Oral Nutritional Supplementation of Hemodialysis Patients | NCT05333692

Studies
Oral Nutritional Supplementation of Hemodialysis Patients

NCT05333692

Sponsor

Fresenius Kabi Taiwan Ltd.

Status

Completed

Last Update Posted

Apr 19, 2022Actual

Enrollment

90Actual

Phase

Not Applicable

Conditions

Hemodialysis Complication

Interventions

Fresubin® Protein Energy DRINK
NEPRO® , Abbott

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2020Actual

Primary Completion Date

May 6, 2021Actual

Completion Date

May 6, 2021Actual

First Submitted Date

Apr 7, 2022

First Submission Date that Met QC Criteria

Apr 17, 2022

First Posted Date

Apr 19, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2022

Last Update Posted Date

Apr 19, 2022Actual

Name	Class
Chung Shan Medical University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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®.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NEPRO®	Active Comparator		Dietary Supplement: NEPRO® , Abbott
Fresubin® Protein Energy DRINK	Experimental		Dietary Supplement: Fresubin® Protein Energy DRINK

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fresubin® Protein Energy DRINK	Dietary Supplement	1-2 bottles of Fresubin® Protein Energy DRINK per day	Fresubin® Protein Energy DRINK

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 40-80 years
Acute or chronic renal failure patients who need dialysis and already dialysis for 3 months at least.
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:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chung Shan Medical University		Taichung		40201	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided