A Multicenter single-arm Extension Study to Describe the Long-term Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis.
- Conditions
- Patients with Chronic Kidney Disease on Hemodialysis and Secondary Hyperparathyroidism1003394910038430
- Registration Number
- NL-OMON41088
- Lead Sponsor
- Amgen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 4
-Subject has provided informed consent prior to initiation of any study-specific
activities/procedures.
-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).
-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 an acceptable method of 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.
-Subject must be receiving hemodialysis 3 or 4 times weekly for at least 3 months.
-Currently receiving treatment in another investigational device or drug study
(other than in one of the designated parent studies).
-Other investigational procedures while participating in this study are excluded.
-Subject has known sensitivity to any of the products or components to be
administered during dosing.
-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.
-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.
-Subject is receiving dialysis prescription dialysate calcium concentration
< 2.25 mEq/L
-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 judgment of the Investigator would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To characterize the long-term safety and tolerability of AMG 416 in the<br /><br>treatment of secondary hyperparathyroidism (SHPT) in subjects with chronic<br /><br>kidney disease (CKD) on hemodialysis.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To characterize intact parathyroid hormone (iPTH), total serum albumin<br /><br>corrected calcium (cCa), and serum phosphorous (P) values in the treatment of<br /><br>SHPT in subjects with CKD who are on hemodialysis, who are being treated with<br /><br>AMG 416.</p><br>