An open, randomised, multicentre clinical study to uinvestigate the safety and efficacy of steroid withdrawal with tacrolimus, mychopenolate mofetil and daclizumab against tacrolimus, mychopenolate mofetil and steroids in children after kidney transplantation - TWIST-Tacrolimus and WIthdrawal of STeroids

Astellas Pharma GmbH0 sites200 target enrollmentApril 21, 2006

DrugsPROGRAF 100 CPS 0,5 MG ZENAPAX IV 1 FL 5 ML 5 MG/ML CELLCEPT 100 CPS 250 MG

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Astellas Pharma GmbH
Enrollment: 200
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 21, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Astellas Pharma GmbH

Eligibility Criteria

Inclusion Criteria

•1\. Male or female patient younger than 18 but not younger than 2 years of age, regardless of race. 2\. Skeletal age of boys 8804;17, girls 8804;15 years 3\. Patient has end stage kidney disease and is a suitable candidate for primary renal transplantation or re\-transplantation. 4\. Patient is receiving a kidney transplant, from a cadaveric or living donor not HLA identical with compatible AB0 blood type. 5\. Female patient of childbearing potential must have a negative serum pregnancy test prior to enrolment and must agree to practice effective birth control during the study and 6 weeks thereafter. 6\. The patient, or in case the patient is minor, the patients parent s or their legal representative, has been fully informed and has given written informed consent to participate in the study. If the minor is in the position to comprehend the nature, significance and scope of the study and to determine his decision accordingly, then his written consent shall also be required. Witnessed informed consent is accepted in case the patient if not a minor is capable of making the decision but not capable of signing the document.
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) no
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

•1\. Patient has a most recently measured PRA grade of 8805; 50 within the previous six months and/or having a retransplantation due to immunological reason. 2\. Patient is allergic or intolerant to corticosteroids, macrolide antibiotics, tacrolimus, mycophenolate mofetil, mycophenolic acid, daclizumab and/or to the excipients of the study medication. 3\. Patient requires ongoing dosing with corticosteroids. 4\. Patient requires initial sequential or parallel therapy with immunosuppressive antibody preparation s or prohibited medication. 5\. Patient and/or donor is known to be HIV positive. 6\. Patient has significant liver disease, defined as having during the past 28 days continuously elevated AST SGOT and/or ALT SGPT levels greater than 2 times the upper value of the normal range of the investigational site. 7\. Patient with malignancy or history of malignancy except non\-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully. 8\. Patient has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting or active peptic ulcer. 9\. Patient has previously received or is receiving an organ transplant other than kidney. 10\. Patient is participating or has participated in another investigational drug trial or is receiving or has received an investigational drug within the last 28 days before entry into this study. 11\. Patient has been previously enrolled in this study. 12\. Patient with the relapsing and non\-diarrhoeal form of haemolytic uraemic syndrome. 13\. Patient is unlikely to comply with the visits scheduled in the protocol. 14\. Patient has any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may invalidate communication with the investigator 15\. Patient is pregnant or a breast\-feeding mother.