Information:
Fel:
ID
20396
Beskrivning
A Study to Determine the Pharmacokinetic and Pharmacodynamic Profiles of PROCRIT (Epoetin Alfa) in Anemic Patients With Chronic Kidney Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00641589
Länk
https://clinicaltrials.gov/show/NCT00641589
Nyckelord
Versioner (1)
- 2017-02-21 2017-02-21 -
Uppladdad den
21 februari 2017
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Chronic Kidney Disease NCT00641589
Eligibility Chronic Kidney Disease NCT00641589
- StudyEvent: Eligibility
Similar models
Eligibility Chronic Kidney Disease NCT00641589
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Glomerular filtration rate
Item
patients with a glomerular filtration rate (gfr) within 15-60 ml/min/1.73m2 and stable creatinine over the past 6 months and no expected need for dialysis during the study
boolean
C0017654 (UMLS CUI [1])
Hemoglobin
Item
patients with a hemoglobin (hg) < 11 g/dl at screening
boolean
C0019046 (UMLS CUI [1])
Transferrin saturation or ferritin
Item
patients with a transferrin saturation >= 20% or a ferritin >= 50 ng/ml.
boolean
C1277709 (UMLS CUI [1])
C0015879 (UMLS CUI [2])
C0015879 (UMLS CUI [2])
Erythropoietic agents
Item
patients who have not received any erythropoietic agents within 6 weeks prior to the first study dose
boolean
C0312829 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0013216 (UMLS CUI [1,2])
Pregnancy test
Item
patients with reproductive potential must have a negative b-hcg pregnancy test within 14 days of the first dose of study drug and a negative urine pregnancy test on the day of the first dose of study drug
boolean
C0032976 (UMLS CUI [1])
Contraception
Item
patients and their partners must be practicing an effective method of birth control before entry and throughout the study
boolean
C0700589 (UMLS CUI [1])
Hematological disease
Item
exclusion criteria include but are not limited to the following: patients with significant hematological disease (disorders of the blood and blood forming tissues
boolean
C0018939 (UMLS CUI [1])
Myelodysplastic syndrome, hematological malignancy, hemolytic syndromes, hemoglobinopathy
Item
including but not limited to myelodysplastic syndrome, hematological malignancy, hemolytic syndromes, hemoglobinopathy)
boolean
C3463824 (UMLS CUI [1])
C0376545 (UMLS CUI [2])
C2945560 (UMLS CUI [3])
C0019045 (UMLS CUI [4])
C0376545 (UMLS CUI [2])
C2945560 (UMLS CUI [3])
C0019045 (UMLS CUI [4])
Liver function test
Item
patients with liver function test results > 2 or more times the normal value
boolean
C0023901 (UMLS CUI [1])
Seizures
Item
patients with new onset seizures (within the last 3 months) or seizures not controlled by medication prior to admission in to the study
boolean
C0036572 (UMLS CUI [1])
Thrombotic vascular events
Item
patients with a history of thrombotic vascular events (including by not limited to acute myocardial infarction (ami) within the previous 6 months, stroke, transient ischemic attack (tia), deep vein thrombosis,(dt) and pulmonary embolism (pe)
boolean
C1869077 (UMLS CUI [1])
Uncontrolled hypertension
Item
patients with poorly controlled or uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Anemia due to blood loss
Item
patients with anemia due to blood loss.
boolean
C0002871 (UMLS CUI [1,1])
C3163616 (UMLS CUI [1,2])
C3163616 (UMLS CUI [1,2])