Periodic Versus Continuous IV Iron Supplementation in HD Patients

September 19, 2017 updated by: Efstathios Mitsopoulos, Papageorgiou General Hospital

Periodic Versus Continuous (at Every Session of Hemodialysis) iv Iron Supplementation in Chronic HD Patients

The purpose of this study was to compare the efficacy of two regimens of intravenous iron sucrose [continuous (in every hemodialysis session) versus intermittent (every 1-4 weeks)] on the response of rHuEPO in the maintenance phase of its administration in hemodialysis patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Thessaloniki, Greece, 56403
        • Papageorgiou General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Constant rHu-EPO and iron dose for at least 2 months before starting the study
  • Hemoglobin ≥ 8,5g/dl and <12,5 g/dl
  • Ferritin < 1000 mg/dl
  • TSAT < 50%
  • CRP < 5 mg/dl

Exclusion Criteria:

  • Malignant tumor disease
  • Oral iron supplementation
  • Active bleeding issues
  • Surgical intervention within the last 8 weeks before study inclusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: continuous iv administration of iron sucrose
Prior to the study, all our patients were receiving intravenous iron sucrose in an intermittent mode (every 1-4 weeks).Patients on this arm will receive the same previous dose of iron glucose but in a continuous mode (smaller doses of iron sucrose in every session).
Drug: Iron Sucrose Supplement
Active Comparator: intermittent iv administration of iron sucrose
Patients on this arm will continue to receive the same previous intermittent mode of iron sucrose.
Drug: Iron Sucrose Supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of serum hemoglobin level (g/dl)
Time Frame: Month 0, 1, 2, 3, 4
Month 0, 1, 2, 3, 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Papageorgiou General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

May 24, 2016

First Submitted That Met QC Criteria

May 26, 2016

First Posted (Estimate)

June 1, 2016

Study Record Updates

Last Update Posted (Actual)

September 20, 2017

Last Update Submitted That Met QC Criteria

September 19, 2017

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 637/13.7

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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