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Triferic Pediatric Pharmacokinetic Protocol

NCT02595437 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2018-10-25

Study results available
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Summary

The main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered intravenously in pediatric patients with chronic kidney disease on chronic hemodialysis (CKD-5HD). It is an open-label, two-period sequential dosing study.

Conditions

Interventions

DRUG

Triferic

Sponsors & Collaborators

  • Rockwell Medical Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Raymond D Pratt, MD FACP · Rockwell Medical, Inc

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-01
Primary Completion
2016-12-31
Completion
2017-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02595437 on ClinicalTrials.gov