Safety and Efficacy of Converting Maintenance Kidney and Liver Transplant Recipients With Abnormal Glucose Metabolism From Tacrolimus to Cyclosporine Micro-emulsion

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Novartis

Status and phase

Terminated
Phase 4

Conditions

Tacrolimus-associated Abnormal Glucose Metabolism in Kidney and Liver Transplant Recipients

Treatments

Drug: cyclosporine micro-emulsion

Study type

Interventional

Funder types

Industry

Identifiers

NCT00150085
COLO400AUS06

Details and patient eligibility

About

New onset diabetes mellitus (NODM) post- transplantation decreases patient and graft survival. Some immunosuppressive agents are associated with a higher incidence of NODM. This study evaluates the safety and efficacy of converting patients with NODM from tacrolimus to cyclosporine micro-emulsion as a primary immunosuppressant for kidney and liver recipients.

Enrollment

50 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Recipients of first or second cadaveric or living donor kidney transplantation or first cadaveric or living donor liver transplantation
  • Receiving tacrolimus as a primary immunosuppressant
  • Currently on any diabetic agent or meets the American Diabetes Association definition of diabetes mellitus

Exclusion criteria

  • History of treated diabetes mellitus prior to transplantation
  • Less than 2 weeks post-transplantation for kidney and less than 8 weeks for liver
  • Greater than 36 months post-transplantation
  • Onset of diabetes is greater than 12 months prior to time of study entry
  • Has unacceptable or unstable graft function

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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