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The Biomarker for Immunosuppressive Agents Metabolism in Chinese Renal Transplant Recipients

NCT ID: NCT01699360

Last Updated: 2012-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Kidney Transplantation

Keywords

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Kidney Transplantation Immunosuppressive Agents Hydrocortisone Cortisone

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cyclosporine A, Tacrolimus, Sirolimus

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.

Group Type EXPERIMENTAL

Cyclosporine A, Tacrolimus, Sirolimus

Intervention Type DRUG

Interventions

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Cyclosporine A, Tacrolimus, Sirolimus

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Central South University

OTHER

Sponsor Role lead

Responsible Party

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Xi Luo

clinical research assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zeneng cheng, doctor

Role: STUDY_DIRECTOR

Central South University

Locations

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The third xiangya hospital, Central South University

Changsha, Hunan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xi Luo, master

Role: CONTACT

Phone: +86 731 2650451

Email: [email protected]

References

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Cai N, Li B, Huang X, Xu K, Feng H, Cheng Z, Zhu L, Zheng L, Luo X. A non-invasive CYP3A4 biomarker and body mass index predict cyclosporine dosage requirements in Chinese renal transplant recipients. Pharmazie. 2015 Dec;70(12):815-8.

Reference Type DERIVED
PMID: 26817280 (View on PubMed)

Other Identifiers

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H3110-81072700

Identifier Type: -

Identifier Source: org_study_id