Safety & Tolerability of Cinacalcet in Pediatric Patients With Chronic Kidney Disease and Secondary Hyperparathyroidism

June 12, 2020 updated by: Amgen

An Open-label, Single-arm Study to Assess the Safety & Tolerability of Cinacalcet in Addition to Standard of Care in Pediatric Subjects Age 28 Days to < 6 Yrs With Chronic Kidney Disease & Secondary Hyperparathyroidism Receiving Dialysis

The primary objective was to characterize corrected serum calcium levels on treatment with cinacalcet in pediatric patients with secondary hyperparathyroidism (HPT).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a multicenter, 26-week, single-arm, open-label, safety study. Participants were to remain on study for 26 weeks or until time of kidney transplantation, whichever came first.

The study and enrollment was placed on partial clinical hold in February 2013 which resulted in changes to the protocol. The study was restarted in April 2014 following these changes.

Participants who completed the 26-week study or were on study when the study was closed in June 2016 were eligible to participate in an open-label extension study (Study 20140159; NCT02341417).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

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

  • Belgium
      • Bruxelles, Belgium, 1020
        • Research Site
      • Gent, Belgium, 9000
        • Research Site
      • Leuven, Belgium, 3000
        • Research Site
  • Czechia
      • Praha 5, Czechia, 150 06
        • Research Site
  • France
      • Bron cedex, France, 69677
        • Research Site
      • Lille, France, 59800
        • Research Site
      • Paris, France, 75012
        • Research Site
      • Paris, France, 75015
        • Research Site
      • Paris, France, 75019
        • Research Site
  • Germany
      • Heidelberg, Germany, 69120
        • Research Site
  • Hungary
      • Budapest, Hungary, 1083
        • Research Site
      • Debrecen, Hungary, 4032
        • Research Site
      • Szeged, Hungary, 6720
        • Research Site
  • Italy
      • Genova, Italy, 16147
        • Research Site
      • Roma, Italy, 00165
        • Research Site
      • Torino, Italy, 10126
        • Research Site
  • Mexico
      • Chihuahua, Mexico, 31000
        • Research Site
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Research Site
  • New Zealand
      • Grafton, Auckland, New Zealand, 1023
        • Research Site
  • Poland
      • Gdansk, Poland, 80-952
        • Research Site
      • Krakow, Poland, 30-663
        • Research Site
      • Warszawa, Poland, 00-576
        • Research Site
  • Russian Federation
      • Moscow, Russian Federation, 107014
        • Research Site
      • Saint Petersburg, Russian Federation, 198205
        • Research Site
  • Slovakia
      • Kosice, Slovakia, 040 11
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Research Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Research Site
    • California
      • Los Angeles, California, United States, 90095
        • 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
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Research Site
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Research Site
      • Saint Louis, Missouri, United States, 63110
        • Research Site
    • New York
      • Bronx, New York, United States, 10467
        • Research Site
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75390
        • Research Site
      • Houston, Texas, United States, 77030
        • Research Site
      • San Antonio, Texas, United States, 78229
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

4 weeks to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Subjects between the ages of 28 days to < 6 years of age at enrollment (Czech Republic minimum age is ≥ 2 years of age at enrollment)
  • Screening plasma iPTH level > 300 pg/mL (31.8 pmol/L) from the central laboratory, and not have received any cinacalcet therapy for at least 30 days prior to start of dosing
  • Screening corrected calcium from the central laboratory:
  • ≥ 9.4 mg/dL (2.35 mmol/L) if age 28 days to < 2 years
  • ≥ 8.8 (2.2 mmol/L) if age ≥ 2 to < 6 years
  • Serum phosphorus from the central laboratory:
  • ≥ 5.0 mg/dL (1.25 mmol/L) if age 28 days to < 1 year
  • ≥ 4.5 mg/dL (1.13 mmol/L) if age ≥ 1 to < 6 years
  • SHPT not due to vitamin D deficiency, per investigator assessment
  • Dry weight ≥ 7 kg at the time of screening

Exclusion criterion:

  • 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 CYP 3A4 inhibitors (e.g., erythromycin, clarithromycin, ketoconazole, itraconazole)
  • Use of concomitant medications that may prolong the QTc interval (e.g., 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cinacalcet

Prior to the partial clinical hold, the starting dose was 0.25 mg/kg (based on dry weight) and was titrated upwards (maximum allowed daily dose of 4.2 mg/kg) based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms.

After the partial clinical hold the starting dose was 0.20 mg/kg (based on dry weight) and was titrated upwards (maximum allowed daily dose of 2.5 or 60 mg, whichever was lower) based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms.

All participants also received standard of care, which may have included vitamin D sterols.
Drug: Cinacalcet hydrochloride
Cinacalcet was provided as 5 mg capsules that were opened, and the contents were either sprinkled on soft food or suspended into a sucrose syrup to create a liquid suspension for administration. All doses were administered with food or shortly after a meal at the same time daily.
Other Names:
  • Sensipar®
  • Mimpara®
Drug: Standard of Care
Standard of care may have included vitamin D sterols (25 OH vitamin D and/or 1-25 OH vitamin D and its analogs) at the discretion of the investigator.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Hypocalcemia
Time Frame: 26 weeks
Hypocalcemia was defined as corrected serum calcium levels < 9.0 mg/dL (2.25 mmol/L) for participants aged 28 days to < 2 years, and < 8.4 mg/dL (2.1 mmol/L) for participants aged ≥ 2 years to < 6 years at any time during the study.
26 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Corrected Serum Calcium Levels < 8.8 mg/dL (2.2 mmol/L) During the Study
Time Frame: 26 weeks
26 weeks
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Time Frame: Baseline and weeks 3, 7, 11, 15, 19, 22, and 24
Baseline and weeks 3, 7, 11, 15, 19, 22, and 24
Percent Change From Baseline in Corrected Serum Calcium
Time Frame: Baseline and weeks 3, 7, 11, 15, 19, 22, and 24
Baseline and weeks 3, 7, 11, 15, 19, 22, and 24
Percent Change From Baseline in Serum Phosphorous
Time Frame: Baseline and weeks 3, 7, 11, 15, 19, 22, and 24
Baseline and weeks 3, 7, 11, 15, 19, 22, and 24
Percent Change From Baseline in Calcium Phosphorus Product (Ca x P)
Time Frame: Baseline and weeks 3, 7, 11, 15, 19, 22, and 24
Baseline and weeks 3, 7, 11, 15, 19, 22, and 24
Percentage of Participants Who Achieved > 30% Reduction in iPTH From Baseline at Any Two Consecutive Measurements
Time Frame: 26 weeks
A participant was considered to have achieved > 30% reduction in iPTH from baseline at any 2 consecutive measurements if percent change of any two consecutive post-baseline iPTH values were < -30% regardless if there was a missing value in between.
26 weeks
Percentage of Participants Who Achieved ≥ 30% Reduction in iPTH From Baseline During the Study
Time Frame: 26 weeks
A participant was considered to have achieved ≥ 30% reduction in iPTH if the percent change of any post-baseline iPTH value was ≤ -30% from baseline.
26 weeks
Percentage of Participants Who Achieved iPTH Values Between 200 and 300 pg/mL at Any Two Consecutive Measurements
Time Frame: 26 weeks
A participant was considered to have achieved iPTH between 200 and 300 pg/mL (21.2 and 31.8 pmol/L) at any 2 consecutive measurements if any two consecutive post-baseline iPTH values were within the range regardless if there was a missing value in between. The analysis included all enrolled subjects with at least 1 post-baseline assessment.
26 weeks
Percentage of Participants Who Achieved iPTH Values < 300 pg/mL During the Study
Time Frame: 26 weeks
A participant was considered to have achieved iPTH < 300 pg/mL (31.8 pmol/L) during the study if any post-baseline iPTH value was < 300 pg/mL.
26 weeks
Dose- and Weight-Normalized Maximum Plasma Concentration (Cmax) of Cinacalcet
Time Frame: Week 12
Week 12
Dose- and Weight-Normalized Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUClast) for Cinacalcet
Time Frame: Week 12
Week 12

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 22, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 3, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 3, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 22, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20110100
  • 2011-004618-40 (EudraCT Number)

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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