Age
Item
age 18 years or older
boolean
C0001779 (UMLS CUI [1])
Chronic Kidney Disease Moderate | Chronic Kidney Disease Severe | Dialysis Unexpected | Kidney Transplantation Unexpected
Item
moderate to severe ckd, not anticipated to require dialysis or renal transplant within the next 6 months
boolean
C1561643 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C1561643 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0011946 (UMLS CUI [3,1])
C4055646 (UMLS CUI [3,2])
C0022671 (UMLS CUI [4,1])
C4055646 (UMLS CUI [4,2])
Life Expectancy
Item
patient survival expected to be no less than one year
boolean
C0023671 (UMLS CUI [1])
Creatinine measurement, serum | Gender
Item
serum creatinine in men >= 2.0 mg/dl (>= 177 µmol/l) and <= 5.0 mg/dl (<= 442
boolean
C0201976 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Creatinine measurement, serum | Gender | Screening
Item
µmol/l), and in women >= 1.5 mg/dl (>= 133 µmol/l) and <= 5.0 mg/dl (<= 442 µmol/l) at screening
boolean
C0201976 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0220908 (UMLS CUI [3])
Urine protein/creatinine ratio measurement
Item
urinary total protein to urinary total creatinine ratio must be >= 0.5 on a spot void obtained at screening
boolean
C1096054 (UMLS CUI [1])
Blood pressure | Patient Hypertensive Stable blood pressure
Item
blood pressure <= 160/90 mmhg at both screening and baseline visits. in addition, blood pressure, if measured, must have been stable in hypertensive patients over the 3 months prior to screening, with no more than 1 blood pressure reading > 160/90 mmhg
boolean
C1271104 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C0857121 (UMLS CUI [2,2])
C0428896 (UMLS CUI [2,3])
Therapeutic procedure Hypertensive disease | Antihypertensive therapy Stable
Item
in patients being treated for hypertension, they should be on a stable anti-hypertensive regimen
boolean
C0087111 (UMLS CUI [1,1])
C0020538 (UMLS CUI [1,2])
C0585941 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
Kidney Disease Obstructive | Kidney Disease Cause Reversible
Item
obstructive or reversible cause of kidney disease
boolean
C0022658 (UMLS CUI [1,1])
C0549186 (UMLS CUI [1,2])
C0022658 (UMLS CUI [2,1])
C0015127 (UMLS CUI [2,2])
C0205343 (UMLS CUI [2,3])
Nephrotic Syndrome | Urine protein/creatinine ratio measurement
Item
nephrotic syndrome defined as a ratio of urinary total protein to urinary creatinine of > 6.0 as measured on a spot void
boolean
C0027726 (UMLS CUI [1])
C1096054 (UMLS CUI [2])
Polycystic Kidney Disease Adult
Item
adult polycystic kidney disease
boolean
C0022680 (UMLS CUI [1,1])
C0001675 (UMLS CUI [1,2])
Kidney Transplantation
Item
history of previous kidney transplant
boolean
C0022671 (UMLS CUI [1])
Malignant Hypertension
Item
history of recent (within the past 6 months) accelerated or malignant hypertension
boolean
C0020540 (UMLS CUI [1])
Cardiac Arrhythmia Uncontrolled | Heart Disease Severe
Item
uncontrolled arrhythmia or severe cardiac disease within the past 6 months
boolean
C0003811 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0018799 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Malabsorption | Inflammatory Bowel Diseases | Hiatal Hernia | Peptic Ulcer | Gastrointestinal dysmotility Severe | Phosphate Binder Etiology aspects Absent
Item
history of malabsorption, inflammatory bowel disease, hiatal hernia, active peptic ulcer, or severe gi dysmotility, not attributable to the use of a phosphate binder
boolean
C3714745 (UMLS CUI [1])
C0021390 (UMLS CUI [2])
C3489393 (UMLS CUI [3])
C0030920 (UMLS CUI [4])
C1836923 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C2267031 (UMLS CUI [6,1])
C0015127 (UMLS CUI [6,2])
C0332197 (UMLS CUI [6,3])
Investigational New Drugs | Study Subject Participation Status
Item
received any investigational agent or participated in a clinical study within the previous 3 months
boolean
C0013230 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
Medical condition At risk Study Subject Participation Status | Medical condition Interferes with Safety Study data | Medical condition Interferes with Effectiveness Study data
Item
presence of any significant medical condition that might create an undue risk with study participation, or significantly confound the collection of safety and efficacy data in this study
boolean
C3843040 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0036043 (UMLS CUI [2,3])
C0681873 (UMLS CUI [2,4])
C3843040 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C1280519 (UMLS CUI [3,3])
C0681873 (UMLS CUI [3,4])