Clinical trial NCT01254565: Safety, Tolerability and Efficacy of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism
Official title: A Double-Blind, Randomized, Placebo-Controlled Multiple Ascending Dose Study to Assess the Safety, Tolerability and Efficacy of KAI-4169 in Hemodialysis Subjects With Secondary Hyperparathyroidism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Secondary Hyperparathyroidism
Keywords: Clinical Trial, Phase 2
Renal Dialysis
Secondary Hyperparathyroidism
Parathyroid hormone
Lead sponsor: KAI Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-12-06
Enrollment: 87
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 and efficacy of multiple ascending doses of etelcalcetide in hemodialysis patients for the treatment of secondary hyperparathyroidism (HPT).


Eligibility criteria: Inclusion Criteria:

* Subject provides written informed consent.
* Intact parathyroid hormone (PTH) at least 350 pg/mL.
* Corrected calcium at least 9.0 mg/dL.
* Hemoglobin at least 9.0 g/dL.
* Adequate hemodialysis three times per week.
* 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.
* Serum transaminases (alanine aminotransferase, aspartate aminotransferase) greater than two times the upper limit of normal at screening.

Primary outcomes:
measure: Percent Change From Baseline in Mean Pre-hemodialysis Parathyroid Hormone (PTH) During the Efficacy Assessment Phase
timeFrame: Baseline and the efficacy assessment phase (EAP; defined as the period between 3 days before and 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)
Secondary outcomes:
measure: Percentage of Participants With ≥ 30% Reduction From Baseline in Mean Parathyroid Hormone During the Efficacy Assessment Phase
timeFrame: Baseline and the efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)
measure: Percentage of Participants With Mean Parathyroid Hormone ≤ 300 pg/mL During the Efficacy Assessment Phase
timeFrame: Efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)
measure: Percent Change From Baseline in Mean Corrected Calcium (cCa) During the Efficacy Assessment Phase
timeFrame: Baseline and the efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)
measure: Percent Change From Baseline in Mean Phosphorus (P) During the Efficacy Assessment Phase
timeFrame: Baseline and the efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)
measure: Percent Change From Baseline in Corrected Calcium Phosphorus Product (cCa x P) During the Efficacy Assessment Phase
timeFrame: Baseline and the efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)
measure: Percentage of Participants With Mean Phosphorus ≤ 4.5 mg/dL or ≤ 5.5 mg/dL During the Efficacy Assessment Phase
timeFrame: Efficacy assessment phase
Other outcomes:
Locations:
city: Azusa
country: United States
state: California
city: Costa Mesa
country: United States
state: California
city: Lynwood
country: United States
state: California
city: Riverside
country: United States
state: California
city: San Diego
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Macon
country: United States
state: Georgia
city: Shreveport
country: United States
state: Louisiana
city: Brooklyn Center
country: United States
state: Minnesota
city: Philadelphia
country: United States
state: Pennsylvania
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Chesapeake
country: United States
state: Virginia
Study officials:
affiliation: Amgen
name: M D
role: STUDY_DIRECTOR
References: