Periodic Versus Continuous IV Iron Supplementation in HD Patients

Anemia of Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02787824
• Other study ID #: 637/13.7
• Status: Completed
• Phase: Phase 4
• First received: May 24, 2016
• Last updated: September 19, 2017
• Start date: May 2016
• Est. completion date: October 2016

Study information

• Verified date: May 2016
• Source: Papageorgiou General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia of Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Iron Sucrose Supplement

Locations

Country	Name	City	State
Greece	Papageorgiou General Hospital	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Papageorgiou General Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of serum hemoglobin level (g/dl)		Month 0, 1, 2, 3, 4