EUCTR2020-002956-20-IT进行中（未招募）1 期
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 个研究点目标入组 20 人开始时间: 2020年11月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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