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Completed

NCT Number: NCT00171717

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

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.

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Key information

Conditions

Maintenance Liver Transplant Patients With New Onset Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyclosporine - cyclosporine microemulsion

Drug

Primary outcomes

  1. % of patients whose diabetes resolves 6 months after the conversion (fasting glucose < 1.26 g/L without hypoglycemic treatment).

Secondary outcomes

  1. % of patients whose diabetes has resolved 1 year after the conversion (fasting glucose < 1.26 g/L without hypoglycemic treatment).

  2. % of patients treated with insulin and oral ant diabetics and status of the drug doses 6 months and 1 year after the conversion.

  3. % of patients with HbA1c ≤ 7% 6 months and 1 year after the conversion.

  4. Blood pressure % of patients with a diastolic value ≥ 90 mmHg, mean systolic and diastolic values,

  5. % of patients receiving antihypertensive treatment),

  6. BMI, kidney function (creatinine and creatinine clearance), microalbuminuria, hyperlipidemia, adverse events, serious adverse events, dropouts, at 6 months and at 1 year.

  7. Incidence of acute and chronic rejection treated at 6 months and at 1 year.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Sep 15, 2005
Registry last updated
Feb 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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