ID

21215

Beschreibung

Prospective, Multicenter Study of the Efficacy and Tolerance of Tacrolimus on Refractory Nephrotic Syndrome (RNS); ODM derived from: https://clinicaltrials.gov/show/NCT00615667

Link

https://clinicaltrials.gov/show/NCT00615667

Stichworte

Versionen (2)
  1. 12.04.17 12.04.17 -
  2. 13.04.17 13.04.17 -
Hochgeladen am

13. April 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Kidney Diseases NCT00615667

Englisch

Eligibility Kidney Diseases NCT00615667

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. diagnosis of nephrotic syndrome with hypoalbuminemia (<3.0g/dl) and heavy proteinuria (> 3.5g/24hr);
Beschreibung

Nephrotic Syndrome | Hypoalbuminemia | Heavy proteinuria

Datentyp

boolean

Alias
UMLS CUI [1]
C0027726
UMLS CUI [2]
C0239981
UMLS CUI [3]
C4022830
3. provision of written informed consent by subject or guardian;
Beschreibung

Informed Consent | Informed Consent Guardian

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1274041
4. refractory nephrotic syndrome:
Beschreibung

Nephrotic Syndrome refractory

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027726
UMLS CUI [1,2]
C0205269
steroid resistant: persistence of proteinuria despite prednisone therapy 1mg/kg/d for 16 weeks; steroid dependent: ns recurs when steroid dosage decease.twice within 6 months, and 3 times within 1 year.
Beschreibung

Steroid-resistant nephrotic syndrome | Persistent proteinuria | Prednisone mg/kg/day | Steroid-dependent nephrotic syndrome | Nephrotic Syndrome Recurrent Frequency | Steroid Dosage Decreased

Datentyp

boolean

Alias
UMLS CUI [1]
C0403397
UMLS CUI [2]
C0477762
UMLS CUI [3,1]
C0032952
UMLS CUI [3,2]
C3665414
UMLS CUI [4]
C0403398
UMLS CUI [5,1]
C0027726
UMLS CUI [5,2]
C2945760
UMLS CUI [5,3]
C0439603
UMLS CUI [6,1]
C0038317
UMLS CUI [6,2]
C0178602
UMLS CUI [6,3]
C0205216
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

Informed Consent Unable | Informed Consent Unwilling

Datentyp

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;
Beschreibung

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

Datentyp

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;
Beschreibung

Therapeutic immunosuppression | mycophenolate mofetil | Cyclophosphamide | Cyclosporine | Methotrexate

Datentyp

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;
Beschreibung

Pregnancy | Breast Feeding | Contraceptive methods Inadequate

Datentyp

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;
Beschreibung

Dialysis Continuous

Datentyp

boolean

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

Kidney Transplant | Kidney Transplant Planned

Datentyp

boolean

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

Creatinine measurement, serum

Datentyp

boolean

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

Hepatitis | Liver Dysfunction

Datentyp

boolean

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

Diabetes Mellitus

Datentyp

boolean

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

Study Subject Participation Status | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
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Ähnliche Modelle

Eligibility Kidney Diseases NCT00615667

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. subjects of either sex, 14-65 years of age;
boolean
C0001779 (UMLS CUI [1])
Nephrotic Syndrome | Hypoalbuminemia | Heavy proteinuria
Item
2. diagnosis of nephrotic syndrome with hypoalbuminemia (<3.0g/dl) and heavy proteinuria (> 3.5g/24hr);
boolean
C0027726 (UMLS CUI [1])
C0239981 (UMLS CUI [2])
C4022830 (UMLS CUI [3])
Informed Consent | Informed Consent Guardian
Item
3. provision of written informed consent by subject or guardian;
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
Nephrotic Syndrome refractory
Item
4. refractory nephrotic syndrome:
boolean
C0027726 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
Steroid-resistant nephrotic syndrome | Persistent proteinuria | Prednisone mg/kg/day | Steroid-dependent nephrotic syndrome | Nephrotic Syndrome Recurrent Frequency | Steroid Dosage Decreased
Item
steroid resistant: persistence of proteinuria despite prednisone therapy 1mg/kg/d for 16 weeks; steroid dependent: ns recurs when steroid dosage decease.twice within 6 months, and 3 times within 1 year.
boolean
C0403397 (UMLS CUI [1])
C0477762 (UMLS CUI [2])
C0032952 (UMLS CUI [3,1])
C3665414 (UMLS CUI [3,2])
C0403398 (UMLS CUI [4])
C0027726 (UMLS CUI [5,1])
C2945760 (UMLS CUI [5,2])
C0439603 (UMLS CUI [5,3])
C0038317 (UMLS CUI [6,1])
C0178602 (UMLS CUI [6,2])
C0205216 (UMLS CUI [6,3])
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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