Age | Non-Insulin-Dependent Diabetes Mellitus Prior diagnosis
Item
aged 18-75 years inclusive, with documented previously diagnosed type 2 diabetes mellitus (per american diabetes association [ada] criteria)
boolean
C0001779 (UMLS CUI [1])
C0011860 (UMLS CUI [2,1])
C0332132 (UMLS CUI [2,2])
Albuminuria Residual | Angiotensin-Converting Enzyme Inhibitors Stable | Angiotensin II receptor antagonist Stable | Albumin To Creatinine Protein Ratio Measurement
Item
residual albuminuria despite stable treatment with an angiotensin-converting enzyme (ace) inhibitor or an angiotensin receptor blocker (arb) for at least 8 weeks prior to screening (albumin:creatinine ratio [acr] of 100 to 3000 mg/g creatinine, inclusive)
boolean
C0001925 (UMLS CUI [1,1])
C1609982 (UMLS CUI [1,2])
C0003015 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0521942 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
C0486293 (UMLS CUI [4])
Renal function GFR estimation by MDRD
Item
estimated glomerular filtration rate based on serum creatinine (egfr, determined by modification of diet in renal disease [mdrd] equation) of ≥ 25 ml/min/1.73 m(2)
boolean
C2170215 (UMLS CUI [1])
Angiotensin-Converting Enzyme Inhibitors Dose Stable | Angiotensin II receptor antagonist Dose Stable | Combined Modality Therapy Absent
Item
must be on a stable dose of an ace inhibitor or arb for at least 8 weeks prior to screening, but subjects must not be on both an ace inhibitor and an arb
boolean
C0003015 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0521942 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0009429 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Hemoglobin A1c measurement | Plasma fasting glucose measurement
Item
hemoglobin a1c (hba1c) > 6.0% but not > 10.0% and fasting plasma glucose less than 270 mg/dl at screening
boolean
C0474680 (UMLS CUI [1])
C0583513 (UMLS CUI [2])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Diabetes Mellitus, Insulin-Dependent | Diabetic Ketoacidosis
Item
type 1 diabetes mellitus or history of diabetic ketoacidosis
boolean
C0011854 (UMLS CUI [1])
C0011880 (UMLS CUI [2])
Kidney Transplantation | Kidney Disease | Exception Diabetic Nephropathy | Exception Relationship Hypertensive disease
Item
previous renal transplant or known non-diabetic renal disease, except related to hypertension
boolean
C0022671 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0011881 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0439849 (UMLS CUI [4,2])
C0020538 (UMLS CUI [4,3])
Dialysis
Item
undergone renal dialysis at any time in the past
boolean
C0011946 (UMLS CUI [1])
Systemic Glucocorticoids chronic | Therapeutic immunosuppression chronic
Item
received chronic (more than 7 days continuously) systemic glucocorticoid or other immunosuppressive treatment within 8 weeks of screening
boolean
C3540777 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0021079 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
bardoxolone | atrasentan | Endothelin receptor antagonist
Item
use of bardoxolone, atrasentan or other endothelin antagonist within 8 weeks of screening
boolean
C0762434 (UMLS CUI [1])
C0935914 (UMLS CUI [2])
C1134681 (UMLS CUI [3])
NSAIDs chronic
Item
received chronic (more than 7 days continuously) non-steroidal anti-inflammatory drug (nsaid) treatment within 2 weeks of screening
boolean
C0003211 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Heart failure New York Heart Association Classification | Angina, Unstable | Coronary Artery Disease Symptomatic | Myocardial Infarction | Cerebrovascular accident
Item
cardiac failure (class iii or iv), history of unstable angina, symptomatic coronary artery disease, myocardial infarction or stroke within 12 weeks of screening
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0002965 (UMLS CUI [2])
C1956346 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C0027051 (UMLS CUI [4])
C0038454 (UMLS CUI [5])
Blood Pressure Poorly controlled | Sitting systolic blood pressure | Sitting diastolic blood pressure | Status post Rest Number of minutes
Item
poorly-controlled blood pressure (systolic blood pressure >155 or diastolic blood pressure >95, with blood pressure measured in the seated position after at least 5 minutes of rest)
boolean
C0005823 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C1319893 (UMLS CUI [2])
C1319894 (UMLS CUI [3])
C0231290 (UMLS CUI [4,1])
C0035253 (UMLS CUI [4,2])
C1562039 (UMLS CUI [4,3])