Clinical Trials Directory

Trials / Completed

CompletedNCT01414114

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

A Single-arm, Open-label, Multicenter, Dose Titration Study of KAI-4169 to Treat Secondary Hyperparathyroidism in Hemodialysis Subjects With Chronic Kidney Disease-Mineral and Bone Disorder

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
37 (actual)
Sponsor
KAI Pharmaceuticals · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

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

Timeline

Start date
2011-12-05
Primary completion
2012-05-21
Completion
2012-05-21
First posted
2011-08-11
Last updated
2017-04-11
Results posted
2017-04-11

Regulatory

Source: ClinicalTrials.gov record NCT01414114. Inclusion in this directory is not an endorsement.