Clinical trial: Phase III Study to Investigate the Safety and Efficacy of Fermagate and Sevelamer Hydrochloride (NCT00844662)

Eligibility criteria:
Inclusion Criteria:

        Subjects will be considered eligible for entry in the study if they meet all of the
        following criteria.

          1. Male or female, aged > 18 years.

          2. Able to comply with the study procedures and medication.

          3. Written informed consent given.

          4. On a stable haemodialysis regimen (at least 3x per week) for ≥12 weeks prior to
             screening.

          5. (a) Subject receiving phosphate binder medication(s) at screening, must have been on a
             stable regimen (dose and medication) for at least 1 month prior to screening and will
             remain on this regimen until entry into the washout period OR (b)Subject (i) is not
             currently receiving any phosphate binding medication at screening (or medication
             likely to act as a phosphate binder) and (ii) must not have done so for at least one
             month and (iii) has sustained hyperphosphataemia.

          6. Willing to abstain from taking any phosphate binder or oral magnesium-, oral
             aluminium- or oral iron-containing products and preparations other than the study
             medication.

          7. If required to take >6000 mg/day of fermagate, the subject will be willing to have at
             least three meals per day.

             Specifically, for randomisation and inclusion into the treatment period, the following
             criterion must be fulfilled:

          8. Has a serum phosphate value of ≥1.94 mmol/L (≥6.0 mg/dL) within the 2 to 4 week
             washout period or above 3.0 mmol/L (9.3 mg/dL) at any time during washout.

        Exclusion Criteria:

        Subjects will not be considered eligible for entry in the study if they meet one or more of
        the following criteria.

          1. Participation in any clinical trial using an investigational product or device during
             the 30 days preceding the Screening Visit.

          2. Previous experience of fermagate treatment.

          3. A significant history of alcohol, drug or solvent abuse in the opinion of the
             investigator.

          4. Any disease or condition, physical or psychological that, in the opinion of the
             investigator, would compromise the safety of the subject or the likelihood of
             achieving reliable results or increase the likelihood of the subject being withdrawn.

          5. Laboratory findings at screening which, in the opinion of the investigator, are
             clinically significant for this subject population.

          6. A screen serum magnesium concentration of >1.25 mmol/L (>3.0 mg/dL).

          7. A known history of haemochromatosis.

          8. Subjects receiving either tetracycline or lithium treatment.

          9. A serum ferritin level of ≥1000 ng/mL.

         10. Non-elective hospitalisation in the 4 weeks prior to screening.

         11. Female subjects who are of childbearing potential and who are neither surgically
             sterilised nor using reliable contraceptive methods (hormonal, barrier methods or
             intrauterine device) or who are lactating or pregnant.

         12. Current hypophosphataemia at screening (last 2 consecutive phosphate values of <0.7
             mmol/L [<2.2 mg/dL]).

         13. Known history of colorectal malignancy, familial polyposis coli and/or strong family
             history (in 2 or more first degree relatives) of these terms.

         14. A QTcF interval of >560 ms at screen.

         15. Known persistent (>1 month) non compliance (<70%) with prescribed medication regimens
             at screen.

         16. Current clinically significant intestinal motility disorder.

         17. Bowel obstruction with current or previous use of sevelamer HCl.

         18. Known intolerance to sevelamer HCl or any excipients of fermagate or Renagel
             medication.

         19. Subjects with inflammatory bowel disease that, in the investigator's opinion, is
             poorly controlled.
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