ID

17363

Description

A Research Study for Patients With End-Stage Renal Disease (ESRD); ODM derived from: https://clinicaltrials.gov/show/NCT00110890

Link

https://clinicaltrials.gov/show/NCT00110890

Keywords

Versions (1)
  1. 9/8/16 9/8/16 -
Uploaded on

September 8, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility End Stage Renal Disease NCT00110890

English

Eligibility End Stage Renal Disease NCT00110890

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
esrd patients requiring maintenance dialysis (haemodialysis, haemodiafiltration, haemofiltration, or peritoneal dialysis) for at least 1 month
Description

Chronic Kidney Failure Requirement Dialysis Maintenance | Hemodialysis | Hemodiafiltration | Hemofiltration | Peritoneal Dialysis

Data type

boolean

Alias
UMLS CUI [1,1]
C0022661
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0011946
UMLS CUI [1,4]
C0024501
UMLS CUI [2]
C0019004
UMLS CUI [3]
C0206075
UMLS CUI [4]
C0019014
UMLS CUI [5]
C0031139
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)
Description

Intact Parathyroid Hormone Measurement Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C2697755
UMLS CUI [1,2]
C1265611
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)
Description

Serum calcium measurement Corrected for albumin Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0728876
UMLS CUI [1,2]
C1439360
UMLS CUI [1,3]
C1265611
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
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
Description

medical condition Unstable | Hospitalization | Revision Dialysis access Vascular

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0443343
UMLS CUI [2]
C0019993
UMLS CUI [3,1]
C0558347
UMLS CUI [3,2]
C3483464
UMLS CUI [3,3]
C1801960
have had a parathyroidectomy in the 6 months before day 1
Description

Parathyroidectomy

Data type

boolean

Alias
UMLS CUI [1]
C0079989
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.
Description

Vitamin D Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0042866
UMLS CUI [1,2]
C0087111
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. -
Description

Pharmaceutical Preparations Metabolized CYP2D6 | Flecainide | Vinblastine | Thioridazine | Tricyclic Antidepressive Agents | Amitriptyline

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1524026
UMLS CUI [1,3]
C0057223
UMLS CUI [2]
C0016229
UMLS CUI [3]
C0042670
UMLS CUI [4]
C0039943
UMLS CUI [5]
C0003290
UMLS CUI [6]
C0002600
experienced a myocardial infarction within 3 months prior to day 1
Description

Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
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)
Description

Study Subject Participation Status | Investigational Medical Device | Investigational New Drugs | Renal Dialysis Machine experimental

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C2346570
UMLS CUI [3]
C0013230
UMLS CUI [4,1]
C3489407
UMLS CUI [4,2]
C1517586
have a gastrointestinal disorder that may be associated with impaired absorption or orally administered medications or an inability to swallow tablets
Description

Gastrointestinal Disease Associated with Impaired intestinal absorption | Impaired Oral Administration | Unable to swallow Tablets

Data type

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0392687
UMLS CUI [2,1]
C0001563
UMLS CUI [2,2]
C0221099
UMLS CUI [3,1]
C4048182
UMLS CUI [3,2]
C0039225
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Similar models

Eligibility End Stage Renal Disease NCT00110890

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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