Status:
COMPLETED
Pre-transplant Assessment of Tacrolimus Blood Level Concentration, as a Predictor of Tacrolimus Dose Requirements After Kidney Transplantation
Lead Sponsor:
Janssen-Cilag Pty Ltd
Conditions:
Kidney Transplantation
Transplantation
Eligibility:
All Genders
14+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate two groups of kidney transplant recipients, to determine the proportion of patients that achieve therapeutic blood concentrations of tacrolimus by Day 3 after ...
Detailed Description
This study is a multicentre, open-label, prospective, 2-arm, phase IV study of tacrolimus in renal transplant recipients. Patients will be randomized to receive current clinical practice or to have a ...
Eligibility Criteria
Inclusion
- Patient has end-stage kidney disease and is a suitable candidate for primary renal transplantation or re-transplantation
- Patient is receiving a kidney transplant from a cadaveric or living (not HLA identical) donor, at least 10 years of age, with compatible ABO blood type
Exclusion
- Patients receiving a graft from a non-heart-beating donor
- known to have significant liver disease, or is receiving a graft from a hepatitis C or B positive donor
- previously received or is receiving an organ transplant other than a kidney
- taking diltiazem, or any of the other disallowed medications during the 7 days prior to, and the 30 day trial period, or has been taking an investigational drug in the past 28 days
- patient or donor known to be HIV positive
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT00297310
Start Date
May 1 2004
End Date
April 1 2007
Last Update
June 20 2011
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