ID

29431

Beschrijving

Impact of Conversion From Tacrolimus to Sirolimus in African American Renal Transplant Recipients; ODM derived from: https://clinicaltrials.gov/show/NCT00999258

Link

https://clinicaltrials.gov/show/NCT00999258

Trefwoorden

Versies (1)
  1. 23-03-18 23-03-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

23 maart 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Glomerular Filtration Rate NCT00999258

Engels

Eligibility Glomerular Filtration Rate NCT00999258

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
african american (self-identified) renal transplant recipients.
Beschrijving

African American | Kidney Transplant Recipient

Datatype

boolean

Alias
UMLS CUI [1]
C0085756
UMLS CUI [2,1]
C0022671
UMLS CUI [2,2]
C1709854
primary or re-transplant kidney-only recipients.
Beschrijving

Kidney Transplant Primary Recipient | Renal retransplantation Recipient

Datatype

boolean

Alias
UMLS CUI [1,1]
C0022671
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C1709854
UMLS CUI [2,1]
C4087495
UMLS CUI [2,2]
C1709854
recipients on tacrolimus-based immunosuppression regimen.
Beschrijving

Recipient Therapeutic immunosuppression | Tacrolimus

Datatype

boolean

Alias
UMLS CUI [1,1]
C1709854
UMLS CUI [1,2]
C0021079
UMLS CUI [2]
C0085149
time interval after transplant: at least 3 months but not greater than 5 years.
Beschrijving

Time Interval Post Transplantation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0872291
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0040732
renal transplant recipients with 10% decrease in gfr from baseline.
Beschrijving

Kidney Transplant Recipient | Decreased glomerular filtration rate Percentage

Datatype

boolean

Alias
UMLS CUI [1,1]
C0022671
UMLS CUI [1,2]
C1709854
UMLS CUI [2,1]
C0853068
UMLS CUI [2,2]
C0439165
women of childbearing potential must have a negative pregnancy test upon enrollment, and must consent to receive contraceptive counseling and to use effective contraception while enrolled in the study. two reliable forms of contraception must be used simultaneously unless abstinence is the chosen method.
Beschrijving

Childbearing Potential Pregnancy test negative | Childbearing Potential Contraception counseling | Childbearing Potential Contraceptive methods | Contraceptive methods Quantity | Exception Sexual Abstinence

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C1443484
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C1265611
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0036899
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
gfr <40ml/min.
Beschrijving

Glomerular Filtration Rate

Datatype

boolean

Alias
UMLS CUI [1]
C0017654
urine protein-to-creatinine ratio >0.5.
Beschrijving

Urine protein/creatinine ratio measurement

Datatype

boolean

Alias
UMLS CUI [1]
C1096054
significant chronic allograft nephropathy grade 3 banff score.
Beschrijving

Chronic rejection of renal transplant Grade Other Coding

Datatype

boolean

Alias
UMLS CUI [1,1]
C0403592
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C3846158
evidence of acute rejection episodes within the past 3 months.
Beschrijving

Graft rejection episode

Datatype

boolean

Alias
UMLS CUI [1]
C0877542
evidence of active infection within the past month.
Beschrijving

Communicable Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
any malignancy except treated non-melanoma skin cancer within the past 3 years.
Beschrijving

Malignant Neoplasms | Exception Skin carcinoma Treated

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [2,3]
C1522326
leucopenia <2,000/mm3 within the past month.
Beschrijving

Leukopenia

Datatype

boolean

Alias
UMLS CUI [1]
C0023530
thrombocytopenia <100,000/mm3 within the past month.
Beschrijving

Thrombocytopenia

Datatype

boolean

Alias
UMLS CUI [1]
C0040034
total cholesterol >300mg/dl, despite adequate treatment.
Beschrijving

Serum total cholesterol measurement | Therapeutic procedure Adequate

Datatype

boolean

Alias
UMLS CUI [1]
C1445957
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0205411
triglycerides >500mg/dl, despite adequate treatment.
Beschrijving

Triglycerides measurement | Therapeutic procedure Adequate

Datatype

boolean

Alias
UMLS CUI [1]
C0202236
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0205411
non-healed post-surgical or non-surgical wound.
Beschrijving

Non-healed wound Postoperative | Wound Free of Operative Surgical Procedures

Datatype

boolean

Alias
UMLS CUI [1,1]
C0750433
UMLS CUI [1,2]
C0032790
UMLS CUI [2,1]
C0043250
UMLS CUI [2,2]
C0332296
UMLS CUI [2,3]
C0543467
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Eligibility Glomerular Filtration Rate NCT00999258

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
African American | Kidney Transplant Recipient
Item
african american (self-identified) renal transplant recipients.
boolean
C0085756 (UMLS CUI [1])
C0022671 (UMLS CUI [2,1])
C1709854 (UMLS CUI [2,2])
Kidney Transplant Primary Recipient | Renal retransplantation Recipient
Item
primary or re-transplant kidney-only recipients.
boolean
C0022671 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C1709854 (UMLS CUI [1,3])
C4087495 (UMLS CUI [2,1])
C1709854 (UMLS CUI [2,2])
Recipient Therapeutic immunosuppression | Tacrolimus
Item
recipients on tacrolimus-based immunosuppression regimen.
boolean
C1709854 (UMLS CUI [1,1])
C0021079 (UMLS CUI [1,2])
C0085149 (UMLS CUI [2])
Time Interval Post Transplantation
Item
time interval after transplant: at least 3 months but not greater than 5 years.
boolean
C0872291 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0040732 (UMLS CUI [1,3])
Kidney Transplant Recipient | Decreased glomerular filtration rate Percentage
Item
renal transplant recipients with 10% decrease in gfr from baseline.
boolean
C0022671 (UMLS CUI [1,1])
C1709854 (UMLS CUI [1,2])
C0853068 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
Childbearing Potential Pregnancy test negative | Childbearing Potential Contraception counseling | Childbearing Potential Contraceptive methods | Contraceptive methods Quantity | Exception Sexual Abstinence
Item
women of childbearing potential must have a negative pregnancy test upon enrollment, and must consent to receive contraceptive counseling and to use effective contraception while enrolled in the study. two reliable forms of contraception must be used simultaneously unless abstinence is the chosen method.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C1443484 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0700589 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0036899 (UMLS CUI [5,2])
Item Group
C0680251 (UMLS CUI)
Glomerular Filtration Rate
Item
gfr <40ml/min.
boolean
C0017654 (UMLS CUI [1])
Urine protein/creatinine ratio measurement
Item
urine protein-to-creatinine ratio >0.5.
boolean
C1096054 (UMLS CUI [1])
Chronic rejection of renal transplant Grade Other Coding
Item
significant chronic allograft nephropathy grade 3 banff score.
boolean
C0403592 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C3846158 (UMLS CUI [1,3])
Graft rejection episode
Item
evidence of acute rejection episodes within the past 3 months.
boolean
C0877542 (UMLS CUI [1])
Communicable Disease
Item
evidence of active infection within the past month.
boolean
C0009450 (UMLS CUI [1])
Malignant Neoplasms | Exception Skin carcinoma Treated
Item
any malignancy except treated non-melanoma skin cancer within the past 3 years.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
Leukopenia
Item
leucopenia <2,000/mm3 within the past month.
boolean
C0023530 (UMLS CUI [1])
Thrombocytopenia
Item
thrombocytopenia <100,000/mm3 within the past month.
boolean
C0040034 (UMLS CUI [1])
Serum total cholesterol measurement | Therapeutic procedure Adequate
Item
total cholesterol >300mg/dl, despite adequate treatment.
boolean
C1445957 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0205411 (UMLS CUI [2,2])
Triglycerides measurement | Therapeutic procedure Adequate
Item
triglycerides >500mg/dl, despite adequate treatment.
boolean
C0202236 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0205411 (UMLS CUI [2,2])
Non-healed wound Postoperative | Wound Free of Operative Surgical Procedures
Item
non-healed post-surgical or non-surgical wound.
boolean
C0750433 (UMLS CUI [1,1])
C0032790 (UMLS CUI [1,2])
C0043250 (UMLS CUI [2,1])
C0332296 (UMLS CUI [2,2])
C0543467 (UMLS CUI [2,3])
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