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Quantitative Mass Transfer of SFP-iron From Dialysate to Blood in CKD-HD Patients

NCT01894906 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2015-02-16

Study results available
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Summary

The purpose of this study is to determine the quantity of iron derived from SFP that is transferred from the dialysate to patients during a single dialysis session. The effects of various conditions which may affect the transfer of iron such as blood and dialysate flow rate, changes in bicarbonate delivery, dialyzer membrane type and the effect of reuse will also be investigated. The absorption and removal of iron from the blood will also be investigated.

Conditions

Interventions

DRUG

Soluble Ferric Pyrophosphate

OTHER

Placebo

Sponsors & Collaborators

  • Rockwell Medical Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Raymond D Pratt, MC FACP · Rockwell Medical Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • United States

Study Locations

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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 NCT01894906 on ClinicalTrials.gov