ID

30113

Beschreibung

Aliskiren Combined With Losartan in Proteinuric, Non-diabetic Chronic Kidney Disease; ODM derived from: https://clinicaltrials.gov/show/NCT01150201

Link

https://clinicaltrials.gov/show/NCT01150201

Stichworte

Versionen (2)
  1. 11.05.18 11.05.18 -
  2. 11.05.18 11.05.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

11. Mai 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Kidney Disease NCT01150201

Englisch

Eligibility Kidney Disease NCT01150201

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female 18 - 80 years of age
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
presence of nondiabetic ckd stages 3 to 4 as defined by estimated glomerular filtration rate (egfr by 4-variable mdrd equation) as follows:
Beschreibung

Chronic Kidney Disease Stage | Renal function GFR estimation by MDRD | Other Coding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1561643
UMLS CUI [1,2]
C2074731
UMLS CUI [2]
C2170215
UMLS CUI [3]
C3846158
stage 3: moderate decrease in gfr 30-59 ml/min/1.73 sq.m
Beschreibung

Chronic kidney disease stage | Decreased glomerular filtration rate Moderate

Datentyp

boolean

Alias
UMLS CUI [1]
C2074731
UMLS CUI [2,1]
C0853068
UMLS CUI [2,2]
C0205081
stage 4: severe decrease in gfr 15-29 ml/min/1.73 sq.m
Beschreibung

Chronic kidney disease stage | Decreased glomerular filtration rate Severe

Datentyp

boolean

Alias
UMLS CUI [1]
C2074731
UMLS CUI [2,1]
C0853068
UMLS CUI [2,2]
C0205082
ckd is defined as either kidney damage or gfr <60 ml/min/1.73 m2 for > 3 months with variations of less than 30% in the 3 months before screening
Beschreibung

Chronic Kidney Diseases | Kidney damage | Glomerular Filtration Rate | Variation Percentage

Datentyp

boolean

Alias
UMLS CUI [1]
C1561643
UMLS CUI [2]
C1408258
UMLS CUI [3]
C0017654
UMLS CUI [4,1]
C0205419
UMLS CUI [4,2]
C0439165
early-morning urinary protein-to-creatinine ratio of >500 mg/g or 57 mg/mmol on at least 2 occasions four weeks apart
Beschreibung

Urine protein/creatinine ratio measurement Morning Early | Urine protein/creatinine ratio measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1096054
UMLS CUI [1,2]
C0332170
UMLS CUI [1,3]
C1279919
UMLS CUI [2]
C1096054
patients who are willing to give written, informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
egfr < 15 or > 60 ml/min/1.73m2
Beschreibung

Estimated Glomerular Filtration Rate

Datentyp

boolean

Alias
UMLS CUI [1]
C3811844
early-morning urinary protein-to-creatinine ratio of >5000 mg/g or 570 mg/mmol, or urinary protein-to-creatinine ratio of <500 mg/g or 57 mg/mmol
Beschreibung

Urine protein/creatinine ratio measurement Morning Early | Urine protein/creatinine ratio measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1096054
UMLS CUI [1,2]
C0332170
UMLS CUI [1,3]
C1279919
UMLS CUI [2]
C1096054
serum k+ > 5.2 mmol/l
Beschreibung

Serum potassium measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0302353
presence of bilateral renal artery stenosis
Beschreibung

Bilateral renal artery stenosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0856760
known allergy to losartan or aliskiren
Beschreibung

Losartan allergy | Hypersensitivity Aliskiren

Datentyp

boolean

Alias
UMLS CUI [1]
C0571952
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1120110
patients who are receiving angiotensin ii receptor blocker / angiotensin converting enzyme inhibitor combination within 12 weeks of randomization
Beschreibung

Angiotensin II receptor antagonist | Angiotensin-Converting Enzyme Inhibitors | Combined Modality Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0521942
UMLS CUI [2]
C0003015
UMLS CUI [3]
C0009429
concurrent treatment with corticosteroids, nonsteroidal antiinflammatory drugs, or immunosuppressive agent
Beschreibung

Adrenal Cortex Hormones | Anti-Inflammatory Agents, Non-Steroidal | Immunosuppressive Agents

Datentyp

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2]
C0003211
UMLS CUI [3]
C0021081
patients with connective tissue disease or obstructive uropathy
Beschreibung

Connective Tissue Diseases | Urinary tract obstruction

Datentyp

boolean

Alias
UMLS CUI [1]
C0009782
UMLS CUI [2]
C0178879
patients with concomitant malignancy or any such conditions that will severely limit life expectancy
Beschreibung

Malignant Neoplasms | Life Expectancy Limited

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0023671
UMLS CUI [2,2]
C0439801
female who are pregnant or intending to conceive
Beschreibung

Pregnancy | Pregnancy, Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
female of child-bearing age who are unwilling to practice effective contraception
Beschreibung

Childbearing Potential Contraceptive methods Unwilling

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
patients who are unable to give informed consent
Beschreibung

Informed Consent Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
patients simultaneously participating in another study or who have participated in another study within the last 30 days of entry into this study
Beschreibung

Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
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Ähnliche Modelle

Eligibility Kidney Disease NCT01150201

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female 18 - 80 years of age
boolean
C0001779 (UMLS CUI [1])
Chronic Kidney Disease Stage | Renal function GFR estimation by MDRD | Other Coding
Item
presence of nondiabetic ckd stages 3 to 4 as defined by estimated glomerular filtration rate (egfr by 4-variable mdrd equation) as follows:
boolean
C1561643 (UMLS CUI [1,1])
C2074731 (UMLS CUI [1,2])
C2170215 (UMLS CUI [2])
C3846158 (UMLS CUI [3])
Chronic kidney disease stage | Decreased glomerular filtration rate Moderate
Item
stage 3: moderate decrease in gfr 30-59 ml/min/1.73 sq.m
boolean
C2074731 (UMLS CUI [1])
C0853068 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
Chronic kidney disease stage | Decreased glomerular filtration rate Severe
Item
stage 4: severe decrease in gfr 15-29 ml/min/1.73 sq.m
boolean
C2074731 (UMLS CUI [1])
C0853068 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Chronic Kidney Diseases | Kidney damage | Glomerular Filtration Rate | Variation Percentage
Item
ckd is defined as either kidney damage or gfr <60 ml/min/1.73 m2 for > 3 months with variations of less than 30% in the 3 months before screening
boolean
C1561643 (UMLS CUI [1])
C1408258 (UMLS CUI [2])
C0017654 (UMLS CUI [3])
C0205419 (UMLS CUI [4,1])
C0439165 (UMLS CUI [4,2])
Urine protein/creatinine ratio measurement Morning Early | Urine protein/creatinine ratio measurement
Item
early-morning urinary protein-to-creatinine ratio of >500 mg/g or 57 mg/mmol on at least 2 occasions four weeks apart
boolean
C1096054 (UMLS CUI [1,1])
C0332170 (UMLS CUI [1,2])
C1279919 (UMLS CUI [1,3])
C1096054 (UMLS CUI [2])
Informed Consent
Item
patients who are willing to give written, informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Estimated Glomerular Filtration Rate
Item
egfr < 15 or > 60 ml/min/1.73m2
boolean
C3811844 (UMLS CUI [1])
Urine protein/creatinine ratio measurement Morning Early | Urine protein/creatinine ratio measurement
Item
early-morning urinary protein-to-creatinine ratio of >5000 mg/g or 570 mg/mmol, or urinary protein-to-creatinine ratio of <500 mg/g or 57 mg/mmol
boolean
C1096054 (UMLS CUI [1,1])
C0332170 (UMLS CUI [1,2])
C1279919 (UMLS CUI [1,3])
C1096054 (UMLS CUI [2])
Serum potassium measurement
Item
serum k+ > 5.2 mmol/l
boolean
C0302353 (UMLS CUI [1])
Bilateral renal artery stenosis
Item
presence of bilateral renal artery stenosis
boolean
C0856760 (UMLS CUI [1])
Losartan allergy | Hypersensitivity Aliskiren
Item
known allergy to losartan or aliskiren
boolean
C0571952 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C1120110 (UMLS CUI [2,2])
Angiotensin II receptor antagonist | Angiotensin-Converting Enzyme Inhibitors | Combined Modality Therapy
Item
patients who are receiving angiotensin ii receptor blocker / angiotensin converting enzyme inhibitor combination within 12 weeks of randomization
boolean
C0521942 (UMLS CUI [1])
C0003015 (UMLS CUI [2])
C0009429 (UMLS CUI [3])
Adrenal Cortex Hormones | Anti-Inflammatory Agents, Non-Steroidal | Immunosuppressive Agents
Item
concurrent treatment with corticosteroids, nonsteroidal antiinflammatory drugs, or immunosuppressive agent
boolean
C0001617 (UMLS CUI [1])
C0003211 (UMLS CUI [2])
C0021081 (UMLS CUI [3])
Connective Tissue Diseases | Urinary tract obstruction
Item
patients with connective tissue disease or obstructive uropathy
boolean
C0009782 (UMLS CUI [1])
C0178879 (UMLS CUI [2])
Malignant Neoplasms | Life Expectancy Limited
Item
patients with concomitant malignancy or any such conditions that will severely limit life expectancy
boolean
C0006826 (UMLS CUI [1])
C0023671 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
Pregnancy | Pregnancy, Planned
Item
female who are pregnant or intending to conceive
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Unwilling
Item
female of child-bearing age who are unwilling to practice effective contraception
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Informed Consent Unable
Item
patients who are unable to give informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Study Subject Participation Status
Item
patients simultaneously participating in another study or who have participated in another study within the last 30 days of entry into this study
boolean
C2348568 (UMLS CUI [1])
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