Effect of i.v. iron supplementation on white blood cells after kidney transplantation

Effect of single dose i.v. iron supplementation on whole-genome transcription in patients with chronic kidney graft failure

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003915-73-AT

Enrollment

Registered

2016-08-23

Start date

2016-08-19

Completion date

Unknown

Last updated

2026-02-09

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

Conditions

Anemia and iron deficiency in renal transplant recipients

Interventions

Trade Name: Ferinject Product Name: Ferinject Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: FERRIC CARBOXYMALTOSE CAS Number: 9007-72-1 Current Sponsor code: ferric carboxy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Renal transplant recipients > 18 years - Renal function >20ml/h eGFR - Transplant vintage >6months - Hb =65 years) no F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: - History of alcohol or drug addiction - Malignancy - Nursing mothers - Surgical intervention - Chronic or acute infection - Active bleeding - Pregnancy - Current ESA therapy. - Current oral iron therapy - History of vascular disease event in the last 3 months

Design outcomes

Primary

Measure	Time frame
Main Objective: Assess changes in gene expression in lymphocytes before and after administration of iron carboxmyaltose in renal transplant recipients with iron-deficiency anemia;Secondary Objective: Assess changes in hemoglobin levels and iron status (ferritin, transferrin, transferrin saturation, iron);Primary end point(s): Change in gene expression in lymphocytes;Timepoint(s) of evaluation of this end point: 3 hours after application of iron	—

Measure

Time frame

Main Objective: Assess changes in gene expression in lymphocytes before and after administration of iron carboxmyaltose in renal transplant recipients with iron-deficiency anemia;Secondary Objective: Assess changes in hemoglobin levels and iron status (ferritin, transferrin, transferrin saturation, iron);Primary end point(s): Change in gene expression in lymphocytes;Timepoint(s) of evaluation of this end point: 3 hours after application of iron

—

Secondary

Measure	Time frame
Secondary end point(s): Hemoglobin levels within target range (above 12g/dl/13g/dl, respectively, for men/women), replenishment of iron stores;Timepoint(s) of evaluation of this end point: 4 weeks after administration of iron	—

Countries

Austria

Contacts

Public ContactAbt. f. Nephrologie und Dialyse

Medizinische Universität Wien/Universitätsklinik für Innere Medizin III/Abteilung für Nephrologie und Dialyse

+4314040073817

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 13, 2026