Clinical trial NCT01134562: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hyperparathyroidism, Secondary
Keywords: Clinical Trial, Phase 1
Renal Dialysis
Secondary Hyperparathyroidism
Parathyroid hormone
Lead sponsor: KAI Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-06-02
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 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 outcomes:
measure: Percent Change From Baseline in Serum Parathyroid Hormone (PTH)
timeFrame: 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
measure: Percent Change From Baseline in Serum Corrected Calcium
timeFrame: 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
measure: Percent Change From Baseline in Ionized Calcium
timeFrame: Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, and day 4 (discharge).
measure: Percent Change From Baseline in Serum Phosphorus
timeFrame: Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, and day 4 (discharge).
measure: Percent Change From Baseline in Calcium Phosphorus Product
timeFrame: Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, and day 4 (discharge).
measure: Maximum Observed Plasma Concentration (Cmax) of Etelcalcetide
timeFrame: 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).
measure: Area Under the Concentration-time Curve From Time 0 to 65 Hours Post-dose for Etelcalcetide
timeFrame: 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).
measure: Observed Area Under the Concentration-time Curve Extrapolated to Infinity (AUCINFobs) for Etelcalcetide
timeFrame: 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).
measure: Percent AUC Extrapolated to Infinity (AUCINF) Resulting From Extrapolation From 65 Hours Onward for Etelcalcetide
timeFrame: 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).
Other outcomes:
Locations:
city: Cypress
country: United States
state: California
city: Shreveport
country: United States
state: Louisiana
city: Houston
country: United States
state: Texas
city: Brisbane
country: Australia
state: Queensland
city: Melbourne
country: Australia
state: Victoria
Study officials:
affiliation: KAI Pharmaceuticals
name: Gregory Bell, MD
role: STUDY_DIRECTOR
References: