ID

17748

Beschreibung

Iron Sucrose in Stage 3/4 Kidney Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00202345

Link

https://clinicaltrials.gov/show/NCT00202345

Stichworte

Versionen (1)
  1. 02.10.16 02.10.16 -
Hochgeladen am

2. Oktober 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Kidney Failure NCT00202345

Englisch

Eligibility Kidney Failure NCT00202345

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. initial hb concentrations ≥ 110g/l (males and females)
Beschreibung

Hemoglobin concentration Initial | Gender

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019029
UMLS CUI [1,2]
C0205265
UMLS CUI [2]
C0079399
2. calculated gfr ≤ 35ml/min (≤ 50ml/min for diabetics)
Beschreibung

Glomerular Filtration Rate | Glomerular Filtration Rate Diabetics

Datentyp

boolean

Alias
UMLS CUI [1]
C0017654
UMLS CUI [2,1]
C0017654
UMLS CUI [2,2]
C0241863
3. demonstration of a clinically significant rise in creatinine and/or a drop in hb concentration in the previous 18 months. if such data are not available, the investigator will make a decision regarding eligibility based on the clinical circumstances.
Beschreibung

creatinine rise Clinical Significance | Hemoglobin concentration Decrease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0742904
UMLS CUI [1,2]
C2826293
UMLS CUI [2,1]
C0019029
UMLS CUI [2,2]
C0547047
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. age > 80
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. pregnancy*
Beschreibung

Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
3. unstable ischaemic heart disease*
Beschreibung

Myocardial Ischemia Unstable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0151744
UMLS CUI [1,2]
C0443343
4. uncontrolled, severe, congestive cardiac failure
Beschreibung

Congestive heart failure Severe Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0205318
5. haemochromatosis or iron overload* (ferritin >300µg/l and tsat >25%)
Beschreibung

Hemochromatosis | Iron Overload | Ferritin measurement | Transferrin saturation measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0018995
UMLS CUI [2]
C0282193
UMLS CUI [3]
C0373607
UMLS CUI [4]
C1277709
6. liver failure
Beschreibung

Liver Failure

Datentyp

boolean

Alias
UMLS CUI [1]
C0085605
7. myelodysplastic syndromes or monoclonal gammopathies
Beschreibung

MYELODYSPLASTIC SYNDROME | Monoclonal Gammapathies

Datentyp

boolean

Alias
UMLS CUI [1]
C3463824
UMLS CUI [2]
C1136085
8. active malignancy or gastrointestinal bleeding*
Beschreibung

Malignant Neoplasms | Gastrointestinal Hemorrhage

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0017181
9. persistent sepsis* or significant chronic inflammation (crp > 25)*
Beschreibung

Sepsis persistent | Chronic inflammation Significant | C-reactive protein measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243026
UMLS CUI [1,2]
C0205322
UMLS CUI [2,1]
C0021376
UMLS CUI [2,2]
C0750502
UMLS CUI [3]
C0201657
10. iron deficiency* (ferritin <30ug/l and tsat <15%)or other haematinic disorder
Beschreibung

Iron deficiency | Ferritin measurement | Transferrin saturation measurement | Disease Hematinics

Datentyp

boolean

Alias
UMLS CUI [1]
C0240066
UMLS CUI [2]
C0373607
UMLS CUI [3]
C1277709
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0018928
11. active and significant haemolysis*
Beschreibung

Hemolysis Significant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019054
UMLS CUI [1,2]
C0750502
12. previous organ transplantation
Beschreibung

Organ Transplantation Previous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0029216
UMLS CUI [1,2]
C0205156
13. concurrent or significant past (>6 months) immuno-suppression
Beschreibung

Immunosuppression Significant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4048329
UMLS CUI [1,2]
C0750502
14. adult polycystic kidney disease
Beschreibung

Polycystic Kidney Disease Adult

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022680
UMLS CUI [1,2]
C0001675
15. current use of an esa
Beschreibung

Erythropoiesis-stimulating Agent

Datentyp

boolean

Alias
UMLS CUI [1]
C2917382
16. on dialysis *: patients can still be considered eligible after condition is reversed or treated
Beschreibung

Dialysis

Datentyp

boolean

Alias
UMLS CUI [1]
C0011946
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Ähnliche Modelle

Eligibility Kidney Failure NCT00202345

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Hemoglobin concentration Initial | Gender
Item
1. initial hb concentrations ≥ 110g/l (males and females)
boolean
C0019029 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2])
Glomerular Filtration Rate | Glomerular Filtration Rate Diabetics
Item
2. calculated gfr ≤ 35ml/min (≤ 50ml/min for diabetics)
boolean
C0017654 (UMLS CUI [1])
C0017654 (UMLS CUI [2,1])
C0241863 (UMLS CUI [2,2])
creatinine rise Clinical Significance | Hemoglobin concentration Decrease
Item
3. demonstration of a clinically significant rise in creatinine and/or a drop in hb concentration in the previous 18 months. if such data are not available, the investigator will make a decision regarding eligibility based on the clinical circumstances.
boolean
C0742904 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0019029 (UMLS CUI [2,1])
C0547047 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Age
Item
1. age > 80
boolean
C0001779 (UMLS CUI [1])
Pregnancy
Item
2. pregnancy*
boolean
C0032961 (UMLS CUI [1])
Myocardial Ischemia Unstable
Item
3. unstable ischaemic heart disease*
boolean
C0151744 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
Congestive heart failure Severe Uncontrolled
Item
4. uncontrolled, severe, congestive cardiac failure
boolean
C0018802 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
Hemochromatosis | Iron Overload | Ferritin measurement | Transferrin saturation measurement
Item
5. haemochromatosis or iron overload* (ferritin >300µg/l and tsat >25%)
boolean
C0018995 (UMLS CUI [1])
C0282193 (UMLS CUI [2])
C0373607 (UMLS CUI [3])
C1277709 (UMLS CUI [4])
Liver Failure
Item
6. liver failure
boolean
C0085605 (UMLS CUI [1])
MYELODYSPLASTIC SYNDROME | Monoclonal Gammapathies
Item
7. myelodysplastic syndromes or monoclonal gammopathies
boolean
C3463824 (UMLS CUI [1])
C1136085 (UMLS CUI [2])
Malignant Neoplasms | Gastrointestinal Hemorrhage
Item
8. active malignancy or gastrointestinal bleeding*
boolean
C0006826 (UMLS CUI [1])
C0017181 (UMLS CUI [2])
Sepsis persistent | Chronic inflammation Significant | C-reactive protein measurement
Item
9. persistent sepsis* or significant chronic inflammation (crp > 25)*
boolean
C0243026 (UMLS CUI [1,1])
C0205322 (UMLS CUI [1,2])
C0021376 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C0201657 (UMLS CUI [3])
Iron deficiency | Ferritin measurement | Transferrin saturation measurement | Disease Hematinics
Item
10. iron deficiency* (ferritin <30ug/l and tsat <15%)or other haematinic disorder
boolean
C0240066 (UMLS CUI [1])
C0373607 (UMLS CUI [2])
C1277709 (UMLS CUI [3])
C0012634 (UMLS CUI [4,1])
C0018928 (UMLS CUI [4,2])
Hemolysis Significant
Item
11. active and significant haemolysis*
boolean
C0019054 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
Organ Transplantation Previous
Item
12. previous organ transplantation
boolean
C0029216 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Immunosuppression Significant
Item
13. concurrent or significant past (>6 months) immuno-suppression
boolean
C4048329 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
Polycystic Kidney Disease Adult
Item
14. adult polycystic kidney disease
boolean
C0022680 (UMLS CUI [1,1])
C0001675 (UMLS CUI [1,2])
Erythropoiesis-stimulating Agent
Item
15. current use of an esa
boolean
C2917382 (UMLS CUI [1])
Dialysis
Item
16. on dialysis *: patients can still be considered eligible after condition is reversed or treated
boolean
C0011946 (UMLS CUI [1])
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