ID

21170

Description

Prospective, Randomized, Multicenter, Control Study to Assess the Efficacy and Safety of Tacrolimus in Induction and Maintenance Phase Treatment in Lupus Nephritis; ODM derived from: https://clinicaltrials.gov/show/NCT00615173

Link

https://clinicaltrials.gov/show/NCT00615173

Keywords

Versions (1)
  1. 4/12/17 4/12/17 -
Uploaded on

April 12, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Kidney Diseases NCT00615173

English

Eligibility Kidney Diseases NCT00615173

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. subjects of either sex, 14-65 years of age;
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. diagnosis of sle according to the acr criteria(1997);
Description

Lupus Erythematosus, Systemic

Data type

boolean

Alias
UMLS CUI [1]
C0024141
3. kidney biopsy within the 6 months prior to first randomization with a histologic diagnosis (isn/rps 2003 classification of ln) class iii, iv, v;
Description

Kidney biopsy | Lupus Nephritis Classification

Data type

boolean

Alias
UMLS CUI [1]
C0194073
UMLS CUI [2,1]
C0024143
UMLS CUI [2,2]
C0008902
4. class iv ln: proteinuria >1g/24hr or scr>115umol/l;
Description

Lupus Nephritis Classification | Proteinuria | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1,1]
C0024143
UMLS CUI [1,2]
C0008902
UMLS CUI [2]
C0033687
UMLS CUI [3]
C0201976
5. class iii or v ln: proteinuria >2g/24hr or scr>115umol/l;
Description

Lupus Nephritis Classification | Proteinuria | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1,1]
C0024143
UMLS CUI [1,2]
C0008902
UMLS CUI [2]
C0033687
UMLS CUI [3]
C0201976
6. provision of written informed consent by subject or guardian.
Description

Informed Consent | Informed Consent Guardian

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1274041
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. inability or unwillingness to provide written informed consent ;
Description

Informed Consent Unable | Informed Consent Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0558080
2. known hypersensitivity or contraindication to tacrolimus, cyclophosphamide , azathioprine, corticosteroids;
Description

Hypersensitivity Tacrolimus | Medical contraindication Tacrolimus | Hypersensitivity Cyclophosphamide | Medical contraindication Cyclophosphamide | Azathioprine allergy | Medical contraindication Azathioprine | Corticosteroids allergy | Medical contraindication Adrenal Cortex Hormones

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0085149
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0085149
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0010583
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0010583
UMLS CUI [5]
C0570721
UMLS CUI [6,1]
C1301624
UMLS CUI [6,2]
C0004482
UMLS CUI [7]
C0571586
UMLS CUI [8,1]
C1301624
UMLS CUI [8,2]
C0001617
3. usage of immunosuppression therapy (mmf, ctx, cysa, mtx ect) for more than 1 week within 1 month prior to first randomization;
Description

Therapeutic immunosuppression | mycophenolate mofetil | Cyclophosphamide | Cyclosporine | Methotrexate

Data type

boolean

Alias
UMLS CUI [1]
C0021079
UMLS CUI [2]
C0209368
UMLS CUI [3]
C0010583
UMLS CUI [4]
C0010592
UMLS CUI [5]
C0025677
4. pregnancy, nursing or use of a non-reliable method of contraception;
Description

Pregnancy | Breast Feeding | Contraceptive methods Inadequate

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C0205412
5. continuous dialysis starting more than 2 weeks before randomization into the induction phase and/or continuous dialysis with an anticipated duration of more than 8 weeks;
Description

Dialysis Continuous

Data type

boolean

Alias
UMLS CUI [1,1]
C0011946
UMLS CUI [1,2]
C0549178
6. previous kidney transplant or planted transplant;
Description

Kidney Transplant | Kidney Transplant Planned

Data type

boolean

Alias
UMLS CUI [1]
C0022671
UMLS CUI [2,1]
C0022671
UMLS CUI [2,2]
C1301732
7. scr > 4mg/dl (353umol/l);
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
8. active hepatitis, with liver dysfunction;
Description

Hepatitis | Liver Dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C0019158
UMLS CUI [2]
C0086565
9. diagnosed dm;
Description

Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0011849
10. participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening .
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
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Similar models

Eligibility Kidney Diseases NCT00615173

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. subjects of either sex, 14-65 years of age;
boolean
C0001779 (UMLS CUI [1])
Lupus Erythematosus, Systemic
Item
2. diagnosis of sle according to the acr criteria(1997);
boolean
C0024141 (UMLS CUI [1])
Kidney biopsy | Lupus Nephritis Classification
Item
3. kidney biopsy within the 6 months prior to first randomization with a histologic diagnosis (isn/rps 2003 classification of ln) class iii, iv, v;
boolean
C0194073 (UMLS CUI [1])
C0024143 (UMLS CUI [2,1])
C0008902 (UMLS CUI [2,2])
Lupus Nephritis Classification | Proteinuria | Creatinine measurement, serum
Item
4. class iv ln: proteinuria >1g/24hr or scr>115umol/l;
boolean
C0024143 (UMLS CUI [1,1])
C0008902 (UMLS CUI [1,2])
C0033687 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
Lupus Nephritis Classification | Proteinuria | Creatinine measurement, serum
Item
5. class iii or v ln: proteinuria >2g/24hr or scr>115umol/l;
boolean
C0024143 (UMLS CUI [1,1])
C0008902 (UMLS CUI [1,2])
C0033687 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
Informed Consent | Informed Consent Guardian
Item
6. provision of written informed consent by subject or guardian.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Informed Consent Unable | Informed Consent Unwilling
Item
1. inability or unwillingness to provide written informed consent ;
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Hypersensitivity Tacrolimus | Medical contraindication Tacrolimus | Hypersensitivity Cyclophosphamide | Medical contraindication Cyclophosphamide | Azathioprine allergy | Medical contraindication Azathioprine | Corticosteroids allergy | Medical contraindication Adrenal Cortex Hormones
Item
2. known hypersensitivity or contraindication to tacrolimus, cyclophosphamide , azathioprine, corticosteroids;
boolean
C0020517 (UMLS CUI [1,1])
C0085149 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0085149 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0010583 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C0010583 (UMLS CUI [4,2])
C0570721 (UMLS CUI [5])
C1301624 (UMLS CUI [6,1])
C0004482 (UMLS CUI [6,2])
C0571586 (UMLS CUI [7])
C1301624 (UMLS CUI [8,1])
C0001617 (UMLS CUI [8,2])
Therapeutic immunosuppression | mycophenolate mofetil | Cyclophosphamide | Cyclosporine | Methotrexate
Item
3. usage of immunosuppression therapy (mmf, ctx, cysa, mtx ect) for more than 1 week within 1 month prior to first randomization;
boolean
C0021079 (UMLS CUI [1])
C0209368 (UMLS CUI [2])
C0010583 (UMLS CUI [3])
C0010592 (UMLS CUI [4])
C0025677 (UMLS CUI [5])
Pregnancy | Breast Feeding | Contraceptive methods Inadequate
Item
4. pregnancy, nursing or use of a non-reliable method of contraception;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C0205412 (UMLS CUI [3,2])
Dialysis Continuous
Item
5. continuous dialysis starting more than 2 weeks before randomization into the induction phase and/or continuous dialysis with an anticipated duration of more than 8 weeks;
boolean
C0011946 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Kidney Transplant | Kidney Transplant Planned
Item
6. previous kidney transplant or planted transplant;
boolean
C0022671 (UMLS CUI [1])
C0022671 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Creatinine measurement, serum
Item
7. scr > 4mg/dl (353umol/l);
boolean
C0201976 (UMLS CUI [1])
Hepatitis | Liver Dysfunction
Item
8. active hepatitis, with liver dysfunction;
boolean
C0019158 (UMLS CUI [1])
C0086565 (UMLS CUI [2])
Diabetes Mellitus
Item
9. diagnosed dm;
boolean
C0011849 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs
Item
10. participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening .
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
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