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Etelcalcetide to Treat Secondary Hyperparathyroidism in Hemodialysis Patients With Chronic Kidney Disease-Mineral and Bone Disorder

NCT01414114 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2017-04-11

Study results available
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Summary

The purpose of this study is to evaluate the effect of thrice weekly intravenous (IV) administration of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in hemodialysis patients with chronic kidney disease-mineral and bone disorder (CKD-MBD).

Conditions

  • Secondary Hyperparathyroidism

Interventions

DRUG

Etelcalcetide

Administered 3 times a week by bolus injection into the venous line of the dialysis circuit after the end of hemodialysis.

Sponsors & Collaborators

  • KAI Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Gregory Bell, MD · KAI Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-05
Primary Completion
2012-05-21
Completion
2012-05-21
FDA Drug
Yes

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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 NCT01414114 on ClinicalTrials.gov