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

Lien

https://clinicaltrials.gov/show/NCT00324376

Mots-clés

  1. 31/07/2016 31/07/2016 -
Téléchargé le

31 juillet 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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Eligibility Chronic Kidney Disease NCT00324376

Eligibility Chronic Kidney Disease NCT00324376

Inclusion Criteria
Description

Inclusion Criteria

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

Life Expectancy

Type de données

boolean

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

Hemodialysis

Type de données

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

Type de données

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

Type de données

boolean

Alias
UMLS CUI [1]
C0021843
dysphagia,
Description

Deglutition Disorders

Type de données

boolean

Alias
UMLS CUI [1]
C0011168
wallowing dsisorders,
Description

swallowing disorder

Type de données

boolean

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

Gastrointestinal motility disorder Severe

Type de données

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

Type de données

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

Type de données

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

Type de données

boolean

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

Vasculitis

Type de données

boolean

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

Malignant Neoplasms | Basal cell carcinoma

Type de données

boolean

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

HIV Infections

Type de données

boolean

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

medical condition Unstable Clinical Significance

Type de données

boolean

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

Similar models

Eligibility Chronic Kidney Disease NCT00324376

Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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