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Periodic Versus Continuous IV Iron Supplementation in HD Patients

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ClinicalTrials.gov Identifier: NCT02787824
Recruitment Status : Completed
First Posted : June 1, 2016
Last Update Posted : September 20, 2017
Sponsor:
Information provided by (Responsible Party):
Efstathios Mitsopoulos, Papageorgiou General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anemia of Chronic Kidney Disease Drug: Iron Sucrose Supplement Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Periodic Versus Continuous (at Every Session of Hemodialysis) iv Iron Supplementation in Chronic HD Patients
Study Start Date : May 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

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



Primary Outcome Measures :
  1. Change of serum hemoglobin level (g/dl) [ Time Frame: Month 0, 1, 2, 3, 4 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02787824


Locations
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Greece
Papageorgiou General Hospital
Thessaloniki, Greece, 56403
Sponsors and Collaborators
Papageorgiou General Hospital
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Responsible Party: Efstathios Mitsopoulos, Director of Nephrology Dept, Papageorgiou General Hospital
ClinicalTrials.gov Identifier: NCT02787824    
Other Study ID Numbers: 637/13.7
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: September 20, 2017
Last Verified: May 2016
Keywords provided by Efstathios Mitsopoulos, Papageorgiou General Hospital:
iron deficiency
hemodialysis
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Ferric Oxide, Saccharated
Hematinics