Comparison Study of Two Iron Compounds for Treatment of Anemia in Hemodialysis Patients

Anemia of Chronic Kidney Disease Clinical Trial

— COPEFER  

Official title:

Continuous Versus Periodic Intravenous Iron Supplementation in Maintenance Hemodialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02198495
• Other study ID #: COPEFER
• Status: Completed
• Phase: Phase 4
• Start date: September 2014
• Est. completion date: May 2019

Study information

• Verified date: September 2020
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients with end-stage kidney disease on maintenance hemodialysis frequently require iron supplementation to compensate for ongoing iron losses, and to maintain hemoglobin levels with or without additional use of erythropoiesis-stimulating agents (ESA).

The investigators aim to compare two different intravenous iron preparations, ferric carboxymaltose and iron sucrose in 140 hemodialysis patients. The investigators primary objective is to assess whether both agents are equally effective to maintain a target haemoglobin within 10-12 mg/dl. The investigators will also measure ferritin, transferrin, transferrin saturation, and how much ESA therapy is administered.

Patients will be randomly assigned to either treatment group and followed in parallel over an active study period of 40 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Signed informed consent

• Male and female patients aged = 18

• Patients with anemia and end stage kidney disease on dialysis

• Hemoglobin = 8,5g/dl

• Ferritin < 1000mg/dl

• TSAT < 50%

• CRP < 5mg/dl

Exclusion Criteria:

• Hemoglobin < 8,5g/dl

• Pregnancy or Nursing

• Known allergic reaction to i.v. iron supplementation or to ingredients of Investigational Medicinal Product (IMP)

• Chronic infections (HIV, Hep B, Hep C)

• Acute infections (CRP>5mg/dl; Antibiotic therapy except for prophylactic use)

• Malignant tumor disease

• Oral iron supplementation at study inclusion

• Participation in a different study at the same time

• Active bleeding issues

• Surgical intervention within the last 4 weeks before study inclusion

• Mental diseases

• Bronchial asthma

• Atopic allergy

• Eczema

• Receipt of red blood cell (RBC) concentrate within the last 4 weeks before study inclusion

Related Conditions & MeSH terms

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

Intervention

Drug:
• Supplementation of ferric carboxymaltose

• Supplementation of iron sucrose

Locations

Country	Name	City	State
Austria	Medical University of Vienna, Division of Nephrology and Dialysis	Vienna
Austria	Wiener Dialysezentrum GmbH	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum hemoglobin level (g/dl)		40 weeks
Secondary	Serum ferritin level (µg/l)		Week 0, 10, 20, 30, 40
Secondary	Serum transferrin level (mg/dl)		Week 0, 10, 20, 30, 40
Secondary	Serum level of transferrin saturation (TSAT) (%)		Week 0, 10, 20, 30, 40
Secondary	ESA consumption in I.E./week or µg/week as appropriate		Week 0, 10, 20, 30, 40