ID

27956

Description

A Clinical Study to Evaluate the Safety, Tolerability and Activity of a New Phosphate Binder (SBR759) in Patients With Chronic Kidney Disease on Hemodialysis; ODM derived from: https://clinicaltrials.gov/show/NCT00750295

Link

https://clinicaltrials.gov/show/NCT00750295

Keywords

Versions (1)
  1. 12/7/17 12/7/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 7, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Chronic Kidney Disease NCT00750295

English

Eligibility Chronic Kidney Disease NCT00750295

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must be treated with maintenance hemodialysis and prescribed a phosphate binder.
Description

Maintenance hemodialysis | Phosphate Binder prescribed

Data type

boolean

Alias
UMLS CUI [1]
C4040576
UMLS CUI [2,1]
C2267031
UMLS CUI [2,2]
C0278329
a controlled serum phosphorus.
Description

Serum phosphorus measurement Controlled

Data type

boolean

Alias
UMLS CUI [1,1]
C2229833
UMLS CUI [1,2]
C2587213
constant dose of concomitant medications.
Description

Pharmaceutical Preparations Dose Constant

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1948059
women of child bearing potential must be practicing an acceptable form of birth control (i.e. double barrier method - intrauterine device plus condom, spermicidal gel plus condom). all female patients must have a negative pregnancy test at screening in order to be eligible to participate in the study.
Description

Childbearing Potential Contraceptive methods | Barrier Contraception Double | Intrauterine Devices | Female Condoms | Vaginal Spermicides | Gender Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0004764
UMLS CUI [2,2]
C0205173
UMLS CUI [3]
C0021900
UMLS CUI [4]
C0221829
UMLS CUI [5]
C0087145
UMLS CUI [6,1]
C0079399
UMLS CUI [6,2]
C0427780
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient has been hospitalized within 30 days prior to screening or has a surgery scheduled during the study.
Description

Hospitalization | Patient scheduled for surgery

Data type

boolean

Alias
UMLS CUI [1]
C0019993
UMLS CUI [2]
C3242215
patient has an unstable medical condition, an active infection, active malignancy (except for basal cell carcinoma of the skin), a history of major gi tract surgery, or a history of hemochromatosis.
Description

Medical condition Unstable | Communicable Disease | Malignant Neoplasms | Exception Basal cell carcinoma | Operation on gastrointestinal tract Major | Hemochromatosis

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0443343
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0006826
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007117
UMLS CUI [5,1]
C0399610
UMLS CUI [5,2]
C0205164
UMLS CUI [6]
C0018995
patient is receiving or has received an investigational drug (or is currently using an investigational device) within 30 days prior to screening.
Description

Investigational New Drugs | Investigational Medical Device

Data type

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2346570
other protocol-defined inclusion/exclusion criteria may apply.
Description

Eligibility Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Chronic Kidney Disease NCT00750295

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Maintenance hemodialysis | Phosphate Binder prescribed
Item
patients must be treated with maintenance hemodialysis and prescribed a phosphate binder.
boolean
C4040576 (UMLS CUI [1])
C2267031 (UMLS CUI [2,1])
C0278329 (UMLS CUI [2,2])
Serum phosphorus measurement Controlled
Item
a controlled serum phosphorus.
boolean
C2229833 (UMLS CUI [1,1])
C2587213 (UMLS CUI [1,2])
Pharmaceutical Preparations Dose Constant
Item
constant dose of concomitant medications.
boolean
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1948059 (UMLS CUI [1,3])
Childbearing Potential Contraceptive methods | Barrier Contraception Double | Intrauterine Devices | Female Condoms | Vaginal Spermicides | Gender Pregnancy test negative
Item
women of child bearing potential must be practicing an acceptable form of birth control (i.e. double barrier method - intrauterine device plus condom, spermicidal gel plus condom). all female patients must have a negative pregnancy test at screening in order to be eligible to participate in the study.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0004764 (UMLS CUI [2,1])
C0205173 (UMLS CUI [2,2])
C0021900 (UMLS CUI [3])
C0221829 (UMLS CUI [4])
C0087145 (UMLS CUI [5])
C0079399 (UMLS CUI [6,1])
C0427780 (UMLS CUI [6,2])
Item Group
C0680251 (UMLS CUI)
Hospitalization | Patient scheduled for surgery
Item
patient has been hospitalized within 30 days prior to screening or has a surgery scheduled during the study.
boolean
C0019993 (UMLS CUI [1])
C3242215 (UMLS CUI [2])
Medical condition Unstable | Communicable Disease | Malignant Neoplasms | Exception Basal cell carcinoma | Operation on gastrointestinal tract Major | Hemochromatosis
Item
patient has an unstable medical condition, an active infection, active malignancy (except for basal cell carcinoma of the skin), a history of major gi tract surgery, or a history of hemochromatosis.
boolean
C3843040 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0006826 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
C0399610 (UMLS CUI [5,1])
C0205164 (UMLS CUI [5,2])
C0018995 (UMLS CUI [6])
Investigational New Drugs | Investigational Medical Device
Item
patient is receiving or has received an investigational drug (or is currently using an investigational device) within 30 days prior to screening.
boolean
C0013230 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply.
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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