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

Continuous Versus Periodic Intravenous Iron Supplementation in Maintenance Hemodialysis Patients

Sponsors

Lead Sponsor: Medical University of Vienna

Source Medical University of Vienna
Brief 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.

Overall Status Active, not recruiting
Start Date September 2014
Completion Date May 2019
Primary Completion Date May 2019
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Serum hemoglobin level (g/dl) 40 weeks
Secondary Outcome
Measure Time Frame
Serum ferritin level (µg/l) Week 0, 10, 20, 30, 40
Serum transferrin level (mg/dl) Week 0, 10, 20, 30, 40
Serum level of transferrin saturation (TSAT) (%) Week 0, 10, 20, 30, 40
ESA consumption in I.E./week or µg/week as appropriate Week 0, 10, 20, 30, 40
Enrollment 143
Condition
Intervention

Intervention Type: Drug

Intervention Name: Supplementation of ferric carboxymaltose

Arm Group Label: Ferric carboxymaltose

Intervention Type: Drug

Intervention Name: Supplementation of iron sucrose

Arm Group Label: Iron sucrose

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Gere Sunder-Plassmann, MD Principal Investigator Medical University of Vienna
Location
Facility:
Medical University of Vienna, Division of Nephrology and Dialysis | Vienna, 1090, Austria
Wiener Dialysezentrum GmbH | Vienna, 1220, Austria
Location Countries

Austria

Verification Date

September 2018

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Medical University of Vienna

Investigator Full Name: Gere Sunder-Plassmann

Investigator Title: Prof. Dr.

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Ferric carboxymaltose

Type: Active Comparator

Description: Supplementation of ferric carboxymaltose 500 mg at week 0, 10, 20, 30

Label: Iron sucrose

Type: Active Comparator

Description: Supplementation of iron sucrose 100 mg at week 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38

Acronym COPEFER
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov