Clinical Trial: Safety and Efficacy of Converting Maintenance Kidney and Liver Transplant Recipients with Abnormal Glucose Metabolism from Tacrolimus to Cyclosporine Micro-Emulsion

This study is no longer recruiting patients.

Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00150085

Purpose

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.
Condition Intervention Phase
Tacrolimus-associated abnormal glucose metabolism in kidney and liver transplant recipients
 Drug: cyclosporine micro-emulsion
Phase IV

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title: A Prospective, Randomized, Open-Label, Twenty-Six Week Study of the Efficacy and Safety of Converting Kidney and Liver Transplant Recipients with Tacrolimus-Associated Abnormal Glucose Metabolism to Cyclosporine Micro-Emulsion with C2 Monitoring

Further Study Details: 

Study start: February 2004

Eligibility

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both
Criteria

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.

Location Information

Study chairs or principal investigators

Novartis,  Study Director,  Novartis   

More Information

Study ID Numbers:  COLO400AUS06
Last Updated:  September 7, 2005
Record first received:  September 6, 2005
ClinicalTrials.gov Identifier:  NCT00150085
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13

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