Secondary hyperparathyroidism in subjects with chronic kidney disease MedDRA version: 18.0 Level: PT Classification code 10020708 Term: Hyperparathyroidism secondary System Organ Class: 10014698 - Endocrine disorders MedDRA version: 18.0 Level: LLT Classification code 10020706 Term: Hyperparathyroidism NOS System Organ Class: 10014698 - Endocrine disorders
Conditions
Interventions
Product Code: AMG 416
Pharmaceutical Form: Solution for injection
INN or Proposed INN: (AMG 416)
CAS Number: 8000019-76-3
Other descriptive name: POLYPEPTIDE
Concentration unit: mg milligram(s)
Concen
Sponsors
KAI Pharmaceuticals, Inc. (a subsidiary of Amgen, Inc.)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 101. Subject has provided informed consent prior to initiation of any study-specific activities/procedures. 102. Subject has completed treatment in Study 20120231 (also known as KAI-4169-008) or Study 20120360, or has participated in Study 20120334 (also known as KAI-4169-005-01). 103. Female subjects who are: • post menopausal (post menopausal is defined as no menses for the previous 1 year and over the age of 50 years) • surgically sterilized • have a medical condition that prevents pregnancy • remain abstinent • or are willing to use highly effective contraception during the study and for 3 months after the last dose Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test within 2 weeks prior to the first dose of AMG 416 in the current study. 104. Subject must be receiving hemodialysis 3 or 4 times weekly for at least 3 months. 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 261 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 554
Exclusion criteria
Exclusion criteria: 201. Currently receiving treatment in another investigational device or drug study (other than in one of the designated parent studies). 202. Other investigational procedures while participating in this study are excluded. 203. Subject has known sensitivity to any of the products or components to be administered during dosing. 204. Subject has been prescribed cinacalcet by the primary nephrologist between the conclusion of the parent study and the start of dosing with AMG 416 in the current study. 205. Subject has any illness that, in the judgment of the Investigator, might confound the results of the study or pose additional risk to the subject. 206. Subject is receiving dialysis prescription dialysate calcium concentration < 2.25 mEq/L 207. Subject is pregnant or nursing. 208. History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the judgment of the Investigator would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterize the long-term safety and tolerability of AMG 416 in the treatment of SHPT in subjects with CKD on hemodialysis. ;Secondary Objective: To characterize intact parathyroid hormone (iPTH), total serum corrected calcium (cCa), and serum phosphorous (P) values in the treatment of SHPT in subjects with CKD on hemodialysis, who are being treated with AMG 416. ;Primary end point(s): Subject incidence of adverse events reported throughout the study;Timepoint(s) of evaluation of this end point: Throughout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Occurrence of iPTH value at Months 6, 12, and 18 which is within 2x to 9x the upper limit of normal (ULN) for the assay used • Occurrence of P = the ULN for the assay used at Months 6, 12, and 18 ;Timepoint(s) of evaluation of this end point: At 6, 12 & 18 months. | — |
Countries
Austria, Belgium, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Israel, Italy, Latvia, Lithuania, Mexico, Netherlands, Poland, Portugal, Russian Federation, Spain, Sweden, Switzerland, Turkey, United Kingdom
Contacts
Public ContactIHQ Medical Info-Clinical Trials
Amgen (EUROPE) GmbH
Outcome results
None listed