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

NCT ID: NCT02341417

Last Updated: 2020-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-10
• Study Completion Date: 2017-03-15

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.

Conditions

Secondary Hyperparathyroidism, Chronic Kidney Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cinacalcet

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.

Group Type: EXPERIMENTAL

Cinacalcet

Intervention Type: DRUG

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.

Interventions

Cinacalcet

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.

Intervention Type: DRUG

Other Intervention Names

Cinacalcet hydrochloride, Cinacalcet HCL, Sensipar®, Mimpara®

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

• 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)

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Locations

Research Site

Los Angeles, California, United States

Research Site

Tucker, Georgia, United States

Research Site

Baltimore, Maryland, United States

Research Site

Boston, Massachusetts, United States

Research Site

Minneapolis, Minnesota, United States

Research Site

Jackson, Mississippi, United States

Research Site

Kansas City, Missouri, United States

Research Site

St Louis, Missouri, United States

Research Site

West Orange, New Jersey, United States

Research Site

New York, New York, United States

Research Site

Greenville, North Carolina, United States

Research Site

Cincinnati, Ohio, United States

Research Site

Cleveland, Ohio, United States

Research Site

Columbus, Ohio, United States

Research Site

Oklahoma City, Oklahoma, United States

Research Site

Dallas, Texas, United States

Research Site

Houston, Texas, United States

Research Site

Salt Lake City, Utah, United States

Research Site

Brussels, , Belgium

Research Site

Prague, , Czechia

Research Site

Paris, , France

Research Site

Hanover, , Germany

Research Site

Heidelberg, , Germany

Research Site

Marburg, , Germany

Research Site

Athens, , Greece

Research Site

Szeged, , Hungary

Research Site

Genova, , Italy

Research Site

Krakow, , Poland

Research Site

Lodz, , Poland

Research Site

Moscow, , Russia

Research Site

Saint Petersburg, , Russia

Research Site

Samara, , Russia

Research Site

Kyiv, , Ukraine

Countries

United States; Belgium; Czechia; France; Germany; Greece; Hungary; Italy; Poland; Russia; Ukraine

References

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.

Reference Type: BACKGROUND

PMID: 32367309 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

2014-003563-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

20140159

Identifier Type: -

Identifier Source: org_study_id