Conversion From Tacrolimus to Cyclosporine Microemulsion in Liver Transplant Patients With New Onset Diabetes After the 3rd Month Post-transplant
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00171717|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : February 1, 2011
|Condition or disease||Intervention/treatment||Phase|
|Maintenance Liver Transplant Patients With New Onset Diabetes||Drug: Cyclosporine - cyclosporine microemulsion||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official 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.|
|Study Start Date :||February 2004|
|Actual Primary Completion Date :||December 2005|
|Actual Study Completion Date :||December 2005|
- % of patients whose diabetes resolves 6 months after the conversion (fasting glucose < 1.26 g/L without hypoglycemic treatment).
- % of patients whose diabetes has resolved 1 year after the conversion (fasting glucose < 1.26 g/L without hypoglycemic treatment).
- % of patients treated with insulin and oral ant diabetics and status of the drug doses 6 months and 1 year after the conversion.
- % of patients with HbA1c ≤ 7% 6 months and 1 year after the conversion.
- Blood pressure % of patients with a diastolic value ≥ 90 mmHg, mean systolic and diastolic values,
- % of patients receiving antihypertensive treatment),
- BMI, kidney function (creatinine and creatinine clearance), microalbuminuria, hyperlipidemia, adverse events, serious adverse events, dropouts, at 6 months and at 1 year.
- Incidence of acute and chronic rejection treated at 6 months and at 1 year.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00171717