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

Hyperparathyroidism, Secondary Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01134562
• Other study ID #: KAI-4169-002
• Secondary ID: 20130139
• Status: Completed
• Phase: Phase 1
• First received: May 28, 2010
• Last updated: May 26, 2017
• Start date: September 7, 2010
• Est. completion date: April 2, 2011

Study information

• Verified date: May 2017
• Source: KAI Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 2, 2011
• Est. primary completion date: April 2, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Neoplasm Metastasis

Intervention

Drug:
• Placebo
Single IV injection.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
KAI Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events		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	Percent Change From Baseline in Serum Parathyroid Hormone (PTH)		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
Secondary	Percent Change From Baseline in Serum Corrected Calcium		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
Secondary	Percent Change From Baseline in Ionized Calcium		Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, and day 4 (discharge).
Secondary	Percent Change From Baseline in Serum Phosphorus		Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, and day 4 (discharge).
Secondary	Percent Change From Baseline in Calcium Phosphorus Product		Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, and day 4 (discharge).
Secondary	Maximum Observed Plasma Concentration (Cmax) of Etelcalcetide		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).
Secondary	Area Under the Concentration-time Curve From Time 0 to 65 Hours Post-dose for Etelcalcetide		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).
Secondary	Observed Area Under the Concentration-time Curve Extrapolated to Infinity (AUCINFobs) for Etelcalcetide		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).
Secondary	Percent AUC Extrapolated to Infinity (AUCINF) Resulting From Extrapolation From 65 Hours Onward for Etelcalcetide		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).