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

• Register: EUCTR
• Last refreshed on: 4 September 2017
• Main ID: EUCTR2013-004136-30-LT
• Date of registration: 19/02/2014
• Prospective Registration: Yes
• Primary sponsor: KAI Pharmaceuticals, Inc. (a subsidiary of Amgen, Inc.)
• Public title: A study of AMG 416 in the treatment of secondary hyperparathyroidism in chronic kidney disease
• Scientific title: 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
• Date of first enrolment: 19/06/2014
• Target sample size: 815
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-004136-30
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

• Name: IHQ Medical Info-Clinical Trials
• Affiliation: Amgen (EUROPE) GmbH

• Name: IHQ Medical Info-Clinical Trials
• Affiliation: Amgen (EUROPE) GmbH

Key inclusion & exclusion 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:
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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

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

Intervention(s)

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)
Concentration type: equal
Concentration number: 5-

Primary Outcome(s)

Primary end point(s): Subject incidence of adverse events reported throughout the study

Timepoint(s) of evaluation of this end point: Throughout the study

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.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: At 6, 12 & 18 months.

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

Secondary ID(s)

2013-004136-30-SE

20130213

Source(s) of Monetary Support

KAI Pharmaceuticals, Inc. (a subsidiary of Amgen, Inc.)