ID

20072

Description

Cross-Over Study of Sevelamer Hydrochloride and Sevelamer Carbonate; ODM derived from: https://clinicaltrials.gov/show/NCT00440648

Link

https://clinicaltrials.gov/show/NCT00440648

Keywords

Versions (1)
  1. 2/5/17 2/5/17 -
Uploaded on

February 5, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Chronic Kidney Disease NCT00440648

English

Eligibility Chronic Kidney Disease NCT00440648

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient had received hemodialysis three times per week for 3 months or longer;
Description

Hemodialysis Frequency Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0019004
UMLS CUI [1,2]
C0376249
UMLS CUI [1,3]
C0449238
patients were maintained on sevelamer hydrochloride as their primary phosphate binder with a total daily dose of ≤ 13.6 g with serum phosphorus concentrations at the last two measurements between 3.0 and 6.5 mg/dl, the most recent ipth ≤ 600 pg/ml and the most recent serum calcium within the normal range.
Description

Sevelamer hydrochloride Daily Dose | Phosphate Binder Primary | serum phosphorus measurement Quantity | Intact Parathyroid Hormone Measurement | Serum calcium normal

Data type

boolean

Alias
UMLS CUI [1,1]
C0772463
UMLS CUI [1,2]
C2348070
UMLS CUI [2,1]
C2267031
UMLS CUI [2,2]
C0205225
UMLS CUI [3,1]
C2229833
UMLS CUI [3,2]
C1265611
UMLS CUI [4]
C2697755
UMLS CUI [5]
C0858094
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
if patient had active bowel obstruction, dysphagia, swallowing disorders, or severe gastrointestinal motility disorders;
Description

Intestinal Obstruction | Deglutition Disorders | Gastrointestinal motility disorder Severe

Data type

boolean

Alias
UMLS CUI [1]
C0021843
UMLS CUI [2]
C0011168
UMLS CUI [3,1]
C0854121
UMLS CUI [3,2]
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 Patient need for | Anticonvulsants Patient need for

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521124
UMLS CUI [1,3]
C0003811
UMLS CUI [1,4]
C0686904
UMLS CUI [2,1]
C0003286
UMLS CUI [2,2]
C0686904
poorly controlled diabetes mellitus or hypertension;
Description

poorly controlled diabetes mellitus | Hypertensive disease Poorly controlled

Data type

boolean

Alias
UMLS CUI [1]
C0554876
UMLS CUI [2,1]
C0020538
UMLS CUI [2,2]
C3853134
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; or
Description

HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019693
any clinically significant unstable medical condition as judge 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 NCT00440648

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hemodialysis Frequency Duration
Item
patient had received hemodialysis three times per week for 3 months or longer;
boolean
C0019004 (UMLS CUI [1,1])
C0376249 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Sevelamer hydrochloride Daily Dose | Phosphate Binder Primary | serum phosphorus measurement Quantity | Intact Parathyroid Hormone Measurement | Serum calcium normal
Item
patients were maintained on sevelamer hydrochloride as their primary phosphate binder with a total daily dose of ≤ 13.6 g with serum phosphorus concentrations at the last two measurements between 3.0 and 6.5 mg/dl, the most recent ipth ≤ 600 pg/ml and the most recent serum calcium within the normal range.
boolean
C0772463 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
C2267031 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
C2229833 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C2697755 (UMLS CUI [4])
C0858094 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Intestinal Obstruction | Deglutition Disorders | Gastrointestinal motility disorder Severe
Item
if patient had active bowel obstruction, dysphagia, swallowing disorders, or severe gastrointestinal motility disorders;
boolean
C0021843 (UMLS CUI [1])
C0011168 (UMLS CUI [2])
C0854121 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
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 Patient need for | Anticonvulsants Patient need for
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])
C0686904 (UMLS CUI [1,4])
C0003286 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
poorly controlled diabetes mellitus | Hypertensive disease Poorly controlled
Item
poorly controlled diabetes mellitus or hypertension;
boolean
C0554876 (UMLS CUI [1])
C0020538 (UMLS CUI [2,1])
C3853134 (UMLS CUI [2,2])
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 Infection
Item
hiv infection; or
boolean
C0019693 (UMLS CUI [1])
Medical condition Unstable Clinical Significance
Item
any clinically significant unstable medical condition as judge by the investigator.
boolean
C3843040 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
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