Chronic Kidney Failure Requirement Dialysis Maintenance | Hemodialysis | Hemodiafiltration | Hemofiltration | Peritoneal Dialysis
Item
esrd patients requiring maintenance dialysis (haemodialysis, haemodiafiltration, haemofiltration, or peritoneal dialysis) for at least 1 month
boolean
C0022661 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0011946 (UMLS CUI [1,3])
C0024501 (UMLS CUI [1,4])
C0019004 (UMLS CUI [2])
C0206075 (UMLS CUI [3])
C0019014 (UMLS CUI [4])
C0031139 (UMLS CUI [5])
Intact Parathyroid Hormone Measurement Quantity
Item
the mean of 2 ipth determinations within 21 days before randomization and drawn at least 2 days apart must be greater than or equal to 300 pg/ml (31.8 pmol/l) and less than 800 pg/ml (84.8 pmol/l). if bipth is determined, the mean levels must be greater than or equal to 150 pg/ml (15.9 pmol/l) and less than 410 pg/ml (43.5 pmol/l)
boolean
C2697755 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Serum calcium measurement Corrected for albumin Quantity
Item
the mean of 2 serum calcium determinations (corrected for albumin) drawn on the same day as the pth determinations must be greater than or equal to 8.4 mg/dl (2.1 mmol/l)
boolean
C0728876 (UMLS CUI [1,1])
C1439360 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
medical condition Unstable | Hospitalization | Revision Dialysis access Vascular
Item
have an unstable medical condition, defined as having been hospitalised, other than for dialysis vascular access revision, within 30 days before day 1, or otherwise unstable in the judgment of the investigator
boolean
C3843040 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0019993 (UMLS CUI [2])
C0558347 (UMLS CUI [3,1])
C3483464 (UMLS CUI [3,2])
C1801960 (UMLS CUI [3,3])
Parathyroidectomy
Item
have had a parathyroidectomy in the 6 months before day 1
boolean
C0079989 (UMLS CUI [1])
Vitamin D Therapeutic procedure
Item
have received vitamin d therapy for less than 21 days before day 1 or required a change in prescribed vitamin d brand or dose within 21 days before day 1. if subjects are not prescribed vitamin d therapy, they must remain free of vitamin d therapy for the 21 days before day 1.
boolean
C0042866 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Pharmaceutical Preparations Metabolized CYP2D6 | Flecainide | Vinblastine | Thioridazine | Tricyclic Antidepressive Agents | Amitriptyline
Item
received, within 21 days before day 1 of the dose titration phase, therapy with medications that are predominantly metabolized by the enzyme cyp2d6 and have a narrow therapeutic index (e.g., flecainide, vinblastine, thioridazine, and most tricyclic antidepressants). the tricyclic antidepressant amitriptyline is permitted. -
boolean
C0013227 (UMLS CUI [1,1])
C1524026 (UMLS CUI [1,2])
C0057223 (UMLS CUI [1,3])
C0016229 (UMLS CUI [2])
C0042670 (UMLS CUI [3])
C0039943 (UMLS CUI [4])
C0003290 (UMLS CUI [5])
C0002600 (UMLS CUI [6])
Myocardial Infarction
Item
experienced a myocardial infarction within 3 months prior to day 1
boolean
C0027051 (UMLS CUI [1])
Study Subject Participation Status | Investigational Medical Device | Investigational New Drugs | Renal Dialysis Machine experimental
Item
are currently enrolled in, or have not yet completed at least 30 days before day 1, other invasive investigational device or investigational drug trials, or are receiving other investigational agents (experimental dialysis machines are acceptable)
boolean
C2348568 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
C3489407 (UMLS CUI [4,1])
C1517586 (UMLS CUI [4,2])
Gastrointestinal Disease Associated with Impaired intestinal absorption | Impaired Oral Administration | Unable to swallow Tablets
Item
have a gastrointestinal disorder that may be associated with impaired absorption or orally administered medications or an inability to swallow tablets
boolean
C0017178 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0392687 (UMLS CUI [1,3])
C0001563 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
C4048182 (UMLS CUI [3,1])
C0039225 (UMLS CUI [3,2])