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

niversitair Medisch Centrum Groningen0 个研究点目标入组 158 人开始时间: 待定最近更新: 2024年7月22日

适应症

试验速览

暂无简介。

•1. Kidney transplant recipients
•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 (or: six
•months after transplantation at baseline)
•4. Age more than 18 years
•5. Ability to comply with the study protocol
•6. Informed consent

•1. Intolerance of any intravenous iron solution
•2. Severe (Hb <10.4 g/dL, <6.5 mmol/L), microcytic or progressive anemia
•3. A positive feces occult blood test or known source of gastrointestinal blood
•loss after endoscopy
•4. Blood transfusion in the past six weeks
•5. Polycythemia (Hb >15.3 g/dL, 9.5 mmol/L)
•6. 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. Hypophosphatemia (serum phosphate <0.35 mmol/L)
•12. Pregnancy
•13. Severe hyponatremia (Na <130 mmol/L) or fluid retention
•14. Participation in another interventional trial

发起方