ID

28001

Beschrijving

Trial to Determine the Effects of Bardoxolone Methyl on eGFR in Patients With Type 2 Diabetes and Chronic Kidney Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00811889

Link

https://clinicaltrials.gov/show/NCT00811889

Trefwoorden

Versies (1)
  1. 08-12-17 08-12-17 -
Houder van rechten

See clinicaltrials.gov

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8 december 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Chronic Kidney Disease NCT00811889

Engels

Eligibility Chronic Kidney Disease NCT00811889

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or female patient, at least 18 years of age with known type 2 diabetes, diagnosis of type 2 diabetes should have been made at > 30 years of age (if diabetes developed at a younger age, c-peptide level may be obtained to confirm diagnosis)
Beschrijving

Age | Diabetes Mellitus, Non-Insulin-Dependent | C-peptide level

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0011860
UMLS CUI [3]
C0202100
2. the average of two egfr values collected during screening must be within 20 - 45 ml/min/1.73m2, inclusive
Beschrijving

Estimated Glomerular Filtration Rate Quantity Average

Datatype

boolean

Alias
UMLS CUI [1,1]
C3811844
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1510992
3. patient must be receiving an angiotensin converting enzyme (ace) inhibitor and/or an angiotensin ii receptor blocker (arb) for at least 3 months prior to screening, where the dose of the ace inhibitor or the arb is considered appropriate for that patient, and has been stable and maintained on that dose for at least 8 weeks prior to the randomization visit
Beschrijving

Angiotensin-Converting Enzyme Inhibitors Dose Stable | Angiotensin II receptor antagonist Dose Stable

Datatype

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
4. for male and female subjects, agreement to use effective contraception during the entire study period and for at least 2 months after the last dose of study drug, unless documentation of infertility exists
Beschrijving

Contraceptive methods | Exception Infertility

Datatype

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0021359
5. women of child-bearing potential, she must have a negative serum pregnancy test at screening and a negative urine pregnancy test confirmed within 72 hours prior to the first dose of study medication
Beschrijving

Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430057
6. patient is willing and able to cooperate with all aspects of the protocol
Beschrijving

Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1]
C0525058
7. patient is willing and able to give written informed consent for study participation.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. type 1 (insulin-dependent; juvenile onset) diabetes, or any history of diabetic ketoacidosis
Beschrijving

Diabetes Mellitus, Insulin-Dependent | Diabetic Ketoacidosis

Datatype

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011880
2. patients with known non-diabetic renal disease or patients with a history of a renal transplant
Beschrijving

Kidney Disease | Exception Diabetes Mellitus | Kidney Transplantation

Datatype

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0011849
UMLS CUI [3]
C0022671
3. patients with a hemoglobin a1c >10% collected at the screening a visit
Beschrijving

Glucohemoglobin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0202054
4. cardiovascular disease as follows: unstable angina pectoris within 3 months prior to study randomization; myocardial infarction, coronary artery bypass graft surgery, or percutaneous transluminal coronary angioplasty/stent within 3 months prior to study randomization; transient ischemic attack within 3 months of study randomization; cerebrovascular accident within 3 months of study randomization; obstructive valvular heart disease or hypertrophic cardiomyopathy; diagnosis of class iii or iv congestive heart failure at any time
Beschrijving

Cardiovascular Diseases | Angina, Unstable | Myocardial Infarction | Coronary Artery Bypass Surgery | Percutaneous Transluminal Coronary Angioplasty | Transient Ischemic Attack | Cerebrovascular accident | Heart valve disease Obstructive | Hypertrophic Cardiomyopathy | Congestive heart failure New York Heart Association Classification

Datatype

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0010055
UMLS CUI [5]
C2936173
UMLS CUI [6]
C0007787
UMLS CUI [7]
C0038454
UMLS CUI [8,1]
C0018824
UMLS CUI [8,2]
C0549186
UMLS CUI [9]
C0007194
UMLS CUI [10,1]
C0018802
UMLS CUI [10,2]
C1275491
5. systolic blood pressure (bp) >160 mmhg and diastolic blood pressure > 90 determined by the average of three seated readings taken at least 5 minutes apart, at each of two time-points at least 5 days apart during the screening period
Beschrijving

Systolic Pressure | Diastolic blood pressure

Datatype

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
6. qtc fredericia interval > 450 milliseconds determined by the average of values reported by a central reader from three ecgs taken at the screening a visit. each of the three ecgs will be obtained using only equipment provided by the sponsor, and the ecgs shall be obtained at least ten minutes apart.
Beschrijving

QTc interval ECG Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0489625
UMLS CUI [1,2]
C0013798
UMLS CUI [1,3]
C1265611
7. second or third degree atrioventricular block not successfully treated with a pacemaker
Beschrijving

Second degree atrioventricular block | Complete atrioventricular block | Artificial cardiac pacemaker Unsuccessful

Datatype

boolean

Alias
UMLS CUI [1]
C0264906
UMLS CUI [2]
C0151517
UMLS CUI [3,1]
C0030163
UMLS CUI [3,2]
C1272705
8. need for chronic (>2 weeks) immunosuppressive therapy, or need for corticosteroids (excluding intraarticular injections,inhaled or nasal steroids) within 3 months of study randomization
Beschrijving

Therapeutic immunosuppression chronic Patient need for | Adrenal Cortex Hormones Patient need for | Exception Intra-Articular Injections | Exception Inhaled steroids | Exception Steroids Nasal

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021079
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C0686904
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C0686904
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0021488
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C2065041
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0038317
UMLS CUI [5,3]
C1522019
9. evidence of hepatic or biliary dysfunction including total bilirubin >1.0 mg/dl (>17 micromol/l), aspartate aminotransferase (ast) or alanine aminotransferase (alt) > upper limit of normal (uln), or alkaline phosphatase >2.0 uln on any screening lab
Beschrijving

Liver Dysfunction | Dysfunction biliary | Serum total bilirubin measurement | Aspartate aminotransferase increased | Alanine aminotransferase increased | Alkaline phosphatase raised

Datatype

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2,1]
C3887504
UMLS CUI [2,2]
C0521378
UMLS CUI [3]
C1278039
UMLS CUI [4]
C0151904
UMLS CUI [5]
C0151905
UMLS CUI [6]
C0151849
10. if female, patient is pregnant, nursing or planning a pregnancy
Beschrijving

Pregnancy | Breast Feeding | Pregnancy, Planned

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
11. patient has any concurrent clinical conditions that in the judgment of the investigator could either potentially pose a health risk to the patient while involved in the study or could potentially influence the study outcome
Beschrijving

Medical condition Study Subject Participation Status At risk Patient | Medical condition Influence Research results

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
UMLS CUI [1,4]
C0030705
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C4054723
UMLS CUI [2,3]
C0683954
12. patient has known hypersensitivity to any component of the study drug
Beschrijving

Hypersensitivity Investigational New Drug Component

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C1705248
13. patient has undergone a diagnostic or interventional procedure requiring a contrast agent within 30 days prior to randomization
Beschrijving

Diagnostic procedure Requirement Contrast Media | Interventional procedure Requirement Contrast Media

Datatype

boolean

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0009924
UMLS CUI [2,1]
C0184661
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0009924
14. change or dose adjustment in any of the following medications within 8 weeks prior to randomization into the study or anticipated change in dose within 30 days following randomization into the study: ace inhibitors, angiotensin ii receptor blockers.
Beschrijving

Pharmaceutical Preparations Change | Pharmaceutical Preparations Dose Adjustment | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392747
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C2826232
UMLS CUI [3]
C0003015
UMLS CUI [4]
C0521942
15. change or dose adjustment of any other anti-hypertensive, and other anti-diabetic medications within 8 weeks prior to randomization or anticipated change in dose within 30 days following randomization into the study
Beschrijving

Pharmaceutical Preparations Change | Pharmaceutical Preparations Dose Adjustment | Antihypertensive Agents | Antidiabetics

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392747
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C2826232
UMLS CUI [3]
C0003364
UMLS CUI [4]
C0935929
16. patient has a current history of drug or alcohol abuse as per the investigator's assessment
Beschrijving

Substance Use Disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
17. patient has participated in another investigational study within 30 days prior to randomization into the study or would concomitantly participate in such a study, or has previously participated in a trial involving bardoxolone methyl.
Beschrijving

Study Subject Participation Status | Bardoxolone methyl

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C1100924
18. patient is unable to communicate or cooperate with the investigator due to language problems, poor mental development or impaired cerebral function
Beschrijving

Lacking Able to communicate | Compliance behavior Lacking | Language problems | Development; delayed, mental | Cerebral function Impaired

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2364293
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0332268
UMLS CUI [3]
C1405458
UMLS CUI [4]
C1410968
UMLS CUI [5,1]
C0234386
UMLS CUI [5,2]
C0221099
19. patient is unable or unwilling to utilize the daily phone diary to track the date and time they take their study medication
Beschrijving

Subject Diary Use of Unable | Subject Diary Use of Unwilling

Datatype

boolean

Alias
UMLS CUI [1,1]
C3890583
UMLS CUI [1,2]
C1524063
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C3890583
UMLS CUI [2,2]
C1524063
UMLS CUI [2,3]
C0558080
20. patients on any of the following known hepatotoxic agents: antioxidant n-acetly-cysteine (mucomyst, acetadote, fluimucil, parvolex), niacin (nicotinic acid), dantrium (dantrolene), naizide (isoniazid), normodyne (labetalol), cylert (pemoline), felbatol (felbamate), zyflo (zileuton), tasmar (tolcapone), or trovan (trovafloxacin). patients must have been off the aforementioned medications for a minimum of two weeks prior to randomization
Beschrijving

Pharmaceutical Preparations Hepatotoxicity | Acetylcysteine | Mucomyst | Acetadote | Fluimucil | Parvolex | Niacin | Nicotinic Acids | Dantrium | Dantrolene | isoniazid | Normodyne | Labetalol | Cylert | Pemoline | Felbatol | felbamate | Zyflo | zileuton | Tasmar | tolcapone | Trovan | trovafloxacin

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0235378
UMLS CUI [2]
C0001047
UMLS CUI [3]
C0699252
UMLS CUI [4]
C1330030
UMLS CUI [5]
C0699251
UMLS CUI [6]
C0135546
UMLS CUI [7]
C0027996
UMLS CUI [8]
C0028049
UMLS CUI [9]
C0010975
UMLS CUI [10]
C0010976
UMLS CUI [11]
C0022209
UMLS CUI [12]
C0600256
UMLS CUI [13]
C0022860
UMLS CUI [14]
C0719594
UMLS CUI [15]
C0030800
UMLS CUI [16]
C0728742
UMLS CUI [17]
C0060135
UMLS CUI [18]
C0724508
UMLS CUI [19]
C0081408
UMLS CUI [20]
C0595276
UMLS CUI [21]
C0246330
UMLS CUI [22]
C0723938
UMLS CUI [23]
C0379881
21. patients who are unable or unwilling to discontinue fenofibrate (antara, fenoglide, lipofen, lofibra, tricor, triglide) during the first three months of study treatment. patients must have been off fenofibrate for a minimum of two weeks prior to randomization
Beschrijving

Fenofibrate Discontinue Unable | Fenofibrate Discontinue Unwilling | Antara | Fenoglide | Lipofen | Lofibra | Tricor | Triglide | Fenofibrate To be stopped

Datatype

boolean

Alias
UMLS CUI [1,1]
C0033228
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0033228
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C0558080
UMLS CUI [3]
C1617247
UMLS CUI [4]
C2342283
UMLS CUI [5]
C1701349
UMLS CUI [6]
C1170377
UMLS CUI [7]
C0723893
UMLS CUI [8]
C1620426
UMLS CUI [9,1]
C0033228
UMLS CUI [9,2]
C1272691
22. patients who require more than occasional (once or twice weekly) use of non-steroidal anti-inflammatory agents (nsaids)
Beschrijving

Non-Steroidal Anti-Inflammatory Agents Regular Patient need for

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C0205272
UMLS CUI [1,3]
C0686904
23. patients with a history of neoplastic disease (except basal or squamous cell carcinoma of the skin) within 5 years prior to the randomization visit;
Beschrijving

Neoplastic disease | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin

Datatype

boolean

Alias
UMLS CUI [1]
C1882062
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
24. patients who have had prior dialysis within three months of randomization and/or have not maintained a stable level of kidney function within three months of randomization per investigator assessment
Beschrijving

Dialysis | Renal function Unstable

Datatype

boolean

Alias
UMLS CUI [1]
C0011946
UMLS CUI [2,1]
C0232804
UMLS CUI [2,2]
C0443343
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Similar models

Eligibility Chronic Kidney Disease NCT00811889

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age | Diabetes Mellitus, Non-Insulin-Dependent | C-peptide level
Item
1. male or female patient, at least 18 years of age with known type 2 diabetes, diagnosis of type 2 diabetes should have been made at > 30 years of age (if diabetes developed at a younger age, c-peptide level may be obtained to confirm diagnosis)
boolean
C0001779 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C0202100 (UMLS CUI [3])
Estimated Glomerular Filtration Rate Quantity Average
Item
2. the average of two egfr values collected during screening must be within 20 - 45 ml/min/1.73m2, inclusive
boolean
C3811844 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1510992 (UMLS CUI [1,3])
Angiotensin-Converting Enzyme Inhibitors Dose Stable | Angiotensin II receptor antagonist Dose Stable
Item
3. patient must be receiving an angiotensin converting enzyme (ace) inhibitor and/or an angiotensin ii receptor blocker (arb) for at least 3 months prior to screening, where the dose of the ace inhibitor or the arb is considered appropriate for that patient, and has been stable and maintained on that dose for at least 8 weeks prior to the randomization visit
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])
Contraceptive methods | Exception Infertility
Item
4. for male and female subjects, agreement to use effective contraception during the entire study period and for at least 2 months after the last dose of study drug, unless documentation of infertility exists
boolean
C0700589 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0021359 (UMLS CUI [2,2])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative
Item
5. women of child-bearing potential, she must have a negative serum pregnancy test at screening and a negative urine pregnancy test confirmed within 72 hours prior to the first dose of study medication
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
Protocol Compliance
Item
6. patient is willing and able to cooperate with all aspects of the protocol
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
7. patient is willing and able to give written informed consent for study participation.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Diabetic Ketoacidosis
Item
1. type 1 (insulin-dependent; juvenile onset) diabetes, or any history of diabetic ketoacidosis
boolean
C0011854 (UMLS CUI [1])
C0011880 (UMLS CUI [2])
Kidney Disease | Exception Diabetes Mellitus | Kidney Transplantation
Item
2. patients with known non-diabetic renal disease or patients with a history of a renal transplant
boolean
C0022658 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0011849 (UMLS CUI [2,2])
C0022671 (UMLS CUI [3])
Glucohemoglobin measurement
Item
3. patients with a hemoglobin a1c >10% collected at the screening a visit
boolean
C0202054 (UMLS CUI [1])
Cardiovascular Diseases | Angina, Unstable | Myocardial Infarction | Coronary Artery Bypass Surgery | Percutaneous Transluminal Coronary Angioplasty | Transient Ischemic Attack | Cerebrovascular accident | Heart valve disease Obstructive | Hypertrophic Cardiomyopathy | Congestive heart failure New York Heart Association Classification
Item
4. cardiovascular disease as follows: unstable angina pectoris within 3 months prior to study randomization; myocardial infarction, coronary artery bypass graft surgery, or percutaneous transluminal coronary angioplasty/stent within 3 months prior to study randomization; transient ischemic attack within 3 months of study randomization; cerebrovascular accident within 3 months of study randomization; obstructive valvular heart disease or hypertrophic cardiomyopathy; diagnosis of class iii or iv congestive heart failure at any time
boolean
C0007222 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0010055 (UMLS CUI [4])
C2936173 (UMLS CUI [5])
C0007787 (UMLS CUI [6])
C0038454 (UMLS CUI [7])
C0018824 (UMLS CUI [8,1])
C0549186 (UMLS CUI [8,2])
C0007194 (UMLS CUI [9])
C0018802 (UMLS CUI [10,1])
C1275491 (UMLS CUI [10,2])
Systolic Pressure | Diastolic blood pressure
Item
5. systolic blood pressure (bp) >160 mmhg and diastolic blood pressure > 90 determined by the average of three seated readings taken at least 5 minutes apart, at each of two time-points at least 5 days apart during the screening period
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
QTc interval ECG Quantity
Item
6. qtc fredericia interval > 450 milliseconds determined by the average of values reported by a central reader from three ecgs taken at the screening a visit. each of the three ecgs will be obtained using only equipment provided by the sponsor, and the ecgs shall be obtained at least ten minutes apart.
boolean
C0489625 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Second degree atrioventricular block | Complete atrioventricular block | Artificial cardiac pacemaker Unsuccessful
Item
7. second or third degree atrioventricular block not successfully treated with a pacemaker
boolean
C0264906 (UMLS CUI [1])
C0151517 (UMLS CUI [2])
C0030163 (UMLS CUI [3,1])
C1272705 (UMLS CUI [3,2])
Therapeutic immunosuppression chronic Patient need for | Adrenal Cortex Hormones Patient need for | Exception Intra-Articular Injections | Exception Inhaled steroids | Exception Steroids Nasal
Item
8. need for chronic (>2 weeks) immunosuppressive therapy, or need for corticosteroids (excluding intraarticular injections,inhaled or nasal steroids) within 3 months of study randomization
boolean
C0021079 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,3])
C0001617 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0021488 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C2065041 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0038317 (UMLS CUI [5,2])
C1522019 (UMLS CUI [5,3])
Liver Dysfunction | Dysfunction biliary | Serum total bilirubin measurement | Aspartate aminotransferase increased | Alanine aminotransferase increased | Alkaline phosphatase raised
Item
9. evidence of hepatic or biliary dysfunction including total bilirubin >1.0 mg/dl (>17 micromol/l), aspartate aminotransferase (ast) or alanine aminotransferase (alt) > upper limit of normal (uln), or alkaline phosphatase >2.0 uln on any screening lab
boolean
C0086565 (UMLS CUI [1])
C3887504 (UMLS CUI [2,1])
C0521378 (UMLS CUI [2,2])
C1278039 (UMLS CUI [3])
C0151904 (UMLS CUI [4])
C0151905 (UMLS CUI [5])
C0151849 (UMLS CUI [6])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
10. if female, patient is pregnant, nursing or planning a pregnancy
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Medical condition Study Subject Participation Status At risk Patient | Medical condition Influence Research results
Item
11. patient has any concurrent clinical conditions that in the judgment of the investigator could either potentially pose a health risk to the patient while involved in the study or could potentially influence the study outcome
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0030705 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C4054723 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
Hypersensitivity Investigational New Drug Component
Item
12. patient has known hypersensitivity to any component of the study drug
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
Diagnostic procedure Requirement Contrast Media | Interventional procedure Requirement Contrast Media
Item
13. patient has undergone a diagnostic or interventional procedure requiring a contrast agent within 30 days prior to randomization
boolean
C0430022 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0009924 (UMLS CUI [1,3])
C0184661 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0009924 (UMLS CUI [2,3])
Pharmaceutical Preparations Change | Pharmaceutical Preparations Dose Adjustment | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist
Item
14. change or dose adjustment in any of the following medications within 8 weeks prior to randomization into the study or anticipated change in dose within 30 days following randomization into the study: ace inhibitors, angiotensin ii receptor blockers.
boolean
C0013227 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C2826232 (UMLS CUI [2,2])
C0003015 (UMLS CUI [3])
C0521942 (UMLS CUI [4])
Pharmaceutical Preparations Change | Pharmaceutical Preparations Dose Adjustment | Antihypertensive Agents | Antidiabetics
Item
15. change or dose adjustment of any other anti-hypertensive, and other anti-diabetic medications within 8 weeks prior to randomization or anticipated change in dose within 30 days following randomization into the study
boolean
C0013227 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C2826232 (UMLS CUI [2,2])
C0003364 (UMLS CUI [3])
C0935929 (UMLS CUI [4])
Substance Use Disorders
Item
16. patient has a current history of drug or alcohol abuse as per the investigator's assessment
boolean
C0038586 (UMLS CUI [1])
Study Subject Participation Status | Bardoxolone methyl
Item
17. patient has participated in another investigational study within 30 days prior to randomization into the study or would concomitantly participate in such a study, or has previously participated in a trial involving bardoxolone methyl.
boolean
C2348568 (UMLS CUI [1])
C1100924 (UMLS CUI [2])
Lacking Able to communicate | Compliance behavior Lacking | Language problems | Development; delayed, mental | Cerebral function Impaired
Item
18. patient is unable to communicate or cooperate with the investigator due to language problems, poor mental development or impaired cerebral function
boolean
C0332268 (UMLS CUI [1,1])
C2364293 (UMLS CUI [1,2])
C1321605 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
C1405458 (UMLS CUI [3])
C1410968 (UMLS CUI [4])
C0234386 (UMLS CUI [5,1])
C0221099 (UMLS CUI [5,2])
Subject Diary Use of Unable | Subject Diary Use of Unwilling
Item
19. patient is unable or unwilling to utilize the daily phone diary to track the date and time they take their study medication
boolean
C3890583 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C3890583 (UMLS CUI [2,1])
C1524063 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Pharmaceutical Preparations Hepatotoxicity | Acetylcysteine | Mucomyst | Acetadote | Fluimucil | Parvolex | Niacin | Nicotinic Acids | Dantrium | Dantrolene | isoniazid | Normodyne | Labetalol | Cylert | Pemoline | Felbatol | felbamate | Zyflo | zileuton | Tasmar | tolcapone | Trovan | trovafloxacin
Item
20. patients on any of the following known hepatotoxic agents: antioxidant n-acetly-cysteine (mucomyst, acetadote, fluimucil, parvolex), niacin (nicotinic acid), dantrium (dantrolene), naizide (isoniazid), normodyne (labetalol), cylert (pemoline), felbatol (felbamate), zyflo (zileuton), tasmar (tolcapone), or trovan (trovafloxacin). patients must have been off the aforementioned medications for a minimum of two weeks prior to randomization
boolean
C0013227 (UMLS CUI [1,1])
C0235378 (UMLS CUI [1,2])
C0001047 (UMLS CUI [2])
C0699252 (UMLS CUI [3])
C1330030 (UMLS CUI [4])
C0699251 (UMLS CUI [5])
C0135546 (UMLS CUI [6])
C0027996 (UMLS CUI [7])
C0028049 (UMLS CUI [8])
C0010975 (UMLS CUI [9])
C0010976 (UMLS CUI [10])
C0022209 (UMLS CUI [11])
C0600256 (UMLS CUI [12])
C0022860 (UMLS CUI [13])
C0719594 (UMLS CUI [14])
C0030800 (UMLS CUI [15])
C0728742 (UMLS CUI [16])
C0060135 (UMLS CUI [17])
C0724508 (UMLS CUI [18])
C0081408 (UMLS CUI [19])
C0595276 (UMLS CUI [20])
C0246330 (UMLS CUI [21])
C0723938 (UMLS CUI [22])
C0379881 (UMLS CUI [23])
Fenofibrate Discontinue Unable | Fenofibrate Discontinue Unwilling | Antara | Fenoglide | Lipofen | Lofibra | Tricor | Triglide | Fenofibrate To be stopped
Item
21. patients who are unable or unwilling to discontinue fenofibrate (antara, fenoglide, lipofen, lofibra, tricor, triglide) during the first three months of study treatment. patients must have been off fenofibrate for a minimum of two weeks prior to randomization
boolean
C0033228 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0033228 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C1617247 (UMLS CUI [3])
C2342283 (UMLS CUI [4])
C1701349 (UMLS CUI [5])
C1170377 (UMLS CUI [6])
C0723893 (UMLS CUI [7])
C1620426 (UMLS CUI [8])
C0033228 (UMLS CUI [9,1])
C1272691 (UMLS CUI [9,2])
Non-Steroidal Anti-Inflammatory Agents Regular Patient need for
Item
22. patients who require more than occasional (once or twice weekly) use of non-steroidal anti-inflammatory agents (nsaids)
boolean
C0003211 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,3])
Neoplastic disease | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin
Item
23. patients with a history of neoplastic disease (except basal or squamous cell carcinoma of the skin) within 5 years prior to the randomization visit;
boolean
C1882062 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
Dialysis | Renal function Unstable
Item
24. patients who have had prior dialysis within three months of randomization and/or have not maintained a stable level of kidney function within three months of randomization per investigator assessment
boolean
C0011946 (UMLS CUI [1])
C0232804 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
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