ID

37203

Beschrijving

Zibotentan Better Renal Scleroderma Outcome Study; ODM derived from: https://clinicaltrials.gov/show/NCT02047708

Link

https://clinicaltrials.gov/show/NCT02047708

Trefwoorden

Versies (1)
  1. 07-07-19 07-07-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

7 juli 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Scleroderma NCT02047708

Engels

Eligibility Scleroderma NCT02047708

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. adults with scleroderma and:
Beschrijving

Adult | Scleroderma

Datatype

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0011644
2. ckd 2/3 (zebra 1)
Beschrijving

Chronic Kidney Diseases

Datatype

boolean

Alias
UMLS CUI [1]
C1561643
3. renal crisis not on dialysis (zebra 2a)
Beschrijving

Kidney crisis | Dialysis Absent

Datatype

boolean

Alias
UMLS CUI [1]
C1408261
UMLS CUI [2,1]
C0011946
UMLS CUI [2,2]
C0332197
4. renal crisis on dialysis (zebra 2b)
Beschrijving

Kidney crisis | Dialysis

Datatype

boolean

Alias
UMLS CUI [1]
C1408261
UMLS CUI [2]
C0011946
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. previous use of an endothelin receptor antagonist within 3 months of the study start
Beschrijving

Endothelin receptor antagonist

Datatype

boolean

Alias
UMLS CUI [1]
C1134681
2. significant abnormalities in liver function testing (alt, alp, bilirubin) more than three times upper limit of normal)
Beschrijving

Liver Function Tests Abnormality | Alanine aminotransferase increased | Aspartate aminotransferase increased | Elevated total bilirubin

Datatype

boolean

Alias
UMLS CUI [1,1]
C0023901
UMLS CUI [1,2]
C1704258
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0741494
3. patients with body weight <40kg.
Beschrijving

Body Weight

Datatype

boolean

Alias
UMLS CUI [1]
C0005910
4. patients with conditions which prevent compliance with the protocol or failure to adhere to therapy.
Beschrijving

Patient condition Preventing Protocol Compliance | Patient condition Treatment Compliance failed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0683521
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0683521
UMLS CUI [2,2]
C4319828
UMLS CUI [2,3]
C0231175
5. patients with any other life threatening condition.
Beschrijving

Condition Life Threatening

Datatype

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2826244
6. patients with known hypersensitivity to zibotentan or its excipients
Beschrijving

Hypersensitivity Zibotentan | Hypersensitivity Zibotentan Excipient

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2713006
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C2713006
UMLS CUI [2,3]
C0015237
7. previous history of epilepsy or other cns aes, neurologic symptoms or signs consistent with acute or evolving spinal cord compression, and cns metastases
Beschrijving

Epilepsy | Central Nervous System Adverse events | Neurologic Symptoms Consistent with Compression of spinal cord | Neurologic Signs Consistent with Compression of spinal cord | CNS metastases

Datatype

boolean

Alias
UMLS CUI [1]
C0014544
UMLS CUI [2,1]
C3714787
UMLS CUI [2,2]
C0877248
UMLS CUI [3,1]
C0235031
UMLS CUI [3,2]
C0332290
UMLS CUI [3,3]
C0037926
UMLS CUI [4,1]
C0751378
UMLS CUI [4,2]
C0332290
UMLS CUI [4,3]
C0037926
UMLS CUI [5]
C0686377
8. patients with a baseline left ventricular ejection fraction < 40% (prior to any scleroderma renal crisis), patients with acute myocardial infarction within six months or patients who are judged by the trial clinician to be at unacceptable risk from cardiac complications.
Beschrijving

Left ventricular ejection fraction | Status pre- Scleroderma renal crisis | Myocardial Infarction | Patients At risk Cardiac complication

Datatype

boolean

Alias
UMLS CUI [1]
C0428772
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C1262147
UMLS CUI [3]
C0027051
UMLS CUI [4,1]
C0030705
UMLS CUI [4,2]
C1444641
UMLS CUI [4,3]
C0161816
9. history of chronic alcohol or drug abuse or any condition associated with poor compliance as judged by the investigator
Beschrijving

Substance Use Disorders chronic | Condition Associated with Poor compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C0032646
10. patients receiving cyclosporin a within 1 week of screening or expecting to receive this agent during the study.
Beschrijving

Cyclosporine A | Cyclosporine A Expected

Datatype

boolean

Alias
UMLS CUI [1]
C0010592
UMLS CUI [2,1]
C0010592
UMLS CUI [2,2]
C1517001
11. patients who have received an investigational agent in the month prior to screening. these patients may be eligible if after a month of washout period, they are still within 112 months of the onset of the scleroderma renal crisis.
Beschrijving

Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
12. active malignancy or neoplastic disease in the previous 12 months
Beschrijving

Malignant Neoplasms | Neoplastic disease

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C1882062
13. women who rely on oestrogencontaining contraceptives (due to potential drug interaction with zibotentan).
Beschrijving

Gender | Estrogen Contraceptive Agents

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0009907
14. females who are pregnant or breastfeeding.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Scleroderma NCT02047708

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Scleroderma
Item
1. adults with scleroderma and:
boolean
C0001675 (UMLS CUI [1])
C0011644 (UMLS CUI [2])
Chronic Kidney Diseases
Item
2. ckd 2/3 (zebra 1)
boolean
C1561643 (UMLS CUI [1])
Kidney crisis | Dialysis Absent
Item
3. renal crisis not on dialysis (zebra 2a)
boolean
C1408261 (UMLS CUI [1])
C0011946 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Kidney crisis | Dialysis
Item
4. renal crisis on dialysis (zebra 2b)
boolean
C1408261 (UMLS CUI [1])
C0011946 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Endothelin receptor antagonist
Item
1. previous use of an endothelin receptor antagonist within 3 months of the study start
boolean
C1134681 (UMLS CUI [1])
Liver Function Tests Abnormality | Alanine aminotransferase increased | Aspartate aminotransferase increased | Elevated total bilirubin
Item
2. significant abnormalities in liver function testing (alt, alp, bilirubin) more than three times upper limit of normal)
boolean
C0023901 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0741494 (UMLS CUI [4])
Body Weight
Item
3. patients with body weight <40kg.
boolean
C0005910 (UMLS CUI [1])
Patient condition Preventing Protocol Compliance | Patient condition Treatment Compliance failed
Item
4. patients with conditions which prevent compliance with the protocol or failure to adhere to therapy.
boolean
C0683521 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0683521 (UMLS CUI [2,1])
C4319828 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
Condition Life Threatening
Item
5. patients with any other life threatening condition.
boolean
C0348080 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
Hypersensitivity Zibotentan | Hypersensitivity Zibotentan Excipient
Item
6. patients with known hypersensitivity to zibotentan or its excipients
boolean
C0020517 (UMLS CUI [1,1])
C2713006 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C2713006 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
Epilepsy | Central Nervous System Adverse events | Neurologic Symptoms Consistent with Compression of spinal cord | Neurologic Signs Consistent with Compression of spinal cord | CNS metastases
Item
7. previous history of epilepsy or other cns aes, neurologic symptoms or signs consistent with acute or evolving spinal cord compression, and cns metastases
boolean
C0014544 (UMLS CUI [1])
C3714787 (UMLS CUI [2,1])
C0877248 (UMLS CUI [2,2])
C0235031 (UMLS CUI [3,1])
C0332290 (UMLS CUI [3,2])
C0037926 (UMLS CUI [3,3])
C0751378 (UMLS CUI [4,1])
C0332290 (UMLS CUI [4,2])
C0037926 (UMLS CUI [4,3])
C0686377 (UMLS CUI [5])
Left ventricular ejection fraction | Status pre- Scleroderma renal crisis | Myocardial Infarction | Patients At risk Cardiac complication
Item
8. patients with a baseline left ventricular ejection fraction < 40% (prior to any scleroderma renal crisis), patients with acute myocardial infarction within six months or patients who are judged by the trial clinician to be at unacceptable risk from cardiac complications.
boolean
C0428772 (UMLS CUI [1])
C0332152 (UMLS CUI [2,1])
C1262147 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
C0030705 (UMLS CUI [4,1])
C1444641 (UMLS CUI [4,2])
C0161816 (UMLS CUI [4,3])
Substance Use Disorders chronic | Condition Associated with Poor compliance
Item
9. history of chronic alcohol or drug abuse or any condition associated with poor compliance as judged by the investigator
boolean
C0038586 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0348080 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0032646 (UMLS CUI [2,3])
Cyclosporine A | Cyclosporine A Expected
Item
10. patients receiving cyclosporin a within 1 week of screening or expecting to receive this agent during the study.
boolean
C0010592 (UMLS CUI [1])
C0010592 (UMLS CUI [2,1])
C1517001 (UMLS CUI [2,2])
Investigational New Drugs
Item
11. patients who have received an investigational agent in the month prior to screening. these patients may be eligible if after a month of washout period, they are still within 112 months of the onset of the scleroderma renal crisis.
boolean
C0013230 (UMLS CUI [1])
Malignant Neoplasms | Neoplastic disease
Item
12. active malignancy or neoplastic disease in the previous 12 months
boolean
C0006826 (UMLS CUI [1])
C1882062 (UMLS CUI [2])
Gender | Estrogen Contraceptive Agents
Item
13. women who rely on oestrogencontaining contraceptives (due to potential drug interaction with zibotentan).
boolean
C0079399 (UMLS CUI [1])
C0009907 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
14. females who are pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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