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| Name | Class |
|---|---|
| Abbott Nutrition | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Active Comparator | Standard of Care for malnourished maintenance hemodialysis patients |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nepro with Carb Steady | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Monthly for the 6 month study period |
| Measure | Description | Time Frame |
|---|---|---|
| Malnutrition Inflammation Score (MIS) | Month 0 and Month 6 | |
| Body Mass Index (BMI) | Monthly for the 6 month study period | |
| Estimated Dry Weight (EDW) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Debbie Benner, MA | DaVita, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DaVita | Irvine | California | 92618 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32390133 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 8, 2020 | |
| Reset | Jan 17, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 8, 2020 | Jan 17, 2020 |
| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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|
| Standard of Care | Other | Standard of Care for malnourished maintenance hemodialysis patients |
|
| Monthy for the 6 monthly study period |
| Prealbumin level | Months 0,2,4,&6 |
| C-Reactive protein level | Month 0,3 &6 |
| D019984 |
| Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |