Randomized clinical trial to compare the administration of intravenous iron in patient in hemodialysis according to practice guidelines or according to expert recommendations.

Randomized clinical trial to assess the monocitary functionality and their relationship with the administration of intravenous iron in patient in hemodialysis according to practice guidelines or according to expert recommendations.

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-002195-14-ES

Enrollment

Registered

2019-07-05

Start date

2019-11-12

Completion date

Unknown

Last updated

2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Monocyte function in patients with anemia in hemodialysis MedDRA version: 20.0 Level: LLT Classification code 10002272 Term: Anemia System Organ Class: 100000004851 MedDRA version: 20.0 Level: LLT Classification code 10027884 Term: Monocytes System Organ Class: 100000004848 MedDRA version: 20.1 Level: L

Interventions

Trade Name: Feriv Pharmaceutical Form: Concentrate for solution for injection/infusion INN or Proposed INN: Iron, parenteral preparations CAS Number: 80

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Older than 18. - Hemodialysis indicence patients (between 2 and 6 months in hemodialysis). - Having signed the inform consent. - Patients with anemia who require intravenous iron - Have not received intravenous iron before hemodialysis. - Clinically stable. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: - Patients with a ferritin level higher than 500mg/dl - Patients who have exceeded transferrin levels in the prior year to be included in the clinical trial. - Patients who, before the hemodialysis, had received intravenous iron. - Patients with chronic HIV or hepatitis C infection. - Pregnant women or breastfeeding period

Design outcomes

Primary

Measure	Time frame
Main Objective: Assess if the administration of intravenous iron,based only in levels of transferrin saturation index, does not generate relevants changes (higher than 15%) in the proportion of monocytes (CD14+ and CD16+) compared with patients that received treatment with intravenous iron according to the practice guidelines in place.; Secondary Objective: Evaluate: . The mortality rate of patients in 2 years-interval. - The number and severity of infections in 2 years-interval. - The mean haemoglobin levels - Number of Erythropoiesis-stimulating agents administered and blood transfusions. - The iron build up in liver tissue measured by magnetic resonance (NMR), as well as the hepatocellular function - The iron accumulates in serum monocytes. ;Primary end point(s): Serum monocyte;Timepoint(s) of evaluation of this end point: Monthly for 2 years period.	—

Measure

Time frame

Main Objective: Assess if the administration of intravenous iron,based only in levels of transferrin saturation index, does not generate relevants changes (higher than 15%) in the proportion of monocytes (CD14+ and CD16+) compared with patients that received treatment with intravenous iron according to the practice guidelines in place.; Secondary Objective: Evaluate: . The mortality rate of patients in 2 years-interval. - The number and severity of infections in 2 years-interval. - The mean haemoglobin levels - Number of Erythropoiesis-stimulating agents administered and blood transfusions. - The iron build up in liver tissue measured by magnetic resonance (NMR), as well as the hepatocellular function - The iron accumulates in serum monocytes. ;Primary end point(s): Serum monocyte;Timepoint(s) of evaluation of this end point: Monthly for 2 years period.

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Secondary

Measure	Time frame
Secondary end point(s): Mortality and number of infections.;Timepoint(s) of evaluation of this end point: 2 years	—

Countries

Spain

Contacts

Public ContactKorina

University Hospital "Príncipe de Asturias"

korinapenae@yahoo.com+349188781004097

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026