EUCTR2020-002956-20-IT
Active, not recruiting
Phase 1
Prospective, interventional, open-label single center pilot study to evaluate FERInject Efficacy in 20 maintenance kidney transplant recipients. - FERIE
FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE0 sites20 target enrollmentNovember 6, 2020
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- This study is aimed at kidney transplant recipient with chronic kidney disease, iron deficiency and anemia.
- Sponsor
- FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
- Enrollment
- 20
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion criteria for Baseline visit
- •1\.Age \> 18 years
- •2\.Transplant vintage \> 3 months (living or deceased, useful subpopulation)
- •3\.In active ESA therapy (last ESA dose within 6 weeks before screening)
- •4\.GFR between 30 and 60 ml/min/1\.73 m2 according to CKD\-EPI equation
- •5\.Anemia with hemoglobin between 8\-12 g/dl ,
- •6\.TSAT \< 30% and Ferritin \< 300 ug/L (6\)
- •7\.Patient able to understanding and sign an informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
Exclusion Criteria
- •1\.Need for HD
- •2\.Active bleeding
- •3\.Recent transfusion (within 30 days before screening) or need for transfusion
- •4\.Patients currently in therapy with ferric carboxymaltose (last dose within 60 days before screening)
- •5\.Patient is participating or has participated in another clinical trial and/or is taking or has been taking an investigational drug in the past 30 days before screening.
- •6\.Patient is unlikely to comply with the visits scheduled in the protocol
- •7\.Female patients of childbearing potential, which do not want to maintain effective birth control, practice during the study and 3 months thereafter.
- •8\.Female patients pregnant or during feeding time.
- •9\.Patient has any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, may invalidate communication with the investigator.
- •10\.Known hypersensitivity to iron sulfate, ferric carboxymaltose, foline or one of the excipients.
Outcomes
Primary Outcomes
Not specified
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