ID

14315

Beschrijving

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

Trefwoorden

  1. 10-04-16 10-04-16 -
Geüploaded op

10 april 2016

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0

Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Kidney Diseases NCT00309218

Eligibility Kidney Diseases NCT00309218

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
age < 18.0 years
Beschrijving

Age

Datatype

boolean

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

Bone age

Datatype

boolean

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

Kidney transplantation and transplant function

Datatype

boolean

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

Kidney transplant

Datatype

boolean

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

Cyclosporine, MMF, daily steroids

Datatype

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)
Beschrijving

Informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

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

Rejection

Datatype

boolean

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

Lymphocytotoxic antibodies

Datatype

boolean

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

Steroid-resistant rejection

Datatype

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
Beschrijving

Acute rejection

Datatype

boolean

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

Glomerular filtration rate: Schwartz formula

Datatype

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
Beschrijving

Acute rejection and serum creatinine

Datatype

boolean

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

Compliance

Datatype

boolean

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

Immunosuppression differs from study protocol

Datatype

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
Beschrijving

Growth hormone therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0744483

Similar models

Eligibility Kidney Diseases NCT00309218

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial