Clinical trial NCT02198495: Comparison Study of Two Iron Compounds for Treatment of Anemia in Hemodialysis Patients
Official title: Continuous Versus Periodic Intravenous Iron Supplementation in Maintenance Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anemia of Chronic Kidney Disease
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2014-07-23
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Serum hemoglobin level (g/dl)
timeFrame: 40 weeks
Secondary outcomes:
measure: Serum ferritin level (µg/l)
timeFrame: Week 0, 10, 20, 30, 40
measure: Serum transferrin level (mg/dl)
timeFrame: Week 0, 10, 20, 30, 40
measure: Serum level of transferrin saturation (TSAT) (%)
timeFrame: Week 0, 10, 20, 30, 40
measure: ESA consumption in I.E./week or µg/week as appropriate
timeFrame: Week 0, 10, 20, 30, 40
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Division of Nephrology and Dialysis
city: Vienna
country: Austria
facility: Wiener Dialysezentrum GmbH
Study officials:
affiliation: Medical University of Vienna
name: Gere Sunder-Plassmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bielesz B, Lorenz M, Monteforte R, Prikoszovich T, Gabriel M, Wolzt M, Gleiss A, Horl WH, Sunder-Plassmann G. Comparison of Iron Dosing Strategies in Patients Undergoing Long-Term Hemodialysis: A Randomized Controlled Trial. Clin J Am Soc Nephrol. 2021 Oct;16(10):1512-1521. doi: 10.2215/CJN.03850321. Epub 2021 Sep 1.