ID

14315

Description

Steroid Withdrawal in Pediatric Renal Transplant Recipients Under Cyclosporine (CyA) and Mycophenolate Mofetil (MMF); ODM derived from: https://clinicaltrials.gov/show/NCT00309218

Link

https://clinicaltrials.gov/show/NCT00309218

Keywords

  1. 4/10/16 4/10/16 -
Uploaded on

April 10, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Kidney Diseases NCT00309218

Eligibility Kidney Diseases NCT00309218

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age < 18.0 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
bone age of boys < 15 years, of girls < 13 years
Description

Bone age

Data type

boolean

Alias
UMLS CUI [1]
C0429620
patients 12-24 months after renal transplantation with stable transplant function
Description

Kidney transplantation and transplant function

Data type

boolean

Alias
UMLS CUI [1]
C0022671
UMLS CUI [2]
C2170323
first or second kidney transplant, living or cadaver kidney donation
Description

Kidney transplant

Data type

boolean

Alias
UMLS CUI [1]
C0022671
triple immunosuppression with cyclosporine (cya), mmf, and daily steroids at study entry
Description

Cyclosporine, MMF, daily steroids

Data type

boolean

Alias
UMLS CUI [1]
C0010592
UMLS CUI [2]
C0627079
UMLS CUI [3]
C0038317
patients and parents, respectively, have given their written consent after enlightenment (informed consent)
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
irreversible rejection of former transplant within 6 months
Description

Rejection

Data type

boolean

Alias
UMLS CUI [1]
C0018129
highly reactive (> 80%) lymphocytotoxic antibodies within 12 months prior to transplantation
Description

Lymphocytotoxic antibodies

Data type

boolean

Alias
UMLS CUI [1]
C0024284
anamnestically steroid-resistant rejection of current transplant
Description

Steroid-resistant rejection

Data type

boolean

Alias
UMLS CUI [1]
C0018129
UMLS CUI [2,1]
C0038317
UMLS CUI [2,2]
C0332325
more than 2 acute rejection reactions prior to study entry (i.e., in the first 12-24 months after kidney transplantation) or 1 acute rejection reaction during the last 6 months before study entry
Description

Acute rejection

Data type

boolean

Alias
UMLS CUI [1]
C0403588
glomerular filtration rate (gfr) < 40 ml/min/1.73 m² (schwartz formula) at study entry
Description

Glomerular filtration rate: Schwartz formula

Data type

boolean

Alias
UMLS CUI [1]
C1980037
acute rejection reaction or unstable transplant function (increase of serum creatinine > 20%) during the last 6 months before study entry or histologically confirmed chronic rejection reaction
Description

Acute rejection and serum creatinine

Data type

boolean

Alias
UMLS CUI [1]
C0403588
UMLS CUI [2]
C0201976
suspected insufficient medication compliance
Description

Compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
patients receiving a basic immunosuppression other than that prescribed in this protocol
Description

Immunosuppression differs from study protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C0021079
UMLS CUI [1,2]
C0443127
UMLS CUI [1,3]
C2348563
simultaneous therapy with growth hormone after renal transplantation
Description

Growth hormone therapy

Data type

boolean

Alias
UMLS CUI [1]
C0744483

Similar models

Eligibility Kidney Diseases NCT00309218

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age < 18.0 years
boolean
C0001779 (UMLS CUI [1])
Bone age
Item
bone age of boys < 15 years, of girls < 13 years
boolean
C0429620 (UMLS CUI [1])
Kidney transplantation and transplant function
Item
patients 12-24 months after renal transplantation with stable transplant function
boolean
C0022671 (UMLS CUI [1])
C2170323 (UMLS CUI [2])
Kidney transplant
Item
first or second kidney transplant, living or cadaver kidney donation
boolean
C0022671 (UMLS CUI [1])
Cyclosporine, MMF, daily steroids
Item
triple immunosuppression with cyclosporine (cya), mmf, and daily steroids at study entry
boolean
C0010592 (UMLS CUI [1])
C0627079 (UMLS CUI [2])
C0038317 (UMLS CUI [3])
Informed consent
Item
patients and parents, respectively, have given their written consent after enlightenment (informed consent)
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Rejection
Item
irreversible rejection of former transplant within 6 months
boolean
C0018129 (UMLS CUI [1])
Lymphocytotoxic antibodies
Item
highly reactive (> 80%) lymphocytotoxic antibodies within 12 months prior to transplantation
boolean
C0024284 (UMLS CUI [1])
Steroid-resistant rejection
Item
anamnestically steroid-resistant rejection of current transplant
boolean
C0018129 (UMLS CUI [1])
C0038317 (UMLS CUI [2,1])
C0332325 (UMLS CUI [2,2])
Acute rejection
Item
more than 2 acute rejection reactions prior to study entry (i.e., in the first 12-24 months after kidney transplantation) or 1 acute rejection reaction during the last 6 months before study entry
boolean
C0403588 (UMLS CUI [1])
Glomerular filtration rate: Schwartz formula
Item
glomerular filtration rate (gfr) < 40 ml/min/1.73 m² (schwartz formula) at study entry
boolean
C1980037 (UMLS CUI [1])
Acute rejection and serum creatinine
Item
acute rejection reaction or unstable transplant function (increase of serum creatinine > 20%) during the last 6 months before study entry or histologically confirmed chronic rejection reaction
boolean
C0403588 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Compliance
Item
suspected insufficient medication compliance
boolean
C1321605 (UMLS CUI [1])
Immunosuppression differs from study protocol
Item
patients receiving a basic immunosuppression other than that prescribed in this protocol
boolean
C0021079 (UMLS CUI [1,1])
C0443127 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Growth hormone therapy
Item
simultaneous therapy with growth hormone after renal transplantation
boolean
C0744483 (UMLS CUI [1])

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