ID

39157

Description

Pilot Feasibility Study of Combined Kidney and Hematopoietic Stem Cell Transplantation to Cure End-stage Renal Disease; ODM derived from: https://clinicaltrials.gov/show/NCT02176434

Link

https://clinicaltrials.gov/show/NCT02176434

Keywords

Versions (1)
  1. 12/6/19 12/6/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 6, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility End Stage Renal Disease NCT02176434

English

Eligibility End Stage Renal Disease NCT02176434

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients, who are eligible for kidney transplantation
Description

Patients Appropriate Kidney Transplantation

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0022671
males or females 18 - 70 years of age.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
subjects must have an hla-matched sibling donor 25-70 years of age
Description

HLA Match Sibling Donor | Age

Data type

boolean

Alias
UMLS CUI [1,1]
C4330149
UMLS CUI [1,2]
C0037047
UMLS CUI [1,3]
C0040288
UMLS CUI [2]
C0001779
men and women of reproductive potential must agree to use a reliable method of birth control
Description

Females & males of reproductive potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
ability to understand and provide informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of uncontrolled active infection (including replicating hiv, hepatitic b and hepatitis c) as defined by:
Description

Communicable Disease Uncontrolled | HIV Infection replicating | Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0019693
UMLS CUI [2,2]
C0205173
UMLS CUI [3]
C0019163
UMLS CUI [4]
C0019196
1. clinical syndrome consistent with viral or bacterial infection, or
Description

Clinical syndrome Consistent with Virus Disease | Clinical syndrome Consistent with Bacterial Infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0221444
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0042769
UMLS CUI [2,1]
C0221444
UMLS CUI [2,2]
C0332290
UMLS CUI [2,3]
C0004623
2. fever with a clinical site of infection identified, or
Description

Fever | Communicable Disease Clinical

Data type

boolean

Alias
UMLS CUI [1]
C0015967
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205210
3. microbiologically documented infection
Description

Communicable Disease Documented Microbiological

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1301725
UMLS CUI [1,3]
C0025953
contraindication to therapy with any one of the proposed agents (e.g. allergy to atg).
Description

Medical contraindication Investigational New Drugs | Hypersensitivity Anti-Thymocyte Globulin

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0003442
serologic positivity to hiv.
Description

HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0019699
women of childbearing age in whom adequate contraception cannot be maintained, pregnant women or nursing mothers.
Description

Childbearing Potential Contraceptive methods Absent | Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
malignancy within the past two years, for which waiting time for transplantation is required by penn registry consult, thereby excluding non-melanoma skin cancer and carcinoma in situ of the cervix.
Description

Malignant Neoplasms | Requirement Waiting time Transplantation | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0814636
UMLS CUI [2,3]
C0040732
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0699893
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
liver transaminases > 3 x normal value.
Description

Elevated hepatic transaminases

Data type

boolean

Alias
UMLS CUI [1]
C1848701
cardiac ejection fraction < 50% by radionuclide ventriculography or echocardiography.
Description

Cardiac ejection fraction Cardiac ventriculography | Cardiac ejection fraction Echocardiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0232174
UMLS CUI [1,2]
C0596683
UMLS CUI [2,1]
C0232174
UMLS CUI [2,2]
C0013516
forced expiratory volume (fev1) < 50% predicted or corrected diffusing capacity for carbon monoxide (dlco) < 50 % predicted.
Description

Percent predicted FEV1 | Percent Predicted Hemoglobin Corrected Diffusion Capacity of the Lung for Carbon Monoxide

Data type

boolean

Alias
UMLS CUI [1]
C0730561
UMLS CUI [2]
C4054205
blood group incompatibility in the host-vs-graft direction.
Description

Blood Group Incompatibility Host vs Graft Reaction

Data type

boolean

Alias
UMLS CUI [1,1]
C0005806
UMLS CUI [1,2]
C0020033
panel reactive antibody (pra) > 20%
Description

Panel-reactive antibody

Data type

boolean

Alias
UMLS CUI [1]
C1141951
high risk of primary kidney disease recurrence
Description

High risk of Kidney Disease Recurrence

Data type

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C0022658
UMLS CUI [1,3]
C0034897
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Similar models

Eligibility End Stage Renal Disease NCT02176434

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Patients Appropriate Kidney Transplantation
Item
patients, who are eligible for kidney transplantation
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0022671 (UMLS CUI [1,3])
Age
Item
males or females 18 - 70 years of age.
boolean
C0001779 (UMLS CUI [1])
HLA Match Sibling Donor | Age
Item
subjects must have an hla-matched sibling donor 25-70 years of age
boolean
C4330149 (UMLS CUI [1,1])
C0037047 (UMLS CUI [1,2])
C0040288 (UMLS CUI [1,3])
C0001779 (UMLS CUI [2])
Females & males of reproductive potential Contraceptive methods
Item
men and women of reproductive potential must agree to use a reliable method of birth control
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Informed Consent
Item
ability to understand and provide informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Communicable Disease Uncontrolled | HIV Infection replicating | Hepatitis B | Hepatitis C
Item
evidence of uncontrolled active infection (including replicating hiv, hepatitic b and hepatitis c) as defined by:
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0019693 (UMLS CUI [2,1])
C0205173 (UMLS CUI [2,2])
C0019163 (UMLS CUI [3])
C0019196 (UMLS CUI [4])
Clinical syndrome Consistent with Virus Disease | Clinical syndrome Consistent with Bacterial Infection
Item
1. clinical syndrome consistent with viral or bacterial infection, or
boolean
C0221444 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0042769 (UMLS CUI [1,3])
C0221444 (UMLS CUI [2,1])
C0332290 (UMLS CUI [2,2])
C0004623 (UMLS CUI [2,3])
Fever | Communicable Disease Clinical
Item
2. fever with a clinical site of infection identified, or
boolean
C0015967 (UMLS CUI [1])
C0009450 (UMLS CUI [2,1])
C0205210 (UMLS CUI [2,2])
Communicable Disease Documented Microbiological
Item
3. microbiologically documented infection
boolean
C0009450 (UMLS CUI [1,1])
C1301725 (UMLS CUI [1,2])
C0025953 (UMLS CUI [1,3])
Medical contraindication Investigational New Drugs | Hypersensitivity Anti-Thymocyte Globulin
Item
contraindication to therapy with any one of the proposed agents (e.g. allergy to atg).
boolean
C1301624 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0003442 (UMLS CUI [2,2])
HIV Seropositivity
Item
serologic positivity to hiv.
boolean
C0019699 (UMLS CUI [1])
Childbearing Potential Contraceptive methods Absent | Pregnancy | Breast Feeding
Item
women of childbearing age in whom adequate contraception cannot be maintained, pregnant women or nursing mothers.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Malignant Neoplasms | Requirement Waiting time Transplantation | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix
Item
malignancy within the past two years, for which waiting time for transplantation is required by penn registry consult, thereby excluding non-melanoma skin cancer and carcinoma in situ of the cervix.
boolean
C0006826 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C0814636 (UMLS CUI [2,2])
C0040732 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
Elevated hepatic transaminases
Item
liver transaminases > 3 x normal value.
boolean
C1848701 (UMLS CUI [1])
Cardiac ejection fraction Cardiac ventriculography | Cardiac ejection fraction Echocardiography
Item
cardiac ejection fraction < 50% by radionuclide ventriculography or echocardiography.
boolean
C0232174 (UMLS CUI [1,1])
C0596683 (UMLS CUI [1,2])
C0232174 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
Percent predicted FEV1 | Percent Predicted Hemoglobin Corrected Diffusion Capacity of the Lung for Carbon Monoxide
Item
forced expiratory volume (fev1) < 50% predicted or corrected diffusing capacity for carbon monoxide (dlco) < 50 % predicted.
boolean
C0730561 (UMLS CUI [1])
C4054205 (UMLS CUI [2])
Blood Group Incompatibility Host vs Graft Reaction
Item
blood group incompatibility in the host-vs-graft direction.
boolean
C0005806 (UMLS CUI [1,1])
C0020033 (UMLS CUI [1,2])
Panel-reactive antibody
Item
panel reactive antibody (pra) > 20%
boolean
C1141951 (UMLS CUI [1])
High risk of Kidney Disease Recurrence
Item
high risk of primary kidney disease recurrence
boolean
C0332167 (UMLS CUI [1,1])
C0022658 (UMLS CUI [1,2])
C0034897 (UMLS CUI [1,3])
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