ProStat Supplementation in Dialysis Patients

Stopped early · Not applicable · Has a placebo group

Conditions studied: Malnutrition, ESRD

In brief

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.

Key facts

Study ID

NCT00435123

Run by

Fresenius Medical Care North America

People needed

16

Starts

2007-07-01

Expected to finish

2008-01-01

Last updated by the study team

2008-02-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Protein catabolic rate less than 1.0 g/kg/d on at least 2 occasions over the past 6 months
• 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
• Subjective Global Assessment Score consistent with Moderate to Severe Malnutrition within the last month
• Biochemical parameters of malnutrition defined by 1 of 2 of the following measurements (if available) over the consecutive two months prior to inclusion:
• Serum transferrin concentration less than 225 mg/dl
• 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).

You may not qualify if…

• 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.

Where it is running

• Kansas Nephrology Physicians, PA — Wichita, Kansas, United States
• Western New England Renal Transplant Associates — Springfield, Massachusetts, United States
• Nephrology Associates — Columbus, Mississippi, United States
• Midwest Nephrology Associates — City of Saint Peters, Missouri, United States
• Metro Hypertension & Kidney Center, LLC. — St Louis, Missouri, United States
• Lankenau Center for Medical Research — Wynnewood, Pennsylvania, United States

Full record on ClinicalTrials.gov

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