Pharmacy based dosing of darbepoetin in haemodialysis patients of the Sint Franciscus Gasthuis

Treatment of anaemia with haematopoetic growth factors in end stage renal
disease does not always lead to adequate haemoglobin values. At this moment,
approximately a quarter of the dialysis population has an adequate haemoglobin
value, defined as within the target range of 6.8 to 7.4 mmol/l. Previous
research has shown that haemoglobin values lower or higher than within the
target range may have serious consequences for the health of haemodialysis
patients. Lower values can lead to lower quality of life and may deteriorate
cardiac disease. Higher haemoglobin values may lead to higher cardiovascular
mortality as recent research has shown. Further, higher haemoglobin values may
lead to an increased incidence of shunt thrombosis, although studies are not
conclusive on this subject.

To investigate if a dosage advice for darbepoetin and iron generated by a
pharmacist leads to an increase of haemodialysis patients whose haemoglobin
values lie within the target range, compared to dosage of darbepoetin by the
nephrologist alone.

This study is a prospective, randomized controlled trial with partial
retrospective analysis. Patients are randomized between two groups: treatment
by nephrologist alone, or treatment by nephrologist and pharmacist. The first
group is the control group and gets standard treatment, The second group is the
experimental group. For this last group treatment advice for darbepoetin and
iron is monthly generated by a pharmacist, based on laboratory values
(haemoglobin, ferritin, transferrin saturation) and recent dosage of
darbepoetin and iron.

In the intervention group, the pharmacist advizes the nephrologist regarding
the dosage of darbepoetin and iron based on recent haemoglobin values and iron
status, as well as previous dosages of darbepoetin and iron. In the control
group, dosage of darbepoetin is solely determined by the nephrologist.

The burden for patients is minimal. The only differences between the two groups
are that in the group treated by nephrologist and pharmacist administration of
iron may be more frequent (three times a week vs. once a week or less) and that
during monthly blood withdrawal an extra vial of blood is necessary to
determine iron status (once monthly vs. once in three months). Both differences
do not lead to extra burden, because these procedures are executed during
regular haemodialysis moments.

The risk for patients is nil. In all cases, the nephrologist is responsible for
the treatment and has the possibility to diverge from the pharmacist's advice
for clinical reasons.

Benefits of participation with this study may be better regulated haemoglobin
values.