The Biomarker for Immunosuppressive Agents Metabolism in Chinese Renal Transplant Recipients

Central South University

Status and phase: Unknown; Phase 4

Conditions: Kidney Transplantation

Treatments: Drug: Cyclosporine A, Tacrolimus, Sirolimus

Study type: Interventional

Funder types: Other

Identifiers

NCT01699360

H3110-81072700

Details and patient eligibility

About

The aim of this study is to evaluate the potential of endogenous cortisol and cortisone metabolism as a biomarker for immunosuppressive agents disposition in Chinese renal transplant recipients. If the blood concentrations of immunosuppressants can be predicted successfully, this new probe may take place of current drug monitoring post transplantation.

Full description

Immunosuppressive agents, including cyclosporine A, tacrolimus, and sirolimus, have been widely used to improve the outcome of organ transplantation. The need for frequent and specific monitoring of drug concentrations remains essential, since the therapeutic dosing and pharmacokinetics show great variability among recipients. However, this may be time and cost consuming. Indeed, cyclosporine A, tacrolimus, and sirolimus are all metabolized by CYP3A, consisting with the metabolic characteristic of endogenous cortisol and cortisone. Hence, the present study is designed to determine if the endogenous cortisol and cortisone metabolism can be used as an noninvasive probe for immunosuppressants pharmacokinetics in Chinese renal transplant recipients.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Chinese adult patients who had undergone their first renal transplantation； All patients received an immunosuppressive regimen containing immunosuppressive agents, mycophenolate mofetil, and corticosteroids; All patients had normal liver and renal function.

Exclusion criteria

• an acute rejection episode or infection; multiple organ transplantation; taking any other medications known to interact with immunosuppressive agents, with exception of calcium-channel blockers; abnormal findings on physical examination or laboratory tests.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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600 participants in 1 patient group

Cyclosporine A, Tacrolimus, Sirolimus

Experimental group

Description:

Cyclosporine A：soft capsule,2-6mg/kg/d, the same twice daily dose at least five days. Tacrolimus:capsule,0.15-0.3mg/kg/d, the same twice daily dose at least five days. Sirolimus:tablet,2mg/d, once a day.

Treatment:

Drug: Cyclosporine A, Tacrolimus, Sirolimus