Assess Impact on Calcium Levels When Hemodialysis Subjects With SHPT Switch From Cinacalcet HCl to AMG 416

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01932970
First received: August 28, 2013
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

This is a multicenter, multiple-dose, single-arm, open-label study to assess the impact on serum corrected calcium levels when switching subjects from cinacalcet to AMG 416.


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, Multiple-dose, Single-arm Study to Switch Hemodialysis Subjects With Secondary Hyperparathyroidism From Oral Cinacalcet HCl to Intravenous AMG 416

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Measure the subject incidence of serum cCa values <7.5 mg/dL during the treatment period following initiation of treatment with AMG 416 5mg IV TIW. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percent change from baseline in PTH levels during the treatment period [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Incidence of serum cCa values <8.3 mg/dL during the treatment period [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Assess the nature, frequency, severity, and relationship to treatment of all adverse events [ Time Frame: from informed consent to 30 days after treatment ] [ Designated as safety issue: Yes ]
  • Assess the incidence of symptomatic hypocalcemia during the treatment period [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 158
Study Start Date: August 2013
Study Completion Date: April 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMG 416
AMG 416 is provided as a sterile lyophilized powder to be reconstituted with sterile water for injection.
Drug: AMG 416
Subjects will be administered IV AMG 416 at the end of their regularly scheduled hemodialysis sessions, for a total of 4 weeks.
Other Name: KAI 4169

Detailed Description:

This is a multicenter, multiple-dose, single-arm study in which subjects with secondary hyperparathyroidism currently receiving hemodialysis will be switched from oral cinacalcet HCl to intravenous AMG 416.

The study will estimate the subject incidence of serum corrected calcium (cCa) values < 7.5 mg/dL during the 4-week treatment period after initiating of AMG 416 three times per week (TIW) with hemodialysis, 7 days following the discontinuation of daily oral cinacalcet.

  Eligibility

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

Inclusion Criteria

  • Subject is 18 years of age or older at the time of informed consent.
  • Subject must be receiving maintenance hemodialysis 3 times weekly for at least 8 weeks.
  • Subject must have SHPT as defined by having a mean of 3 consecutive central laboratory screening predialysis serum PTH values ≥ 200 pg/mL, with measurements obtained from 3 different calendar weeks in the 4-week screening period while receiving cinacalcet.
  • Subject must have a mean of 3 consecutive central laboratory screening predialysis serum cCa values ≥ 7.5 mg/dL, with measurements obtained from 3 different calendar weeks in the 4-week screening period while receiving cinacalcet.
  • Subject must be on a stable dose of cinacalcet before screening (defined as no dose change within the 4 weeks prior to screening).
  • Other Inclusion Criteria may apply.

Exclusion Criteria

  • Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s).
  • Subject has received AMG 416 in a prior clinical trial of AMG 416 (also known as KAI-4169).
  • Subject has known sensitivity to any of the products or components of AMG 416 to be administered during dosing.
  • Subject is unwilling to use effective contraception during the study, and for women, up to a period of up to 3 months after the last dose of AMG 416.
  • Subject is pregnant or nursing.
  • Anticipated or scheduled parathyroidectomy during the study period.
  • Subject has received a parathyroidectomy within 6 months prior to dosing.
  • 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: NCT01932970

  Show 40 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01932970     History of Changes
Other Study ID Numbers: 20120359, 2013-000964-28, KAI-4169
Study First Received: August 28, 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
Neoplasm Metastasis
Endocrine System Diseases
Neoplasms
Neoplastic Processes
Parathyroid Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014