Iron deficiency in kidney transplant recipients MedDRA version: 20.0 Level: HLT Classification code 10022971 Term: Iron deficiencies System Organ Class: 100000004861
Conditions
Interventions
Trade Name: Ferinject
Product Name: Ferinject or Ferric Carboxymaltose
Pharmaceutical Form: Solution for injection/infusion
Pharmaceutical form of the placebo: Solution for solution for infusion
Route
Sponsors
University Medical Center Groningen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 1. Intolerance of any intravenous iron solution 2. Severe anemia (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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the effects of FCM on exercise tolerance in iron-deficient kidney transplant recipients (KTR’s).;Secondary Objective: To study the effects of FCM on haematinic parameters, quality of life, cardiac function, muscle function, bone and mineral parameters, focus, microbiota, the immune system, the incidence of infections, allograft failure and mortality in iron-deficient kidney transplant recipients (KTR’s).;Primary end point(s): The main study endpoint of the EFFECT-KTx study is change in exercise tolerance, quantified by the six-minute walk test (6MWT);Timepoint(s) of evaluation of this end point: After a maximum of four dosages of ferric carboxymaltose compared to placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary study endpoints of the EFFECT-KTx study are changes, between t=0 and t=24 weeks and between the intervention and the control group, in: • Haematinic and iron parameters: haemoglobin, haematocrit, mean corpuscular volume (MCV), free serum iron, serum ferritin, serum transferrin, serum hepcidin and C-reactive protein • Systolic and diastolic cardiac function analysed with a transthoracic echocardiography measuring left ventricular ejection fraction (LVEF), diastolic function and strain; serum NTproBNP and high-sensitive troponin-T • Quality of life, assessed by the Short-Form-36 (SF-36) questionnaire, the Kidney Disease Quality of Life Test (KDQOL-SF), the Checklist Individual Strength (CIS) and the 5Dimensial EuroQol (EQ-5D) instrument • Muscle strength, measured by neurological physical examination of the major muscle groups, the ‘Five-Times-Sit-to-Stand-test (FTSTS), the Timed-up-and-Go test (TUG) and a handgrip dynamometry • Cognitive performance, measured by: the dutch version of the National Adult Reading Test, the Digit Span which is a component of the Wechsler Adult Intelligence Scale, a dutch version of the Rey Auditory Verbal Learning Test, the Cognitive Screening Test, the Trial Making Test, the Clock Drawing Test, the Word Fluency subtest of the Groninger Intelligentietest, the Controlled Oral Word Association Test, the Symbol Digit Modalities Test and the Key Search Test • Parameters of phosphate and bone metabolism: - Serum: phosphate, calcium, vitamin D, vitamin D3, parathyroid hormone, total FGF23 and intact FGF23 - 24-hour urine: phosphate, calcium • Characteristics of the immune system: peripheral blood mononuclear cell (PBMC) count, macrophage count, T-lymfocyte count, B-cell count, neutrophil count and analysis of cytokines • Hepatic parameters: serum aspartate aminotransferase and alanine aminotransferase • Parameters of kidney function and injury: - Blood: creatinin - Urine: MCD1, CD163 | — |
Countries
Netherlands
Contacts
Public ContactJunior Investigator
University Medical Center Groningen
Outcome results
None listed