ID

16669

Description

Study to Compare Once A Day Sevelamer Dosing With Three Times Per Day Sevelamer Dosing; ODM derived from: https://clinicaltrials.gov/show/NCT00324376

Link

https://clinicaltrials.gov/show/NCT00324376

Keywords

Versions (1)
  1. 7/31/16 7/31/16 -
Uploaded on

July 31, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Chronic Kidney Disease NCT00324376

English

Eligibility Chronic Kidney Disease NCT00324376

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
life expectancy of at least 12 months,
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
patients have received hemodialysis three times per week for 3 months or longer,
Description

Hemodialysis

Data type

boolean

Alias
UMLS CUI [1]
C0019004
patients maintained on sevelamer in a daily dose of ≤ 9,600 mg as their only phosphate binder with serum phosphorus concentrations at the last two measurements between 3.0 and 6.5 mg/dl (0.97 and 2.10 mmol/l).
Description

sevelamer | Phosphate Binder | serum phosphorus measurement

Data type

boolean

Alias
UMLS CUI [1]
C0718050
UMLS CUI [2]
C2267031
UMLS CUI [3]
C2229833
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
active bowel obstruction,
Description

Intestinal Obstruction

Data type

boolean

Alias
UMLS CUI [1]
C0021843
dysphagia,
Description

Deglutition Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0011168
wallowing dsisorders,
Description

swallowing disorder

Data type

boolean

Alias
UMLS CUI [1]
C0011168
severe gastrointestinal motility disorders,
Description

Gastrointestinal motility disorder Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0854121
UMLS CUI [1,2]
C0205082
active ethanol or drug abuse (excluding tobacco),
Description

Substance Use Disorders | Tobacco Use Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0040336
need for antidysrhythmic or antiseizure medications used to control these conditions,
Description

Pharmaceutical Preparations Against Cardiac Arrhythmia Needed | Anticonvulsant therapy Needed

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521124
UMLS CUI [1,3]
C0003811
UMLS CUI [1,4]
C0027552
UMLS CUI [2,1]
C0521306
UMLS CUI [2,2]
C0027552
poorly controlled diabetes mellitus or hypertension,
Description

poorly controlled diabetes mellitus | Poor hypertension control

Data type

boolean

Alias
UMLS CUI [1]
C0554876
UMLS CUI [2]
C0421190
active vasculitis,
Description

Vasculitis

Data type

boolean

Alias
UMLS CUI [1]
C0042384
active malignancy other than basal-cell carcinoma,
Description

Malignant Neoplasms | Basal cell carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0007117
hiv infection,
Description

HIV Infections

Data type

boolean

Alias
UMLS CUI [1]
C0019693
any clinically significant unstable medical condition as judged by the investigator.
Description

medical condition Unstable Clinical Significance

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0443343
UMLS CUI [1,3]
C2826293
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Similar models

Eligibility Chronic Kidney Disease NCT00324376

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Life Expectancy
Item
life expectancy of at least 12 months,
boolean
C0023671 (UMLS CUI [1])
Hemodialysis
Item
patients have received hemodialysis three times per week for 3 months or longer,
boolean
C0019004 (UMLS CUI [1])
sevelamer | Phosphate Binder | serum phosphorus measurement
Item
patients maintained on sevelamer in a daily dose of ≤ 9,600 mg as their only phosphate binder with serum phosphorus concentrations at the last two measurements between 3.0 and 6.5 mg/dl (0.97 and 2.10 mmol/l).
boolean
C0718050 (UMLS CUI [1])
C2267031 (UMLS CUI [2])
C2229833 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Intestinal Obstruction
Item
active bowel obstruction,
boolean
C0021843 (UMLS CUI [1])
Deglutition Disorders
Item
dysphagia,
boolean
C0011168 (UMLS CUI [1])
swallowing disorder
Item
wallowing dsisorders,
boolean
C0011168 (UMLS CUI [1])
Gastrointestinal motility disorder Severe
Item
severe gastrointestinal motility disorders,
boolean
C0854121 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Substance Use Disorders | Tobacco Use Disorder
Item
active ethanol or drug abuse (excluding tobacco),
boolean
C0038586 (UMLS CUI [1])
C0040336 (UMLS CUI [2])
Pharmaceutical Preparations Against Cardiac Arrhythmia Needed | Anticonvulsant therapy Needed
Item
need for antidysrhythmic or antiseizure medications used to control these conditions,
boolean
C0013227 (UMLS CUI [1,1])
C0521124 (UMLS CUI [1,2])
C0003811 (UMLS CUI [1,3])
C0027552 (UMLS CUI [1,4])
C0521306 (UMLS CUI [2,1])
C0027552 (UMLS CUI [2,2])
poorly controlled diabetes mellitus | Poor hypertension control
Item
poorly controlled diabetes mellitus or hypertension,
boolean
C0554876 (UMLS CUI [1])
C0421190 (UMLS CUI [2])
Vasculitis
Item
active vasculitis,
boolean
C0042384 (UMLS CUI [1])
Malignant Neoplasms | Basal cell carcinoma
Item
active malignancy other than basal-cell carcinoma,
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
HIV Infections
Item
hiv infection,
boolean
C0019693 (UMLS CUI [1])
medical condition Unstable Clinical Significance
Item
any clinically significant unstable medical condition as judged by the investigator.
boolean
C3843040 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
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