Chronic Kidney DiseaseNCT02046746
The Effect of a Renal Specific Oral Nutritional Supplement on Nutritional Status
A study testing Oral Nutritional Supplement (ONS) in people with Chronic Kidney Disease, run by Abbott Nutrition at 2 sites in Taiwan.
Trial summary
The study objective is to evaluate if a renal specific oral nutrition supplement (ONS) aids in maintaining nutritional status. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Oral Nutritional Supplement (ONS)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 2 sitesTaiwan
- Study dates
- Nov 2013to May 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject, or subject's legally acceptable representative (LAR), has voluntarily signed and dated an informed consent form (ICF), approved by an IEC/IRB, and provided Health Insurance Portability and Accountability Act (HIPAA)
- Subject is >18 years of age.
- Subject has been diagnosed with Chronic Kidney Disease (CKD) and is classified as being between Stages 3b to 5.
- Subject has an eGFR 45 and 10 ml/min/1.73m2 at screening.
- Subject is a male or non-pregnant female at least six weeks postpartum and non-lactating.
- Subject with CKD is either:
Show all 19Show fewer
- not diagnosed with Type 2 Diabetes Mellitus (T2DM) OR
- diagnosed with T2DM and had no changes in glycemic medication (dose or type) for at least 2 months prior to screening
- Subject has a serum albumin 3.0 g/dl at screening.
- Subject has a BMI 30 kg/m2.
- If diagnosed with T2DM, subject has A1c level 9.0% at screening.
- Subject is not scheduled or expected to receive dialysis in the next 18 months.
- Subject's life expectancy is 18 months determined by the study physician.
- Subject is willing to follow the protocol as described.
- With regard to ONS use the subject must qualify as one of the following:
- be naïve to ONS
- if the subject is already prescribed another ONS that is not the study product, and they have consumed 8 servings over the last 28 days prior to screening, they will undergo a washout period (3 weeks)
- if the subject is already prescribed the study product, and they have consumed ≤ 8 servings over the last 28 days prior to screening, or have poor daily compliance (< 75%), they will undergo a washout period (3 weeks)
- if the subject is already prescribed the study product, and they have been consuming 1-2 servings daily, with >75% compliance, for < 3 months, they do not require a washout period, and can be retrospectively included in the study protocol (provided proper records can be obtained)
Who cannot join
- Subject has type 1 diabetes.
- Subject is considered malnourished (SGA = 1 to 3).
- Subject has received intravenous albumin treatment within the last 6 months.
- Subject has overt symptomatic peripheral neuropathy, retinopathy, or autonomic neuropathy.
- Subject has poorly controlled chronic hypertension
- Subject has had major surgery, inpatient or outpatient, requiring >7 days of hospitalization in the last 3 weeks prior to screening visit,
Show all 14Show fewer
- Subject has a known chronic/contagious infectious disease, clotting or bleeding disorder, active malignancy
- Subject is missing, or has had an amputation of, a limb.
- Subject has had a significant cardiovascular event
- Subject has a known obstruction of the gastrointestinal tract, inflammatory bowel disease, short bowel syndrome or other forms of gastrointestinal disease
- Subject is currently diagnosed with, or has a history of severe dementia or delirium, eating disorder, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures
- Subject is currently consuming, or cannot refrain from taking, medications/dietary supplements/herbal preparations or substances,
- Subject is known to be allergic or intolerant to any ingredient found in the study product.
- Subject is considered unsuitable for the study based on the study physician's assessment.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Kaohsiung Medical University Hospital (KMUH)
Kaohsiung City, 80708
Taipei Veterans General Hospital
Taipei, 11217
About this study
Official title: The Effect of a Renal Specific Oral Nutritional Supplement on Nutritional Status and Other Outcomes
The study objective is to evaluate if a renal specific oral nutrition supplement (ONS) aids in maintaining nutritional status.
Read the detailed description
This study is an unblinded, prospective, multicenter, single arm study in Taiwan. Eligible subjects (see inclusion and exclusion criteria in Section 5.2) will receive standard of care (which includes dietary counseling) and ONS supplementation (1-2 servings/day depending on subject's needs) for 24 weeks (6 months). A follow up visit (phone call/medical chart review) will occur 12 months after the study intervention has ended to collect mortality data, to determine whether or not dialysis was initiated, and if ONS use continued.
Subjects will be informed of the study results when available. Subjects may continue use of the commercially available study product if it is recommended by their nephrologist, primary care physician, dietitian, or if the subject chooses.
For this study enrollment is defined as when the subject is stratified and begins to consume the study product (Study Visit 1, Month 0).
The target population described above may be stratified into the following groups (n=18 evaluable/group):
- Male CKD Stage 3b-5 without T2DM
- Male CKD Stage 3b-5 with T2DM
- Female CKD Stage 3b-5 without T2DM
- Female CKD Stage 3b-5 with T2DM
In addition, for those subjects enrolled, retrospective data (previous 6 to 12 months) identical to the study variables will be collected. Retrospective data collection will focus on the following measures, however, all data points are not expected to be available:
- Serum albumin
- SGA
- Compliance to protein intake guidelines
- Compliance to energy intake guidelines
- Hand grip strength
- Anthropometrics (weight, height, BMI)
- Quality of Life (WHOQOL-BREF Taiwan Version)
- eGFR (whichever equation is used as standard of care)
- Serum creatinine
- Proteinuria (retrospective - if available on medical records)
- BUN
- Body composition data from BIA (especially fat mass and muscle mass, units or exact terminology will be model specific)
- C reactive protein (CRP)
- Blood chemistries,
- Conditions
- Chronic Kidney Disease
- Being tested
- Oral Nutritional Supplement (ONS)
- 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.
Oral Nutritional Supplement (ONS)Other
renal specific commercially available ONS
| Study group | Role | What they receive |
|---|---|---|
| Oral Nutritional Supplement (ONS) | Experimental | 1-2 serving per day of a renal specific oral nutritional supplement Receives: Other: Oral Nutritional Supplement (ONS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Albumin
Measured: Change from Month 0 to Month 6
Secondary outcomes (6)
Subjective Global Assessment
Measured: Change from Month 0 to Month 6
Dietary Intake Compliance
Measured: Change from Month 0 to Month 6
Hand Grip Strength
Measured: Change from Month 0 to Month 6
Appetite
Measured: Change from Month 0 to Month 6
Body Mass Index
Measured: Change from Month 0 to Month 6
Quality of Life
Measured: Change from Month 0 to Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startNov 2013
- Primary completionMay 2016
- Study completionMay 2017
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Owen Kelly, Ph.D, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02046746
- Sponsor's protocol ID
- DA03
- Status last verified
- Aug 2017
- First submitted
- 24 Jan 2014
- Last updated
- 30 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Renal Specific Oral Nutritional Supplement on Nutritional Status and Other Outcomes
- ClinicalTrials.gov ID
- NCT02046746
- Acronym / sponsor ID
- DA03
- Conditions
- Chronic Kidney Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- May 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 28 Jan 2014 (estimated)
- 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.
The study objective is to evaluate if a renal specific oral nutrition supplement (ONS) aids in maintaining nutritional status.
Detailed description
This study is an unblinded, prospective, multicenter, single arm study in Taiwan. Eligible subjects (see inclusion and exclusion criteria in Section 5.2) will receive standard of care (which includes dietary counseling) and ONS supplementation (1-2 servings/day depending on subject's needs) for 24 weeks (6 months). A follow up visit (phone call/medical chart review) will occur 12 months after the study intervention has ended to collect mortality data, to determine whether or not dialysis was initiated, and if ONS use continued.
Subjects will be informed of the study results when available. Subjects may continue use of the commercially available study product if it is recommended by their nephrologist, primary care physician, dietitian, or if the subject chooses.
For this study enrollment is defined as when the subject is stratified and begins to consume the study product (Study Visit 1, Month 0).
The target population described above may be stratified into the following groups (n=18 evaluable/group):
- Male CKD Stage 3b-5 without T2DM
- Male CKD Stage 3b-5 with T2DM
- Female CKD Stage 3b-5 without T2DM
- Female CKD Stage 3b-5 with T2DM
In addition, for those subjects enrolled, retrospective data (previous 6 to 12 months) identical to the study variables will be collected. Retrospective data collection will focus on the following measures, however, all data points are not expected to be available:
- Serum albumin
- SGA
- Compliance to protein intake guidelines
- Compliance to energy intake guidelines
- Hand grip strength
- Anthropometrics (weight, height, BMI)
- Quality of Life (WHOQOL-BREF Taiwan Version)
- eGFR (whichever equation is used as standard of care)
- Serum creatinine
- Proteinuria (retrospective - if available on medical records)
- BUN
- Body composition data from BIA (especially fat mass and muscle mass, units or exact terminology will be model specific)
- C reactive protein (CRP)
- Blood chemistries,
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral Nutritional Supplement (ONS) | Experimental | Other: Oral Nutritional Supplement (ONS)1-2 serving per day of a renal specific oral nutritional supplement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Subject, or subject's legally acceptable representative (LAR), has voluntarily signed and dated an informed consent form (ICF), approved by an IEC/IRB, and provided Health Insurance Portability and Accountability Act (HIPAA)
- Subject is >18 years of age.
- Subject has been diagnosed with Chronic Kidney Disease (CKD) and is classified as being between Stages 3b to 5.
- Subject has an eGFR 45 and 10 ml/min/1.73m2 at screening.
- Subject is a male or non-pregnant female at least six weeks postpartum and non-lactating.
Key exclusion criteria (14 listed)
- Subject has type 1 diabetes.
- Subject is considered malnourished (SGA = 1 to 3).
- Subject has received intravenous albumin treatment within the last 6 months.
- Subject has overt symptomatic peripheral neuropathy, retinopathy, or autonomic neuropathy.
- Subject has poorly controlled chronic hypertension
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 |
|---|---|---|
| Oral Nutritional Supplement (ONS)renal specific commercially available ONS | Other | Oral Nutritional Supplement (ONS) |
Primary outcome
Serum Albumin
Time frame: Change from Month 0 to Month 6
6 secondary outcomes
Subjective Global Assessment
Time frame: Change from Month 0 to Month 6
Dietary Intake Compliance
Time frame: Change from Month 0 to Month 6
Hand Grip Strength
Time frame: Change from Month 0 to Month 6
Appetite
Time frame: Change from Month 0 to Month 6
Body Mass Index
Time frame: Change from Month 0 to Month 6
Quality of Life
Time frame: Change from Month 0 to Month 6
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 30 Aug 2017.
- Individual participant dataSharing planned: No
Related trials for Chronic Kidney Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
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.
Owen Kelly, Ph.D study chair
Abbott Nutrition
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Nutritional Supplement (ONS) in people with Chronic Kidney Disease, run by Abbott Nutrition at 2 sites 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 19 inclusion and 14 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 30 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 (time frame: Change from Month 0 to Month 6). 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 30 Aug 2017.