ID

30114

Description

Reduction or Discontinuation of CNI's With Conversion to Everolimus-Based Immunosuppresion; ODM derived from: https://clinicaltrials.gov/show/NCT00443508

Link

https://clinicaltrials.gov/show/NCT00443508

Keywords

Versions (1)
  1. 5/12/18 5/12/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 12, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Kidney Diseases NCT00443508

English

Eligibility Kidney Diseases NCT00443508

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients on cni fk < 5 ng/m"l with mpa / imuran with or without steroids
Description

Calcineurin inhibitor | Tacrolimus | Mycophenolic Acid | Imuran | Steroids

Data type

boolean

Alias
UMLS CUI [1]
C1562036
UMLS CUI [2]
C0085149
UMLS CUI [3]
C0026933
UMLS CUI [4]
C0699279
UMLS CUI [5]
C0038317
renal impairment gfr between 30 - 70 m"l/minute/
Description

Renal Insufficiency | Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0017654
patient who signed informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
patient with no contraindication to renal biopsy
Description

Medical contraindication Absent Kidney biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0194073
women who are not pregnant and will use contraception
Description

Gender Pregnancy Absent | Gender Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0032961
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
proteinuria > 100 m"g/mmol creatinine
Description

Proteinuria | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0033687
UMLS CUI [2]
C0201976
acute rejection during 3 months before screening
Description

Graft Rejection

Data type

boolean

Alias
UMLS CUI [1]
C0018129
wbc < 2500, plt < 50,000,
Description

White Blood Cell Count procedure | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0032181
nephropathy due to polyoma virus
Description

Kidney Disease Due to Polyomavirus

Data type

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0032556
patients on other investigational drugs
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
patients on rapamycin
Description

Sirolimus

Data type

boolean

Alias
UMLS CUI [1]
C0072980
patients with hiv or other systemic infection
Description

HIV Infections | Sepsis

Data type

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0243026
inability to comply with protocol requirements
Description

Protocol Compliance Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
active or history of malignancy
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
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Similar models

Eligibility Kidney Diseases NCT00443508

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Calcineurin inhibitor | Tacrolimus | Mycophenolic Acid | Imuran | Steroids
Item
patients on cni fk < 5 ng/m"l with mpa / imuran with or without steroids
boolean
C1562036 (UMLS CUI [1])
C0085149 (UMLS CUI [2])
C0026933 (UMLS CUI [3])
C0699279 (UMLS CUI [4])
C0038317 (UMLS CUI [5])
Renal Insufficiency | Glomerular Filtration Rate
Item
renal impairment gfr between 30 - 70 m"l/minute/
boolean
C1565489 (UMLS CUI [1])
C0017654 (UMLS CUI [2])
Informed Consent
Item
patient who signed informed consent
boolean
C0021430 (UMLS CUI [1])
Medical contraindication Absent Kidney biopsy
Item
patient with no contraindication to renal biopsy
boolean
C1301624 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0194073 (UMLS CUI [1,3])
Gender Pregnancy Absent | Gender Contraceptive methods
Item
women who are not pregnant and will use contraception
boolean
C0079399 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Proteinuria | Creatinine measurement, serum
Item
proteinuria > 100 m"g/mmol creatinine
boolean
C0033687 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Graft Rejection
Item
acute rejection during 3 months before screening
boolean
C0018129 (UMLS CUI [1])
White Blood Cell Count procedure | Platelet Count measurement
Item
wbc < 2500, plt < 50,000,
boolean
C0023508 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Kidney Disease Due to Polyomavirus
Item
nephropathy due to polyoma virus
boolean
C0022658 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0032556 (UMLS CUI [1,3])
Investigational New Drugs
Item
patients on other investigational drugs
boolean
C0013230 (UMLS CUI [1])
Sirolimus
Item
patients on rapamycin
boolean
C0072980 (UMLS CUI [1])
HIV Infections | Sepsis
Item
patients with hiv or other systemic infection
boolean
C0019693 (UMLS CUI [1])
C0243026 (UMLS CUI [2])
Protocol Compliance Unable
Item
inability to comply with protocol requirements
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Malignant Neoplasms
Item
active or history of malignancy
boolean
C0006826 (UMLS CUI [1])
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