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

2014-08-27 03:13:58 | BioPortfolio


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 (Fosreonl™) 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.



Based on the hypothesis that the efficacy and potency of Fosrenol enables increasing dietary protein intake and provision of meals during dialysis treatment for improving nutritional status in malnourished dialysis patients with a low serum albumin (<4.0 g/dL) while serum phosphorus can be effectively controlled with the target range of 3.5 to 5.5 mg/dL.


1. In all subjects: Recommend adequate dietary protein intake to achieve or maintain an nPCR (nPNA) above 1.0 g/kg/day for 2 months. Encourage aggressive increase in protein intake while avoiding high phos/protein ratio esp. higher intake of egg whites, meat, fish, poultries, legumes, etc. via counseling by renal dietician (RD) and/or study staff.

2. Both groups will receive free meal boxes during the first 60 min of HD treatment for 8 weeks (24 meals during 24 HD treatment sessions). Cases will receive high protein meals (~50 gm, with phos/proteinratio <10 mg//gm), whereas controls will receive salad with almost no protein.

3. In CASES (n=55): Switch binder simultaneously to (or start) Fosrenol 500 mg to 1,500 per meal/snack, according to the meal size at different times of the day. Recommend crushing the pills using the pill-crusher that will be provided to subjects, and recommend placing or sprinkling Fosrenol pieces on the food. Titrate the dose every 2 weeks according to serum phosphorus.

4. In CONTROLLS (n=55): Continue the same binder (other than Fosrenol). In All subjects: Ttitrate the binder as indicated to control serum phosphorus <5.5 mg/dL.


1. Routine safety measures for food ingestion and binder administration

2. Bi-weekly measures of minerals and monthly measures of PTH


The t test, the chi square test, and the Mann-Whitney rank sum test to compare the baseline characteristics of intervention and control participants in serum albumin and other measures. To simplify presentation of results, some Likert scale responses will be dichotomized. The corresponding P values will be based on the complete ordinal scales used by participants to respond to questions quality of life, satisfaction, and food intake and about how often they eat meals from specific fast-food restaurants.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


End-Stage Renal Disease


Meals during hemodialysis accompanied by lanthanum carbonate to control phosphorus


Harbor-UCLA/MFI Dialysis
Long Beach
United States




Los Angeles Biomedical Research Institute

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:13:58-0400

Clinical Trials [785 Associated Clinical Trials listed on BioPortfolio]

Outcome Study of Lanthanum Carbonate Compared With Calcium Carbonate in Hemodialysis Patients : Landmark Study

The purpose of this study is to demonstrate decrease in cardiovascular mortality and morbidity in Japanese hemodialysis patients treated with Lanthanum carbonate compared with those with C...

Chewed vs. Crushed Lanthanum Carbonate in Hemodialysis Patients

Patients with end-stage renal disease (ESRD) commonly develop hyperphosphatemia due to the loss of excretory function of the kidney. This in turn may lead to the development of secondary h...

A Long Term Study of Lanthanum Carbonate in Patients Requiring Dialysis Who Have Ived Lanthanum Carbonate in Previous Studies Defined by the Protocol.

The purpose of this study is to assess the safety of lanthanum carbonate in patients undergoing dialysis who have received lanthanum carbonate in the previous studies and wish to continue ...

Pharmacodynamic Study of Two Lanthanum Carbonate Formulations in Healthy Adults

This study is being conducted to assess any potential differences in the absorption and excretion between two lanthanum carbonate formulations. This study is also being done to assess the ...

Comparing Absorption of Dietary Phosphorus When Administering FOSRENOL® or RENVELA® in Healthy Adult Volunteers

The purpose of this study is to compare the absorption of dietary phosphorus following a single dose with lanthanum carbonate (1000mg) and a single dose of sevelamer carbonate (2400mg).

PubMed Articles [8782 Associated PubMed Articles listed on BioPortfolio]

Evaluation of the effect of lanthanum carbonate hydrate on the pharmacokinetics of roxadustat in non-elderly healthy adult male subjects.

Roxadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor currently being investigated for the treatment of anemia in chronic kidney disease. Lanthanum carbonate is a phosphate binder that...

Adsorption of phosphorus from slaughterhouse wastewater by carboxymethyl konjac glucomannan loaded with lanthanum.

Phosphorus removal was an important measure in the control of eutrophication of water environment. In this study, a novel phosphorus removal adsorbent of lanthanum-loaded carboxymethyl konjac glucoman...

Long-Term Mortality and Bone Safety in Patients with End-Stage Renal Disease Receiving Lanthanum Carbonate.

This post-marketing observational study assessed the long-term safety of lanthanum carbonate (LaC) in US patients with end-stage renal disease (NCT00567723).

Targets and Therapeutics for Glycemic Control in Diabetes Patients on Hemodialysis.

For diabetes patients without nephropathy, glycemic control is important to reduce the risk or delay the progression of diabetes complications, including nephropathy. In diabetes patients on hemodialy...

Effect of cross-linked chitosan iron (III) on vascular calcification in uremic rats.

Cross-linked chitosan iron (III) is a chitin-derived polymer with a chelating effect on phosphorus, but it is untested in vascular calcification. We evaluated this compound's ability to reduce hyperph...

Medical and Biotech [MESH] Definitions

Lanthanum. The prototypical element in the rare earth family of metals. It has the atomic symbol La, atomic number 57, and atomic weight 138.91. Lanthanide ion is used in experimental biology as a calcium antagonist; lanthanum oxide improves the optical properties of glass.

Solutions prepared for hemodialysis. The composition of the pre-dialysis solution may be varied in order to determine the effect of solvated metabolites on anoxia, malnutrition, acid-base balance, etc. Of principal interest are the effect of the choice of buffers (e.g., acetate or carbonate), the addition of cations (Na+, K+, Ca2+), and addition of carbohydrates (glucose).

Carbonic acid calcium salt (CaCO3). An odorless, tasteless powder or crystal that occurs in nature. It is used therapeutically as a phosphate buffer in hemodialysis patients and as a calcium supplement.

Stable phosphorus atoms that have the same atomic number as the element phosphorus, but differ in atomic weight. P-31 is a stable phosphorus isotope.

A food service control process involving scheduling of meals in advance.

More From BioPortfolio on "Fosrenol for Enhancing Dietary Protein Intake in Hypoalbuminemic Dialysis Patients (FrEDI) Study"

Quick Search


Relevant Topics

Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Nephrology - kidney function
Nephrology is a specialty of medicine and pediatrics that concerns itself with the study of normal kidney function, kidney problems, the treatment of kidney problems and renal replacement therapy (dialysis and kidney transplantation). Systemic conditions...

Searches Linking to this Trial