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The purpose of this study is to evaluate the effects of conversion from cyclosporine to tacrolimus on the changes of cardiovascular risk profiles and serum metabolites in renal transplant recipients.
During the past two decades, cyclosporine has proved to be a valuable immunosuppressive drug that has contributed to a significant reduction in the incidence of acute rejection after kidney transplantation. However, cyclosporine is known as a major factor causing cardiovascular death in kidney transplant recipients. Moreover, cyclosporine has an adverse effect on the lipid profile and fibrinolytic system and result in hypertension and cardiovascular disease. Immunosupressive mechanism of tacrolimus is identical that of cyclosporine but it is 100 times more potent T cell inhibitor than cyclosporine. In multicenter study of Europe and United states, tacrolimus showed low incidence of acute rejection and was known to effective in acute rejection resistant to other therapy. Tacrolimus has a lot of advantages compared to cyclosporine in terms of hypertensive and hyperlipidemic effects although evidences are lacking. One study demonstrated cardiovascular risk profile and renal function has been improved in kidney transplant patients after randomized conversion from cyclosporine to tacrolimus Previous study analyzing metabolites of tacrolimus and cyclosporine revealed that differences were observed in the metabolite level of hypoxanthine, lactate, succinate, and taurine between two immunosupressants. The objective of this study is to evaluate changes in cardiovascular risk profiles and metabolite patterns after conversion from cyclosporine to tacrolimus in kidney transplant recipients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tacrolimus conversion group | Experimental | Cyclosprine was converted to tacrolimus in kidney transplant recipients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tacrolimus | Drug | Tacrolimus for maintenance immunosupression in kidney transplant recipients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Blood Pressure at 6 months | 3 months, 6 months | |
| Change from Baseline in Lipid Profile at 6 months | 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assessing glucose regulation using blood glucose and hemoglobin A1c | 3 months, 6 months | |
| Assessing other metabolic cardiovascular risk factors using fibrinogen, tPA, PAI-I, homocysteine, pro-BNP, hs-CRP, uric acid | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chan-Duck Kim, M.D., PhD | Contact | drcdkim@knu.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Chan-Duck Kim | Kyungpook National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyungpook National University Hospital | Recruiting | Daegu | South Korea |
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| Assessing serum metabolite using ELISA | 3 months, 6 months |
| Assessing renal function using blood urea nitrogen and creatinine | 3 months, 6 months |
| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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