Chronic Kidney DiseaseNCT05330663
Low Protein Renal Formula as Meal Replacement in Predialysis CKD Patients
A study testing Low protein diet with Fresubin® renal and Low protein diet with normal food in people with Chronic Kidney Disease, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
A high energy and low protein renal formula tailored for the specific needs of pre-dialysis CKD patients. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Low protein diet with Fresubin® renal and Low protein diet with normal food
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Apr 2020to 18 Dec 2020
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic kidney disease stage 4-5 (eGFR <30 mL/min/1.73m2)
- Age: 20-80 years
- Patients on low protein diet (0.6-0.8 g protein/kg/d) for at least 3 months
- Written informed consent
Who cannot join
- Dialysis or planned start of dialysis within next 3 months
- Patients awaiting kidney transplantation
- BMI <18 and >30 kg/m2
- Malnourished patients with albumin levels less than 3 g/dL who need additional supplementation of calories and nutrients
- Severe liver disease, malignant disease, infectious disease
- Existing gastrointestinal diseases or pathological findings, which do not allow EN, e.g. intestinal atony, ileus, acute upper GI bleeding, shock, or malabsorption, e.g. inflammatory bowel disease, pancreatic disease, or previous surgical GI resection
Show all 15Show fewer
- Severely impaired gastrointestinal function, i.e. severe constipation or acute diarrhea (≥ 3 loose or watery stools per day)
- Dysphagia or high aspiration risk
- Relevant CNS and/or psychiatric disorders
- Known allergic reaction or intolerance to any of the ingredients of the study product
- Planned surgery or hospitalization during study period
- Suspicion of drug abuse
- Patients unable to follow study instructions or keeping a dietary diary
- Pregnant or lactating women
- Participation in another clinical trial with an investigational product within 30 days prior to start of study or during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Energy Low Protein Renal Formula as Meal Replacement in Predialysis CKD Patients
A high energy and low protein renal formula tailored for the specific needs of pre-dialysis CKD patients.
Read the detailed description
Previous studies indicated that low-protein formula nutritional supplements may improve compliance with an LPD and are beneficial in the management of pre-dialysis CKD patients
This study will evaluate the suitability of the disease-specific enteral formula Fresubin® renal in predialysis chronic kidney disease patients.
- Conditions
- Chronic Kidney Disease
- Being tested
- Low protein diet with Fresubin® renal, Low protein diet with normal food
- Keywords
- Chronic kidney disease, Oral nutrition supplement
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low protein diet with Fresubin® renalDietary supplement
Low protein diet with Fresubin® renal Dosage: 1 bottle per day as a replacement for one regular meal. All patients will get individualized dietary counseling aimed at achieving a protein intake of 0.6-0.8 g/kg actual body weight/day and an energy intake of 30-35 kcal/kg actual body weight.
Low protein diet with normal foodOther
All patients will get individualized dietary counseling aimed at achieving a protein intake of 0.6-0.8 g/kg actual body weight/day and an energy intake of 30-35 kcal/kg actual body weight/day.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Low protein diet with Fresubin® renal Receives: Dietary Supplement: Low protein diet with Fresubin® renal |
| Standard of care | Other | Low protein diet with normal food Receives: Other: Low protein diet with normal food |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of body weight
Body weight measured in kilograms
Measured: baseline to week 4
Secondary outcomes (12)
Change 3-day dietary record
Total energy intake,3 macronutrients (carbohydrates, protein and lipids) and micronutrients
Measured: baseline to week 4
Change body composition
Body composition measured by bioelectrical impedance analyses
Measured: baseline to week 4
Change of renal fuction
blood urea nitrogen,serum creatinine and estimated glomerular filtration rate
Measured: baseline to week 4
Change of electrolytes
Sodium,potassium,calciam,phosphorus and magnesium in the blood
Measured: baseline to week 4
Safety and compliance.
gastrointestinal symptoms measured by questionnaire
Measured: baseline to week 4
Change in lipid analysis
Change of cholesterol ,triglyceride ,and LDL-cholesterol in the blood
Measured: baseline to week 4
Change of Body Mass Index (BMI) levels
BMI was calculate by body weight (kg) divided by the square of the height (m^2)
Measured: baseline to week 4
Change of waist circumference levels
Waist circumference was measured by a tape
Measured: baseline to week 4
Change of grip strength levels
hand grip strength was measured by grip strength device
Measured: baseline to week 4
Change of CRP
Change of CRP in the blood
Measured: baseline to week 4
Change of nutrition status in blood test
Serum albumin, pre-albumin, total protein, uric acid
Measured: baseline to week 4
Change of daily protein intake
24-hour urine estimated protein intake with Maroni formula
Measured: baseline to week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start8 Apr 2020
- Primary completion18 Dec 2020
- Study completion18 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fresenius Kabi Taiwan Ltd.
- Responsible party
- Sponsor
- Investigators
- Cheng-Hsu Chen, MDPHD, Principal investigator, Division of Nephrology in Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05330663
- Sponsor's protocol ID
- SF20045B
- Status last verified
- Apr 2022
- First submitted
- 26 Mar 2022
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Energy Low Protein Renal Formula as Meal Replacement in Predialysis CKD Patients
- ClinicalTrials.gov ID
- NCT05330663
- Acronym / sponsor ID
- SF20045B
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic kidney disease, Oral nutrition supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Collaborators
- Fresenius Kabi Taiwan Ltd.
- Study start
- 8 Apr 2020 (actual)
- Primary completion
- 18 Dec 2020 (actual)
- Study completion
- 18 Dec 2020 (actual)
- First posted
- 15 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.
A high energy and low protein renal formula tailored for the specific needs of pre-dialysis CKD patients.
Detailed description
Previous studies indicated that low-protein formula nutritional supplements may improve compliance with an LPD and are beneficial in the management of pre-dialysis CKD patients
This study will evaluate the suitability of the disease-specific enteral formula Fresubin® renal in predialysis chronic kidney disease patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: Low protein diet with Fresubin® renalLow protein diet with Fresubin® renal |
| Standard of care | Other | Other: Low protein diet with normal foodLow protein diet with normal food |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic kidney disease stage 4-5 (eGFR <30 mL/min/1.73m2)
- Age: 20-80 years
- Patients on low protein diet (0.6-0.8 g protein/kg/d) for at least 3 months
- Written informed consent
Key exclusion criteria (15 listed)
- Dialysis or planned start of dialysis within next 3 months
- Patients awaiting kidney transplantation
- BMI <18 and >30 kg/m2
- Malnourished patients with albumin levels less than 3 g/dL who need additional supplementation of calories and nutrients
- Severe liver disease, malignant disease, infectious disease
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 |
|---|---|---|
| Low protein diet with Fresubin® renalLow protein diet with Fresubin® renal Dosage: 1 bottle per day as a replacement for one regular meal. All patients will get individualized dietary counseling aimed at achieving a protein intake of 0.6-0.8 g/kg actual body weight/day and an energy intake of 30-35 kcal/kg actual body weight. | Dietary supplement | Intervention group |
| Low protein diet with normal foodAll patients will get individualized dietary counseling aimed at achieving a protein intake of 0.6-0.8 g/kg actual body weight/day and an energy intake of 30-35 kcal/kg actual body weight/day. | Other | Standard of care |
Primary outcome
Change of body weight
Time frame: baseline to week 4
Body weight measured in kilograms
12 secondary outcomes
Change 3-day dietary record
Time frame: baseline to week 4
Change body composition
Time frame: baseline to week 4
Change of renal fuction
Time frame: baseline to week 4
Change of electrolytes
Time frame: baseline to week 4
Safety and compliance.
Time frame: baseline to week 4
Change in lipid analysis
Time frame: baseline to week 4
Change of Body Mass Index (BMI) levels
Time frame: baseline to week 4
Change of waist circumference levels
Time frame: baseline to week 4
Change of grip strength levels
Time frame: baseline to week 4
Change of CRP
Time frame: baseline to week 4
Change of nutrition status in blood test
Time frame: baseline to week 4
Change of daily protein intake
Time frame: baseline to week 4
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 15 Apr 2022.
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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.
Cheng-Hsu Chen, MDPHD principal investigator
Division of Nephrology in Taichung Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low protein diet with Fresubin® renal and Low protein diet with normal food in people with Chronic Kidney Disease, run by Taichung Veterans General Hospital 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 4 inclusion and 15 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 15 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?
Change of body weight (time frame: baseline to week 4). 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 15 Apr 2022.