EFFECT OF FERRIC CARBOXYMALTOSE ON EXERCISE CAPACITY AFTER KIDNEY TRANSPLANTATION: A MULTICENTER RANDOMIZED CONTROLLED TRIAL - EFFECT KTx

niversity Medical Center Groningen0 个研究点目标入组 158 人开始时间: 2018年9月26日最近更新: 2021年3月22日

试验速览

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•1.Kidney transplant recipient
•2.Iron deficiency, defined by a ferritin level of =100 ug/L, or 100-299 ug/L combined with a transferrin saturation of =20%
•3.At least four months after transplantation at the time of inclusion (and six months after transplantation at baseline)
•4.Age =18 years
•5.Ability to comply with the study protocol
•6.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 79
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 79

•1.Intolerance of any intravenous iron solution
•2.Severe anemia (Hb <10.4 g/dL, <6.5 mmol/L), microcytic anemia or progressive anemia (?1 mmol/L per month decline for two months or more)
•3.A positive feces occult blood test or otherwise demonstrated gastrointestinal, or urogenital, blood loss
•4.Blood transfusion in the past six weeks
•5.Polycythemia (Hb >15.3 g/dL, 9.5 mmol/L)
•6.History of haemochromatosis
•7. An estimated glomerular filtration rate (eGFR) of = 30 ml/min per 1.73 m2 at screening.
•8.Resting heart rate of more than 120 per minute
•9.Unstable angina or myocardial infarction during the previous month
•10.Disability to walk
•11.Severe hypophosphatemia in the month before baseline (serum phosphate <0.35 mmol/L)
•12.Pregnancy or inability to take adequate contraceptive measures when at childbearing age
•13.Severe hyponatremia (Na <130 mmol/L) or fluid overload
•14.Participation in another interventional study

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