ID

28003

Descripción

Study of Phosphate Levels in Patients With Chronic Kidney Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00824460

Link

https://clinicaltrials.gov/show/NCT00824460

Palabras clave

Versiones (1)
  1. 8/12/17 8/12/17 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

8 de diciembre de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Chronic Kidney Disease NCT00824460

Inglés

Eligibility Chronic Kidney Disease NCT00824460

1 formularios  
Criteria
Descripción

Criteria

≥ 18 years of age,
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
receiving stable maintenance hemodialysis 3 times a week
Descripción

Maintenance hemodialysis Stable Frequency

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4040576
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0439603
on restricted phosphate diet at screening and throughout study
Descripción

Low phosphate diet

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0452351
receiving stable dose of phosphate binder for at least 1 month
Descripción

Phosphate Binder Dose Stable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2267031
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
serum phosphate levels >1.78 mmol/l
Descripción

Serum Phosphate Measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1883013
main exclusion criteria:
Descripción

Exclusion Criteria Main

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
uncontrolled hyperphosphatemia
Descripción

Hyperphosphatemia Uncontrolled

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0085681
UMLS CUI [1,2]
C0205318
hypercalcemia at screening or during washout
Descripción

Hypercalcemia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020437
serum calcium < 1.9 mmol/l (<7.6 mg/dl)
Descripción

Serum calcium measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0728876
severe hyperparathyroidism (ipth levels >600 ng/l)
Descripción

Hyperparathyroidism Severe | Intact Parathyroid Hormone Measurement

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020502
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C2697755
pregnancy or lactation
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
iron deficiency anemia
Descripción

Iron deficiency anemia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0162316
history of hemochromatosis or ferritin >800 mg/l,
Descripción

Hemochromatosis | Ferritin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018995
UMLS CUI [2]
C0373607
hepatitis b, hepatitis c or other significant concurrent liver disorders
Descripción

Hepatitis B | Hepatitis C | Liver diseases

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0023895
known positivity to hiv
Descripción

HIV Seropositivity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019699
use of oral iron preparations 1 month before screening,
Descripción

Oral iron agent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1298638
serious medical condition or uncontrolled systemic disease
Descripción

Medical condition Serious | Systemic disease Uncontrolled

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0442893
UMLS CUI [2,2]
C0205318
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Similar models

Eligibility Chronic Kidney Disease NCT00824460

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Age
Item
≥ 18 years of age,
boolean
C0001779 (UMLS CUI [1])
Maintenance hemodialysis Stable Frequency
Item
receiving stable maintenance hemodialysis 3 times a week
boolean
C4040576 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
Low phosphate diet
Item
on restricted phosphate diet at screening and throughout study
boolean
C0452351 (UMLS CUI [1])
Phosphate Binder Dose Stable
Item
receiving stable dose of phosphate binder for at least 1 month
boolean
C2267031 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Serum Phosphate Measurement
Item
serum phosphate levels >1.78 mmol/l
boolean
C1883013 (UMLS CUI [1])
Exclusion Criteria Main
Item
main exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Hyperphosphatemia Uncontrolled
Item
uncontrolled hyperphosphatemia
boolean
C0085681 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Hypercalcemia
Item
hypercalcemia at screening or during washout
boolean
C0020437 (UMLS CUI [1])
Serum calcium measurement
Item
serum calcium < 1.9 mmol/l (<7.6 mg/dl)
boolean
C0728876 (UMLS CUI [1])
Hyperparathyroidism Severe | Intact Parathyroid Hormone Measurement
Item
severe hyperparathyroidism (ipth levels >600 ng/l)
boolean
C0020502 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2697755 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Iron deficiency anemia
Item
iron deficiency anemia
boolean
C0162316 (UMLS CUI [1])
Hemochromatosis | Ferritin measurement
Item
history of hemochromatosis or ferritin >800 mg/l,
boolean
C0018995 (UMLS CUI [1])
C0373607 (UMLS CUI [2])
Hepatitis B | Hepatitis C | Liver diseases
Item
hepatitis b, hepatitis c or other significant concurrent liver disorders
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
HIV Seropositivity
Item
known positivity to hiv
boolean
C0019699 (UMLS CUI [1])
Oral iron agent
Item
use of oral iron preparations 1 month before screening,
boolean
C1298638 (UMLS CUI [1])
Medical condition Serious | Systemic disease Uncontrolled
Item
serious medical condition or uncontrolled systemic disease
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0442893 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
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