MalnutritionPhase 4DANSENCT00895401
DaVita Assessment of Nutritional Supplement Effects (DANSE)
A Phase 4 study testing Nepro with Carb Steady in people with Malnutrition, run by Davita Clinical Research at 1 site in United States.
Trial summary
This is a Phase IV randomized controlled study assessing the effectiveness of a commercially available nutritional supplement on malnourished prevalent hemodialysis patients. Patients will be randomized to either receive one can of Nepro with Carb Steady at each dialysis treatment for 6 months or to receive the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- Nepro with Carb Steady
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Jan 2011
- Phase
- Phase 4
- 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
- Patient is at least 18 years of age
- Patient has been on hemodialysis >6 months at the time of study entry
- Patient dialyzes three times a week
- Patient agrees to try ONS for the 6 month study period.
- Patient has demonstrated an albumin <3.5 g/dL on last available lab drawn in dialysis facility
- Patient is adequately dialyzed with a Kt/V > 1.4 at the most recent lab draw
- Patient is capable of reading and comprehending Informed Consent Form and provides written informed consent
Who cannot join
- Peritoneal dialysis
- Dysphagia
- Aspiration risk
- Difficulty swallowing
- History of symptomatic intolerance to food or liquid consumption during dialysis treatments
- Terminal illnesses with life expectancy <6 months, e.g. stage IV cancer or full blown AIDS
Show all 18Show fewer
- Concurrent appetite stimulants
- Use of IDPN in last 3 months
- Inability to follow and to comply with the instructions and guidelines
- Severe liver disease defined as most recent SGOT > 78
- Active malignancy (other than skin)
- Major surgery within previous 6 months or anticipated during the 90-day study period
- Females who are pregnant or are breast-feeding
- Considered clinically unstable by the treating nephrologists
- Noncompliance with dialysis treatments ( Missed > 2 treatments in prior month due to noncompliance)
- Extended or frequent hospitalizations defined as hospitalization of longer than 15 days with discharge within the last 30 days or greater than 3 admissions within the last 30 days
- Regular supplement use defined as consumption of > 7 servings of a commercially available kcal/ protein supplement in the prior month
- Any clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a patient's ability to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DaVita Assessment of Nutritional Supplement Effects
This is a Phase IV randomized controlled study assessing the effectiveness of a commercially available nutritional supplement on malnourished prevalent hemodialysis patients. Patients will be randomized to either receive one can of Nepro with Carb Steady at each dialysis treatment for 6 months or to receive the standard of care counseling for malnutrition. The primary hypothesis is that hypoalbuminemic maintenance hemodialysis patients will demonstrate an improvement in albumin levels with oral nutritional supplement provided in-center thrice weekly in addition to standard of care as compared to malnourished maintenance hemodialysis patients provided standard of care alone.
- Conditions
- Malnutrition
- Being tested
- Nepro with Carb Steady, Standard of Care
- Keywords
- Nutritional supplement, Malnutrition, Hemodialysis, Nepro with Carb Steady
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nepro with Carb SteadyDietary supplement
Also called Oral Nutritional Supplement
Nepro with Carb Steady is a commercially available renal specific oral nutritional supplement designed to meet the nutrient needs of dialysis patients. The supplement is 8 oz and provides 425 kcal and 19 grams of protein.
Standard of CareOther
Standard of Care for malnourished maintenance hemodialysis patients
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Standard of Care for malnourished maintenance hemodialysis patients Receives: Other: Standard of Care |
| Nepro with Carb Steady | Experimental | Nepro with Carb Steady is a commercially available nutritional supplement designed to meet the nutritional needs of malnourished hemodialysis patients. The serving size is 8 oz which provides 425 kcal and 19 g protein Receives: Dietary Supplement: Nepro with Carb Steady |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure of this study is albumin level, both mean albumin level and percentage of patients achieving an albumin level of >3.8 and > 4.0
Measured: Monthly for the 6 month study period
Secondary outcomes (5)
Malnutrition Inflammation Score (MIS)
Measured: Month 0 and Month 6
Body Mass Index (BMI)
Measured: Monthly for the 6 month study period
Estimated Dry Weight (EDW)
Measured: Monthy for the 6 monthly study period
Prealbumin level
Measured: Months 0,2,4,&6
C-Reactive protein level
Measured: Month 0,3 &6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2009 (estimated)
- Study startApr 2009
- Primary completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Davita Clinical Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Abbott Nutrition
- Investigators
- Debbie Benner, MA, Principal investigator, DaVita, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00895401
- Sponsor's protocol ID
- 2009-001
- Acronym
- DANSE
- Status last verified
- Feb 2011
- First submitted
- 7 May 2009
- Last updated
- 8 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mah JY, Choy SW, Roberts MA, Desai AM, Corken M, Gwini SM, McMahon LP. Oral protein-based supplements versus placebo or no treatment for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2020 May 11;5(5):CD012616. doi: 10.1002/14651858.CD012616.pub2.
PubMed 32390133
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DaVita Assessment of Nutritional Supplement Effects
- ClinicalTrials.gov ID
- NCT00895401
- Acronym / sponsor ID
- DANSE / 2009-001
- Conditions
- Malnutrition
- Keywords
- Nutritional supplement, Malnutrition, Hemodialysis, Nepro with Carb Steady
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Davita Clinical ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Abbott Nutrition
- Study start
- Apr 2009
- Primary completion
- Jan 2011 (actual)
- First posted
- 8 May 2009 (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.
This is a Phase IV randomized controlled study assessing the effectiveness of a commercially available nutritional supplement on malnourished prevalent hemodialysis patients. Patients will be randomized to either receive one can of Nepro with Carb Steady at each dialysis treatment for 6 months or to receive the standard of care counseling for malnutrition. The primary hypothesis is that hypoalbuminemic maintenance hemodialysis patients will demonstrate an improvement in albumin levels with oral nutritional supplement provided in-center thrice weekly in addition to standard of care as compared to malnourished maintenance hemodialysis patients provided standard of care alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Other: Standard of CareStandard of Care for malnourished maintenance hemodialysis patients |
| Nepro with Carb Steady | Experimental | Dietary Supplement: Nepro with Carb SteadyNepro with Carb Steady is a commercially available nutritional supplement designed to meet the nutritional needs of malnourished hemodialysis patients. The serving size is 8 oz which provides 425 kcal and 19 g protein |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient is at least 18 years of age
- Patient has been on hemodialysis >6 months at the time of study entry
- Patient dialyzes three times a week
- Patient agrees to try ONS for the 6 month study period.
- Patient has demonstrated an albumin <3.5 g/dL on last available lab drawn in dialysis facility
Key exclusion criteria (18 listed)
- Peritoneal dialysis
- Dysphagia
- Aspiration risk
- Difficulty swallowing
- History of symptomatic intolerance to food or liquid consumption during dialysis treatments
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 |
|---|---|---|
| Nepro with Carb SteadyAlso: Oral Nutritional SupplementNepro with Carb Steady is a commercially available renal specific oral nutritional supplement designed to meet the nutrient needs of dialysis patients. The supplement is 8 oz and provides 425 kcal and 19 grams of protein. | Dietary supplement | Nepro with Carb Steady |
| Standard of CareStandard of Care for malnourished maintenance hemodialysis patients | Other | Standard of Care |
Primary outcome
The primary outcome measure of this study is albumin level, both mean albumin level and percentage of patients achieving an albumin level of >3.8 and > 4.0
Time frame: Monthly for the 6 month study period
5 secondary outcomes
Malnutrition Inflammation Score (MIS)
Time frame: Month 0 and Month 6
Body Mass Index (BMI)
Time frame: Monthly for the 6 month study period
Estimated Dry Weight (EDW)
Time frame: Monthy for the 6 monthly study period
Prealbumin level
Time frame: Months 0,2,4,&6
C-Reactive protein level
Time frame: Month 0,3 &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 8 Feb 2011.
- Derived from this study: PubMed 32390133Mah JY, Choy SW, Roberts MA, Desai AM, Corken M, Gwini SM, McMahon LP. Oral protein-based supplements versus placebo or no treatment for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2020 May 11;5(5):CD012616. doi: 10.1002/14651858.CD012616.pub2.
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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.
Debbie Benner, MA principal investigator
DaVita, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nepro with Carb Steady in people with Malnutrition, run by Davita Clinical Research at 1 site in United States.
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 7 inclusion and 18 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 8 Feb 2011. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The primary outcome measure of this study is albumin level, both mean albumin level and percentage of patients achieving an albumin level of >3.8 and > 4.0 (time frame: Monthly for the 6 month study period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00895401, which also lists 1 linked publication.
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 8 Feb 2011.