Clinical trial NCT00435123: ProStat Supplementation in Dialysis Patients
Official title: A Randomized, Placebo Controlled, Double Blind Study of the Use of a Nutritional Supplement, ProStat-64, in Chronic Hemodialysis Patients With Poor Nutritional Status.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Malnutrition
ESRD
Keywords: Malnutrition
ESRD
Hemodialysis
Lead sponsor: Fresenius Medical Care North America
Sponsor class: INDUSTRY
Collaborators: name: Medical Nutrition USA, Inc.
First posted: 2007-02-14
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a long-term, randomized, placebo-controlled, double blind clinical study of a nutritional supplement, ProStat 64, in chronic hemodialysis patients with poor nutrition. Subjects receive either ProStat 64 or Placebo for three months. At the end of this period, all subjects will receive ProStat-64 for a further 3 months at which time the study is ended. Parameters of nutritional status (lean body mass and serum protein) will be collected at baseline, 3 months and 6 months.

Detailed description: Fifty patients identified as having poor nutrition by the following criteria:

1. Average of Serum Albumin for the consecutive two months prior to inclusion \</= 3.7 g/dl and the serum albumin for the previous month is \< 3.7 mg/dl.
2. one of the four following criteria:

   1. Protein catabolic rate less than 1.0 g/kg/d on at least 2 occasions over the past 6 months
   2. Progressive unintentional weight loss more than 2.5% of the initial or ideal body weight and/or patients who are less than 90% of Standard Body Weight
   3. Subjective Global Assessment Score consistent with Moderate to Severe Malnutrition within the last month
   4. Biochemical parameters of malnutrition defined by 1 of 2 of the following measurements (if available) over the consecutive two months prior to inclusion:

      1. Serum transferrin concentration less than 225 mg/dl
      2. Serum prealbumin concentration less than 32 mg/dl

will be randomized to receive either ProStat 64 or placebo for 3 months. At Baseline a Dexa for lean body mass and labs for BUN, creatinine, glucose, serum albumin, prealbumin and C-reactive protein will be drawn. Cholesterol and transferrin will be recorded from the regular monthly labs if available. In addition, a protein catabolic rate will be calculated and a SGA will be completed.

Patients will take the supplement/placebo twice a day. Measurements will be repeated at month 3. At the end of these measurements, all patients will be switched to open label ProStat64 for an additional 3 months. At month 6 all study procedures/labs are repeated and the study is complete.

Eligibility criteria: Inclusion Criteria:

* On hemodialysis
* Optimally dialyzed with a biocompatible membrane (URR \> 70% and/or delivered Kt/V \>1.2)
* Patient or next of kin able to sign consent form
* Average of Serum Albumin for the consecutive two months prior to inclusion \</= 3.7 g/dl and the serum albumin for the previous month is \< 3.7 mg/dl.
* Sub-optimal nutritional status identified by one of the four following criteria:

  1. Protein catabolic rate less than 1.0 g/kg/d on at least 2 occasions over the past 6 months
  2. Progressive unintentional weight loss more than 2.5% of the initial or ideal body weight and/or patients who are less than 90% of Standard Body Weight
  3. Subjective Global Assessment Score consistent with Moderate to Severe Malnutrition within the last month
  4. Biochemical parameters of malnutrition defined by 1 of 2 of the following measurements (if available) over the consecutive two months prior to inclusion:

     1. Serum transferrin concentration less than 225 mg/dl
     2. Serum prealbumin concentration less than 32 mg/dl
* Patient is able to transfer with minimal or no assistance.
* Not taking a caloric nutritional supplement for the last 30 days (e.g. Nepro, ProStat, Boost,etc).

Exclusion Criteria:

* Active auto-immune, inflammatory or infectious disease
* Documented malignancy within the last 12 months
* Patients on unusual dietary restrictions
* Life-expectancy less than 6 months
* Inability to tolerate nutritional supplements
* Patient does not exceed the DEXA machine weight limit.

Primary outcomes:
measure: Increase in visceral protein stores as measured by serum albumin
timeFrame: 3 months minimum; 6 months max
Secondary outcomes:
Other outcomes:
Locations:
city: Wichita
country: United States
facility: Kansas Nephrology Physicians, PA
state: Kansas
city: Springfield
country: United States
facility: Western New England Renal Transplant Associates
state: Massachusetts
city: Columbus
country: United States
facility: Nephrology Associates
state: Mississippi
city: St. Louis
country: United States
facility: Metro Hypertension & Kidney Center, LLC.
state: Missouri
city: St. Peters
country: United States
facility: Midwest Nephrology Associates
state: Missouri
city: Wynnewood
country: United States
facility: Lankenau Center for Medical Research
state: Pennsylvania
Study officials:
affiliation: Fresenius Medical Care North America
name: Mark Kaplan, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University
name: Alp Ikizler, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ikizler TA, Wingard RL, Harvell J, Shyr Y, Hakim RM. Association of morbidity with markers of nutrition and inflammation in chronic hemodialysis patients: a prospective study. Kidney Int. 1999 May;55(5):1945-51. doi: 10.1046/j.1523-1755.1999.00410.x.
citation: Ikizler TA, Hakim RM. Nutrition in end-stage renal disease. Kidney Int. 1996 Aug;50(2):343-57. doi: 10.1038/ki.1996.323.
citation: Caglar K, Fedje L, Dimmitt R, Hakim RM, Shyr Y, Ikizler TA. Therapeutic effects of oral nutritional supplementation during hemodialysis. Kidney Int. 2002 Sep;62(3):1054-9. doi: 10.1046/j.1523-1755.2002.00530.x.
citation: Pupim LB, Flakoll PJ, Brouillette JR, Levenhagen DK, Hakim RM, Ikizler TA. Intradialytic parenteral nutrition improves protein and energy homeostasis in chronic hemodialysis patients. J Clin Invest. 2002 Aug;110(4):483-92. doi: 10.1172/JCI15449.