Oral Nutritional Supplementation of Hemodialysis Patients

This study is aimed to demonstrate that increase in serum albumin concentration (week 8 -baseline) after test treatment (Fresubin® Protein Energy DRINK), a standard ONS, is not relevantly smaller than that after control treatment with NEPRO®.

Study Overview

• Status: Completed
• Conditions: Hemodialysis Complication
• Intervention / Treatment: Dietary supplement: NEPRO® , Abbott; Dietary supplement: Fresubin® Protein Energy DRINK

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 40201
    • Chung Shan Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 40-80 years
2. Acute or chronic renal failure patients who need dialysis and already dialysis for 3 months at least.
3. Malnutrition patients. Definition of Malnutrition is serum albumin level<3.5g/dL, calorie digestion below 35kcal/IBW or protein digestion below 1.2g/IBW.

Exclusion Criteria:

1. BMI<18.5 and calorie intake unable to reach 50% of the recommended level
2. BMI>30 kg/m2,
3. abnormal liver function,
4. malignant disease,
5. scheduled surgery within a month or after surgery,
6. infectious disease,
7. suboptimal tolerance of nutritional supplements,
8. inflammatory bowel disease, bowel obstruction,
9. acute condition complicated with multiple organ failure or under palliative care.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: NEPRO®	Dietary supplement: NEPRO® , Abbott; 2-4 cans NEPRO® per day
Experimental: Fresubin® Protein Energy DRINK	Dietary supplement: Fresubin® Protein Energy DRINK; 1-2 bottles of Fresubin® Protein Energy DRINK per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Serum Albumin level change	baseline, weerk 4 and week 8

Secondary Outcome Measures

Outcome Measure	Time Frame
Body Weight (kg) and Height(cm) change, and these results will be combine to report BMI (kg/m^2) change	baseline, weerk 4 and week 8

Collaborators and Investigators

• Sponsor: Fresenius Kabi Taiwan Ltd.
• Collaborators: Chung Shan Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): May 6, 2021
• Study Completion (Actual): May 6, 2021

Study Registration Dates

• First Submitted: April 7, 2022
• First Submitted That Met QC Criteria: April 17, 2022
• First Posted (Actual): April 19, 2022

Study Record Updates

• Last Update Posted (Actual): April 19, 2022
• Last Update Submitted That Met QC Criteria: April 17, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: FrPE-005-IEN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No