20120230: Assess the Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease on Hemodialysis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01788046
First received: February 7, 2013
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

This study is designed to assess the efficacy and safety of AMG 416 compared with placebo in the treatment of SHPT in CKD subjects receiving hemodialysis as assessed by the change from baseline in serum iPTH, cCa x P and phosphorus.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Assess the 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:
  • The proportion of subjects with >30% reduction from baseline in predialysis iPTH during the Efficacy Assessment Phase (EAP) which is defined as the period between Week 20 and Week 27. [ Time Frame: 27 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects with predialysis iPTH ≤ 300 pg/mL during the Efficacy Assessment Phase [ Time Frame: 27 weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline in predialysis iPTH during the Efficacy Assessment Phase [ Time Frame: 27 weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline in predialysis serum cCa during the Efficacy Assessment Phase [ Time Frame: 27 weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline in predialysis cCa x P during the Efficacy Assessment Phase [ Time Frame: 27 weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline in predialysis serum phosphorus during the Efficacy Assessment Phase [ Time Frame: 27 weeks ] [ Designated as safety issue: No ]

Enrollment: 515
Study Start Date: March 2013
Study Completion Date: May 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMG 416 Drug: AMG 416
Subjects randomized 1:1 to AMG 416 or placebo. Minimum dose of 2.5mg to maximum dose of 15mg, 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).
Placebo Comparator: Placebo Drug: Placebo
Subjects randomized 1:1 to AMG 416 or placebo. Minimum dose of 2.5mg to maximum dose of 15mg, 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 is 18 years of age or older.
  • Subject agrees to not participate in another study of an investigational agent during the study.
  • Subject must be receiving hemodialysis 3 times weekly for at least 3 months
  • Other Inclusion Criteria may apply

Exclusion Criteria:

  • Currently receiving treatment in another investigational device or drug study, or ended treatment on another investigational device or drug study(s) within 8 weeks prior to screening.
  • Other investigational procedures while participating in this study are excluded.
  • Anticipated or scheduled parathyroidectomy during the study period.
  • Subject has received a parathyroidectomy within 3 months prior to dosing.
  • Anticipated or scheduled kidney transplant during the study period.
  • Subject has known sensitivity to any of the products or components to be administered during dosing.
  • Subject has participated in a prior clinical trial of AMG 416
  • 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.
  • Subject has a history of any illness that, in the opinion of the Investigator, might confound the results of the study or pose additional risk to the subject.
  • 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: NCT01788046

  Show 106 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01788046     History of Changes
Other Study ID Numbers: 20120230, KAI-4169-007, 2012-002806-31
Study First Received: February 7, 2013
Last Updated: May 20, 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
Endocrine System Diseases
Neoplasms
Neoplastic Processes
Parathyroid Diseases
Pathologic Processes
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on October 23, 2014