Status:
COMPLETED
Initial Dosage Range of Tacrolimus by Genotyping in Chinese Renal Transplantation
Lead Sponsor:
The Second Artillery General Hospital
Collaborating Sponsors:
Capital Medical University
Shanghai Changzheng Hospital
Conditions:
Renal Transplantation
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Acute rejection (AR) is the main complication after transplantation, which is a severe risk of chronic rejection and implant devitalization. Tacrolimus (FK506) is an immunosuppressant used for the pr...
Detailed Description
VISITS The participation of the patient in this study will be 3 months. For this period, 9 visits are planned •Before transplantation Visit 1: inclusion visit(in the 4-7 days before transplantation...
Eligibility Criteria
Inclusion
- Patients of renal inadequacy , necessary to receive renal transplantation , male or female , 18 to 65 years old;
- Patients receiving a first isolated renal graft with administration of FK506;
- Patient willing to provide informed consent prior to the specimen collection procedure.
Exclusion
- Patients who received another clinical pharmaceutical study less than 3 months before the entry in this study , and who have already completed or dropped out of this study.
- Patients with contraindications of FK506 in immunosuppressive therapy : being in pregnancy and being allergic or intolerant with FK506 or other macrolides.
- Patients suffering from severe diseases of cardiovascular system (essential hypertension), liver (anamnesis of type B hepatitis , type C hepatitis) , hemopoietic system , nervous system , and psychotics.
- Patients interfered with their blood concentrations of FK506 by administration of cytochrome P4503A4 and P4503A5 enzyme inhibitors , such as lidocaine , midazolam , nicardipine , niludipine , cortisone , itraconazole , fluconazole , ketoconazole , miconazole , clotrimazole ，Bromocriptine and so on.
- Patients having anaemia (hemoglobin lower than 7g/dl).
- Patients Diagnosed DM.
- Patients interfered with their capacity to absorb FK506 by anorexia nervosa , malabsorption syndrome or gastro-intestinal resection according to the viewpoint of the investigators.
- Patients who lacks understanding of the medicinal knowledge of tacrolimus and the risks of the study according to the viewpoint of the investigators.
- Patients with allergic constitution or a history of serious allergy.
- Patients with bad compliance according to viewpoint of the investigators.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT00935298
Start Date
July 1 2009
End Date
June 1 2011
Last Update
December 22 2011
Active Locations (5)
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1
Chaoyang Hospital, affiliated Hospital of Capital Medical University
Beijing, Beijing Municipality, China, 100020
2
General Hospital of Air Force of Chinese PLA
Beijing, Beijing Municipality, China, 100036
3
The Second Artillery Gernal Hospital
Beijing, Beijing Municipality, China, 100088
4
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052