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ProStat Supplementation in Dialysis Patients

Primary Purpose

Malnutrition, ESRD

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nutritional Supplement ProStat 64 twice a day
Placebo supplement
Sponsored by
Fresenius Medical Care North America
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malnutrition focused on measuring Malnutrition, ESRD, Hemodialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kansas Nephrology Physicians, PA
  • Western New England Renal Transplant Associates
  • Nephrology Associates
  • Metro Hypertension & Kidney Center, LLC.
  • Midwest Nephrology Associates
  • Lankenau Center for Medical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A

B

Arm Description

Patients are randomly assigned to receive either Active Comparator (ProStat 64) or placebo for the first 3 months. At the end of this, all patients receive open label ProStat64.

Patients are randomly assigned to Placebo Comparator or Active Comparator (ProStat 64). At the end of 3 months, all patients receive active ProStat 64

Outcomes

Primary Outcome Measures

Increase in visceral protein stores as measured by serum albumin

Secondary Outcome Measures

Full Information

First Posted
February 12, 2007
Last Updated
February 12, 2008
Sponsor
Fresenius Medical Care North America
Collaborators
Medical Nutrition USA, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00435123
Brief Title
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

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Terminated
Why Stopped
Increased use of commercial product; less eligible patients & poor enrollment.
Study Start Date
July 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Fresenius Medical Care North America
Collaborators
Medical Nutrition USA, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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. 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, ESRD
Keywords
Malnutrition, ESRD, Hemodialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Patients are randomly assigned to receive either Active Comparator (ProStat 64) or placebo for the first 3 months. At the end of this, all patients receive open label ProStat64.
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Patients are randomly assigned to Placebo Comparator or Active Comparator (ProStat 64). At the end of 3 months, all patients receive active ProStat 64
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutritional Supplement ProStat 64 twice a day
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo supplement
Intervention Description
Patients randomly assigned to Placebo for the first 3 months will receive open label Prostat for the last 3 months
Primary Outcome Measure Information:
Title
Increase in visceral protein stores as measured by serum albumin
Time Frame
3 months minimum; 6 months max

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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). 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Kaplan, M.D.
Organizational Affiliation
Fresenius Medical Care North America
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alp Ikizler, M.D.
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kansas Nephrology Physicians, PA
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Western New England Renal Transplant Associates
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
Nephrology Associates
City
Columbus
State/Province
Mississippi
ZIP/Postal Code
39705
Country
United States
Facility Name
Metro Hypertension & Kidney Center, LLC.
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63136
Country
United States
Facility Name
Midwest Nephrology Associates
City
St. Peters
State/Province
Missouri
ZIP/Postal Code
63376
Country
United States
Facility Name
Lankenau Center for Medical Research
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
10231458
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.
Results Reference
background
PubMed Identifier
8840260
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.
Results Reference
background
PubMed Identifier
12164890
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.
Results Reference
background
PubMed Identifier
12189242
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.
Results Reference
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ProStat Supplementation in Dialysis Patients

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