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

NCT01254565 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2017-04-13

Study results available
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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).

Conditions

  • Secondary Hyperparathyroidism

Interventions

DRUG

Etelcalcetide

Administered intravenously (IV) at the end of hemodialysis

DRUG

Placebo

Administered intravenously at the end of hemodialysis

Sponsors & Collaborators

  • KAI Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • M D · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-20
Primary Completion
2011-07-31
Completion
2011-08-24
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01254565 on ClinicalTrials.gov