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

Phase 1

• Conditions: Anemia and iron deficiency in renal transplant recipients; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2012-003915-73-AT
• Lead Sponsor: Medizinische Universität Wien/Univ.klinik für Innere Medizin III/Abteilung für Nephrologie und Dialyse/Prof Josef Smolen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-23
• Last Update Posted: 29 August 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Renal transplant recipients > 18 years
- Renal function >20ml/h eGFR
- Transplant vintage >6months
- Hb <12g/dl (women), <13g/dl (men)
- TSAT < 20% or ferritin <300ng/ml
- Immunosuppressive regimen consisting of Tacrolimus/CsA, Mycophenolat Mofetil/ EC-MPS und Prednisolon (max 5mg/d)

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 5
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 5

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified