Age
Item
1. >18 years of age
boolean
C0001779 (UMLS CUI [1])
Chronic kidney disease stage
Item
2. diagnosed with chronic kidney disease (ckd); stages 3b to 5
boolean
C2074731 (UMLS CUI [1])
Estimated Glomerular Filtration Rate
Item
3. egfr ≤ 45 and ≥ 10 ml/min/1.73m2
boolean
C3811844 (UMLS CUI [1])
Gender | Gender Pregnancy Absent | Postpartum Period | Gender Breast Feeding Absent
Item
4. male or non-pregnant female at least six weeks postpartum and non-lactating
boolean
C0079399 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0032961 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0086839 (UMLS CUI [3])
C0079399 (UMLS CUI [4,1])
C0006147 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Chronic Kidney Disease | Non-Insulin-Dependent Diabetes Mellitus Absent | Diabetes Mellitus, Non-Insulin-Dependent | Glycemic Agents Dose unchanged | Glycemic Agents Type unchanged
Item
5. subject with ckd is either: 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
boolean
C1561643 (UMLS CUI [1])
C0011860 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0011860 (UMLS CUI [3])
C4020583 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0442739 (UMLS CUI [4,3])
C4020583 (UMLS CUI [5,1])
C0332307 (UMLS CUI [5,2])
C0442739 (UMLS CUI [5,3])
Serum albumin measurement
Item
6. serum albumin ≥ 3.0g/dl
boolean
C0523465 (UMLS CUI [1])
Body mass index
Item
7. bmi ≤ 27 kg/m2
boolean
C1305855 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent | Hemoglobin A1c measurement
Item
8. if t2dm, subject has a1c level ≤ 9.0%
boolean
C0011860 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
Absence Dialysis Scheduled | Absence Dialysis Expected
Item
9. not scheduled or expected to receive dialysis in the next 18 months
boolean
C0332197 (UMLS CUI [1,1])
C0011946 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
C0332197 (UMLS CUI [2,1])
C0011946 (UMLS CUI [2,2])
C1517001 (UMLS CUI [2,3])
Life Expectancy
Item
10. life expectancy >18 months
boolean
C0023671 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent
Item
1. type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Subjective global assessment
Item
2. subjective global assessment = 1 to 3
boolean
C0451514 (UMLS CUI [1])
Albumin Intravenous
Item
3. intravenous albumin treatment within the last 6 months.
boolean
C0001924 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
Peripheral Neuropathy Symptomatic | Retinal Disease Symptomatic | Autonomic neuropathy Symptomatic
Item
4. overt symptomatic peripheral neuropathy, retinopathy, or autonomic neuropathy.
boolean
C0031117 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0035309 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0259749 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
Hypertension chronic Poorly controlled | Chronic hypotension Poorly controlled
Item
5. poorly controlled chronic hypertension >200/100 or hypotension <90/60 defined by the joint national committee 7 (jnc 7).
boolean
C0745114 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C0155800 (UMLS CUI [2,1])
C3853134 (UMLS CUI [2,2])
Major surgery Inpatient | Major surgery Outpatients | Hospitalization length of stay (___ days) | Major surgery elective
Item
6. major surgery, inpatient or outpatient, requiring >7 days of hospitalization in the last 3 weeks prior to screening visit, or is having major elective surgery requiring >7 days of hospitalization throughout the course of the entire study.
boolean
C0679637 (UMLS CUI [1,1])
C0021562 (UMLS CUI [1,2])
C0679637 (UMLS CUI [2,1])
C0029921 (UMLS CUI [2,2])
C3694481 (UMLS CUI [3])
C0679637 (UMLS CUI [4,1])
C0439608 (UMLS CUI [4,2])
Chronic infectious disease | Blood Coagulation Disorders | Malignant Neoplasms | Liver Dysfunction
Item
7. chronic/contagious infectious disease, clotting or bleeding disorder, active malignancy or impaired liver function
boolean
C0151317 (UMLS CUI [1])
C0005779 (UMLS CUI [2])
C0006826 (UMLS CUI [3])
C0086565 (UMLS CUI [4])
Missing limb | Amputation of limb
Item
8. missing, or has had an amputation of, a limb.
boolean
C1719258 (UMLS CUI [1])
C0002689 (UMLS CUI [2])
Cardiovascular event | Congestive heart failure
Item
9. significant cardiovascular event ≤ 6 months; or stated history of congestive heart failure
boolean
C1320716 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
Gastrointestinal obstruction | Inflammatory Bowel Disease | Short Bowel Syndrome | Gastrointestinal Disease | Gastroparesis | Pancreatitis | Hepatitis | Icterus | Celiac Disease | Intestinal dysmotility | Colitis, Ischemic
Item
10. obstruction of the gastrointestinal tract, inflammatory bowel disease, short bowel syndrome or other forms of gastrointestinal disease such as gastroparesis, pancreatitis, hepatitis, jaundice, celiac disease, intestinal dysmotility and ischemic colitis.
boolean
C0236124 (UMLS CUI [1])
C0021390 (UMLS CUI [2])
C0036992 (UMLS CUI [3])
C0017178 (UMLS CUI [4])
C0152020 (UMLS CUI [5])
C0030305 (UMLS CUI [6])
C0019158 (UMLS CUI [7])
C0022346 (UMLS CUI [8])
C0007570 (UMLS CUI [9])
C3552513 (UMLS CUI [10])
C0162529 (UMLS CUI [11])
Severe dementia | Delirium Severe | Eating Disorders | Nervous system disorder | Mental disorders | Alcoholic Intoxication, Chronic | Substance Use Disorders
Item
11. current diagnosis or history of severe dementia or delirium, eating disorder, history of significant neurological or psychiatric disorder, alcoholism, substance abuse
boolean
C3494652 (UMLS CUI [1])
C0011206 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0013473 (UMLS CUI [3])
C0027765 (UMLS CUI [4])
C0004936 (UMLS CUI [5])
C0001973 (UMLS CUI [6])
C0038586 (UMLS CUI [7])
Pharmaceutical Preparations Modulating Glucose metabolism | Dietary Supplements Modulating Glucose metabolism | Plant Preparations Modulating Glucose metabolism | Substance Modulating Glucose metabolism | Anabolic Agents | Reducing diet | Protein supplement | Amino acid supplement | Amino acid supplement modified | Keto Acids | Growth Hormone | Tetrahydrocannabinol | Marihuana | Calcium beta-hydroxy-beta-methylbutyrate | Fish Oil Supplements High dose | Omega-3 Fatty Acids | Vitamin D
Item
12. medications/dietary supplements/herbals or substances that could modulate glucose metabolism, or are considered anabolic, or can reduce fat mass, including but not limited to protein/amino acid supplements, or modified amino acid supplements such as keto acids, growth hormone, dronabinol, marijuana, calcium beta-hydroxyl-beta-methylbutyrate, high dose fish oil supplements (>0.5 g omega-3/d) or vitamin d (>400iu/d),
boolean
C0013227 (UMLS CUI [1,1])
C0443264 (UMLS CUI [1,2])
C0596620 (UMLS CUI [1,3])
C0242295 (UMLS CUI [2,1])
C0443264 (UMLS CUI [2,2])
C0596620 (UMLS CUI [2,3])
C0949854 (UMLS CUI [3,1])
C0443264 (UMLS CUI [3,2])
C0596620 (UMLS CUI [3,3])
C0439861 (UMLS CUI [4,1])
C0443264 (UMLS CUI [4,2])
C0596620 (UMLS CUI [4,3])
C1258800 (UMLS CUI [5])
C0012167 (UMLS CUI [6])
C0770246 (UMLS CUI [7])
C0556082 (UMLS CUI [8])
C0556082 (UMLS CUI [9,1])
C0392747 (UMLS CUI [9,2])
C0022618 (UMLS CUI [10])
C0037663 (UMLS CUI [11])
C0039663 (UMLS CUI [12])
C0024808 (UMLS CUI [13])
C2741019 (UMLS CUI [14])
C0016157 (UMLS CUI [15,1])
C0242295 (UMLS CUI [15,2])
C0444956 (UMLS CUI [15,3])
C0015689 (UMLS CUI [16])
C0042866 (UMLS CUI [17])
Allergic Reaction Investigational New Drug Ingredient | Intolerance to Investigational New Drug Ingredient
Item
13. allergic or intolerant to any ingredient found in the study product.
boolean
C1527304 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1550600 (UMLS CUI [1,3])
C1744706 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C1550600 (UMLS CUI [2,3])