Extension Study of Cinacalcet for Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Patients With Chronic Kidney Disease on Dialysis
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
2 other identifiers
interventional
28
11 countries
33
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2015
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2014
CompletedFirst Posted
Study publicly available on registry
January 19, 2015
CompletedStudy Start
First participant enrolled
June 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2017
CompletedResults Posted
Study results publicly available
May 18, 2018
CompletedJune 29, 2020
June 1, 2020
1.8 years
December 2, 2014
March 7, 2018
June 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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?
From first dose of study drug in the extension study up to 4 weeks after the last dose; 32 weeks.
Secondary Outcomes (13)
Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Baseline to Mean Value During Weeks 11 and 15
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
Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Baseline to Mean Value During Weeks 23 and 28
Extension study baseline and weeks 23 and 28
Percent Change From Baseline in iPTH to the Mean Value During Weeks 23 and 28
Extension study baseline and weeks 23 and 28
Percentage of Participants Who Achieved Mean iPTH ≤ 300 pg/mL During Weeks 23 and 28
Weeks 23 and 28
Change From Baseline in Corrected Serum Calcium to the Mean Value During Weeks 23 to 28
Extension study baseline and weeks 23 and 28
- +8 more secondary outcomes
Study Arms (1)
Cinacalcet
EXPERIMENTALParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (33)
Research Site
Los Angeles, California, 90027, United States
Research Site
Tucker, Georgia, 30084, United States
Research Site
Baltimore, Maryland, 21287, United States
Research Site
Boston, Massachusetts, 02115, United States
Research Site
Minneapolis, Minnesota, 55454, United States
Research Site
Jackson, Mississippi, 39216, United States
Research Site
Kansas City, Missouri, 64108, United States
Research Site
St Louis, Missouri, 63110, United States
Research Site
West Orange, New Jersey, 07052, United States
Research Site
New York, New York, 10029, United States
Research Site
Greenville, North Carolina, 27834, United States
Research Site
Cincinnati, Ohio, 45229, United States
Research Site
Cleveland, Ohio, 44195, United States
Research Site
Columbus, Ohio, 43205, United States
Research Site
Oklahoma City, Oklahoma, 73104, United States
Research Site
Dallas, Texas, 75235, United States
Research Site
Houston, Texas, 77030, United States
Research Site
Salt Lake City, Utah, 84113, United States
Research Site
Brussels, 1020, Belgium
Research Site
Prague, 150 06, Czechia
Research Site
Paris, 75015, France
Research Site
Hanover, 30625, Germany
Research Site
Heidelberg, 69120, Germany
Research Site
Marburg, 35043, Germany
Research Site
Athens, 11527, Greece
Research Site
Szeged, 6720, Hungary
Research Site
Genova, 16147, Italy
Research Site
Krakow, 30-663, Poland
Research Site
Lodz, 93-338, Poland
Research Site
Moscow, 107014, Russia
Research Site
Saint Petersburg, 198205, Russia
Research Site
Samara, 443095, Russia
Research Site
Kyiv, 01135, Ukraine
Related Publications (1)
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.
PMID: 32367309BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2014
First Posted
January 19, 2015
Study Start
June 10, 2015
Primary Completion
March 15, 2017
Study Completion
March 15, 2017
Last Updated
June 29, 2020
Results First Posted
May 18, 2018
Record last verified: 2020-06