20120231: Describe the Long-term Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease on Hemodialysis

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01785875
First received: February 5, 2013
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

This study is designed to describe the long-term safety and efficacy of IV administration of AMG 416 for the treatment of SHPT in subjects with CKD on hemodialysis.


Condition Intervention Phase
Hyperparathyroidism, Secondary
Drug: AMG 416
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter Single-arm Extension Study to Describe the Long-term Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Long-term safety and tolerability of intravenous administration of AMG 416 in hemodialysis subjects with secondary hyperparathyroidism (SHPT) as assessed by the nature, frequency, severity, and relationship to treatment of all reported adverse events. [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Proportion of subjects with >30% reduction from baseline in predialysis iPTH during the Efficacy Assessment Phase (EAP) and 12 month Efficacy Assessment Phase (EAP12) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects with predialysis iPTH ≤ 300 pg/mL during the Efficacy Assessment Phase (EAP) and 12 month Efficacy Assessment Phase (EAP12) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline in predialysis iPTH during the Efficacy Assessment Phase (EAP) and 12 month Efficacy Assessment Phase (EAP12) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline in predialysis serum cCa during the Efficacy Assessment Phase (EAP) and 12 month Efficacy Assessment Phase (EAP12) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline in predialysis serum cCa x P during the Efficacy Assessment Phase (EAP) and 12 month Efficacy Assessment Phase (EAP12) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline in predialysis serum phosphorus during the Efficacy Assessment Phase (EAP) and 12 month Efficacy Assessment Phase (EAP12) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 1120
Study Start Date: July 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMG 416 Drug: AMG 416
Minimum dose of 2.5 mg to maximum dose of 15 mg, administered by bolus injection into the venous line of the dialysis circuit at the end of hemodialysis treatment, and prior to or during rinse-back with each hemodialysis session (ie, 3 times per week).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
  • Subject must complete the treatment and follow-up period, or have been discontinued for rising iPTH, from an AMG 416 phase 3 parent study prior to the start of dosing in this study.
  • Subject agrees to not participate in another study of an investigational agent during the study.
  • Other Inclusion Criteria may apply

Exclusion Criteria:

  • Currently receiving treatment in another investigational device or drug study.
  • Currently receiving other investigational procedures while participating in this study.
  • Subject has known sensitivity to any of the products or components to be administered during dosing.
  • Subject has an unstable medical condition based on medical history, physical examination, and routine laboratory tests, or is otherwise unstable in the judgment of the Investigator.

Other Exclusion Criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01785875

Contacts
Contact: Amgen Call Center 866-572-6436

  Show 208 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01785875     History of Changes
Other Study ID Numbers: 20120231, KAI-4169-008, 2012-002808-41
Study First Received: February 5, 2013
Last Updated: May 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Secondary Hyperparathyroidism (SHPT), chronic kidney disease (CKD), hemodialysis, parathyroid hormone (PTH), hypocalcemia, bone and mineral metabolism

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Kidney Diseases
Neoplasm Metastasis
Renal Insufficiency, Chronic
Urologic Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Renal Insufficiency
Parathyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 18, 2014