Effect of Ferric Carboxymaltose on Exercise Capacity After Kidney Transplantation

• Status: Recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

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 randomized controlled clinical trial will allow the investigators to analyse the effects of intravenous iron correction with ferric(III) carboxymaltose on exercise tolerance and other parameters, in comparison to a placebo.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Center Groningen
• Collaborators: Dutch Kidney Foundation; Vifor Fresenius Medical Care Renal Pharma
• Treatments: Ferric Compounds

Criteria

Inclusion Criteria:

• 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 four months after transplantation at the time of inclusion (and six months after transplantation at baseline)

• Age ≥18 years

• Ability to comply with the study protocol

• Informed consent

Exclusion Criteria:

• Intolerance of any intravenous iron solution

• 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)

• A positive feces occult blood test or otherwise demonstrated gastrointestinal, or urogenital, blood loss

• Blood transfusion in the past six weeks

• Polycythemia (Hb >15 g/dL, 9.3 mmol/L)

• History of haemochromatosis

• Resting heart rate of more than 120 per minute

• 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

• Severe hyponatremia (Na <130 mmol/L) or fluid overload

• Participation in another interventional study