Complementary Intradialytic Nutritional Supplementation in Dialysis Patients

NCT00179205 | Terminated Phase 2

• 1 other identifier: 50006
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the investigators hypothesize that long-term administration of adequate intradialytic oral nutritional supplementation will increase visceral protein concentrations and somatic protein stores in malnourished chronic hemodialysis patients.

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• increase in serum albumin

  6 months

Secondary Outcomes (1)

• increase in lean body mass

  6 months

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: Nepro nutritional supplement

2

PLACEBO COMPARATOR

Drug: placebo

Interventions

Nepro nutritional supplement DRUG

oral nutritional supplement (1 can) administered during the hemodialysis procedure; every other day, 3 days per week, for 3 months; each can contains a total of 480 calories: 71 calories from protein, 206 calories from carbohydrates and 206 calories from fat.

1

placebo DRUG

oral placebo (1 can) administered during the hemodialysis procedure; every other day, 3 days per week, for 3 months; each can contains a total of 60 calories: 0 calories from protein, 60 calories from carbohydrates, and 0 calories from fat.

2

Eligibility Criteria

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

You may qualify if:

• On hemodialysis for more than 6 months
• Optimally dialyzed with a biocompatible membrane (URR \> 70% and/or delivered Kt/V \> 1.2)
• Suboptimal nutritional status identified by:
• Serum albumin less than or equal to 3.90 g/dl and one of the three following criteria:
• Protein catabolic rate less than 0.95 g/kg/d calculated by three point urea kinetic modeling 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 over the past 6 months and/or patients who are less than 90% of standard body weight
• Serum transferrin concentration less than 225 mg/dl
• Serum prealbumin concentration less than 32 mg/dl

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

Sponsors & Collaborators

• Vanderbilt University: lead
• Ross Laboratories: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• Mah JY, Choy SW, Roberts MA, Desai AM, Corken M, Gwini SM, McMahon LP. Oral protein-based supplements versus placebo or no treatment for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2020 May 11;5(5):CD012616. doi: 10.1002/14651858.CD012616.pub2.

  PMID: 32390133 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

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

• Alp Ikizler, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: May 1, 2005
• Primary Completion: November 1, 2006
• Study Completion: December 1, 2007
• Last Updated: August 6, 2008

Record last verified: 2008-08

Locations

US (1)