NCT02496494

The Effects of Conversion From Cyclosporine to Tacrolimus on the Changes of Cardiovascular Risk Profiles and Serum Metabolites in Renal Transplant Recipients

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Kyungpook National University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• CYCLOSPORINE/TACROLIMUS

Interventions

Type	Name	Description
DRUG	Tacrolimus	Tacrolimus for maintenance immunosupression in kidney transplant recipients

Timeline

• Start date: 2012-09-01
• Primary completion: 2015-07-01
• Completion: 2015-12-01
• First posted: 2015-07-14
• Last updated: 2015-07-14

Locations

1 site across 1 country: South Korea