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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

Tracking Information
First Submitted Date  ICMJE May 28, 2010
First Posted Date  ICMJE June 2, 2010
Results First Submitted Date  ICMJE March 1, 2017
Results First Posted Date  ICMJE January 2, 2018
Last Update Posted Date January 2, 2018
Study Start Date  ICMJE September 7, 2010
Actual Primary Completion Date April 2, 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2017)
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. ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 1, 2010)
Safety and tolerability of rising single doses of KAI-4169 by IV injection in hemodialysis subjects with secondary hyperparathyroidism [ Time Frame: 3 weeks ]
Change History Complete list of historical versions of study NCT01134562 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2017)
  • 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). ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2010)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hyperparathyroidism, Secondary
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 26, 2017)
28
Original Estimated Enrollment  ICMJE
 (submitted: June 1, 2010)
16
Actual Study Completion Date  ICMJE April 2, 2011
Actual Primary Completion Date April 2, 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01134562
Other Study ID Numbers  ICMJE KAI-4169-002
20130139 ( Other Identifier: Amgen, Inc )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party KAI Pharmaceuticals
Study Sponsor  ICMJE KAI Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gregory Bell, MD KAI Pharmaceuticals
PRS Account KAI Pharmaceuticals
Verification Date May 2017

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