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Open-label Study to Assess the Long-term Safety and Efficacy of Etelcalcetide (Also Known as AMG 416 or KAI-4169) in Patients With Secondary Hyperparathyroidism

This study has been terminated.
(Study was terminated early to allow subjects to roll over to study NCT02102204.)
Sponsor:
Information provided by (Responsible Party):
KAI Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01576146
First received: April 5, 2012
Last updated: March 1, 2017
Last verified: March 2017
  Purpose
The purpose of this study is to evaluate the long term safety and efficacy of thrice weekly intravenous (IV) administration of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in patients receiving hemodialysis who had completed 12 weeks of treatment with etelcalcetide in parent study 20120331 (KAI-4169-005; NCT01414114).

Condition Intervention Phase
Secondary Hyperparathyroidism Drug: Etelcalcetide Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Multicenter Open-label Extension Study to Assess the Long-term Safety and Efficacy of KAI-4169 (Also Known as AMG 416) in the Treatment of Chronic Kidney Disease-Mineral and Bone Disorder in Patients With Secondary Hyperparathyroidism

Further study details as provided by KAI Pharmaceuticals:

Primary Outcome Measures:
  • Number of Participants With Adverse Events [ Time Frame: From the first dose of study drug in the parent study (20120331) through 30 days after the last dose in the extension study; actual median duration of treatment was 439 days. ]

Secondary Outcome Measures:
  • Percent Change From Baseline in Parathyroid Hormone [ Time Frame: Baseline (of the parent study 20120331) and Weeks 13, 26 and 52 ]

    Baseline was defined as the average of 3 predialysis results obtained within 3 weeks before the first dose of etelcalcetide in the parent study (20120331).

    The week numbering for this study continued from the parent study 20120331 hence the first measurement for all parameters in the extension study started at week 13.


  • Percent Change From Baseline in Serum Corrected Calcium [ Time Frame: Baseline and Weeks 13, 26 and 52 ]

    Baseline was defined as the average of 3 predialysis results obtained within 3 weeks before the first dose of study drug in the parent study (20120331).

    The week numbering for this study continued from the parent study 20120331; the first measurement for all parameters in the extension study started at week 13.


  • Percent Change From Baseline in Serum Phosphorus [ Time Frame: Baseline and Weeks 13, 26 and 52 ]

    Baseline was defined as the average of 3 predialysis results obtained within 3 weeks before the first dose of study drug in the parent study (20120331).

    The week numbering for this study continued from the parent study 20120331; the first measurement for all parameters in the extension study started at week 13.



Enrollment: 30
Study Start Date: March 2012
Study Completion Date: May 1, 2014
Primary Completion Date: May 1, 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Etelcalcetide
Participants received a bolus IV injection of etelcalcetide 3 times a week (TIW) at the end of each hemodialysis session for up to 144 weeks in the extension study. The starting dose was the same as the final dose administered in the parent study (20120331); the dose was adjusted per protocol-specified guidelines to achieve or maintain parathyroid hormone values in the 150 to 300 pg/mL range.
Drug: Etelcalcetide
Administered as an intravenous bolus three times a week at the end of each hemodialysis session at dosages up to a maximum of 15 mg.
Other Names:
  • KAI-4169
  • AMG 416
  • Parsabiv™

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject provides written informed consent.
  • Subject completed the 12 week treatment phase in the parent study study 20120331 ( KAI-4169-005; NCT01414114).

Exclusion Criteria:

  • Subject pregnant or nursing
  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: NCT01576146

Sponsors and Collaborators
KAI Pharmaceuticals
Investigators
Study Director: M D Amgen
  More Information

Responsible Party: KAI Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01576146     History of Changes
Other Study ID Numbers: KAI-4169-005-01
20120334 ( Other Identifier: Amgen, Inc )
Study First Received: April 5, 2012
Results First Received: March 1, 2017
Last Updated: March 1, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by KAI Pharmaceuticals:
Clinical Trial, Phase 2
Renal Dialysis
Secondary Hyperparathyroidism
Chronic kidney disease-mineral and bone disorder
Parathyroid hormone

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

ClinicalTrials.gov processed this record on June 23, 2017