A study of AMG 416 in the treatment of secondary hyperparathyroidism in chronic kidney disease

• Conditions: Secondary hyperparathyroidism in subjects with chronic kidney disease; MedDRA version: 14.1Level: PTClassification code 10020708Term: Hyperparathyroidism secondarySystem Organ Class: 10014698 - Endocrine disorders; MedDRA version: 14.1Level: LLTClassification code 10020706Term: Hyperparathyroidism NOSSystem Organ Class: 10014698 - Endocrine disorders; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2012-002808-41-IT
• Lead Sponsor: KAI Pharmaceuticals, Inc. (a subsidiary of Amgen, Inc.)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-26
• Last Update Posted: 2 May 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
• Subject must complete the treatment and follow-up period, or have been discontinued for rising iPTH, from an AMG 416 phase 3 parent study prior to the start of dosing in this study.
• Subject agrees to not participate in another study of an investigational agent during the study.
• Dialysis prescription dialysate calcium concentration must be = 2.25 mEq/L.
• Female subject who is post menopausal (post menopausal is defined as no menses for the previous 1 year and over the age of 50 years), surgically sterilized, has a medical condition that prevents pregnancy, remains abstinent, or is willing to use highly effective contraception during the study and for 3 months after the last dose. Women of child-bearing potential must
have a negative serum pregnancy test within 2 weeks prior to the first dose of AMG 416.
• Male subject is willing to use highly effective contraception when sexually active and will not donate sperm during the treatment phase and for 3 months after the last dose.
• Subject’s legally acceptable representative has provided informed consent when the subject has any kind of condition that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 700
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

Exclusion Criteria

• Currently receiving treatment in another investigational device or drug study.
• Currently receiving other investigational procedures while participating in this study.
• Subject has known sensitivity to any of the products or components to be administered during dosing.
• Subject has received cinacalcet between the last dose of investigational product in the parent study (20120229 or 20120230) and the start of dosing with AMG 416 in the current study.
• Subject has an unstable medical condition based on medical history, physical examination, and routine laboratory tests, or is otherwise unstable in the judgment of the Investigator.
• Subject has a history of any illness that, in the opinion of the Investigator, might confound the results of the study or pose additional risk to the subject.
• Subject has a serious concurrent medical condition (eg, malignancy) likely to result in death during the next 12 months.
• Subject is pregnant or nursing.
• 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To characterize the long-term safety and tolerability of AMG 416 in the treatment of SHPT in subjects with chronic kidney disease on hemodialysis.;Secondary Objective: Secondary objectives are to characterize the long-term efficacy of AMG 416 on intact parathyroid hormone (iPTH), corrected calcium (cCa), corrected calcium-phosphorus product (cCa x P), and phosphorus;Primary end point(s): • nature, frequency, severity, and relationship to treatment of all adverse events reported throughout the study<br>• vital signs and changes in laboratory parameters, including clinical chemistry<br>• evaluation of antibody formation to AMG 416;Timepoint(s) of evaluation of this end point: Throughout the efficacy assessment phase

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: Throughout the efficacy assessment phase;Secondary end point(s): • proportion of subjects with > 30% reduction from baseline in predialysis iPTH during the efficacy assessment phase (EAP) and the EAP at 12 months (EAP12) <br>• proportion of subjects with predialysis iPTH = 300 pg/mL during the EAP and EAP12<br>• percent change from baseline in predialysis iPTH during the EAP and EAP12<br>• percent change from baseline in predialysis serum cCa during the EAP and EAP12<br>• percent change from baseline in predialysis cCa x P during the EAP and EAP12<br>• percent change from baseline in predialysis serum phosphorus during the EAP and EAP12