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Extension Study of Cinacalcet for Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Patients With Chronic Kidney Disease on Dialysis

Primary Purpose

Secondary Hyperparathyroidism, Chronic Kidney Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cinacalcet
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Secondary Hyperparathyroidism, Chronic Kidney Disease focused on measuring Chronic Kidney Disease, Dialysis, Secondary Hyperparathyroidism, Pediatric

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA:

All subjects:

  • Subject's legally acceptable representative has provided informed consent when the subject is legally too young to provide informed consent and the subject has provided written assent based on local regulations and/or guidelines prior to any Study 20140159 activities/procedures being initiated.
  • Dialysate calcium concentration ≥ 2.5 mEq/L at day 1

All subjects with > 14 days between the last study visit in Study 20130356 or Study 20110100 and screening for Study 20140159:

  • Subjects on anti-convulsant medication must be on a stable dose

All subjects from 20130356:

  • Completed treatment through week 20 in the 20130356 study or on study at the time of Study 20130356 termination
  • Dry weight ≥ 12.5 kg at day 1 of Study 20140159

Subjects Randomized to the 20130356 Standard of Care Arm Only:

  • intact parathyroid hormone (iPTH) value ≥ 300 pg/mL (within 7 days of day 1 in Study 20140159)
  • Corrected calcium value ≥ 8.8 mg/dL within 7 days of day 1 in Study 20140159

All Subjects from 20110100:

  • Completed week 26 End of Study visit in the, 20110100 study or on study at the time of Study 20110100 termination
  • Dry weight ≥ 7 kg at day 1 of Study 20140159

EXCLUSION CRITERIA:

General (studies 20130356 and 20110100):

  • Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s), other than Amgen Studies 20130356 or 20110100.
  • Other investigational procedures while participating in this study are excluded.
  • Malignancy except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years.
  • Subject has known sensitivity to any of the products to be administered during dosing.
  • Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, electronic patient diary [ediary]) to the best of the subject and investigator's knowledge
  • History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
  • Subject previously has entered this study.
  • If sexually active, subject is not willing to use acceptable contraception during treatment and for at least 9 days after the end of treatment.
  • Subject is pregnant or breast feeding, or planning to become pregnant during the study or within 9 days after the end of treatment
  • History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrythmias, or other conditions associated with prolonged QT interval
  • A new onset of seizures or worsening of pre-existing seizure disorder

All Subjects with > 14 days between the last study visit in Study 20130356 or Study 20110100 and the screening visit in Study 20140159 will have the following exclusion criteria applied during screening and day 1:

  • Unstable chronic heart failure defined as worsening pulmonary edema or other signs and symptoms as per investigator assessment during screening
  • Received therapy with commercial cinacalcet after the last study visit in Study 20130356 or Study 20110100 before day 1 of Study 20140159
  • Scheduled date for kidney transplantation from a known living donor that makes completion of the study unlikely
  • Either new or recurrent cardiac ventricular arrhythmias requiring a change in treatment within 10 days prior to screening visit or day 1 of Study 20140159 screening
  • Hepatic impairment indicated by elevated levels of hepatic transaminase or bilirubin (aspartate aminotransferase [AST] ≥ 1.5 × upper limit of normal [ULN] OR alanine aminotransferase [ALT] ≥ 1.5 × ULN OR total bilirubin ≥ 1 × ULN per institutional laboratory range) during screening

All Subjects - Day 1 Study Visit:

  • Subject has an ongoing adverse event from Studies 20130356 or 20110100 that is considered related to investigational product and is ≥ Common Terminology Criteria for Adverse Events (CTCAE) (v 4.0) grade 3, and/or considered clinically significant in the opinion of the investigator
  • Central laboratory values were not obtained/are not available at day 1 in Study 20140159
  • 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, CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole), or CYP2D6 substrates (eg, flecainide, propafenone, metoprolol, desipramine, nortriptyline, clomipramine)
  • Use of concomitant medications that may prolong the QTc interval (eg, ondansetron, albuterol)

Sites / Locations

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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cinacalcet

Arm Description

Participants received cinacalcet daily for 24 weeks in this extension study. For participants who received standard of care (SOC) in parent study 20130356, the starting dose was 0.20 mg/kg/day. For participants who received SOC and cinacalcet in parent study 20130356 or 20110100 the starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events
Adverse events (AEs) were graded according to the Common Terminology Criteria for Adverse Events (CTCAE, v4.0). The investigator assessed whether the adverse event was possibly related to the study drug as indicated by a "yes" or "no" response to the question: Is there a reasonable possibility that the event may have been caused by the study drug?

Secondary Outcome Measures

Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Baseline to Mean Value During Weeks 11 and 15
This endpoint was analyzed in participants who received SOC only in parent study 20130356. Participants who had no iPTH values during weeks 11 or 15 were considered non-responders. Data collected more than 7 days after the last dose of study drug were excluded.
Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Baseline to Mean Value During Weeks 23 and 28
This endpoint was analyzed in participants who received SOC only in parent study 20130356. For participants who had no values during week 23 and 28, the mean of the last 2 available post-baseline values collected in the dose-titration phase was used. If only 1 post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was considered a non-responder. Data collected more than 7 days after the last dose of study drug were excluded.
Percent Change From Baseline in iPTH to the Mean Value During Weeks 23 and 28
This endpoint was analyzed in participants who received SOC only in parent study 20130356. For participants who had no values during week 23 and week 28, the mean of the last 2 available post-baseline values collected in the dose-titration phase was used. If only 1 post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was excluded from the analysis. Data collected more than 7 days after the last dose of study drug were excluded.
Percentage of Participants Who Achieved Mean iPTH ≤ 300 pg/mL During Weeks 23 and 28
For participants who had no values during week 23 and 28, the mean of the last 2 available post-baseline values collected in the dose-titration phase was used. If only 1 post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was considered a non-responder. Data collected more than 7 days after the last dose of study drug were excluded.
Change From Baseline in Corrected Serum Calcium to the Mean Value During Weeks 23 to 28
For participants who had no values during weeks 23 to 28, the mean of the last 2 available post-baseline values collected in the dose-titration phase was used. If only 1 post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was excluded from the analysis. Data collected more than 7 days after the last dose of study drug were excluded.
Change From Baseline in Serum Phosphorus to the Mean Value During Weeks 23 to 28
For participants who had no values during weeks 23 to 28, the mean of the last 2 available post-baseline values collected in the dose-titration phase was used. If only 1 post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was excluded from the analysis. Data collected more than 7 days after the last dose of study drug were excluded.
Serum Corrected Calcium at Baseline, Week 11, and Week 28
Data collected more than 7 days after the last dose of study drug were excluded.
Serum Phosphorus at Baseline, Week 11, and Week 28
Data collected more than 7 days after the last dose of study drug were excluded.
Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Day 1 of Cinacalcet Treatment to Mean Value During Weeks 11 and 15
The percentage of participants who achieved ≥ 30% reduction in iPTH measured from the date the initial dose of cinacalcet was administered, in parent study 20130356 or 20110100 for participants who received cinacalcet in the parent study, or in the extension study for participants who received SOC only in parent study 20130356. Participants who had no iPTH values during weeks 11 and 15 were considered non-responders. Data collected more than 7 days after the last dose of study drug were excluded.
Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Day 1 of Cinacalcet Treatment to Mean Value During Weeks 23 and 28
The percentage of participants who achieved ≥ 30% reduction in iPTH measured from the date the initial dose of cinacalcet was administered, in parent study 20130356 or 20110100 for participants who received cinacalcet in the parent study, or in the extension study for participants who received SOC only in parent study 20130356. For participants who did not have an iPTH value during weeks 23 and 28, the mean of the last two available post-baseline values collected at protocol-specified visits was used. If only one post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was considered a non-responder. Data collected more than 7 days after the last dose of study drug were excluded.
Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time
Percent change in iPTH measured from the date the initial dose of cinacalcet was administered, either in parent study 20130356 or 20110100, or in the extension study for participants who received SOC only in parent study 20130356. Data collected more than 7 days after the last dose of study drug were excluded.
Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time
Change in corrected calcium measured from the date the initial dose of cinacalcet was administered, either in parent study 20130356 or 20110100, or in the extension study for participants who received SOC only in parent study 20130356. Data collected more than 7 days after the last dose of study drug were excluded.
Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time
Change in phosphorus measured from the date the initial dose of cinacalcet was administered, either in parent study 20130356 or 20110100, or in the extension study for participants who received SOC only in parent study 20130356. Data collected more than 7 days after the last dose of study drug were excluded.

Full Information

First Posted
December 2, 2014
Last Updated
June 12, 2020
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT02341417
Brief Title
Extension Study of Cinacalcet for Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Patients With Chronic Kidney Disease on Dialysis
Official Title
A Multicenter Single-arm Extension Study to Characterize the Long-term Safety of Cinacalcet Hydrochloride in the Treatment of Secondary Hyperparathyroidism in Pediatric Subjects With Chronic Kidney Disease on Dialysis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
June 10, 2015 (Actual)
Primary Completion Date
March 15, 2017 (Actual)
Study Completion Date
March 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study was to characterize the long-term safety and tolerability of cinacalcet in pediatric patients with chronic kidney disease (CKD) receiving dialysis.
Detailed Description
This extension study was designed to characterize the long-term safety and tolerability of cinacalcet in pediatric patients from Amgen Studies 20130356 (NCT02138838) and 20110100 (NCT01439867) who either had completed the parent study or were ongoing at the time an administrative decision was made to end the parent study. After enrolling into this study participants were administered cinacalcet for 28 weeks or until the time of renal transplant or parathyroidectomy, whichever occurred first. The treatment period was followed by a 4-week safety follow-up period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Hyperparathyroidism, Chronic Kidney Disease
Keywords
Chronic Kidney Disease, Dialysis, Secondary Hyperparathyroidism, Pediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cinacalcet
Arm Type
Experimental
Arm Description
Participants received cinacalcet daily for 24 weeks in this extension study. For participants who received standard of care (SOC) in parent study 20130356, the starting dose was 0.20 mg/kg/day. For participants who received SOC and cinacalcet in parent study 20130356 or 20110100 the starting dose was either the same as the last dose received in the parent study or 0.20 mg/kg/day if the last dose of cinacalcet in the parent study was received > 14 days before day 1 of this study. Dose adjustments and withholding were based on weekly assessments of ionized calcium as well as plasma intact parathyroid hormone (iPTH) and corrected serum calcium levels assessed monthly.
Intervention Type
Drug
Intervention Name(s)
Cinacalcet
Other Intervention Name(s)
Cinacalcet hydrochloride, Cinacalcet HCL, Sensipar®, Mimpara®
Intervention Description
Cinacalcet was provided as 5 mg capsules for sprinkling or as 30 mg film-coated tablets for swallowing. The protocol-specified doses were: 1, 2.5, 5, 7.5, 10, 15, 30, 60, 90, 120, and 180 mg.
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Description
Adverse events (AEs) were graded according to the Common Terminology Criteria for Adverse Events (CTCAE, v4.0). The investigator assessed whether the adverse event was possibly related to the study drug as indicated by a "yes" or "no" response to the question: Is there a reasonable possibility that the event may have been caused by the study drug?
Time Frame
From first dose of study drug in the extension study up to 4 weeks after the last dose; 32 weeks.
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Baseline to Mean Value During Weeks 11 and 15
Description
This endpoint was analyzed in participants who received SOC only in parent study 20130356. Participants who had no iPTH values during weeks 11 or 15 were considered non-responders. Data collected more than 7 days after the last dose of study drug were excluded.
Time Frame
Baseline (defined as the mean values of samples collected during the screening period and day 1 pre-dose in the extension study) and weeks 11 and 15
Title
Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Baseline to Mean Value During Weeks 23 and 28
Description
This endpoint was analyzed in participants who received SOC only in parent study 20130356. For participants who had no values during week 23 and 28, the mean of the last 2 available post-baseline values collected in the dose-titration phase was used. If only 1 post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was considered a non-responder. Data collected more than 7 days after the last dose of study drug were excluded.
Time Frame
Extension study baseline and weeks 23 and 28
Title
Percent Change From Baseline in iPTH to the Mean Value During Weeks 23 and 28
Description
This endpoint was analyzed in participants who received SOC only in parent study 20130356. For participants who had no values during week 23 and week 28, the mean of the last 2 available post-baseline values collected in the dose-titration phase was used. If only 1 post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was excluded from the analysis. Data collected more than 7 days after the last dose of study drug were excluded.
Time Frame
Extension study baseline and weeks 23 and 28
Title
Percentage of Participants Who Achieved Mean iPTH ≤ 300 pg/mL During Weeks 23 and 28
Description
For participants who had no values during week 23 and 28, the mean of the last 2 available post-baseline values collected in the dose-titration phase was used. If only 1 post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was considered a non-responder. Data collected more than 7 days after the last dose of study drug were excluded.
Time Frame
Weeks 23 and 28
Title
Change From Baseline in Corrected Serum Calcium to the Mean Value During Weeks 23 to 28
Description
For participants who had no values during weeks 23 to 28, the mean of the last 2 available post-baseline values collected in the dose-titration phase was used. If only 1 post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was excluded from the analysis. Data collected more than 7 days after the last dose of study drug were excluded.
Time Frame
Extension study baseline and weeks 23 and 28
Title
Change From Baseline in Serum Phosphorus to the Mean Value During Weeks 23 to 28
Description
For participants who had no values during weeks 23 to 28, the mean of the last 2 available post-baseline values collected in the dose-titration phase was used. If only 1 post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was excluded from the analysis. Data collected more than 7 days after the last dose of study drug were excluded.
Time Frame
Extension study baseline and weeks 23 and 28
Title
Serum Corrected Calcium at Baseline, Week 11, and Week 28
Description
Data collected more than 7 days after the last dose of study drug were excluded.
Time Frame
Extension study baseline, week 11 and week 28
Title
Serum Phosphorus at Baseline, Week 11, and Week 28
Description
Data collected more than 7 days after the last dose of study drug were excluded.
Time Frame
Extension study baseline, week 11 and week 28
Title
Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Day 1 of Cinacalcet Treatment to Mean Value During Weeks 11 and 15
Description
The percentage of participants who achieved ≥ 30% reduction in iPTH measured from the date the initial dose of cinacalcet was administered, in parent study 20130356 or 20110100 for participants who received cinacalcet in the parent study, or in the extension study for participants who received SOC only in parent study 20130356. Participants who had no iPTH values during weeks 11 and 15 were considered non-responders. Data collected more than 7 days after the last dose of study drug were excluded.
Time Frame
Baseline and weeks 11 and 15, relative to day 1 of cinacalcet treatment.
Title
Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Day 1 of Cinacalcet Treatment to Mean Value During Weeks 23 and 28
Description
The percentage of participants who achieved ≥ 30% reduction in iPTH measured from the date the initial dose of cinacalcet was administered, in parent study 20130356 or 20110100 for participants who received cinacalcet in the parent study, or in the extension study for participants who received SOC only in parent study 20130356. For participants who did not have an iPTH value during weeks 23 and 28, the mean of the last two available post-baseline values collected at protocol-specified visits was used. If only one post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was considered a non-responder. Data collected more than 7 days after the last dose of study drug were excluded.
Time Frame
Baseline and weeks 23 and 28, relative to day 1 of cinacalcet treatment.
Title
Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time
Description
Percent change in iPTH measured from the date the initial dose of cinacalcet was administered, either in parent study 20130356 or 20110100, or in the extension study for participants who received SOC only in parent study 20130356. Data collected more than 7 days after the last dose of study drug were excluded.
Time Frame
Baseline and weeks 3, 7, 11, 15, 17, 18, 19, 20, 23, 27, 31, 35, 39, 43, 48, 52, relative to day 1 of cinacalcet treatment, and at the end of treatment visit and end of study visit (4 weeks after the end of treatment visit).
Title
Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time
Description
Change in corrected calcium measured from the date the initial dose of cinacalcet was administered, either in parent study 20130356 or 20110100, or in the extension study for participants who received SOC only in parent study 20130356. Data collected more than 7 days after the last dose of study drug were excluded.
Time Frame
Baseline and weeks 3, 7, 11, 15, 17, 18, 19, 20, 23, 27, 31, 35, 39, 43, 48, 52, relative to day 1 of cinacalcet treatment, and at the end of treatment visit and end of study visit (4 weeks after the end of treatment visit).
Title
Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time
Description
Change in phosphorus measured from the date the initial dose of cinacalcet was administered, either in parent study 20130356 or 20110100, or in the extension study for participants who received SOC only in parent study 20130356. Data collected more than 7 days after the last dose of study drug were excluded.
Time Frame
Baseline and weeks 3, 7, 11, 15, 17, 18, 19, 20, 23, 27, 31, 35, 39, 43, 48, 52, relative to day 1 of cinacalcet treatment, and at the end of treatment visit and end of study visit (4 weeks after the end of treatment visit).

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA: All subjects: Subject's legally acceptable representative has provided informed consent when the subject is legally too young to provide informed consent and the subject has provided written assent based on local regulations and/or guidelines prior to any Study 20140159 activities/procedures being initiated. Dialysate calcium concentration ≥ 2.5 mEq/L at day 1 All subjects with > 14 days between the last study visit in Study 20130356 or Study 20110100 and screening for Study 20140159: Subjects on anti-convulsant medication must be on a stable dose All subjects from 20130356: Completed treatment through week 20 in the 20130356 study or on study at the time of Study 20130356 termination Dry weight ≥ 12.5 kg at day 1 of Study 20140159 Subjects Randomized to the 20130356 Standard of Care Arm Only: intact parathyroid hormone (iPTH) value ≥ 300 pg/mL (within 7 days of day 1 in Study 20140159) Corrected calcium value ≥ 8.8 mg/dL within 7 days of day 1 in Study 20140159 All Subjects from 20110100: Completed week 26 End of Study visit in the, 20110100 study or on study at the time of Study 20110100 termination Dry weight ≥ 7 kg at day 1 of Study 20140159 EXCLUSION CRITERIA: General (studies 20130356 and 20110100): Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s), other than Amgen Studies 20130356 or 20110100. Other investigational procedures while participating in this study are excluded. Malignancy except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years. Subject has known sensitivity to any of the products to be administered during dosing. Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, electronic patient diary [ediary]) to the best of the subject and investigator's knowledge History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion. Subject previously has entered this study. If sexually active, subject is not willing to use acceptable contraception during treatment and for at least 9 days after the end of treatment. Subject is pregnant or breast feeding, or planning to become pregnant during the study or within 9 days after the end of treatment History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrythmias, or other conditions associated with prolonged QT interval A new onset of seizures or worsening of pre-existing seizure disorder All Subjects with > 14 days between the last study visit in Study 20130356 or Study 20110100 and the screening visit in Study 20140159 will have the following exclusion criteria applied during screening and day 1: Unstable chronic heart failure defined as worsening pulmonary edema or other signs and symptoms as per investigator assessment during screening Received therapy with commercial cinacalcet after the last study visit in Study 20130356 or Study 20110100 before day 1 of Study 20140159 Scheduled date for kidney transplantation from a known living donor that makes completion of the study unlikely Either new or recurrent cardiac ventricular arrhythmias requiring a change in treatment within 10 days prior to screening visit or day 1 of Study 20140159 screening Hepatic impairment indicated by elevated levels of hepatic transaminase or bilirubin (aspartate aminotransferase [AST] ≥ 1.5 × upper limit of normal [ULN] OR alanine aminotransferase [ALT] ≥ 1.5 × ULN OR total bilirubin ≥ 1 × ULN per institutional laboratory range) during screening All Subjects - Day 1 Study Visit: Subject has an ongoing adverse event from Studies 20130356 or 20110100 that is considered related to investigational product and is ≥ Common Terminology Criteria for Adverse Events (CTCAE) (v 4.0) grade 3, and/or considered clinically significant in the opinion of the investigator Central laboratory values were not obtained/are not available at day 1 in Study 20140159 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, CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole), or CYP2D6 substrates (eg, flecainide, propafenone, metoprolol, desipramine, nortriptyline, clomipramine) Use of concomitant medications that may prolong the QTc interval (eg, ondansetron, albuterol)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Research Site
City
Tucker
State/Province
Georgia
ZIP/Postal Code
30084
Country
United States
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Research Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Facility Name
Research Site
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Research Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Research Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Research Site
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Research Site
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Research Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Research Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Research Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Facility Name
Research Site
City
Bruxelles
ZIP/Postal Code
1020
Country
Belgium
Facility Name
Research Site
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Research Site
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Research Site
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Research Site
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Research Site
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
Research Site
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Research Site
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Research Site
City
Genova
ZIP/Postal Code
16147
Country
Italy
Facility Name
Research Site
City
Krakow
ZIP/Postal Code
30-663
Country
Poland
Facility Name
Research Site
City
Lodz
ZIP/Postal Code
93-338
Country
Poland
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
107014
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
198205
Country
Russian Federation
Facility Name
Research Site
City
Samara
ZIP/Postal Code
443095
Country
Russian Federation
Facility Name
Research Site
City
Kyiv
ZIP/Postal Code
01135
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
32367309
Citation
Warady BA, Ng E, Bloss L, Mo M, Schaefer F, Bacchetta J. Cinacalcet studies in pediatric subjects with secondary hyperparathyroidism receiving dialysis. Pediatr Nephrol. 2020 Sep;35(9):1679-1697. doi: 10.1007/s00467-020-04516-4. Epub 2020 May 4.
Results Reference
background
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

Extension Study of Cinacalcet for Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Patients With Chronic Kidney Disease on Dialysis

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