To Assess the Long-term Safety of AMG 416 in the Treatment of SHPT in Subjects With CKD on Hemodialysis



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease, Endocrine
Therapuetic Areas:Endocrinology, Nephrology / Urology
Healthy:No
Age Range:18 - 110
Updated:10/21/2017
Start Date:March 25, 2014
End Date:June 26, 2017

Use our guide to learn which trials are right for you!

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

This is a multicenter, single-arm, extension study to characterize the long-term safety and
tolerability of AMG 416 in the treatment of SHPT in subjects with CKD on hemodialysis.

This is a multicenter, single-arm, extension study in which subjects with secondary
hyperparathyroidism currently receiving hemodialysis previously treated in AMG 20120231,
20120334, or 20120360 will continue to be treated with AMG 416. The study will assess the
long-term safety and tolerability of AMG 416 as well as measuring the intact parathyroid
hormone (iPTH), total serum albumin, corrected calcium (cCa), and serum phosphorous (P)
values in these subjects during the course of their treatment.

Inclusion Criteria:

- 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

Exclusion Criteria:

- Currently receiving treatment in another investigational device or drug study (other
than in one of the designated parent studies)

- 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 is receiving dialysis prescription dialysate calcium concentration < 2.25
mEq/L

- Subject is pregnant or nursing
We found this trial at
69
sites
?
mi
from
New Bern, NC
Click here to add this to my saved trials
?
mi
from
Alhambra, CA
Click here to add this to my saved trials
?
mi
from
Arlington, TX
Click here to add this to my saved trials
?
mi
from
Augusta, GA
Click here to add this to my saved trials
?
mi
from
Aurora, CO
Click here to add this to my saved trials
?
mi
from
Azusa, CA
Click here to add this to my saved trials
?
mi
from
Bakersfield, CA
Click here to add this to my saved trials
?
mi
from
Baton Rouge, LA
Click here to add this to my saved trials
?
mi
from
Bethlehem, PA
Click here to add this to my saved trials
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
?
mi
from
Bluefield, WV
Click here to add this to my saved trials
?
mi
from
Brookhaven, MS
Click here to add this to my saved trials
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
?
mi
from
Burlington, VT
Click here to add this to my saved trials
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
College Point, NY
Click here to add this to my saved trials
?
mi
from
Columbia, SC
Click here to add this to my saved trials
?
mi
from
Columbus, MS
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Cudahy, CA
Click here to add this to my saved trials
?
mi
from
Detroit, MI
Click here to add this to my saved trials
?
mi
from
Dublin, GA
Click here to add this to my saved trials
?
mi
from
Durham, NC
Click here to add this to my saved trials
?
mi
from
Eatontown, NJ
Click here to add this to my saved trials
?
mi
from
Edinburg, TX
Click here to add this to my saved trials
?
mi
from
Fairfax, VA
Click here to add this to my saved trials
Granada Hills, California 91344
?
mi
from
Granada Hills, CA
Click here to add this to my saved trials
?
mi
from
Great Neck, NY
Click here to add this to my saved trials
?
mi
from
Gulfport, MS
Click here to add this to my saved trials
?
mi
from
Hampton, VA
Click here to add this to my saved trials
?
mi
from
Highland Park, IL
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
?
mi
from
Lincoln, NE
Click here to add this to my saved trials
?
mi
from
Liverpool,
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Mechanicsville, VA
Click here to add this to my saved trials
?
mi
from
Meridian, ID
Click here to add this to my saved trials
?
mi
from
Merrillville, IN
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Michigan City, IN
Click here to add this to my saved trials
?
mi
from
Mineola, NY
Click here to add this to my saved trials
?
mi
from
Northridge, CA
Click here to add this to my saved trials
?
mi
from
Ocala, FL
Click here to add this to my saved trials
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
?
mi
from
Pembroke Pines, FL
Click here to add this to my saved trials
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
?
mi
from
Pontiac, MI
Click here to add this to my saved trials
?
mi
from
Reno, NV
Click here to add this to my saved trials
?
mi
from
Riverside, CA
Click here to add this to my saved trials
?
mi
from
Rosedale, NY
Click here to add this to my saved trials
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
?
mi
from
Simi Valley, CA
Click here to add this to my saved trials
Springfield, Massachusetts 01199
?
mi
from
Springfield, MA
Click here to add this to my saved trials
?
mi
from
Stamford, CT
Click here to add this to my saved trials
?
mi
from
Tampa, FL
Click here to add this to my saved trials
?
mi
from
The Bronx, NY
Click here to add this to my saved trials
?
mi
from
Tupelo, MS
Click here to add this to my saved trials
?
mi
from
Vacaville, CA
Click here to add this to my saved trials
?
mi
from
Voorhees, NJ
Click here to add this to my saved trials
?
mi
from
Westminster, CO
Click here to add this to my saved trials
?
mi
from
Whittier, CA
Click here to add this to my saved trials
?
mi
from
Wichita, KS
Click here to add this to my saved trials
Wilmington, North Carolina 28401
?
mi
from
Wilmington, NC
Click here to add this to my saved trials
?
mi
from
Yonkers, NY
Click here to add this to my saved trials