ID

39076

Beschreibung

A Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Diabetic Nephropathy; ODM derived from: https://clinicaltrials.gov/show/NCT01447147

Link

https://clinicaltrials.gov/show/NCT01447147

Stichworte

Versionen (1)
  1. 27.11.19 27.11.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

27. November 2019

DOI

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Creative Commons BY 4.0
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Eligibility Diabetic Nephropathy NCT01447147

Englisch

Eligibility Diabetic Nephropathy NCT01447147

1 Formulare  
Criteria
Beschreibung

Criteria

aged 18-75 years inclusive, with documented previously diagnosed type 2 diabetes mellitus (per american diabetes association [ada] criteria)
Beschreibung

Age | Non-Insulin-Dependent Diabetes Mellitus Prior diagnosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C0332132
residual albuminuria despite stable treatment with an angiotensin-converting enzyme (ace) inhibitor or an angiotensin receptor blocker (arb) for at least 8 weeks prior to screening (albumin:creatinine ratio [acr] of 100 to 3000 mg/g creatinine, inclusive)
Beschreibung

Albuminuria Residual | Angiotensin-Converting Enzyme Inhibitors Stable | Angiotensin II receptor antagonist Stable | Albumin To Creatinine Protein Ratio Measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001925
UMLS CUI [1,2]
C1609982
UMLS CUI [2,1]
C0003015
UMLS CUI [2,2]
C0205360
UMLS CUI [3,1]
C0521942
UMLS CUI [3,2]
C0205360
UMLS CUI [4]
C0486293
estimated glomerular filtration rate based on serum creatinine (egfr, determined by modification of diet in renal disease [mdrd] equation) of ≥ 25 ml/min/1.73 m(2)
Beschreibung

Renal function GFR estimation by MDRD

Datentyp

boolean

Alias
UMLS CUI [1]
C2170215
must be on a stable dose of an ace inhibitor or arb for at least 8 weeks prior to screening, but subjects must not be on both an ace inhibitor and an arb
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003015
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0521942
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3,1]
C0009429
UMLS CUI [3,2]
C0332197
hemoglobin a1c (hba1c) > 6.0% but not > 10.0% and fasting plasma glucose less than 270 mg/dl at screening
Beschreibung

Hemoglobin A1c measurement | Plasma fasting glucose measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0474680
UMLS CUI [2]
C0583513
key exclusion criteria:
Beschreibung

Exclusion Criteria Main

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
type 1 diabetes mellitus or history of diabetic ketoacidosis
Beschreibung

Diabetes Mellitus, Insulin-Dependent | Diabetic Ketoacidosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011880
previous renal transplant or known non-diabetic renal disease, except related to hypertension
Beschreibung

Kidney Transplantation | Kidney Disease | Exception Diabetic Nephropathy | Exception Relationship Hypertensive disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0022671
UMLS CUI [2]
C0022658
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0011881
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0439849
UMLS CUI [4,3]
C0020538
undergone renal dialysis at any time in the past
Beschreibung

Dialysis

Datentyp

boolean

Alias
UMLS CUI [1]
C0011946
received chronic (more than 7 days continuously) systemic glucocorticoid or other immunosuppressive treatment within 8 weeks of screening
Beschreibung

Systemic Glucocorticoids chronic | Therapeutic immunosuppression chronic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3540777
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0021079
UMLS CUI [2,2]
C0205191
use of bardoxolone, atrasentan or other endothelin antagonist within 8 weeks of screening
Beschreibung

bardoxolone | atrasentan | Endothelin receptor antagonist

Datentyp

boolean

Alias
UMLS CUI [1]
C0762434
UMLS CUI [2]
C0935914
UMLS CUI [3]
C1134681
received chronic (more than 7 days continuously) non-steroidal anti-inflammatory drug (nsaid) treatment within 2 weeks of screening
Beschreibung

NSAIDs chronic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C0205191
cardiac failure (class iii or iv), history of unstable angina, symptomatic coronary artery disease, myocardial infarction or stroke within 12 weeks of screening
Beschreibung

Heart failure New York Heart Association Classification | Angina, Unstable | Coronary Artery Disease Symptomatic | Myocardial Infarction | Cerebrovascular accident

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C0002965
UMLS CUI [3,1]
C1956346
UMLS CUI [3,2]
C0231220
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0038454
poorly-controlled blood pressure (systolic blood pressure >155 or diastolic blood pressure >95, with blood pressure measured in the seated position after at least 5 minutes of rest)
Beschreibung

Blood Pressure Poorly controlled | Sitting systolic blood pressure | Sitting diastolic blood pressure | Status post Rest Number of minutes

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C3853134
UMLS CUI [2]
C1319893
UMLS CUI [3]
C1319894
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0035253
UMLS CUI [4,3]
C1562039
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Ähnliche Modelle

Eligibility Diabetic Nephropathy NCT01447147

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Age | Non-Insulin-Dependent Diabetes Mellitus Prior diagnosis
Item
aged 18-75 years inclusive, with documented previously diagnosed type 2 diabetes mellitus (per american diabetes association [ada] criteria)
boolean
C0001779 (UMLS CUI [1])
C0011860 (UMLS CUI [2,1])
C0332132 (UMLS CUI [2,2])
Albuminuria Residual | Angiotensin-Converting Enzyme Inhibitors Stable | Angiotensin II receptor antagonist Stable | Albumin To Creatinine Protein Ratio Measurement
Item
residual albuminuria despite stable treatment with an angiotensin-converting enzyme (ace) inhibitor or an angiotensin receptor blocker (arb) for at least 8 weeks prior to screening (albumin:creatinine ratio [acr] of 100 to 3000 mg/g creatinine, inclusive)
boolean
C0001925 (UMLS CUI [1,1])
C1609982 (UMLS CUI [1,2])
C0003015 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0521942 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
C0486293 (UMLS CUI [4])
Renal function GFR estimation by MDRD
Item
estimated glomerular filtration rate based on serum creatinine (egfr, determined by modification of diet in renal disease [mdrd] equation) of ≥ 25 ml/min/1.73 m(2)
boolean
C2170215 (UMLS CUI [1])
Angiotensin-Converting Enzyme Inhibitors Dose Stable | Angiotensin II receptor antagonist Dose Stable | Combined Modality Therapy Absent
Item
must be on a stable dose of an ace inhibitor or arb for at least 8 weeks prior to screening, but subjects must not be on both an ace inhibitor and an arb
boolean
C0003015 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0521942 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0009429 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Hemoglobin A1c measurement | Plasma fasting glucose measurement
Item
hemoglobin a1c (hba1c) > 6.0% but not > 10.0% and fasting plasma glucose less than 270 mg/dl at screening
boolean
C0474680 (UMLS CUI [1])
C0583513 (UMLS CUI [2])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Diabetes Mellitus, Insulin-Dependent | Diabetic Ketoacidosis
Item
type 1 diabetes mellitus or history of diabetic ketoacidosis
boolean
C0011854 (UMLS CUI [1])
C0011880 (UMLS CUI [2])
Kidney Transplantation | Kidney Disease | Exception Diabetic Nephropathy | Exception Relationship Hypertensive disease
Item
previous renal transplant or known non-diabetic renal disease, except related to hypertension
boolean
C0022671 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0011881 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0439849 (UMLS CUI [4,2])
C0020538 (UMLS CUI [4,3])
Dialysis
Item
undergone renal dialysis at any time in the past
boolean
C0011946 (UMLS CUI [1])
Systemic Glucocorticoids chronic | Therapeutic immunosuppression chronic
Item
received chronic (more than 7 days continuously) systemic glucocorticoid or other immunosuppressive treatment within 8 weeks of screening
boolean
C3540777 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0021079 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
bardoxolone | atrasentan | Endothelin receptor antagonist
Item
use of bardoxolone, atrasentan or other endothelin antagonist within 8 weeks of screening
boolean
C0762434 (UMLS CUI [1])
C0935914 (UMLS CUI [2])
C1134681 (UMLS CUI [3])
NSAIDs chronic
Item
received chronic (more than 7 days continuously) non-steroidal anti-inflammatory drug (nsaid) treatment within 2 weeks of screening
boolean
C0003211 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Heart failure New York Heart Association Classification | Angina, Unstable | Coronary Artery Disease Symptomatic | Myocardial Infarction | Cerebrovascular accident
Item
cardiac failure (class iii or iv), history of unstable angina, symptomatic coronary artery disease, myocardial infarction or stroke within 12 weeks of screening
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0002965 (UMLS CUI [2])
C1956346 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C0027051 (UMLS CUI [4])
C0038454 (UMLS CUI [5])
Blood Pressure Poorly controlled | Sitting systolic blood pressure | Sitting diastolic blood pressure | Status post Rest Number of minutes
Item
poorly-controlled blood pressure (systolic blood pressure >155 or diastolic blood pressure >95, with blood pressure measured in the seated position after at least 5 minutes of rest)
boolean
C0005823 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C1319893 (UMLS CUI [2])
C1319894 (UMLS CUI [3])
C0231290 (UMLS CUI [4,1])
C0035253 (UMLS CUI [4,2])
C1562039 (UMLS CUI [4,3])
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