Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
KAI Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01254565
First received: December 3, 2010
Last updated: March 1, 2017
Last verified: March 2017
  Purpose
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).

Condition Intervention Phase
Secondary Hyperparathyroidism
Drug: Etelcalcetide
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by KAI Pharmaceuticals:

Primary Outcome Measures:
  • Percent Change From Baseline in Mean Pre-hemodialysis Parathyroid Hormone (PTH) During the Efficacy Assessment Phase [ Time Frame: 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) ]
    Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1. The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.


Secondary Outcome Measures:
  • Percentage of Participants With ≥ 30% Reduction From Baseline in Mean Parathyroid Hormone During the Efficacy Assessment Phase [ Time Frame: 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) ]
    Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1. The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.

  • Percentage of Participants With Mean Parathyroid Hormone ≤ 300 pg/mL During the Efficacy Assessment Phase [ Time Frame: 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) ]
    The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.

  • Percent Change From Baseline in Mean Corrected Calcium (cCa) During the Efficacy Assessment Phase [ Time Frame: 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) ]
    Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1. The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.

  • Percent Change From Baseline in Mean Phosphorus (P) During the Efficacy Assessment Phase [ Time Frame: 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) ]
    Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1. The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.

  • Percent Change From Baseline in Corrected Calcium Phosphorus Product (cCa x P) During the Efficacy Assessment Phase [ Time Frame: 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) ]
    Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1. The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.

  • Percentage of Participants With Mean Phosphorus ≤ 4.5 mg/dL or ≤ 5.5 mg/dL During the Efficacy Assessment Phase [ Time Frame: Efficacy assessment phase ]

Enrollment: 87
Study Start Date: February 20, 2011
Study Completion Date: August 24, 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Etelcalcetide
Participants received etelcalcetide administered by intravenous injection at the end of each hemodialysis session three times a week (TIW). The starting dose level was 5 mg; dose escalation was to proceed to 10 and 20 mg pending safety review of the prior cohort.
Drug: Etelcalcetide
Administered intravenously (IV) at the end of hemodialysis
Other Names:
  • KAI-4169
  • AMG 416
  • Parsabiv™
Placebo Comparator: Placebo
Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW).
Drug: Placebo
Administered intravenously at the end of hemodialysis

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01254565

Locations
United States, California
Azusa, California, United States, 91702
Costa Mesa, California, United States, 92626
Lynwood, California, United States, 90262
Riverside, California, United States, 92505
San Diego, California, United States, 92123
United States, Colorado
Denver, Colorado, United States, 80218
United States, Georgia
Macon, Georgia, United States, 31217
United States, Louisiana
Shreveport, Louisiana, United States, 71101
United States, Minnesota
Brooklyn Center, Minnesota, United States, 55430
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19106
United States, Texas
Houston, Texas, United States, 77004
Houston, Texas, United States, 77099
United States, Virginia
Chesapeake, Virginia, United States, 23320
Sponsors and Collaborators
KAI Pharmaceuticals
Investigators
Study Director: M D Amgen
  More Information

Responsible Party: KAI Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01254565     History of Changes
Other Study ID Numbers: KAI-4169-003
20120330 ( Other Identifier: Amgen, Inc )
Study First Received: December 3, 2010
Results First Received: March 1, 2017
Last Updated: March 1, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by KAI Pharmaceuticals:
Clinical Trial, Phase 2
Renal Dialysis
Secondary Hyperparathyroidism
Parathyroid hormone

Additional relevant MeSH terms:
Neoplasm Metastasis
Hyperparathyroidism
Hyperparathyroidism, Secondary
Neoplastic Processes
Neoplasms
Pathologic Processes
Parathyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 25, 2017