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

Phase 1

• Conditions: Secondary hyperparathyroidism in subjects with chronic kidney disease; MedDRA version: 19.0Level: PTClassification code 10020708Term: Hyperparathyroidism secondarySystem Organ Class: 10014698 - Endocrine disorders; MedDRA version: 19.0Level: LLTClassification code 10020706Term: Hyperparathyroidism NOSSystem Organ Class: 10014698 - Endocrine disorders; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2013-004136-30-DE
• Lead Sponsor: KAI Pharmaceuticals, Inc. (a subsidiary of Amgen, Inc.)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-31
• Last Update Posted: 21 May 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 815

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 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 velcalcetide 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

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 velcalcetide 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.

Study & Design

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