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

Abstract

Protein-energy wasting (PEW), reflected by serum albumin 5.5 mg/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 (<4.0 mg/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 (50 g protein, 850 Cal, phosphorus to protein ratio <10 mg/gm) during each HD treatment, along with 0.5 to 1.5 g 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 (<1 g, 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-<5.5 mg/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 ≥0.2 g/dL while maintaining phosphorus in 3.5-<5.5 mg/dL range was achieved in 25.5% and 9.8%, respectively (χ² p-value 0.036). No serious adverse events were reported, and patients reported satisfaction with high protein meals during HD. Hence, provision of high protein meals combined with Fosrenol™ during HD is safe and may improve albumin while controlling serum phosphorus. ClinicalTrials.gov # NCT0111694