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

This study has been completed.
Sponsor:
Collaborators:
DaVita Dialysis
Shire
Information provided by (Responsible Party):
kamyar kalantar-zadeh, md phd mph, Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier:
NCT01116947
First received: May 3, 2010
Last updated: February 27, 2012
Last verified: February 2012

May 3, 2010
February 27, 2012
July 2010
October 2011   (final data collection date for primary outcome measure)
1. Change in serum albumin by +0.2 g/dl or higher over 2 months, i.e., from baseline (Month 0) to Month 2 (main outcome measure) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01116947 on ClinicalTrials.gov Archive Site
  • 2. Percentage of serum phosphorus between 3.5 and 5.5 mg/dL [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • 3. Change in nPCR (nPNA) by +0.1 g/kg/day [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • 4. Change in protein intake via food frequency questionnaire x 2 (baseline vs. after 2 months) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • 5. Change in post-dialysis dry weight [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • 6. Changes in calcium, PTH, and alkaline phosphatase [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • 7. Patients satisfaction and quality of life (KDQOL36) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • 8. RD and MD satisfaction per questionnaires [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • 9. Change in other nutritional or inflammatory markers (CRP, TIBC, MIS, SGA) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Fosrenol for Enhancing Dietary Protein Intake in Hypoalbuminemic Dialysis Patients (FrEDI) Study
Fosrenol for Enhancing Dietary Protein Intake in Hypoalbuminemic Dialysis Patients (FrEDI) Study: An Investigator Initiated 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. Hyperphosphatemia, reflected by serum phosphorus 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 hyperphosphatemia is to restrict protein intake. This, however, may worsen protein-energy wasting as recently showed in large epidemiologic 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 Bio-nutrition 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.

RATIONALE:

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.

STUDY PROCEDURE:

  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/protein ratio <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: Titrate the binder as indicated to control serum phosphorus <5.5 mg/dL.

SAFETY ENDPOINTS:

  1. Routine safety measures for food ingestion and binder administration
  2. Bi-weekly measures of minerals and monthly measures of PTH

STATISTICAL METHODS:

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
End-Stage Renal Disease
Other: Meals during hemodialysis accompanied by lanthanum carbonate to control phosphorus
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
  • Active Comparator: Intervention Arm
    1. Treatment Arm (CASES) will receive high protein meals during thrice weekly hemodialysis in-center (each meal includes ~50 g of protein, ~850 Cal, and phos/protein ratio <10 mg/g) PLUS dietary counseling to continue similar high protein intake with low phosphorus to protein ratio and to avoid foods with high preservative content. Fosrenol 1.0 to 1.5 g per meal will be prescribed (use of pill crusher will be recommended) and will be titrated based on bi-weekly phosphorus levels.
    Intervention: Other: Meals during hemodialysis accompanied by lanthanum carbonate to control phosphorus
  • Active Comparator: Control Arm (CONTROLS)
    2. Control Arm (CONTROLS) will receive salad boxes in-center (no protein, low calorie) and routine dietary counseling and will continue pre-existing phosphorus binder regimen.
    Intervention: Other: Meals during hemodialysis accompanied by lanthanum carbonate to control phosphorus

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
108
February 2012
October 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Prevalent hypoalbuminemic hemodialysis patients with a serum albumin <4.0 g/dL and capable of oral food intake
  2. Adult (18-85 years) hemodialysis patients for 3 months or longer, capable of eating food independently
  3. Protein energy wasting as evident by serum albumin <4.0 g/dL
  4. Not receiving Fosrenol for the past 2 weeks

    Exclusion Criteria:

  5. Not willing to sign the written consent form
  6. Any condition that can interfere with increasing dietary protein intake, e.g. inability to eat or to maintain ingested food (OK to be on vitamin D agents including paricalcitol, calcitriol, doxercalciferol, ergocalciferol and cholecalciferol; or cinacalcet)
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01116947
LABioMed 13892-01
Yes
kamyar kalantar-zadeh, md phd mph, Los Angeles Biomedical Research Institute
Los Angeles Biomedical Research Institute
  • DaVita Dialysis
  • Shire
Principal Investigator: Kamyar Kalantar-Zadeh, MD, MPH, PhD University of California, Los Angeles
Los Angeles Biomedical Research Institute
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP