Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Dialysis MedDRA version: 17.1 Level: PT Classification code 10020708 Term: Hyperparathyroidism secondary System Organ Class: 10014698 - Endocrine disorders
Conditions
Sponsors
Amgen, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 101 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-specific activities/procedures being initiated. 102 Subject must complete treatment through Week 20 in parent study 20130356 103 Dry weight > 12.5 kg at Day 1 104 The mean iPTH value (Week19 in 20130356) = 300 pg/mL (Standard of Care arm) 105 Corrected calcium value (Week 19 in 2010356) = 8.8 mg/dL (Standard of Care arm) 106 Dialysate calcium = 2.5 mEq/L at Day 1 Are the trial subjects under 18? yes Number of subjects for this age range: 48 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 201 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). 202 Other investigational procedures while participating in this study are excluded. 203 Malignancy except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years. 204 Subject has known sensitivity to any of the products to be administered during dosing 205 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) to the best of the subject and investigator’s knowledge 206 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. 207 Subject previously has entered this study. 208 If sexually active, subject is not willing to use highly effective contraception during treatment and for at least 9 days after the end of treatment 209 Subject is pregnant or breast feeding, or planning to become pregnant during the study or within 9 days after the end of treatment 210 History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrythmias or other conditions associated with prolonged QT interval At Day 1 Study Visit 211 Subject has a clinically significant (in the opinion of the investigator) or severe (grade = 3 CTCAE v 4.0) ongoing adverse event related to IP from Study 20130356 212 Corrected QT Interval (QTc) > 500 ms, using Bazett’s formula 213 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 214 Use of grapefruit juice, herbal medications or CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole) 215 Use of concomitant medications that may prolong the corrected QT interval (eg, ondansetron, albuterol)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterize the long-term safety and tolerability of cinacalcet in pediatric subjects with CKD receiving dialysis;Secondary Objective: To characterize the long-term effect of cinacalcet in pediatric subjects receiving dialysis on laboratory parameters associated with CKD-MBD ;Primary end point(s): The primary analysis will be based on Safety Analysis Set. of missing data will be utilized Subject incidence of the primary endpoint will be reported. Events of interest (including hypocalcemia, convulsions/seizure, hypotension, cardiac failure, hypersensitivity, ischemic heart disease, fracture, acute pancreatitis, drug-related hepatic disorders, nervous system disorders (excluding seizures), neoplastic events, QT prolongation/ ventricular tachyarrhythmia, and infection) will be categorized and summarized by parent study treatment group.;Timepoint(s) of evaluation of this end point: DURING THE STUDY | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The primary analysis will be based on FAS for all secondary endpoints. Summary statistics will be provided for percent change in PTH, iPTH, from baseline to week 3, week 7, week 11, week 15, week 19, week 23, and week 28 within the study population and each age group by previous treatment group in the parent study and overall. No missing data imputation will be used. Summary statistics will be provided for serum cCa and phosphorus values from baseline to week 3, week 7, week 11, week 15, week 19, week 23, and week 28 within the study population and each age group by previous treatment group in the parent study and overall. No imputation of missing data will be utilized. Additional summary statistics to include iPTH, cCa, and P values from the baseline of the parent study over time to end of this study will also be provided for subjects who are treated with cinacalcet in both studies ;Timepoint(s) of evaluation of this end point: DAY 1 OF WEEK 11 AND OF WEEK 28 | — |
Countries
Belgium, Czech Republic, France, Germany, Greece, Hungary, Italy, Lithuania, Mexico, New Zealand, Poland, Portugal, Russian Federation, Slovakia, Spain, Ukraine, United States
Contacts
Public ContactIHQ Medical Info - Clinical Trials
Amgen (EUROPE) GmbH
Outcome results
None listed