MedTrace Logo

Treatment of (IDA) by (FPC) Delivered Via Infusion Pump in Patients Receiving Home Infusion Therapy

NCT05110768 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2021-11-08

No results posted yet for this study

Summary

The main purpose is to determine whether FPC, administered via infusion, is safe and effective for the treatment of iron deficiency anemia (IDA) in patients receiving Home Infusion therapies (HI).

Conditions

Interventions

DRUG

Triferic AVNU

Triferic AVNU is an iron salt that is approved for the maintenance of Hgb in chronic kidney disease patients on hemodialysis. It is experimental in this study because it has not yet been approved for patients receiving home infusion therapy

OTHER

Placebo

normal TPN solution without FPC on alternate days with TPN supplemented with multivitamins.

Sponsors & Collaborators

  • Rockwell Medical Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Raymond D Pratt, MD, FACP · Rockwell Medical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-30
Primary Completion
2022-04-30
Completion
2022-05-30
FDA Drug
Yes

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 NCT05110768 on ClinicalTrials.gov