Prospective, interventional, open-label single center pilot study to evaluate FERInject Efficacy in 20 maintenance kidney transplant recipients.

Phase 1

• Conditions: This study is aimed at kidney transplant recipient with chronic kidney disease, iron deficiency and anemia.; MedDRA version: 21.1Level: LLTClassification code 10050308Term: Iron replacementSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2020-002956-20-IT
• Lead Sponsor: FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-06
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

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.
11.Evidence of iron overload or excessive accumulation of iron (hemochromatosis, chronic hemolysis)
12.Disorders of iron metabolism (sideroacrestical anemias, sideroblastic anemia, saturnine anemia, thalassemia).
13.Anemia not attributable to iron deficiency and CKD, e.g. other microcytic anemia.
14.Previous adverse events following iron administration.
15.Patients with LES, Rheumatoid Arthritis, allergic asthma, liver diseases (screening alanine transaminase or aspartate transaminase >3 times the upper limit of the normal range).
16.Active HIV infection or AIDS syndrome, or active hepatitis B or C virus infection
17.Active malignancy
18.Known active infection
19.C-reactive protein >20 mg/L

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary: To evaluate Ferric Carboxymaltose efficacy to improve anemic status in post-transplant CKD patients.;Secondary Objective: Secondary: To define a clinical approach for iron supplementation and ESA management in CKD kidney transplant recipients.;Primary end point(s): 1.Average change in TSAT at 6 months in FCM treatment after non-responsive OIT;Timepoint(s) of evaluation of this end point: 12 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1.Number of patients with TSAT >30% after 6 months of FCM treatment <br>2.Duration of administration of FCM and ESA to reach Hb levels >10.5 g/dL and <11.5 g/dL<br>3.Cumulative ESA dose in 12 weeks<br>4.Cumulative dose and frequency of administration of FCM in order to maintain Hb levels > 11.5 g/dL<br>5.Cumulative ESA dose in the FCM Treatment period<br>6.Cumulative dose of FCM in 12 weeks to reach Hb levels >10,5 g/dL and <11.5 g/dL<br>7.Need of blood transfusions<br>8.ESA hypo-responsiveness in FCM treatment<br>9.GFR slope;Timepoint(s) of evaluation of this end point: 12 months