Clinical trial: Evaluation of Efficacy and Safety of Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia and Impaired Renal Function (NCT00981045)

Eligibility criteria:
Inclusion Criteria:

          -  Male or female subjects > or = to 18 years of age.

          -  Chronically impaired renal function.

          -  Screening visit central laboratory hemoglobin < or = to 11.5 g/dL.

          -  Screening ferritin < or = to 100 ng/mL or < or = to 300 when transferrin saturation
             (TSAT) is < or = to 30%.

          -  If on an erythropoiesis stimulating agent(ESA) a stable dose (+/- 20%) for 4 weeks
             prior to randomization.

        Exclusion Criteria:

          -  Known hypersensitivity reaction to any component of ferric carboxymaltose (FCM) or
             Venofer.

          -  Previously randomized in a clinical study of Ferric Carboxymaltose (FCM).

          -  Requires dialysis for treatment of chronic kidney disease OR is being considered for
             initiation of dialysis during the time period of this trial.

          -  No evidence of iron deficiency.

          -  Any non-viral infection.

          -  AST or ALT at screening as determined by central labs greater than 1.5 times the upper
             limit of normal.

          -  Known positive hepatitis with evidence of active disease.

          -  Received an investigational drug within 30 days of screening.

          -  Alcohol or drug abuse within the past 6 months.

          -  Hemochromatosis or other iron storage disorders.

          -  Estimated life expectancy of less than 6 months, or for cancer patients, an ECOG
             Performance Status greater than 1.

          -  Any other laboratory abnormality, medical condition or psychiatric disorder which in
             the opinion of the investigator would put the subject's disease management at risk or
             may result in the subject being unable to comply with study requirements.

          -  Pregnant or sexually-active female subjects who are not willing to use an acceptable
             form of contraception.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 51-year-old man comes to the office complaining of fatigue and some sexual problems including lack of libido. The patient doesn't smoke or use any illicit drug.  Blood pressure is 120/80 mm Hg and pulse is 70/min.  Oxygen saturation is 99% on room air.  BMI is 24 kg/m2.  Skin examination shows increased pigmentation. Genotype testing is consistent with homozygosity for the C282Y mutation. Laboratory study shows transferrin saturation of 55% and serum ferritin of 550 μg/L. He is diagnosed as a case of hemochromatosis.

Patient description (patient's own words): I am 51 years old and I just came back from the doctor's office. I'm sick and tired of being that exhausted, reaching the point where me and my lovely wife are not touching each other anymore! I'm not smoking or doing drugs! My blood pressure was 120/80 mm Hg, and pulse was 70/min and my oxygen saturation 99%. My BMI is 24. My skin also turned a bit darker lately. He tested my genes and told me that I have a mutation of the C282Y gene. I also did lab tests where my transferrin saturation was 55% and serum ferritin was 550  μg/L. The doctor diagnosed me with iron overload.

Does the patient match the trial criteria? Contradiction