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Periodic Versus Continuous IV Iron Supplementation in HD Patients

NCT ID: NCT02787824

Last Updated: 2017-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2016-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anemia of Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Iron Sucrose Supplement

Intervention Type DRUG

intermittent iv administration of iron sucrose

Patients on this arm will continue to receive the same previous intermittent mode of iron sucrose.

Group Type ACTIVE_COMPARATOR

Iron Sucrose Supplement

Intervention Type DRUG

Interventions

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Iron Sucrose Supplement

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Papageorgiou General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Efstathios Mitsopoulos

Director of Nephrology Dept

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Papageorgiou General Hospital

Thessaloniki, , Greece

Site Status

Countries

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Greece

Other Identifiers

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637/13.7

Identifier Type: -

Identifier Source: org_study_id