NCT01134562

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2010

Shorter than P25 for phase_1

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 2, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

September 7, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2011

Completed
6.8 years until next milestone

Results Posted

Study results publicly available

January 2, 2018

Completed
Last Updated

January 2, 2018

Status Verified

May 1, 2017

Enrollment Period

7 months

First QC Date

May 28, 2010

Results QC Date

March 1, 2017

Last Update Submit

May 26, 2017

Conditions

Hyperparathyroidism, Secondary

Keywords

Clinical Trial, Phase 1Renal DialysisSecondary HyperparathyroidismParathyroid hormone

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • 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

  • 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

  • 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).

  • 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).

  • 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).

  • +4 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Etelcalcetide

EXPERIMENTAL

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

Drug: Etelcalcetide

Interventions

PlaceboDRUG

Single IV injection.

Placebo
EtelcalcetideDRUG

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.

Also known as: KAI-4169, AMG 416
Etelcalcetide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Cypress, California, United States

Location

Unknown Facility

Shreveport, Louisiana, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

Brisbane, Queensland, Australia

Location

Unknown Facility

Melbourne, Victoria, Australia

Location

MeSH Terms

Conditions

Hyperparathyroidism, Secondary

Interventions

etelcalcetide hydrochloride

Condition Hierarchy (Ancestors)

HyperparathyroidismParathyroid DiseasesEndocrine System Diseases

Results Point of Contact

Title
Study Director
Organization
Amgen, Inc
866-572-6436

Study Officials

  • Gregory Bell, MD

    KAI Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2010

First Posted

June 2, 2010

Study Start

September 7, 2010

Primary Completion

April 2, 2011

Study Completion

April 2, 2011

Last Updated

January 2, 2018

Results First Posted

January 2, 2018

Record last verified: 2017-05

Locations

AU(2)US(3)