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Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism

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ClinicalTrials.gov Identifier: NCT01134562
Recruitment Status : Completed
First Posted : June 2, 2010
Results First Posted : January 2, 2018
Last Update Posted : January 2, 2018
Sponsor:
Information provided by (Responsible Party):
KAI Pharmaceuticals

Study Description
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Brief Summary:
The purpose of this study is to characterize the safety and tolerability of single rising doses of etelcalcetide in hemodialysis patients with secondary hyperparathyroidism.

Condition or disease Intervention/treatment Phase
Hyperparathyroidism, Secondary Drug: Placebo Drug: Etelcalcetide Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety and Tolerability of Single Ascending Doses of KAI-4169 in Hemodialysis Subjects With Secondary Hyperparathyroidism
Study Start Date : September 7, 2010
Actual Primary Completion Date : April 2, 2011
Actual Study Completion Date : April 2, 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Participants received a single dose of placebo intravenous (IV) injection after hemodialysis.
 Drug: Placebo
Single IV injection.
Experimental: Etelcalcetide
Participants received a single dose of etelcalcetide by intravenous (IV) injection after hemodialysis.
 Drug: Etelcalcetide
Single IV injection. The initial dose was 5 mg and dose escalation proceeded with subsequent doses of 10 mg, 20 mg, 40 mg and 60 mg.
Other Names:
  • KAI-4169
  • AMG 416


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Adverse Events [ Time Frame: For Cohorts 1 to 3, from administration of study drug up until 21 days after study drug administration; for Cohorts 4 and 5 from administration of study drug until 28 days after study drug administration. ]

Secondary Outcome Measures :
  1. Percent Change From Baseline in Serum Parathyroid Hormone (PTH) [ Time Frame: Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, day 4 (discharge) and for Cohorts 4 and 5 only, days 8, 15 and 29 ]
  2. Percent Change From Baseline in Serum Corrected Calcium [ Time Frame: Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, day 4 (discharge) and for Cohorts 4 and 5 only, days 8, 15 and 29 ]
  3. Percent Change From Baseline in Ionized Calcium [ Time Frame: Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, and day 4 (discharge). ]
  4. Percent Change From Baseline in Serum Phosphorus [ Time Frame: Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, and day 4 (discharge). ]
  5. Percent Change From Baseline in Calcium Phosphorus Product [ Time Frame: Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, and day 4 (discharge). ]
  6. Maximum Observed Plasma Concentration (Cmax) of Etelcalcetide [ Time Frame: Pre-dose and at 0.17, 0.5, 1, 4, 8, 18, 24, 32, and 48 hours after study drug administration and prior to discharge from the clinical research unit (~65 hours). ]
  7. Area Under the Concentration-time Curve From Time 0 to 65 Hours Post-dose for Etelcalcetide [ Time Frame: Pre-dose and at 0.17, 0.5, 1, 4, 8, 18, 24, 32, and 48 hours after study drug administration and prior to discharge from the clinical research unit (~65 hours). ]
  8. Observed Area Under the Concentration-time Curve Extrapolated to Infinity (AUCINFobs) for Etelcalcetide [ Time Frame: Pre-dose and at 0.17, 0.5, 1, 4, 8, 18, 24, 32, and 48 hours after study drug administration and prior to discharge from the clinical research unit (~65 hours). ]
  9. Percent AUC Extrapolated to Infinity (AUCINF) Resulting From Extrapolation From 65 Hours Onward for Etelcalcetide [ Time Frame: Pre-dose and at 0.17, 0.5, 1, 4, 8, 18, 24, 32, and 48 hours after study drug administration and prior to discharge from the clinical research unit (~65 hours). ]

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

Inclusion Criteria:

  • Subjects provides written informed consent.
  • Intact parathyroid hormone (iPTH) ≥ 400 pg/mL (≥ 300 and < 1200 pg/ml for Cohorts 1-3).
  • Serum corrected calcium ≥ 9.0 mg/dL

  • Receiving hemodialysis three times per week for at least 3 months and had adequate hemodialysis with a delivered Kt/V (dialyzer clearance of urea * dialysis time/ volume of distribution of urea) ≥ 1.2 or urea reduction ratio (URR)

    ≥ 65%.

  • Excepting chronic renal failure, subject is judged to be in stable medical condition based on medical history, physical examination, and routine laboratory tests

Exclusion Criteria:

  • History or symptomatic ventricular dysrhythmias
  • History of angina pectoris or congestive heart failure
  • History of myocardial infarction, coronary angioplasty, or coronary artery bypass grafting within the past 6 months
  • History of or treatment for seizure disorder
  • Recent (3 months) parathyroidectomy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01134562


Locations
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United States, California
Cypress, California, United States
United States, Louisiana
Shreveport, Louisiana, United States
United States, Texas
Houston, Texas, United States
Australia, Queensland
Brisbane, Queensland, Australia
Australia, Victoria
Melbourne, Victoria, Australia
Sponsors and Collaborators
KAI Pharmaceuticals
Investigators
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Study Director: Gregory Bell, MD KAI Pharmaceuticals
More Information
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Responsible Party: KAI Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01134562    
Other Study ID Numbers: KAI-4169-002
20130139 ( Other Identifier: Amgen, Inc )
First Posted: June 2, 2010    Key Record Dates
Results First Posted: January 2, 2018
Last Update Posted: January 2, 2018
Last Verified: May 2017
Keywords provided by KAI Pharmaceuticals:
Clinical Trial, Phase 1
Renal Dialysis
Secondary Hyperparathyroidism
Parathyroid hormone
Additional relevant MeSH terms:
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Neoplasm Metastasis
Hyperparathyroidism
Hyperparathyroidism, Secondary
Neoplastic Processes
 Neoplasms
Pathologic Processes
Parathyroid Diseases
Endocrine System Diseases