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

Protein-energy wasting (PEW), reflected by serum albumin <4.0g/dL, is common in maintenance hemodialysis (MHD) patients (pts) and is associated with poor outcomes.Hyperphosphatemia (phosphorus >5.5mg/dL) is also common and is associated with high death risk. The traditional dietary approach to control hyperphosphatemia by limiting protein foods may cause or worsen PEW. We hypothesized that provision of a high protein diet including during HD treatment results in favorable outcomes if a potent phosphorus binder such as lanthanum carbonate (Fosrenol™) can control phosphorus simultaneously and conducted a pilot/feasibility randomized controlled trial in 110 hypoalbuminemic (<4.0mg/dL) MHD patients in several dialysis clinics. After a washout period and upon 1:1 randomization, we provided the INTERVENTION group with 8 weeks of high protein meals as prepared meal boxes (50g protein, 850Cal, phosphorus to protein ratio <10mg/gm) during each HD treatment, along with 0.5 to 1.5g Fosrenol (titrated as needed) plus dietary counseling to maintain a high dietary protein intake at home. The CONTROL group received meal boxes containing low calorie (<50 Cal) and almost no protein (<1g, such as salads) during each HD treatment and continued non-Fosrenol binders. We examined combined change in serum albumin with remaining in target phosphorus range of 3.5-<5.5mg/dL over the 8 weeks of intervention. Among the 51 intervention and 55 control subjects who qualified for the intention-to-treat analyses, the combined rise in albumin ≥0.2g/dL while maintaining phosphorus in 3.5-