ID

39171

Descrição

Renal Allograft Tolerance Through Mixed Chimerism; ODM derived from: https://clinicaltrials.gov/show/NCT01780454

Link

https://clinicaltrials.gov/show/NCT01780454

Palavras-chave

Versões (1)
  1. 07/12/2019 07/12/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

7 de dezembro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility End Stage Renal Disease NCT01780454

Inglês

Eligibility End Stage Renal Disease NCT01780454

1 Formulários  
Criteria
Descrição

Criteria

male or female 18-60 years of age
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
candidate for a living-donor renal allograft with a one haplotype identical donor identified.
Descrição

Patient Appropriate Live donor renal transplant | Haplotype Identical Donor Identified

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0401177
UMLS CUI [2,1]
C0018591
UMLS CUI [2,2]
C0205280
UMLS CUI [2,3]
C0040288
UMLS CUI [2,4]
C0205396
first or second transplant with either a living donor or cadaveric transplant as the first transplant.
Descrição

Live donor renal transplant First | Live donor renal transplant second | Cadaveric renal transplant First

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0401177
UMLS CUI [1,2]
C0205435
UMLS CUI [2,1]
C0401177
UMLS CUI [2,2]
C0205436
UMLS CUI [3,1]
C0401176
UMLS CUI [3,2]
C0205435
positive serologic testing for ebv indicating past exposure.
Descrição

Epstein-Barr Virus Serologic test Positive

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0014644
UMLS CUI [1,2]
C0036743
UMLS CUI [1,3]
C1514241
key exclusion criteria:
Descrição

Exclusion Criteria Main

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
abo blood group-incompatible renal allograft.
Descrição

ABO blood group Inconsistent Live donor renal transplant

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0200499
UMLS CUI [1,2]
C0442809
UMLS CUI [1,3]
C0401177
evidence of anti-hla antibody within 60 days prior to transplant as assessed by routine methodology (ahg and/or elisa)
Descrição

HLA antibody identification | Antihuman globulin | ELISA

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3508207
UMLS CUI [2]
C1441481
UMLS CUI [3]
C0014441
positive testing for: hiv, hepatitis b core antigen, or hepatitis c virus or positivity for hepatitis b surface antigen.
Descrição

HIV Seropositivity | Hepatitis B core antigen positive | Hepatitis C virus test positive | Hepatitis B surface antigen positive

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0262507
UMLS CUI [3]
C2748185
UMLS CUI [4]
C0149709
cardiac ejection fraction < 40% or clinical evidence of insufficiency.
Descrição

Cardiac ejection fraction | Cardiac insufficiency

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232174
UMLS CUI [2]
C0018801
history of cancer other than basal cell carcinoma of the skin or carcinoma in situ of the cervix.
Descrição

Malignant Neoplasms | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
underlying renal disease etiology with a high risk of disease recurrence in the transplanted kidney (such as focal segmental glomerulosclerosis, type i or ii nonproliferative glomerulonephritis).
Descrição

Kidney Disease | High risk of Disease recurrence Transplanted kidney | Primary Focal Segmental Glomerulosclerosis | Glomerulonephritis Type

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2,1]
C0332167
UMLS CUI [2,2]
C0679254
UMLS CUI [2,3]
C1261317
UMLS CUI [3]
C1709661
UMLS CUI [4,1]
C0017658
UMLS CUI [4,2]
C0332307
prior dose-limiting radiation therapy.
Descrição

Prior radiation therapy Dose Limiting

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0439801
abnormal (>2 times lab normal) values for (a) liver function chemistries (alt, ast, ap), (b) bilirubin, (c) coagulation studies (pt, ptt).
Descrição

Liver function tests abnormal | Alanine aminotransferase (ALT) level abnormal | AST/SGOT level abnormal | Alkaline phosphatase abnormal | Bilirubin abnormal | Coagulation test abnormal | Prothrombin time abnormal | Abnormal partial thromboplastin time (PTT)

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0151766
UMLS CUI [2]
C0580469
UMLS CUI [3]
C0580475
UMLS CUI [4]
C0740888
UMLS CUI [5]
C1142335
UMLS CUI [6]
C1504379
UMLS CUI [7]
C0580412
UMLS CUI [8]
C4062448
the presence of any medical condition that the investigator deems incompatible with participation in the trial.
Descrição

Medical condition Study Subject Participation Status Inconsistent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0442809
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Similar models

Eligibility End Stage Renal Disease NCT01780454

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Age
Item
male or female 18-60 years of age
boolean
C0001779 (UMLS CUI [1])
Patient Appropriate Live donor renal transplant | Haplotype Identical Donor Identified
Item
candidate for a living-donor renal allograft with a one haplotype identical donor identified.
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0401177 (UMLS CUI [1,3])
C0018591 (UMLS CUI [2,1])
C0205280 (UMLS CUI [2,2])
C0040288 (UMLS CUI [2,3])
C0205396 (UMLS CUI [2,4])
Live donor renal transplant First | Live donor renal transplant second | Cadaveric renal transplant First
Item
first or second transplant with either a living donor or cadaveric transplant as the first transplant.
boolean
C0401177 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C0401177 (UMLS CUI [2,1])
C0205436 (UMLS CUI [2,2])
C0401176 (UMLS CUI [3,1])
C0205435 (UMLS CUI [3,2])
Epstein-Barr Virus Serologic test Positive
Item
positive serologic testing for ebv indicating past exposure.
boolean
C0014644 (UMLS CUI [1,1])
C0036743 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
ABO blood group Inconsistent Live donor renal transplant
Item
abo blood group-incompatible renal allograft.
boolean
C0200499 (UMLS CUI [1,1])
C0442809 (UMLS CUI [1,2])
C0401177 (UMLS CUI [1,3])
HLA antibody identification | Antihuman globulin | ELISA
Item
evidence of anti-hla antibody within 60 days prior to transplant as assessed by routine methodology (ahg and/or elisa)
boolean
C3508207 (UMLS CUI [1])
C1441481 (UMLS CUI [2])
C0014441 (UMLS CUI [3])
HIV Seropositivity | Hepatitis B core antigen positive | Hepatitis C virus test positive | Hepatitis B surface antigen positive
Item
positive testing for: hiv, hepatitis b core antigen, or hepatitis c virus or positivity for hepatitis b surface antigen.
boolean
C0019699 (UMLS CUI [1])
C0262507 (UMLS CUI [2])
C2748185 (UMLS CUI [3])
C0149709 (UMLS CUI [4])
Cardiac ejection fraction | Cardiac insufficiency
Item
cardiac ejection fraction < 40% or clinical evidence of insufficiency.
boolean
C0232174 (UMLS CUI [1])
C0018801 (UMLS CUI [2])
Malignant Neoplasms | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix
Item
history of cancer other than basal cell carcinoma of the skin or carcinoma in situ of the cervix.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
Kidney Disease | High risk of Disease recurrence Transplanted kidney | Primary Focal Segmental Glomerulosclerosis | Glomerulonephritis Type
Item
underlying renal disease etiology with a high risk of disease recurrence in the transplanted kidney (such as focal segmental glomerulosclerosis, type i or ii nonproliferative glomerulonephritis).
boolean
C0022658 (UMLS CUI [1])
C0332167 (UMLS CUI [2,1])
C0679254 (UMLS CUI [2,2])
C1261317 (UMLS CUI [2,3])
C1709661 (UMLS CUI [3])
C0017658 (UMLS CUI [4,1])
C0332307 (UMLS CUI [4,2])
Prior radiation therapy Dose Limiting
Item
prior dose-limiting radiation therapy.
boolean
C0279134 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
Liver function tests abnormal | Alanine aminotransferase (ALT) level abnormal | AST/SGOT level abnormal | Alkaline phosphatase abnormal | Bilirubin abnormal | Coagulation test abnormal | Prothrombin time abnormal | Abnormal partial thromboplastin time (PTT)
Item
abnormal (>2 times lab normal) values for (a) liver function chemistries (alt, ast, ap), (b) bilirubin, (c) coagulation studies (pt, ptt).
boolean
C0151766 (UMLS CUI [1])
C0580469 (UMLS CUI [2])
C0580475 (UMLS CUI [3])
C0740888 (UMLS CUI [4])
C1142335 (UMLS CUI [5])
C1504379 (UMLS CUI [6])
C0580412 (UMLS CUI [7])
C4062448 (UMLS CUI [8])
Medical condition Study Subject Participation Status Inconsistent
Item
the presence of any medical condition that the investigator deems incompatible with participation in the trial.
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0442809 (UMLS CUI [1,3])
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