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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 1, 2018
Last Update Posted : January 1, 2018
Sponsor:
Information provided by (Responsible Party):

May 28, 2010
June 2, 2010
March 1, 2017
January 1, 2018
January 1, 2018
September 7, 2010
April 2, 2011   (Final data collection date for primary outcome measure)
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. ]
Safety and tolerability of rising single doses of KAI-4169 by IV injection in hemodialysis subjects with secondary hyperparathyroidism [ Time Frame: 3 weeks ]
Complete list of historical versions of study NCT01134562 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • 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). ]
  • 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). ]
  • 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). ]
  • 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). ]
  • 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). ]
  • 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). ]
  • 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). ]
  • Assess the effect of KAI-4169 on iPTH and serum calcium [ Time Frame: 3 days ]
  • Pharmacokinetics of rising single doses of KAI-4169 by IV injection in hemodialysis subjects with secondary hyperparathyroidism [ Time Frame: 3 days ]
Not Provided
Not Provided
 
Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism
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
The purpose of this study is to characterize the safety and tolerability of single rising doses of etelcalcetide in hemodialysis patients with secondary hyperparathyroidism.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Hyperparathyroidism, Secondary
  • Drug: Placebo
    Single IV injection.
  • 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
  • Placebo Comparator: Placebo
    Participants received a single dose of placebo intravenous (IV) injection after hemodialysis.
    Intervention: Drug: Placebo
  • Experimental: Etelcalcetide
    Participants received a single dose of etelcalcetide by intravenous (IV) injection after hemodialysis.
    Intervention: Drug: Etelcalcetide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
April 2, 2011
April 2, 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   United States
 
 
NCT01134562
KAI-4169-002
20130139 ( Other Identifier: Amgen, Inc )
No
Not Provided
Not Provided
KAI Pharmaceuticals
KAI Pharmaceuticals
Not Provided
Study Director: Gregory Bell, MD KAI Pharmaceuticals
KAI Pharmaceuticals
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP