Status:
COMPLETED
Effect of Ferric Carboxymaltose on Exercise Capacity After Kidney Transplantation
Lead Sponsor:
University Medical Center Groningen
Collaborating Sponsors:
Dutch Kidney Foundation
Vifor Fresenius Medical Care Renal Pharma
Conditions:
Iron-deficiency
Transplant-Related Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Iron deficiency is common in kidney transplant recipients and is associated with impaired exercise tolerance and an unfavourable prognosis. This multicentre double-blind, placebo-controlled randomize...
Detailed Description
Rationale: Iron deficiency is common in kidney transplant recipients. The presence of iron deficiency is associated with an unfavourable prognosis in these patients. In patients with heart failure and...
Eligibility Criteria
Inclusion
- Kidney transplant recipient
- Iron deficiency, defined by a ferritin level of ≤100 ug/L, or 100-299 ug/L combined with a transferrin saturation of ≤20%
- At least six months after transplantation at baseline
- Age ≥18 years
- Ability to comply with the study protocol
- Informed consent
Exclusion
- Intolerance to any intravenous iron solution
- Severe anemia (Hb \<10.5 g/dL, \<6.5 mmol/L), microcytic anemia (MCV \<80 fl) or progressive anemia (˃3.2 g/dL per month decline for two months or more)
- A positive feces occult blood test or otherwise demonstrated gastrointestinal, or urogenital, blood loss
- Blood transfusion in the past six weeks
- Polycythemia (Hb \>15.3 g/dL, 9.5 mmol/L)
- Estimated glomerular filtration rate (eGFR) of ≤ 30 ml/min per 1.73 m2
- History of haemochromatosis
- Unstable angina or myocardial infarction during the previous month
- Disability to walk
- Severe hypophosphatemia in the month before baseline (serum phosphate \<0.35 mmol/L)
- Pregnancy or inability to take adequate contraceptive measures when at childbearing age (women)
- Any signs of an active systemic infection
- Participation in another interventional study
Key Trial Info
Start Date :
August 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 19 2024
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT03769441
Start Date
August 2 2019
End Date
August 19 2024
Last Update
August 27 2024
Active Locations (2)
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1
University Medical Center Groningen
Groningen, Netherlands, 9713 GZ
2
University Medical Center Utrecht
Utrecht, Netherlands