ID

30110

Descripción

Fibroblast Growth Factor-23 (FGF23) Reduction in Predialysis Chronic Kidney Disease (CKD); ODM derived from: https://clinicaltrials.gov/show/NCT00843349

Link

https://clinicaltrials.gov/show/NCT00843349

Palabras clave

Versiones (1)
  1. 11/5/18 11/5/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

11 de mayo de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Kidney Disease NCT00843349

Inglés

Eligibility Kidney Disease NCT00843349

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
we will include stage 3a, 3b and 4 ckd patients, aged 18 years or over with normal serum phosphate levels (≤ 4.6 mg/dl)
Descripción

Chronic Kidney Disease Stage | Age | Serum phosphate level normal

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1561643
UMLS CUI [1,2]
C2074731
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0580488
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with rapidly advancing renal failure who thus might develop hyperphosphatemia or end stage renal disease requiring initiation of dialysis during the study period
Descripción

Kidney Failure Advanced Rapidly | Hyperphosphatemia Development | Chronic Kidney Failure Requirement Dialysis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0035078
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C0456962
UMLS CUI [2,1]
C0085681
UMLS CUI [2,2]
C0243107
UMLS CUI [3,1]
C0022661
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0011946
patients expected to require dialysis initiation within the follow up period
Descripción

Dialysis Initiation Expected

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011946
UMLS CUI [1,2]
C1704686
UMLS CUI [1,3]
C1517001
patients with hyperphosphatemia > 4.6 mg/dl
Descripción

Hyperphosphatemia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0085681
patients with any previous or current treatment with phosphate binders or active vitamin d (doxercalciferol or calcitriol)
Descripción

Phosphate Binders | Vitamin D | Doxercalciferol | Calcitriol

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4020599
UMLS CUI [2]
C0042866
UMLS CUI [3]
C0043668
UMLS CUI [4]
C0006674
malnutrition, defined as a serum albumin < 3.0 mg/dl
Descripción

Malnutrition | Serum albumin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0162429
UMLS CUI [2]
C0523465
patients with liver disease (alt or ast > 100 u/l) or cholestasis (direct bilirubin > 1.0 mg/dl) because this can limit their ability to absorb fat soluble vitamins such as vitamin d
Descripción

Liver disease | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Cholestasis | Bilirubin, direct measurement | Limitation Absorption Fat soluble vitamin product | Limitation Absorption Vitamin D

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0008370
UMLS CUI [5]
C0201916
UMLS CUI [6,1]
C0449295
UMLS CUI [6,2]
C0237442
UMLS CUI [6,3]
C0259753
UMLS CUI [7,1]
C0449295
UMLS CUI [7,2]
C0237442
UMLS CUI [7,3]
C0042866
anemia, defined as a hematocrit < 27% at the screening visit
Descripción

Anemia | Hematocrit procedure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0002871
UMLS CUI [2]
C0018935
medical conditions impacting pi metabolism—primary hyper- or hypoparathyroidism; patients with previous subtotal parathyroidectomy; gastrointestinal malabsorption disorders such as crohn's disease, ulcerative colitis, celiac disease, or severe liver dysfunction;
Descripción

Medical condition Impact Phosphatidylinositol metabolic process | Hyperparathyroidism, Primary | Primary hypoparathyroidism | Subtotal parathyroidectomy | Malabsorption Syndrome | Crohn Disease | Ulcerative Colitis | Celiac Disease | Liver Dysfunction Severe

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C4049986
UMLS CUI [1,3]
C1158430
UMLS CUI [2]
C0221002
UMLS CUI [3]
C3828476
UMLS CUI [4]
C0193697
UMLS CUI [5]
C0024523
UMLS CUI [6]
C0010346
UMLS CUI [7]
C0009324
UMLS CUI [8]
C0007570
UMLS CUI [9,1]
C0086565
UMLS CUI [9,2]
C0205082
patients with outpatient counseling by a renal nutritionist within the previous 6 months
Descripción

Outpatient Counseling Nutritionist renal

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0029921
UMLS CUI [1,2]
C0010210
UMLS CUI [1,3]
C0237083
UMLS CUI [1,4]
C0022646
hospitalization within the previous 4 weeks
Descripción

Hospitalization

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019993
pregnancy or breastfeeding mothers
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients unable to independently provide written informed consent - prisoners, mentally incompetent, minors
Descripción

Informed Consent Unable | Prisoners | Mental Incompetency | Minor

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2]
C0033167
UMLS CUI [3]
C0086455
UMLS CUI [4]
C0026193
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Similar models

Eligibility Kidney Disease NCT00843349

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Kidney Disease Stage | Age | Serum phosphate level normal
Item
we will include stage 3a, 3b and 4 ckd patients, aged 18 years or over with normal serum phosphate levels (≤ 4.6 mg/dl)
boolean
C1561643 (UMLS CUI [1,1])
C2074731 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
C0580488 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Kidney Failure Advanced Rapidly | Hyperphosphatemia Development | Chronic Kidney Failure Requirement Dialysis
Item
patients with rapidly advancing renal failure who thus might develop hyperphosphatemia or end stage renal disease requiring initiation of dialysis during the study period
boolean
C0035078 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0456962 (UMLS CUI [1,3])
C0085681 (UMLS CUI [2,1])
C0243107 (UMLS CUI [2,2])
C0022661 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0011946 (UMLS CUI [3,3])
Dialysis Initiation Expected
Item
patients expected to require dialysis initiation within the follow up period
boolean
C0011946 (UMLS CUI [1,1])
C1704686 (UMLS CUI [1,2])
C1517001 (UMLS CUI [1,3])
Hyperphosphatemia
Item
patients with hyperphosphatemia > 4.6 mg/dl
boolean
C0085681 (UMLS CUI [1])
Phosphate Binders | Vitamin D | Doxercalciferol | Calcitriol
Item
patients with any previous or current treatment with phosphate binders or active vitamin d (doxercalciferol or calcitriol)
boolean
C4020599 (UMLS CUI [1])
C0042866 (UMLS CUI [2])
C0043668 (UMLS CUI [3])
C0006674 (UMLS CUI [4])
Malnutrition | Serum albumin measurement
Item
malnutrition, defined as a serum albumin < 3.0 mg/dl
boolean
C0162429 (UMLS CUI [1])
C0523465 (UMLS CUI [2])
Liver disease | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Cholestasis | Bilirubin, direct measurement | Limitation Absorption Fat soluble vitamin product | Limitation Absorption Vitamin D
Item
patients with liver disease (alt or ast > 100 u/l) or cholestasis (direct bilirubin > 1.0 mg/dl) because this can limit their ability to absorb fat soluble vitamins such as vitamin d
boolean
C0023895 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0008370 (UMLS CUI [4])
C0201916 (UMLS CUI [5])
C0449295 (UMLS CUI [6,1])
C0237442 (UMLS CUI [6,2])
C0259753 (UMLS CUI [6,3])
C0449295 (UMLS CUI [7,1])
C0237442 (UMLS CUI [7,2])
C0042866 (UMLS CUI [7,3])
Anemia | Hematocrit procedure
Item
anemia, defined as a hematocrit < 27% at the screening visit
boolean
C0002871 (UMLS CUI [1])
C0018935 (UMLS CUI [2])
Medical condition Impact Phosphatidylinositol metabolic process | Hyperparathyroidism, Primary | Primary hypoparathyroidism | Subtotal parathyroidectomy | Malabsorption Syndrome | Crohn Disease | Ulcerative Colitis | Celiac Disease | Liver Dysfunction Severe
Item
medical conditions impacting pi metabolism—primary hyper- or hypoparathyroidism; patients with previous subtotal parathyroidectomy; gastrointestinal malabsorption disorders such as crohn's disease, ulcerative colitis, celiac disease, or severe liver dysfunction;
boolean
C3843040 (UMLS CUI [1,1])
C4049986 (UMLS CUI [1,2])
C1158430 (UMLS CUI [1,3])
C0221002 (UMLS CUI [2])
C3828476 (UMLS CUI [3])
C0193697 (UMLS CUI [4])
C0024523 (UMLS CUI [5])
C0010346 (UMLS CUI [6])
C0009324 (UMLS CUI [7])
C0007570 (UMLS CUI [8])
C0086565 (UMLS CUI [9,1])
C0205082 (UMLS CUI [9,2])
Outpatient Counseling Nutritionist renal
Item
patients with outpatient counseling by a renal nutritionist within the previous 6 months
boolean
C0029921 (UMLS CUI [1,1])
C0010210 (UMLS CUI [1,2])
C0237083 (UMLS CUI [1,3])
C0022646 (UMLS CUI [1,4])
Hospitalization
Item
hospitalization within the previous 4 weeks
boolean
C0019993 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnancy or breastfeeding mothers
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Informed Consent Unable | Prisoners | Mental Incompetency | Minor
Item
patients unable to independently provide written informed consent - prisoners, mentally incompetent, minors
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0033167 (UMLS CUI [2])
C0086455 (UMLS CUI [3])
C0026193 (UMLS CUI [4])
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