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Study to Assess the Impact on Calcium Levels When Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) Switch From Cinacalcet to Etelcalcetide

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01932970
First received: August 28, 2013
Last updated: February 16, 2017
Last verified: February 2017
  Purpose
This is a multicenter, multiple-dose, single-arm, open-label study to assess the impact on serum corrected calcium levels when switching patients from cinacalcet to etelcalcetide (AMG 416).

Condition Intervention Phase
Hyperparathyroidism, Secondary
Drug: Etelcalcetide
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
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:
  • Percentage of Participants With Serum Corrected Calcium < 7.5 mg/dL During the 4-week Treatment Period [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • Percent Change From Baseline in Parathyroid Hormone During the Treatment Period [ Time Frame: Baseline and weeks 2, 3 and 4 ]
  • Percentage of Participants With Serum Corrected Calcium < 8.3 mg/dL During the 4-week Treatment Period [ Time Frame: 4 weeks ]

Other Outcome Measures:
  • Number of Participants With Adverse Events [ Time Frame: From the first dose of study drug up to 30 days after the last dose; 8 weeks ]
  • Percentage of Participants With Symptomatic Hypocalcemia During the 4-week Treatment Period [ Time Frame: From the first dose of study drug up to 30 days after the last dose; 8 weeks ]
    Hpocalcemia was used for events of decreased calcium accompanied by clinical signs and symptoms of hypocalcemia.


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: Etelcalcetide
Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
Drug: Etelcalcetide
Etelcalcetide is provided as a sterile lyophilized powder to be reconstituted with sterile water for injection.
Other Names:
  • KAI 4169
  • AMG 416
  • Parsabiv™

  Eligibility

Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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 parathyroid hormone (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 corrected calcium (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:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01932970     History of Changes
Other Study ID Numbers: 20120359
2013-000964-28 ( EudraCT Number )
KAI-4169 ( Other Identifier: KAI Pharmaceuticals (wholly owned subsidiary of Amgen Inc.) )
Study First Received: August 28, 2013
Results First Received: February 16, 2017
Last Updated: February 16, 2017

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

Additional relevant MeSH terms:
Neoplasm Metastasis
Hyperparathyroidism
Hyperparathyroidism, Secondary
Neoplastic Processes
Neoplasms
Pathologic Processes
Parathyroid Diseases
Endocrine System Diseases
Cinacalcet Hydrochloride
Calcimimetic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 21, 2017