 77030
        • Research Site
      • San Antonio, Texas, United States, 78229
        • Research Site
    • Utah
      • Salt Lake City, Utah, United States, 84113
        • 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

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 6 - < 18 years
  • Diagnosis of SHPT with the mean of the two consecutive central laboratory iPTH values ≥ 300 pg/mL during screening
  • Corrected calcium value of ≥ 8.8 mg/dL during screening
  • Diagnosis of CKD, receiving either hemodialysis or peritoneal dialysis, for ≥ 30 days prior to screening
  • Parent or legally acceptable representative has provided written informed consent and subject has provided written assent when required by institutional guidelines

Exclusion Criteria:

  • History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrhythmias or other conditions associated with prolonged QT interval
  • Corrected QT interval (QTc) > 500 ms, using Bazett's formula
  • QTc ≥ 450 to ≤ 500 ms, using Bazett's formula, unless written permission to enroll is provided by the investigator after consultation with a pediatric cardiologist
  • Use of grapefruit juice, herbal medications, or potent cytochrome P450 3A4 (CYP3A4) inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole)
  • Use of concomitant medications that may prolong the QTc interval (eg, ondansetron, albuterol)

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard of Care
Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
Experimental: Cinacalcet
In addition to standard of care participants received cinacalcet at a starting dose (based on dry body weight) of 0.20 mg/kg administered once a day by mouth. Dose adjustments and withholding were based on ionized calcium levels, plasma iPTH, and corrected calcium levels.
Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
Capsules were opened and either sprinkled onto soft food (≥ 5 mg dose) or suspended into a sucrose syrup (≥ 2.5 mg dose) to create a liquid suspension for administration. Tablets were used for doses of 30 mg and higher in participants who could swallow tablets.
Other Names:
  • Sensipar®
  • Mimpara®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Achieved a ≥ 30% Reduction From Baseline In Mean Plasma iPTH During Weeks 11 to 15
Time Frame: Baseline and weeks 11 to 15

Intact parathyroid hormone (iPTH) levels were measured at weeks 11 and 15; the mean value from these 2 measurements was calculated.

This endpoint was the primary endpoint in the US only.

Baseline and weeks 11 to 15
Percentage of Participants Who Achieved a ≥ 30% Reduction From Baseline in Mean Plasma Intact Parathyroid Hormone During the Efficacy Assessment Period
Time Frame: Baseline and the efficacy assessment period (EAP), weeks 17 to 20

Intact parathyroid hormone (iPTH) levels were measured at weeks 17, 18, 19 and 20; the mean value from these measurements was calculated.

This endpoint was specified as the the primary endpoint in all countries except the United States (US). In the US this endpoint was specified as a secondary efficacy endpoint.

Baseline and the efficacy assessment period (EAP), weeks 17 to 20

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants Who Achieved a Mean iPTH ≤ 300 pg/mL (31.8 Pmol/L) During Weeks 17 to 20
Time Frame: Efficacy assessment period, weeks 17 to 20
Efficacy assessment period, weeks 17 to 20
Percent Change in iPTH From Baseline to the Mean Value During Weeks 17 to 20
Time Frame: Baseline and weeks 17 to 20
Baseline and weeks 17 to 20
Change in Corrected Serum Calcium From Baseline to the Mean Value During Weeks 17 to 20
Time Frame: Baseline and weeks 17 to 20
Baseline and weeks 17 to 20
Change in Serum Phosphorus From Baseline to the Mean Value During Weeks 17 to 20
Time Frame: Baseline and weeks 17 to 20
Baseline and weeks 17 to 20

Collaborators and Investigators

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

Sponsor

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.

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)

November 7, 2014

Primary Completion (Actual)

June 23, 2016

Study Completion (Actual)

June 23, 2016

Study Registration Dates

First Submitted

April 1, 2014

First Submitted That Met QC Criteria

May 14, 2014

First Posted (Estimate)

May 15, 2014

Study Record Updates

Last Update Posted (Actual)

June 29, 2020

Last Update Submitted That Met QC Criteria

June 12, 2020

Last Verified

June 1, 2020

More Information

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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