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Conversion From Tacrolimus to Cyclosporine Microemulsion in Liver Transplant Patients With New Onset Diabetes After the 3rd Month Post-transplant

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Novartis

Status and phase

Completed
Phase 4

Conditions

Maintenance Liver Transplant Patients With New Onset Diabetes

Treatments

Drug: Cyclosporine - cyclosporine microemulsion

Study type

Interventional

Funder types

Industry

Identifiers

NCT00171717
COLO400AFR04

Details and patient eligibility

About

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 goal of the trial is to assess the percentage of patients in whom diabetes will resolve 6 month after conversion from tacrolimus to cyclosporine micro-emulsion as measured by a fasting blood glucose < 1,26 g/l without the need of hypoglycemic treatment.

Enrollment

39 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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