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Information:
Fel:
ID
21170
Beskrivning
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
Länk
https://clinicaltrials.gov/show/NCT00615173
Nyckelord
Versioner (1)
- 2017-04-12 2017-04-12 -
Uppladdad den
12 april 2017
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Kidney Diseases NCT00615173
Eligibility Kidney Diseases NCT00615173
- StudyEvent: Eligibility
Similar models
Eligibility Kidney Diseases NCT00615173
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
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])
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])
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])
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])
C0021430 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
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])
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])
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])
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])
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])
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])
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])
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])
C0013230 (UMLS CUI [2])