Fosrenol for Enhancing Dietary Protein Intake in Hypoalbuminemic Dialysis Patients (FrEDI) Study

Protein-energy wasting, as reflected by a serum albumin <4.0 g/dL, is very common in
maintenance hemodialysis (MHD) patients and associated with poor clinical outcomes including
high death rates. Hyperphosphoataemia, reflected by serum phjsophorus level >5.5 mg/dL, is
also common disorder and associated with increased death risk in the same population. The
traditional dietary intervention to control hyp[erphosphataemia is to restrict protein
intake. This, however, may worsen protein-energy wasting as recently showed in large
epidemiologc data, which indicated that the best survival was observed in MHD patients with
increased protein intake while serum phosphorus could be controlled. We hypothesize that the
provision of high protein diet will be possible if a potent phosphorus binder (Fosreonlâ„¢)
will be prescribed simultaneously. Hence, we propose to conduct a randomized controlled
trial in 110 hypoalbuminemic (albumin <4.0 mg/dL) MHD patients in several DaVita dialysis
facilities in Los Angeles South Bay area. After 1:1 randomization, we will provide the
participating subjects (the INTERVENTION group) with 8 weeks of high protein meals in form
of prepared meal boxes (50 g protein, 850 Cal, and a phosphorus to protein ratio of <10
mg/gm) during each hemodialysis treatment, along with 0.5 to 1.5 g Fosrenol, to be titrated
if necessary; as well as dietary counselling to maintain a high dietary protein intake at
home (with same or similar binder regimen) for 8 weeks and to avoid food items with high
phosphorus based additives. Meals will be prepared at Harbor-UCLA GCRC Bionutrition
Department. We have reviewed and tested the feasibility of meal preparation and distribution
system and the related logistics. The CONTROL group will also receive meal boxes but the
meal contains low Calorie (<50 Cal) and almost zero protein (<1 g) diet (such as salads)
during each hemodialysis treatment. These patients will continue their pre-existing
phosphorus control regimens. As outcome variables, we will examine change in serum albumin
over the 8 weeks of intervention. We will also examine changes in dietary protein and serum
phosphorus in the 2 groups after 8 weeks of intervention. Quality of life and patient
satisfaction will also be examined before and towards the end of the intervention phase.
Given our ongoing 2-year study with a similar operation known as the AIONID Study and given
DaVita dieticians'' collaboration and support, we anticipate successful recruitment,
retention and data analyses within 8 to 12 months.