Hemodialysis ComplicationNCT05333692
Oral Nutritional Supplementation of Hemodialysis Patients
A study testing Fresubin® Protein Energy DRINK and NEPRO® , Abbott in people with Hemodialysis Complication, run by Fresenius Kabi Taiwan Ltd. at 1 site in Taiwan.
Trial 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®. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Hemodialysis Complication
- What is being tested?
- Fresubin® Protein Energy DRINK and NEPRO® , Abbott
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2020to 6 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- suboptimal tolerance of nutritional supplements,
- inflammatory bowel disease, bowel obstruction,
- acute condition complicated with multiple organ failure or under palliative care.
Trial locations and contacts
1 site in 1 country.
About this study
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®.
- Conditions
- Hemodialysis Complication
- Being tested
- Fresubin® Protein Energy DRINK, NEPRO® , Abbott
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresubin® Protein Energy DRINKDietary supplement
1-2 bottles of Fresubin® Protein Energy DRINK per day
NEPRO® , AbbottDietary supplement
2-4 cans NEPRO® per day
| Study group | Role | What they receive |
|---|---|---|
| NEPRO® | Active comparator | Not described Receives: Dietary Supplement: NEPRO® , Abbott |
| Fresubin® Protein Energy DRINK | Experimental | Not described Receives: Dietary Supplement: Fresubin® Protein Energy DRINK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Albumin level change
Measured: baseline, weerk 4 and week 8
Secondary outcomes (1)
Body Weight (kg) and Height(cm) change, and these results will be combine to report BMI (kg/m^2) change
Measured: baseline, weerk 4 and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start1 Jul 2020
- Primary completion6 May 2021
- Study completion6 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Kabi Taiwan Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chung Shan Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05333692
- Sponsor's protocol ID
- FrPE-005-IEN
- Status last verified
- Apr 2022
- First submitted
- 7 Apr 2022
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Nutritional Supplementation of Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT05333692
- Acronym / sponsor ID
- FrPE-005-IEN
- Conditions
- Hemodialysis Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Fresenius Kabi Taiwan Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Chung Shan Medical University
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 6 May 2021 (actual)
- Study completion
- 6 May 2021 (actual)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NEPRO® | Active comparator | Dietary Supplement: NEPRO® , Abbott |
| Fresubin® Protein Energy DRINK | Experimental | Dietary Supplement: Fresubin® Protein Energy DRINK |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fresubin® Protein Energy DRINK1-2 bottles of Fresubin® Protein Energy DRINK per day | Dietary supplement | Fresubin® Protein Energy DRINK |
| NEPRO® , Abbott2-4 cans NEPRO® per day | Dietary supplement | NEPRO® |
Primary outcome
Serum Albumin level change
Time frame: baseline, weerk 4 and week 8
1 secondary outcome
Body Weight (kg) and Height(cm) change, and these results will be combine to report BMI (kg/m^2) change
Time frame: baseline, weerk 4 and week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fresubin® Protein Energy DRINK and NEPRO® , Abbott in people with Hemodialysis Complication, run by Fresenius Kabi Taiwan Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Albumin level change (time frame: baseline, weerk 4 and week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2022.