Status:
COMPLETED
Conversion From Tacrolimus to Cyclosporine Microemulsion in Liver Transplant Patients With New Onset Diabetes After the 3rd Month Post-transplant
Lead Sponsor:
Novartis
Conditions:
Maintenance Liver Transplant Patients With New Onset Diabetes
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
The trial is conducted in patients who have received a liver transplant, were prescribed tacrolimus to prevent organ rejection and developed diabetes from 3 month post-transplantation onwards. The goa...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- \- Patients who have received a first liver transplantation and who are 18 to 70 year old
- Patients who are treated with tacrolimus post-transplant for at least 3 months and for a maximum of 36 months
- Patients without any known diabetes before transplantation and in whom diabetes mellitus was diagnosed for the first time at least 3 months post-transplantation
- Exclusion Criteria
- Re-transplantation or multi-organ transplantation,
- Diabetes before the transplantation,
- Type I diabetes mellitus.
- Other protocol-defined inclusion / exclusion criteria may apply
Exclusion
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00171717
Start Date
February 1 2004
End Date
December 1 2005
Last Update
February 1 2011
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