ProStat Supplementation in Dialysis Patients

NCT00435123 | Terminated

• 2 other identifiers: 2006002061201 Vanderbilt IRB
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 6

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.

Conditions

Malnutrition; ESRD

Keywords

Malnutrition; ESRD; Hemodialysis

Outcome Measures

Primary Outcomes (1)

• Increase in visceral protein stores as measured by serum albumin

  3 months minimum; 6 months max

Study Arms (2)

A

ACTIVE COMPARATOR

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.

Dietary Supplement: Nutritional Supplement ProStat 64 twice a day

B

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo supplement

Interventions

Nutritional Supplement ProStat 64 twice a day DIETARY_SUPPLEMENT

A

Placebo supplement DIETARY_SUPPLEMENT

Patients randomly assigned to Placebo for the first 3 months will receive open label Prostat for the last 3 months

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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
• 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.

Sponsors & Collaborators

• Fresenius Medical Care North America: lead
• Medical Nutrition USA, Inc.: collaborator

Study Sites (6)

Kansas Nephrology Physicians, PA

Wichita, Kansas, 67214, United States

Location

Western New England Renal Transplant Associates

Springfield, Massachusetts, 01107, United States

Location

Nephrology Associates

Columbus, Mississippi, 39705, United States

Location

Midwest Nephrology Associates

City of Saint Peters, Missouri, 63376, United States

Location

Metro Hypertension & Kidney Center, LLC.

St Louis, Missouri, 63136, United States

Location

Lankenau Center for Medical Research

Wynnewood, Pennsylvania, 19096, United States

Location

Related Publications (4)

• 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.

  PMID: 10231458 BACKGROUND

• Ikizler TA, Hakim RM. Nutrition in end-stage renal disease. Kidney Int. 1996 Aug;50(2):343-57. doi: 10.1038/ki.1996.323.

  PMID: 8840260 BACKGROUND

• 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.

  PMID: 12164890 BACKGROUND

• 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.

  PMID: 12189242 BACKGROUND

MeSH Terms

Conditions

Malnutrition; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark Kaplan, M.D.

  Fresenius Medical Care North America

  PRINCIPAL INVESTIGATOR

• Alp Ikizler, M.D.

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 12, 2007
• First Posted: February 14, 2007
• Study Start: July 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: February 21, 2008

Record last verified: 2008-02

Locations

US (6)