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

Primary Purpose

Hyperparathyroidism, Secondary

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Placebo
Etelcalcetide
Sponsored by
KAI Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperparathyroidism, Secondary focused on measuring Clinical Trial, Phase 1, Renal Dialysis, Secondary Hyperparathyroidism, Parathyroid hormone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Etelcalcetide

Arm Description

Participants received a single dose of placebo intravenous (IV) injection after hemodialysis.

Participants received a single dose of etelcalcetide by intravenous (IV) injection after hemodialysis.

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events

Secondary Outcome Measures

Percent Change From Baseline in Serum Parathyroid Hormone (PTH)
Percent Change From Baseline in Serum Corrected Calcium
Percent Change From Baseline in Ionized Calcium
Percent Change From Baseline in Serum Phosphorus
Percent Change From Baseline in Calcium Phosphorus Product
Maximum Observed Plasma Concentration (Cmax) of Etelcalcetide
Area Under the Concentration-time Curve From Time 0 to 65 Hours Post-dose for Etelcalcetide
Observed Area Under the Concentration-time Curve Extrapolated to Infinity (AUCINFobs) for Etelcalcetide
Percent AUC Extrapolated to Infinity (AUCINF) Resulting From Extrapolation From 65 Hours Onward for Etelcalcetide

Full Information

First Posted
May 28, 2010
Last Updated
May 26, 2017
Sponsor
KAI Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01134562
Brief Title
Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism
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 Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
September 7, 2010 (undefined)
Primary Completion Date
April 2, 2011 (Actual)
Study Completion Date
April 2, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KAI Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperparathyroidism, Secondary
Keywords
Clinical Trial, Phase 1, Renal Dialysis, Secondary Hyperparathyroidism, Parathyroid hormone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received a single dose of placebo intravenous (IV) injection after hemodialysis.
Arm Title
Etelcalcetide
Arm Type
Experimental
Arm Description
Participants received a single dose of etelcalcetide by intravenous (IV) injection after hemodialysis.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Single IV injection.
Intervention Type
Drug
Intervention Name(s)
Etelcalcetide
Other Intervention Name(s)
KAI-4169, AMG 416
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
Title
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).
Title
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).
Title
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).
Title
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).
Title
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).
Title
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).
Title
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Bell, MD
Organizational Affiliation
KAI Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Cypress
State/Province
California
Country
United States
City
Shreveport
State/Province
Louisiana
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Brisbane
State/Province
Queensland
Country
Australia
City
Melbourne
State/Province
Victoria
Country
Australia

12. IPD Sharing Statement

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

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